1 00:00:00,166 --> 00:00:00,199 2 00:00:00,200 --> 00:00:01,200 >> GOOD AFTERNOON, THIS IS 3 00:00:01,200 --> 00:00:02,200 REBECCA WILLIAMS. 4 00:00:02,200 --> 00:00:04,000 I'M THE ASSISTANT DIRECTOR AT 5 00:00:04,000 --> 00:00:05,900 CLINICAL TRIALS.GOV. 6 00:00:05,900 --> 00:00:07,800 AND YOU ARE CURRENTLY LOGGED 7 00:00:07,800 --> 00:00:11,100 INTO OUR FINAL RULE WEBINAR 8 00:00:11,100 --> 00:00:11,333 SERIES. 9 00:00:11,333 --> 00:00:13,499 THIS IS THE SECOND OF 3 PLANNED 10 00:00:13,500 --> 00:00:15,800 WEBINARS THAT WE HAVE, TO WALK 11 00:00:15,800 --> 00:00:18,400 THROUGH VARIOUS REQUIREMENTS OF 12 00:00:18,400 --> 00:00:20,100 THE FINAL RULE. 13 00:00:20,100 --> 00:00:21,900 JUST A FEW HOUSEKEEPING ISSUES 14 00:00:21,900 --> 00:00:24,700 BEFORE I GET STARTED. 15 00:00:24,700 --> 00:00:27,100 WE DO HAVE THE--YOU DO HAVE THE 16 00:00:27,100 --> 00:00:29,866 ABILITY TO ASK QUESTIONS THROUGH 17 00:00:29,866 --> 00:00:37,066 THE Q&A PANEL ON THE WEBINAR 18 00:00:37,066 --> 00:00:37,366 PAGE. 19 00:00:37,366 --> 00:00:38,966 THE KEY IS TO HAVE THE QUESTIONS 20 00:00:38,966 --> 00:00:40,566 ADDRESSED TO ALL PANELISTS. 21 00:00:40,566 --> 00:00:42,066 WE WILL AIM TO ADDRESS QUESTIONS 22 00:00:42,066 --> 00:00:44,866 AT THE END OF THE WEBINAR TODAY 23 00:00:44,866 --> 00:00:46,666 BUT WHAT WE HAVE BEEN DOING IS 24 00:00:46,666 --> 00:00:49,066 ACCUMULATING QUESTIONS AND WE 25 00:00:49,066 --> 00:00:51,466 WILL AIM TO ANSWER THEM AT THE 26 00:00:51,466 --> 00:00:55,666 NEXT WEBINAR OR AT--OR HAVE A 27 00:00:55,666 --> 00:00:56,766 WAY TO ADDRESS THEM ON THE 28 00:00:56,766 --> 00:00:59,766 CLINICAL TRIALS.GOV WEB SITE. 29 00:00:59,766 --> 00:01:01,166 IF YOU DO HAVE QUESTIONS, AFTER 30 00:01:01,166 --> 00:01:03,699 THE WEBINAR, YOU CAN SUBMIT THEM 31 00:01:03,700 --> 00:01:05,700 TO OUR REGULAR E-MAIL ADDRESS 32 00:01:05,700 --> 00:01:08,700 WHICH IS REGISTER 33 00:01:08,700 --> 00:01:13,600 @CLINICALTRIALS .GOV. 34 00:01:13,600 --> 00:01:15,500 AND WITH THAT I THINK THE AUDIO 35 00:01:15,500 --> 00:01:18,400 SOUNDS OKAY, TODAY AND SO ALL OF 36 00:01:18,400 --> 00:01:19,900 THOSE PROBLEMS ARE HOPEFULLY 37 00:01:19,900 --> 00:01:21,500 RESOLVED FROM THE LAST TIME AND 38 00:01:21,500 --> 00:01:23,100 I'LL GO AHEAD AND GET STARTED. 39 00:01:23,100 --> 00:01:24,800 JUST A QUICK OVERVIEW ABOUT THE 40 00:01:24,800 --> 00:01:26,800 WEBINAR SERIES ITSELF. 41 00:01:26,800 --> 00:01:29,433 WE HELD THE FIRST IN THE SERIES 42 00:01:29,433 --> 00:01:31,733 LAST WEEK ON SEPTEMBER27th. 43 00:01:31,733 --> 00:01:34,333 WE DO NOW HAVE THE AUDIO 44 00:01:34,333 --> 00:01:36,966 RECORDINGS AND THE SLIDES 45 00:01:36,966 --> 00:01:38,566 AVAILABLE ON OUR WEB SITE. 46 00:01:38,566 --> 00:01:39,866 YOU CAN SEE THE AT THE BOTTOM OF 47 00:01:39,866 --> 00:01:42,766 THIS PARTICULAR SLIDE, THERE'S A 48 00:01:42,766 --> 00:01:44,066 LINK THAT YOU CAN GO TO TO 49 00:01:44,066 --> 00:01:45,566 ACCESS THAT INFORMATION. 50 00:01:45,566 --> 00:01:46,566 IF YOU'RE FAMILIAR WITH THE 51 00:01:46,566 --> 00:01:49,266 CLINICAL TRIALS.GOV WEB SITE. 52 00:01:49,266 --> 00:01:51,466 YOU WOULD GO TO THE SUBMIT STUDY 53 00:01:51,466 --> 00:01:54,366 SECTION AND THEN THERE'S ANOTHER 54 00:01:54,366 --> 00:01:55,966 SECTION FOR TRAINING MATERIALS 55 00:01:55,966 --> 00:01:58,366 AND THE FINAL RULE WEBINARS ARE 56 00:01:58,366 --> 00:02:00,466 LOCATED UNDER THAT TRAINING 57 00:02:00,466 --> 00:02:02,066 MATERIALS PAGE. 58 00:02:02,066 --> 00:02:04,066 SO YOU CAN ACCESS THOSE WEBINARS 59 00:02:04,066 --> 00:02:06,666 AT ANY TIME. 60 00:02:06,666 --> 00:02:09,699 WITH THIS WEBINAR, WE WILL ALSO 61 00:02:09,700 --> 00:02:11,200 POST IT IN THE SAME PLACE AND WE 62 00:02:11,200 --> 00:02:12,500 WILL DO THE SAME THING FOR THE 63 00:02:12,500 --> 00:02:14,500 SUBSEQUENT WEBINAR. 64 00:02:14,500 --> 00:02:16,100 MOST LIKELY IT WILL TAKE US UP 65 00:02:16,100 --> 00:02:18,700 TO 1 WEEK TO GET THE WEBINARS 66 00:02:18,700 --> 00:02:21,500 POSTED AND YOU CAN CHECK BACK 67 00:02:21,500 --> 00:02:24,200 THEN FOR MORE INFORMATION. 68 00:02:24,200 --> 00:02:26,000 AND SO THE GENERAL SCHEDULE FOR 69 00:02:26,000 --> 00:02:28,033 THE WEBINARS IS THAT WE'RE 70 00:02:28,033 --> 00:02:29,433 AIMING TODAY TO COVER IN MORE 71 00:02:29,433 --> 00:02:31,233 DETAIL, REGISTRATION INFORMATION 72 00:02:31,233 --> 00:02:33,133 REQUIREMENTS AND ALSO SOME 73 00:02:33,133 --> 00:02:35,133 CONTENT RELATED TO UPDATE 74 00:02:35,133 --> 00:02:35,733 REQUIREMENTS. 75 00:02:35,733 --> 00:02:38,033 AND THE NEXT WEBINAR, WILL FOCUS 76 00:02:38,033 --> 00:02:39,733 ON CLINICAL TRIAL RESULTS 77 00:02:39,733 --> 00:02:41,233 INFORMATION AND UPDATE 78 00:02:41,233 --> 00:02:42,866 REQUIREMENTS RELATED TO THAT. 79 00:02:42,866 --> 00:02:44,566 AS WELL AS TALKING A LITTLE BIT 80 00:02:44,566 --> 00:02:45,966 MORE ABOUT THE QUALITY CONTROL 81 00:02:45,966 --> 00:02:48,866 REVIEW PROCEDURES AND 82 00:02:48,866 --> 00:02:50,266 IMPLICATIONS FOR POSTING 83 00:02:50,266 --> 00:02:52,066 SUBMITTED INFORMATION ON 84 00:02:52,066 --> 00:02:55,499 CLINICAL TRIALS.GOV. 85 00:02:55,500 --> 00:02:55,733 CLINICAL TRIALS.GOV. 86 00:02:55,733 --> 00:02:57,933 SO THIS IS JUST A MORE DETAILED 87 00:02:57,933 --> 00:02:59,733 LOOK AT TODAY'S AGENDA. 88 00:02:59,733 --> 00:03:01,233 I WILL PROVIDE AGAIN JUST AN 89 00:03:01,233 --> 00:03:02,433 OVERVIEW OF THE ENVIRONMENTS AND 90 00:03:02,433 --> 00:03:04,633 THE STRUCTURE OF THE FINAL RULE 91 00:03:04,633 --> 00:03:06,733 ITSELF TO ORIENT PEOPLE AGAIN IN 92 00:03:06,733 --> 00:03:09,233 TERMS OF NAVIGATING THE CONTENT 93 00:03:09,233 --> 00:03:10,633 THAT WE HAVE AVAILABLE AND THEN 94 00:03:10,633 --> 00:03:13,533 WE'LL GO INTO A LOT OF THE 95 00:03:13,533 --> 00:03:18,166 BASICS RELATED TO CLINICAL 96 00:03:18,166 --> 00:03:19,866 TRIALS INFORMATION IN TERMS OF 97 00:03:19,866 --> 00:03:22,366 WHO HAS TO DO IT, WHAT TRIALS 98 00:03:22,366 --> 00:03:24,166 MUST BE REGISTERED, WHAT MUST BE 99 00:03:24,166 --> 00:03:26,066 SUBMITTED, AND THEN WHEN MUST 100 00:03:26,066 --> 00:03:28,699 THAT INFORMATION BE UPDATED. 101 00:03:28,700 --> 00:03:30,400 AS WAS THE LAST WEBINAR, I'LL 102 00:03:30,400 --> 00:03:32,600 MOSTLY BE FOCUSING ON THE NEW 103 00:03:32,600 --> 00:03:36,500 REQUIREMENTS THAT WILL BE PLACED 104 00:03:36,500 --> 00:03:37,900 ON THE FINAL RULE AND I'LL AIM 105 00:03:37,900 --> 00:03:39,600 TO BE VERY CLEAR ABOUT 106 00:03:39,600 --> 00:03:41,900 DISTINGUISHING BETWEEN FINAL 107 00:03:41,900 --> 00:03:43,700 RULE REQUIREMENTS VERSUS THINGS 108 00:03:43,700 --> 00:03:45,200 THAT WERE REQUIRED UNDER THE 109 00:03:45,200 --> 00:03:47,533 STATUTE. 110 00:03:47,533 --> 00:03:49,933 AND SO HOPEFULLY, ALL OF THAT 111 00:03:49,933 --> 00:03:52,233 WILL SEEM STRAIGHT FORWARD. 112 00:03:52,233 --> 00:03:54,033 SO IN TERMS OF OVERVIEW, I WANT 113 00:03:54,033 --> 00:03:56,033 TO REMIND PEOPLE THAT 1 OF THE 114 00:03:56,033 --> 00:03:57,633 ITEMS MADE AVAILABLE WILL BE 115 00:03:57,633 --> 00:03:58,933 AVAILABLE WHEN WE PUBLISHED THE 116 00:03:58,933 --> 00:04:00,133 FINAL RULE WAS THE ARTICLE IN 117 00:04:00,133 --> 00:04:01,633 THE NEW ENGLAND JOURNAL OF 118 00:04:01,633 --> 00:04:03,233 MEDICINE THAT HAD A HIGH LEVEL 119 00:04:03,233 --> 00:04:04,833 OVERVIEW OF THE FINAL RULE 120 00:04:04,833 --> 00:04:08,033 ITSELF, WITH THE SUMMARY OF MANY 121 00:04:08,033 --> 00:04:09,933 OF THE KEY ISSUES. 122 00:04:09,933 --> 00:04:11,333 THIS ARTICLE, I THINK IS 123 00:04:11,333 --> 00:04:12,733 PROBABLY USEFUL WHEN 124 00:04:12,733 --> 00:04:16,333 COMMUNICATING WITH INVESTIGATORS 125 00:04:16,333 --> 00:04:18,133 AND OTHERS WITHIN YOUR OWN 126 00:04:18,133 --> 00:04:20,833 INSTITUTION OR JUST OTHER PEOPLE 127 00:04:20,833 --> 00:04:21,866 LOOKING FOR GENERAL KNOWLEDGE 128 00:04:21,866 --> 00:04:23,366 ABOUT THE FINAL RULE ITSELF, AS 129 00:04:23,366 --> 00:04:26,266 WITH EVERYTHING, YOU KNOW IT'S 130 00:04:26,266 --> 00:04:27,999 COMPLICATED SO TO GET A LOT OF 131 00:04:28,000 --> 00:04:30,600 DETAILS, YOU ACTUALLY HAVE TO 132 00:04:30,600 --> 00:04:32,000 DELVE INTO THE CONTENT OF THE 133 00:04:32,000 --> 00:04:34,200 FINAL RULE AND THAT'S WHAT WE'RE 134 00:04:34,200 --> 00:04:35,600 AIMING TO DO HERE OVER THE 135 00:04:35,600 --> 00:04:37,000 COURSE OF THESE WEBINARS. 136 00:04:37,000 --> 00:04:38,900 SO JUST TO A REMINDER THAT IN 137 00:04:38,900 --> 00:04:39,900 TERMS OF THE WAY THAT THE 138 00:04:39,900 --> 00:04:41,700 REGULATIONS THEMSELVES ARE 139 00:04:41,700 --> 00:04:45,600 STRUCTURED IT'S SEGMENTED INTO 140 00:04:45,600 --> 00:04:47,200 DIFFERENT SUBPARTS, WHAT WE'RE 141 00:04:47,200 --> 00:04:49,300 GOING TO BE FOCUSING ON TODAY, 142 00:04:49,300 --> 00:04:51,600 IF YOU HAVE COLORS DISPLAYING OR 143 00:04:51,600 --> 00:04:53,500 HIGHLIGHTED IN RED, BUT 144 00:04:53,500 --> 00:04:56,333 BASICALLY WE'RE FOCUSING ON TO 145 00:04:56,333 --> 00:04:59,033 WHOM DO THESE REGULATIONS APPLY 146 00:04:59,033 --> 00:05:00,833 MEANING THE RESPONSIBILITY PARTY 147 00:05:00,833 --> 00:05:02,433 AND THEN WHAT DEFINITIONS ARE 148 00:05:02,433 --> 00:05:05,533 RELEVANT AS WELL AS MORE DETAILS 149 00:05:05,533 --> 00:05:07,533 ABOUT WHICH INFORMATION MUST BE 150 00:05:07,533 --> 00:05:09,833 SUBMITTED FOR REGISTRATION AND 151 00:05:09,833 --> 00:05:16,533 WHEN IT MUST BE SUBMITTED. 152 00:05:16,533 --> 00:05:18,733 IT IS OTHER PART, SUBPART C 153 00:05:18,733 --> 00:05:19,833 FOCUSES ON INFORMATION AND 154 00:05:19,833 --> 00:05:21,433 THAT'S GOING TO BE THE FOCUS OF 155 00:05:21,433 --> 00:05:24,033 THE NEXT WEBINAR, SUBPART D IS 156 00:05:24,033 --> 00:05:25,433 WHERE YOU FIND INFORMATION IN 157 00:05:25,433 --> 00:05:27,333 SECTION 1164 ON UPDATE 158 00:05:27,333 --> 00:05:27,733 REQUIREMENTS. 159 00:05:27,733 --> 00:05:29,666 SO I'LL BE TALKING ABOUT UPDATE 160 00:05:29,666 --> 00:05:31,066 REQUIREMENTS TODAY IN THE 161 00:05:31,066 --> 00:05:33,266 CONTEXT OF REGISTRATION 162 00:05:33,266 --> 00:05:37,566 INFORMATION. 163 00:05:37,566 --> 00:05:39,166 AND SO GENERALLY SPEAKING IN 164 00:05:39,166 --> 00:05:40,066 TERMS OF THE GENERAL 165 00:05:40,066 --> 00:05:41,466 REQUIREMENTS, IN THE FINAL RULE 166 00:05:41,466 --> 00:05:42,766 AND ACTUALLY REALLY UNDER THE 167 00:05:42,766 --> 00:05:44,866 STATUTE, IT'S BASICALLY THE 168 00:05:44,866 --> 00:05:45,166 SAME. 169 00:05:45,166 --> 00:05:46,866 THERE'S A FEW KEY TERMS THAT YOU 170 00:05:46,866 --> 00:05:48,466 NEED TO BE AWARE OF THAT REALLY 171 00:05:48,466 --> 00:05:50,766 DICTATE WHEN CERTAIN INFORMATION 172 00:05:50,766 --> 00:05:52,766 AND WHICH INFORMATION MUST BE 173 00:05:52,766 --> 00:05:53,566 SUBMITTED. 174 00:05:53,566 --> 00:05:54,766 SO GENERALLY SPEAKING IT'S 175 00:05:54,766 --> 00:05:56,966 ALWAYS THE RESPONSIBLE PARTY 176 00:05:56,966 --> 00:05:58,166 THAT IS RESPONSIBLE FOR 177 00:05:58,166 --> 00:06:00,666 SUBMITTING INFORMATION AND WHAT 178 00:06:00,666 --> 00:06:04,099 WE'RE FOCUSING ON ARE APPLICABLE 179 00:06:04,100 --> 00:06:04,900 CLINICAL TRIALS. 180 00:06:04,900 --> 00:06:07,600 SO THE RESPONSIBLE PARTY FOR AN 181 00:06:07,600 --> 00:06:09,300 APPLICABLE TRIAL, MUST FIRST 182 00:06:09,300 --> 00:06:10,300 REGISTER THAT TRIAL WITH 183 00:06:10,300 --> 00:06:13,000 CLINICAL TRIALS.GOV AND THERE'S 184 00:06:13,000 --> 00:06:14,600 A DEADLINE ASSOCIATED WITH THAT, 185 00:06:14,600 --> 00:06:16,300 THAT SHOULD BE NO LATER THAN 21 186 00:06:16,300 --> 00:06:18,300 DAYS AFTER THE ENROLLMENT OF THE 187 00:06:18,300 --> 00:06:20,300 FIRST PARTICIPANT. 188 00:06:20,300 --> 00:06:21,800 THAT'S PRETTY MUCH THE SAME AS 189 00:06:21,800 --> 00:06:24,700 WHAT'S DESCRIBED IN THE STATUTE. 190 00:06:24,700 --> 00:06:26,000 INFORMATION MUST BE UPDATE 191 00:06:26,000 --> 00:06:27,433 OFFICE OF DIVERSITY CLINICAL 192 00:06:27,433 --> 00:06:30,233 TRIALS.GOV FOR THAT REGISTRATION 193 00:06:30,233 --> 00:06:31,933 INFORMATION AT LEAST ONCE EVERY 194 00:06:31,933 --> 00:06:33,833 12 MONTHS WITH SOME ITEMS 195 00:06:33,833 --> 00:06:39,466 REQUIRING A MORE FREQUENT UPDATE 196 00:06:39,466 --> 00:06:40,866 THAT THAT INFORMATION NEEDS TO 197 00:06:40,866 --> 00:06:43,066 BE UPDATED WITHIN 15 OR 30 DAYS 198 00:06:43,066 --> 00:06:45,166 OF A CHANGE AND WE WILL GO INTO 199 00:06:45,166 --> 00:06:47,266 MORE DETAIL ABOUT WHICH ELEMENTS 200 00:06:47,266 --> 00:06:50,166 ARE SUBJECT TO THOSE 30 DAY 201 00:06:50,166 --> 00:06:52,466 REQUIREMENTS. 202 00:06:52,466 --> 00:06:54,466 THEN FINALLY THE LAST 203 00:06:54,466 --> 00:06:56,066 REQUIREMENT IS TO SUBMIT SUMMARY 204 00:06:56,066 --> 00:06:57,266 RESULTS INFORMATION WHICH 205 00:06:57,266 --> 00:06:59,866 INCLUDES ADVERSE EVENTS 206 00:06:59,866 --> 00:07:02,066 INFORMATION NO LATER THAN 1 YEAR 207 00:07:02,066 --> 00:07:05,366 AFTER THE TRIAL COMPLETION DATE 208 00:07:05,366 --> 00:07:07,566 WITH DELAYS ALLOWED IN CERTAIN 209 00:07:07,566 --> 00:07:08,699 CIRCUMSTANCES SO AGAIN TO 210 00:07:08,700 --> 00:07:10,500 REITERATE WHAT WE'RE FOCUSING ON 211 00:07:10,500 --> 00:07:13,100 TODAY ARE REALLY THOSE FIRST 2 212 00:07:13,100 --> 00:07:17,300 SUBBULLETS IN TERMS OF 213 00:07:17,300 --> 00:07:18,300 REGISTRATION AND REQUIREMENTS. 214 00:07:18,300 --> 00:07:20,100 SO GENERALLY SPEAKING THE 215 00:07:20,100 --> 00:07:22,500 REGULATIONS OUTLINE WHO IT IS 216 00:07:22,500 --> 00:07:24,900 THAT MUST SUBMIT CLINICAL TRIAL 217 00:07:24,900 --> 00:07:26,100 REGISTRATION INFORMATION TO 218 00:07:26,100 --> 00:07:27,633 CLINICAL TRIALS.GOV. 219 00:07:27,633 --> 00:07:30,533 AND WITHIN THE REGULATIONS 220 00:07:30,533 --> 00:07:31,733 THEMSELVES, THERE'S ACTUALLY 2 221 00:07:31,733 --> 00:07:33,333 SECTIONINGS THAT ARE RELEVANT 222 00:07:33,333 --> 00:07:34,933 FOR UNDERSTANDING THESE 223 00:07:34,933 --> 00:07:37,533 REQUIREMENTS. 224 00:07:37,533 --> 00:07:40,633 AND 11.4, WHERE IT HAS A LOT OF 225 00:07:40,633 --> 00:07:42,966 DETAILS ABOUT WHO THIS PART 226 00:07:42,966 --> 00:07:44,166 APPLIES TO. 227 00:07:44,166 --> 00:07:47,366 AND THEN IN SECTION 11.20, IT 228 00:07:47,366 --> 00:07:49,466 REITERATES WHO IT IS THAT MUST 229 00:07:49,466 --> 00:07:51,366 SUBMIT CLINICAL TRIAL 230 00:07:51,366 --> 00:07:52,866 REGISTRATION INFORMATION AND AS 231 00:07:52,866 --> 00:07:55,266 I MENTIONED THE PREVIOUS SLIDE, 232 00:07:55,266 --> 00:07:56,866 THE KEY TERM THAT'S IMPORTANT TO 233 00:07:56,866 --> 00:07:58,566 UNDERSTAND IS THE RESPONSIBLE 234 00:07:58,566 --> 00:07:58,966 PARTY. 235 00:07:58,966 --> 00:08:00,866 IT'S THE RESPONSIBLE PARTY WHO 236 00:08:00,866 --> 00:08:03,566 MUST PUB MITT CLINICAL TRIAL 237 00:08:03,566 --> 00:08:08,266 INFORMATION. 238 00:08:08,266 --> 00:08:10,966 THERE'S ONLY 1 RESPONSIBLE PARTY 239 00:08:10,966 --> 00:08:13,666 AND ONLY 1 AND THAT'S CLARIFIED 240 00:08:13,666 --> 00:08:21,999 BOTH OF THE FINAL RULE ITSELF. 241 00:08:22,000 --> 00:08:24,300 IT'S CONSIDERED THE RESPONSIBLE 242 00:08:24,300 --> 00:08:26,000 PARTY UNLESS THAT SPANSOR HAS 243 00:08:26,000 --> 00:08:27,933 DESIGNATED A PRINCIPLE 244 00:08:27,933 --> 00:08:29,133 INVESTIGATOR TO BE THE 245 00:08:29,133 --> 00:08:30,733 RESPONSIBLE PARTY IS THERE'S 246 00:08:30,733 --> 00:08:32,733 CRITERIA ASSOCIATED WITH THAT. 247 00:08:32,733 --> 00:08:35,033 AND SO, THEN, IN TERMS OF 248 00:08:35,033 --> 00:08:37,433 FIGURING OUT WHO IS--WHO IS THE 249 00:08:37,433 --> 00:08:38,533 RESPONSIBLE PARTY, THE FIRST 250 00:08:38,533 --> 00:08:39,633 THING YOU HAVE TO FIGURE OUT IS 251 00:08:39,633 --> 00:08:40,633 WHO WOULD BE CONSIDERED THE 252 00:08:40,633 --> 00:08:44,433 SPONSOR. 253 00:08:44,433 --> 00:08:46,033 SO EACH APPLICABLE CLINICAL 254 00:08:46,033 --> 00:08:47,633 TRIAL MUST HAVE 1 SPONSOR AND 255 00:08:47,633 --> 00:08:50,366 IT'S OUTLINED IN SECTION 11.4 IN 256 00:08:50,366 --> 00:08:51,166 THIS WAY. 257 00:08:51,166 --> 00:08:52,566 AND IT'S VERY SIMILAR TO 258 00:08:52,566 --> 00:08:54,266 ACTUALLY HOW THIS HAS BEEN 259 00:08:54,266 --> 00:08:56,366 DEFINED PRIOR TO THE FINAL RULE, 260 00:08:56,366 --> 00:08:57,666 SO THIS SHOULD ALL SEEM 261 00:08:57,666 --> 00:09:00,166 RELATIVELY FAMILIAR IF YOU'RE 262 00:09:00,166 --> 00:09:02,566 ALREADY FAMILIAR WITH THE 263 00:09:02,566 --> 00:09:03,666 STATUTE ITSELF. 264 00:09:03,666 --> 00:09:05,166 SO WHAT IT'S BASICALLY SAYING IS 265 00:09:05,166 --> 00:09:08,466 THAT IF THE CLINICAL TRIAL IS 266 00:09:08,466 --> 00:09:10,866 BEING CONDUCTED UNDER AN IND AND 267 00:09:10,866 --> 00:09:13,766 THE IDE, THEN THE IND OR IDE 268 00:09:13,766 --> 00:09:15,166 HOLDER WOULD BE CONSIDERED THE 269 00:09:15,166 --> 00:09:17,566 SPONSOR FOR THAT CLINICAL TRIAL. 270 00:09:17,566 --> 00:09:18,566 HOWEVER, THERE ARE MANY 271 00:09:18,566 --> 00:09:19,566 CIRCUMSTANCES IN WHICH A 272 00:09:19,566 --> 00:09:21,499 CLINICAL TRIAL MAY NOT BE 273 00:09:21,500 --> 00:09:23,700 CONDUCTED UNDER AN IND OR AN 274 00:09:23,700 --> 00:09:25,900 IDE, SO YOU NEED ANOTHER 275 00:09:25,900 --> 00:09:28,133 CRITERIA TO DETERMINE WHO IT IS 276 00:09:28,133 --> 00:09:30,633 THAT WOULD BE RESPONSIBLE. 277 00:09:30,633 --> 00:09:32,533 THE THING THAT IS STATED IS THAT 278 00:09:32,533 --> 00:09:34,033 IT'S AGAIN A SINGLE PERSON 279 00:09:34,033 --> 00:09:36,133 ORANTITY, SO IT MUST BE AN 280 00:09:36,133 --> 00:09:38,433 INDIVIDUAL OR AN ORGANIZATION 281 00:09:38,433 --> 00:09:40,633 WHO IS CONSIDERED TO HAVE 282 00:09:40,633 --> 00:09:43,033 INITIATED THE TRIAL AND THEN 283 00:09:43,033 --> 00:09:44,933 THERE'S SOME ELABORATION ABOUT 284 00:09:44,933 --> 00:09:46,233 WHAT THAT MEANS IN TERMS OF 285 00:09:46,233 --> 00:09:49,033 PREPARING OR PLANNING THE TRIAL, 286 00:09:49,033 --> 00:09:50,133 HAVING AUTHORITY AND CONTROL 287 00:09:50,133 --> 00:09:52,433 OVER THE TRIAL ITSELF THAT IN 288 00:09:52,433 --> 00:09:54,533 THAT CASE, WHOEVER IT IS, THAT 289 00:09:54,533 --> 00:09:56,266 MEETS THOSE CRITERIA, WOULD BE 290 00:09:56,266 --> 00:10:02,066 CONSIDERED THE SPONSOR. 291 00:10:02,066 --> 00:10:04,666 AND FURTHER ARTICULATED WE 292 00:10:04,666 --> 00:10:06,266 INDICATED THAT THE SPONSOR IN 293 00:10:06,266 --> 00:10:08,366 TURN MAY DESIGNATE A PRINCIPLE 294 00:10:08,366 --> 00:10:09,766 INVESTIGATOR TO BE THE 295 00:10:09,766 --> 00:10:10,266 RESPONSIBLE PARTY. 296 00:10:10,266 --> 00:10:13,366 A KEY ASPECT OF THE FINAL RULE, 297 00:10:13,366 --> 00:10:14,966 AND THIS IS ALSO REFLECTED IN 298 00:10:14,966 --> 00:10:17,266 THE STATUTE IS THAT THE 299 00:10:17,266 --> 00:10:18,966 PRINCIPLE INVESTIGATOR MUST BE 300 00:10:18,966 --> 00:10:21,066 ABLE TO MEET CERTAIN 301 00:10:21,066 --> 00:10:22,866 REQUIREMENTS TO BE ELIGIBLE TO 302 00:10:22,866 --> 00:10:33,632 BE THE RESPONSIBLE PARTY. 303 00:10:33,633 --> 00:10:35,933 SO THAT IS ACCESS OR CONTROL 304 00:10:35,933 --> 00:10:37,833 OVER THE DATA AND BE ABLE TO 305 00:10:37,833 --> 00:10:39,733 PUBLISH THE TRIAL AND HAVE THE 306 00:10:39,733 --> 00:10:40,733 ABILITY TO MEET ALL THE 307 00:10:40,733 --> 00:10:41,933 REQUIREMENTS FOR SUBMITTING AND 308 00:10:41,933 --> 00:10:44,133 UPDATING CLINICAL TRIAL 309 00:10:44,133 --> 00:10:47,333 INFORMATION AS DESCRIBED IN THE 310 00:10:47,333 --> 00:10:57,733 REGULATIONS ITSELF. 311 00:10:57,733 --> 00:11:00,633 IT FURLER DESCRIBES HOW THE 312 00:11:00,633 --> 00:11:01,866 PRINCIPLE INVESTIGATOR CAN BE 313 00:11:01,866 --> 00:11:02,666 PART OF THE PARTY. 314 00:11:02,666 --> 00:11:04,266 IT STATES THAT THE SPONSOR MUST 315 00:11:04,266 --> 00:11:06,066 OBTAIN FROM THE PRINCIPLE 316 00:11:06,066 --> 00:11:07,366 INVESTIGATOR AN ACKNOWLEDGMENT 317 00:11:07,366 --> 00:11:11,266 OF THOSE RESPONSIBLE, OF THOSE 318 00:11:11,266 --> 00:11:12,266 RESPONSIBILITIES AS THE 319 00:11:12,266 --> 00:11:14,666 RESPONSIBLE PARTY AND THAT THE 320 00:11:14,666 --> 00:11:16,666 PI MUST ALSO ACKNOWLEDGE THAT 321 00:11:16,666 --> 00:11:19,766 DESIGNATION IN A FORMAT WE 322 00:11:19,766 --> 00:11:20,466 SPECIFIED. 323 00:11:20,466 --> 00:11:22,466 IN THE PREAMBLE ITSELF, WE GO 324 00:11:22,466 --> 00:11:25,066 INTO MORE DETAIL ABOUT THIS, AND 325 00:11:25,066 --> 00:11:26,566 TALK ABOUT CURRENT PRACTICE 326 00:11:26,566 --> 00:11:29,799 WITHIN CLINICAL TRIALS.GOV FOR 327 00:11:29,800 --> 00:11:33,500 DESIGNATING THE PI AS THE 328 00:11:33,500 --> 00:11:34,800 RESPONSIBLE PARTY, CURRENTLY 329 00:11:34,800 --> 00:11:36,933 WITHIN THE PRS, THE MECHANISM BY 330 00:11:36,933 --> 00:11:42,533 WHICH THIS HAPPENS IS THAT THE 331 00:11:42,533 --> 00:11:43,933 PRINCIPLE INVESTIGATOR WILL BE 332 00:11:43,933 --> 00:11:46,533 GIVEN ACCESS TO SPONSORS 333 00:11:46,533 --> 00:11:48,333 ORGANIZATION ACCOUNT WITHIN THE 334 00:11:48,333 --> 00:11:54,533 PRS AND GIVE THEM ACCESS AND THE 335 00:11:54,533 --> 00:11:56,033 INVESTIGATOR WOULD BE IDENTIFIED 336 00:11:56,033 --> 00:11:57,933 IN THE DATA PARTY ELEMENT AS 337 00:11:57,933 --> 00:11:59,833 BEING THE RESPONSIBLE PARTY AND 338 00:11:59,833 --> 00:12:01,733 THAT PI WOULD THEN BE 339 00:12:01,733 --> 00:12:04,233 RESPONSIBLE FOR RELEASING OR 340 00:12:04,233 --> 00:12:06,133 SUBMITTING THE RECORD THROUGH 341 00:12:06,133 --> 00:12:08,966 THE PRS, TO CLINICAL TRIALS.G 342 00:12:08,966 --> 00:12:09,566 OV. 343 00:12:09,566 --> 00:12:12,266 AND THE PREAMBLE FURTHER 344 00:12:12,266 --> 00:12:14,766 REITERATES THAT WE INTEND TO 345 00:12:14,766 --> 00:12:16,466 CONTINUE THAT APPROACH AND TO 346 00:12:16,466 --> 00:12:17,466 CONTINUE TO SUPPORT THAT 347 00:12:17,466 --> 00:12:20,966 MECHANISM FOR DESIGNATION WITHIN 348 00:12:20,966 --> 00:12:30,899 THE PRS ITSELF. 349 00:12:30,900 --> 00:12:35,600 THE REGULATIONS DISCUSS WHETHER 350 00:12:35,600 --> 00:12:43,233 IT'S NECESSARY TO PULL THE 351 00:12:43,233 --> 00:12:45,933 REQUIREMENTS AND IF THEY CAN'T 352 00:12:45,933 --> 00:12:47,133 MEET THE REQUIREMENTS, THE 353 00:12:47,133 --> 00:12:50,733 SPONSOR MUST WITHDRAW THE 354 00:12:50,733 --> 00:12:51,733 DESIGNATION. 355 00:12:51,733 --> 00:12:53,333 THE SPONSOR IN THAT RESPONSIBLE 356 00:12:53,333 --> 00:12:55,433 PARTY DATA ELEMENT FIELD WOULD 357 00:12:55,433 --> 00:12:57,333 BE ABLE TO CHANGE THE 358 00:12:57,333 --> 00:13:00,133 DESIGNATION FROM PI BACK TO 359 00:13:00,133 --> 00:13:00,633 SPONSOR. 360 00:13:00,633 --> 00:13:02,133 AND THE SPONSOR WOULD HAVE THE 361 00:13:02,133 --> 00:13:04,633 RESPONSIBILITY OF RELEASING OR 362 00:13:04,633 --> 00:13:06,133 SUBMITTING THAT RECORD TO 363 00:13:06,133 --> 00:13:08,533 CLINICAL TRIALS.GOV. 364 00:13:08,533 --> 00:13:10,233 SO THOSE METHODS ARE AGAIN 365 00:13:10,233 --> 00:13:15,466 DESCRIBED IN THE PREAMBLE OF 366 00:13:15,466 --> 00:13:15,932 THIS SECTION FOR THE FINAL RULE. 367 00:13:15,933 --> 00:13:16,466 THIS SECTION FOR THE FINAL RULE. 368 00:13:16,466 --> 00:13:17,866 SO THAT GENERALLY COVERS WHO IT 369 00:13:17,866 --> 00:13:19,366 IS THAT'S RESPONSIBLE FOR 370 00:13:19,366 --> 00:13:21,466 REGISTERING AN APPLICABLE 371 00:13:21,466 --> 00:13:22,966 CLINICAL TRIAL AND I THINK IT'S 372 00:13:22,966 --> 00:13:23,999 JUST REALLY IMPORTANT TO 373 00:13:24,000 --> 00:13:26,100 REITERATE THAT AT THE OUTSET OF 374 00:13:26,100 --> 00:13:27,700 A CLINICAL TRIAL, ESPECIALLY A 375 00:13:27,700 --> 00:13:30,500 MULTISITE CLINICAL TRIAL THAT 376 00:13:30,500 --> 00:13:31,500 MIGHT HAVE MANY DIFFERENT 377 00:13:31,500 --> 00:13:33,100 ORGANIZATIONS INVOLVED AND MANY 378 00:13:33,100 --> 00:13:34,200 DIFFERENT PARTIES INVOLVED THAT 379 00:13:34,200 --> 00:13:36,100 IT'S ESPECIALLY IMPORTANT TO 380 00:13:36,100 --> 00:13:39,200 MAKE CLEAR WITHIN--WITHIN ANY 381 00:13:39,200 --> 00:13:41,600 CONSTRUCTING THAT EXISTS FOR THE 382 00:13:41,600 --> 00:13:43,000 TRIAL, WHO IT IS THAT HAS 383 00:13:43,000 --> 00:13:46,033 THAT--WHO HAS THAT RESPONSIBLE 384 00:13:46,033 --> 00:13:49,233 PARTY, RESPONSIBILITY SO THAT 385 00:13:49,233 --> 00:13:50,833 IT'S CLEAR TO EVERYONE WHO WILL 386 00:13:50,833 --> 00:13:52,533 BE MANAGING THIS AND IN SOME 387 00:13:52,533 --> 00:13:54,733 CASES, IT WILL BE DICTATED 388 00:13:54,733 --> 00:13:57,633 BASICALLY BY WHO THE IND OR IDE 389 00:13:57,633 --> 00:13:59,333 HOLDER IS, OR THERE NEEDS TO BE 390 00:13:59,333 --> 00:14:01,033 CLEAR EVALUATION OF WHO IT WAS 391 00:14:01,033 --> 00:14:02,433 THAT WAS CONSIDERED TO HAVE 392 00:14:02,433 --> 00:14:05,299 INITIATED THAT CLINICAL TRIAL. 393 00:14:05,300 --> 00:14:07,100 INITIATED THAT CLINICAL TRIAL. 394 00:14:07,100 --> 00:14:08,500 SO THEN IN TERMS OF WHICH 395 00:14:08,500 --> 00:14:10,300 APPLICABLE TRIALS MUST BE 396 00:14:10,300 --> 00:14:11,900 REGISTERED THIS, IS AGAIN 397 00:14:11,900 --> 00:14:13,100 FURTHER DEFINED WITHIN 398 00:14:13,100 --> 00:14:14,400 REGULATIONS. 399 00:14:14,400 --> 00:14:15,600 THERE'S A COUPLE PLACES WHERE 400 00:14:15,600 --> 00:14:17,100 THIS COMES INTO PLAY, THERE'S 401 00:14:17,100 --> 00:14:19,033 THE DEFINITION SECTION OF THE 402 00:14:19,033 --> 00:14:22,233 REGULATIONS WHICH IS 11.10. 403 00:14:22,233 --> 00:14:26,166 THIS IS 11.10A, THE DEFINITION 404 00:14:26,166 --> 00:14:28,366 IS A APPLICABLE TRIAL AND 2 405 00:14:28,366 --> 00:14:30,066 TYPES OF APPLICABLE CLINICAL 406 00:14:30,066 --> 00:14:31,966 TRIALS ARE DEFINED SO THERE'S 407 00:14:31,966 --> 00:14:34,066 APPLICABLE DRUG CLINICAL TRIAL 408 00:14:34,066 --> 00:14:38,866 AND APPLICABLE DEVICE CLINICAL 409 00:14:38,866 --> 00:14:39,366 TRIAL. 410 00:14:39,366 --> 00:14:42,566 I'VE INCLUDED THE EXAMPLE OF 411 00:14:42,566 --> 00:14:44,066 DRUG APPLICABLE TRIAL AND YOU 412 00:14:44,066 --> 00:14:45,766 CAN SEE THERE'S MULTIPLE 413 00:14:45,766 --> 00:14:47,766 COMPONENTS TO UNDERSTANDING WHAT 414 00:14:47,766 --> 00:14:50,066 IT IS THAT'S CONSIDERED TO BE AN 415 00:14:50,066 --> 00:14:52,499 APPLICABLE DRUG TRIAL. 416 00:14:52,500 --> 00:14:54,200 ONE IT'S A CONTROL CLINICAL 417 00:14:54,200 --> 00:14:56,400 INVESTIGATION, OTHER THAN A 418 00:14:56,400 --> 00:14:58,300 PHASE 1 CLINICAL INVESTIGATION 419 00:14:58,300 --> 00:15:00,500 THAT HAS TO BE A DRUG PRODUCT 420 00:15:00,500 --> 00:15:03,500 THAT'S SUBJECT TO SECTION 505 OF 421 00:15:03,500 --> 00:15:05,300 THE FEDERAL FOOD, DRUG AND 422 00:15:05,300 --> 00:15:07,400 COSMETICS ACT AND THEN THERE'S 423 00:15:07,400 --> 00:15:09,400 FURTHER ELABORATION OF THE 424 00:15:09,400 --> 00:15:10,800 MEANINGS OF CLINICAL 425 00:15:10,800 --> 00:15:13,500 INVESTIGATION AND PHASE 1 IN 426 00:15:13,500 --> 00:15:15,700 RELATIONSHIP TO FDA REGULATIONS 427 00:15:15,700 --> 00:15:22,600 THAT COVER THE SAME TOPICS. 428 00:15:22,600 --> 00:15:25,333 IN RECOGNITION OF COMPLEXITY OF 429 00:15:25,333 --> 00:15:26,433 VARIOUS ASPECTS OF THIS 430 00:15:26,433 --> 00:15:28,433 DEFINITION, ANOTHER SECTION OF 431 00:15:28,433 --> 00:15:32,433 THE REGULATIONS FOCUSES ON HOW 1 432 00:15:32,433 --> 00:15:36,633 WOULD DETERMINE WHETHER OR NOT A 433 00:15:36,633 --> 00:15:37,933 PARTICULAR STUDY IS AN 434 00:15:37,933 --> 00:15:39,333 APPLICABLE CLINICAL TRIAL AND 435 00:15:39,333 --> 00:15:40,833 WOULD BE CONSISTENT WITH THIS 436 00:15:40,833 --> 00:15:48,333 DEFINITION THAT YOU SEE HERE. 437 00:15:48,333 --> 00:15:50,533 SO THAT'S WHAT'S DESCRIBED IN 438 00:15:50,533 --> 00:15:53,033 SECTION 122, FROM'S AN 439 00:15:53,033 --> 00:15:54,733 EXPLANATION OF HOW 1 WOULD 440 00:15:54,733 --> 00:15:57,233 DETERMINE AN APPLICABLE CLINICAL 441 00:15:57,233 --> 00:15:59,566 TRIAL WHETHER IT WAS INITIATED 442 00:15:59,566 --> 00:16:03,066 ON OVER AFTER JANUARY18, 2017. 443 00:16:03,066 --> 00:16:05,366 IF YOU HAD READ THE FIRST 444 00:16:05,366 --> 00:16:07,166 WEBINAR OR READ THE RULES IN 445 00:16:07,166 --> 00:16:09,466 DETAIL, YOU RECOGNIZE JANUARY18 446 00:16:09,466 --> 00:16:10,666 AS THE EFFECTIVE DATE OF THE 447 00:16:10,666 --> 00:16:12,366 REGULATIONS AND SO THAT'S WHY, 448 00:16:12,366 --> 00:16:14,466 IN THIS CASE, WE ARE LIMITING 449 00:16:14,466 --> 00:16:17,666 THIS EXPLANATION TO THOSE TRIALS 450 00:16:17,666 --> 00:16:20,366 THAT ARE INITIATED ON OR AFTER 451 00:16:20,366 --> 00:16:22,366 JANUARY18th, 2017 AND I'LL GO 452 00:16:22,366 --> 00:16:23,899 INTO A LITTLE BIT MORE DETAIL 453 00:16:23,900 --> 00:16:27,800 ABOUT THE IMPLICATIONS OF THAT 454 00:16:27,800 --> 00:16:29,700 IESKTIVE DATE AND SUBSEQUENT 455 00:16:29,700 --> 00:16:30,500 LIVES. 456 00:16:30,500 --> 00:16:32,233 AND SO BASICALLY THE MAIN GOAL 457 00:16:32,233 --> 00:16:34,133 OF THIS DETERMINE NATION OF THIS 458 00:16:34,133 --> 00:16:37,833 APPROACH WAS TO IMP ELEMENT 459 00:16:37,833 --> 00:16:39,333 SOMETHING CLOSER TO A CHECK 460 00:16:39,333 --> 00:16:39,733 LIST. 461 00:16:39,733 --> 00:16:41,133 YOU'LL SEE THAT WORD USED WITHIN 462 00:16:41,133 --> 00:16:43,033 THE PREAMBLE ITSELF THAT YOU CAN 463 00:16:43,033 --> 00:16:45,933 USE DATA ELEMENTS THAT ARE 464 00:16:45,933 --> 00:16:47,433 REQUIREMENTED TO BE SUBMITTED AS 465 00:16:47,433 --> 00:16:49,533 PART OF CLINICAL TRIAL 466 00:16:49,533 --> 00:16:50,733 REGISTRATION INFORMATION TO MAKE 467 00:16:50,733 --> 00:16:52,533 THIS DETERMINE NATION. 468 00:16:52,533 --> 00:16:55,233 AND SO, 1 OF THE CRITERIA, IS 469 00:16:55,233 --> 00:16:57,133 RELATED TO THE STUDY TYPE 470 00:16:57,133 --> 00:16:57,833 ITSELF. 471 00:16:57,833 --> 00:16:59,833 ANOTHER IS RELATED TO WHETHER OR 472 00:16:59,833 --> 00:17:02,433 NOT IT'S STUDYING THE USDA 473 00:17:02,433 --> 00:17:04,866 REGULATED DRUG PRODUCT OR DEVICE 474 00:17:04,866 --> 00:17:11,966 PRODUCT BOTH OF THOSE ARE NEWLY 475 00:17:11,966 --> 00:17:14,066 AVAILABLE WITHIN THE PRS AND I 476 00:17:14,066 --> 00:17:15,366 WILL GO INTO DETAIL ABOUT EACH 477 00:17:15,366 --> 00:17:16,866 OF THESE SO RIGHT NOW I'M JUST 478 00:17:16,866 --> 00:17:20,366 SUMMARIZING IT. 479 00:17:20,366 --> 00:17:23,999 THE STUDY PHASE, EXCLUDES PHASE 480 00:17:24,000 --> 00:17:30,400 1 STUDIES AND SIMILARLY FOR 481 00:17:30,400 --> 00:17:33,100 DEVICES IT EXCLUDES DEVICE 482 00:17:33,100 --> 00:17:34,100 FEASIBILITY STUDIES. 483 00:17:34,100 --> 00:17:35,800 AND AGAIN WE HAVE MORE DETAIL ON 484 00:17:35,800 --> 00:17:36,300 EACH OF THESE. 485 00:17:36,300 --> 00:17:38,233 THERE'S A FEW OTHER CRITERIA 486 00:17:38,233 --> 00:17:39,433 THAT HELP DETERMINE WHETHER OR 487 00:17:39,433 --> 00:17:42,233 NOT SOMETHING IS SUBJECT TO FDA 488 00:17:42,233 --> 00:17:43,533 REGULATION AND THAT HAS TO DO 489 00:17:43,533 --> 00:17:49,333 WITH THE LOCATION OF THE TRIALS 490 00:17:49,333 --> 00:17:50,933 THAT TELL WHETHER OR NOT IT'S 491 00:17:50,933 --> 00:17:53,033 CONDUCTED UNDER IND AND WHETHER 492 00:17:53,033 --> 00:17:55,133 OR NOT IT'S STUDIED IN CLINICAL 493 00:17:55,133 --> 00:17:56,333 TRIAL IS MANUFACTURED IN AND 494 00:17:56,333 --> 00:17:58,033 EXPORTED FROM THE U.S. 495 00:17:58,033 --> 00:18:00,333 AND THAT REALLY, THAT LAST 496 00:18:00,333 --> 00:18:03,033 CRITERIA, ONLY COMES INTO PLAY 497 00:18:03,033 --> 00:18:04,633 IF ANY OF THE OTHER THINGS 498 00:18:04,633 --> 00:18:12,166 HAVEN'T YET APPLIED. 499 00:18:12,166 --> 00:18:13,466 SO IF THEY'RE IN THE 500 00:18:13,466 --> 00:18:15,666 [INDISCERNIBLE] IF IT'S 501 00:18:15,666 --> 00:18:19,466 CONDUCTED UNDER AN IDE OR IND, 502 00:18:19,466 --> 00:18:21,566 THAT LAST POINT ISN'T RELEVANT 503 00:18:21,566 --> 00:18:22,266 THAT WAY. 504 00:18:22,266 --> 00:18:24,099 SO 1 THING THAT MANY OF YOU MAY 505 00:18:24,100 --> 00:18:25,700 BE AWARE OF IN THE ORIGINAL 506 00:18:25,700 --> 00:18:27,000 PROPOSAL IN THE NOTICE OF 507 00:18:27,000 --> 00:18:29,000 PROPOSED RULE MAKING RELATED TO 508 00:18:29,000 --> 00:18:30,600 HOW WE ARE GOING TO IMPLEMENT 509 00:18:30,600 --> 00:18:32,500 THIS DETERMINE NATION OF AN 510 00:18:32,500 --> 00:18:33,600 APPLICABLE CLINICAL 511 00:18:33,600 --> 00:18:36,500 TRIAL--DETERMINATION OF AN 512 00:18:36,500 --> 00:18:38,700 APPLICABLE CLINICAL TRIAL WE 513 00:18:38,700 --> 00:18:40,200 OFFER ASPECTS OF CONTROL. 514 00:18:40,200 --> 00:18:42,700 AND WHAT WE PROPOSED IN THE NPRM 515 00:18:42,700 --> 00:18:45,133 IS THAT THERE WOULD BE A 516 00:18:45,133 --> 00:18:47,833 SPECIFIC DATA ELEMENT FOR 517 00:18:47,833 --> 00:18:49,433 IDENTIFYING WHETHER A STUDY HAD 518 00:18:49,433 --> 00:18:51,633 A SINGLE ARM AND WAS CONSIDERED 519 00:18:51,633 --> 00:18:53,333 TO BE CONTROLLED BECAUSE IN THE 520 00:18:53,333 --> 00:18:56,533 NPRM WE DEFINED ANY 2 ARM STUDY 521 00:18:56,533 --> 00:19:04,833 AS BEING CONTROLLED. 522 00:19:04,833 --> 00:19:06,733 WHAT YOU MAY HAVE NOTICED IS 523 00:19:06,733 --> 00:19:08,533 THAT DATA ELEMENT IS THEN 524 00:19:08,533 --> 00:19:09,933 PRESENT AND THAT'S BECAUSE OF 525 00:19:09,933 --> 00:19:13,133 THE ADDITIONAL ELABORATION THAT 526 00:19:13,133 --> 00:19:14,633 WE INCLUDED IN THE FINAL RULE 527 00:19:14,633 --> 00:19:16,033 THAT BASICALLY SAYS THAT FOR THE 528 00:19:16,033 --> 00:19:19,266 PURPOSES OF THIS PART, ALL 529 00:19:19,266 --> 00:19:21,366 CLINICAL TRIALS MEANING ANY THAT 530 00:19:21,366 --> 00:19:22,566 WOULD BE CONSIDERED TO BE 531 00:19:22,566 --> 00:19:23,999 INTERVENTIONAL THAT HAS 1 OR 532 00:19:24,000 --> 00:19:26,200 MORE ARMS AND PRESPECIFIED 533 00:19:26,200 --> 00:19:27,300 OUTCOME MEASURES WILL BE 534 00:19:27,300 --> 00:19:28,200 CONSIDERED CONTROL FOR THE 535 00:19:28,200 --> 00:19:30,500 PURPOSE OF THIS RULE. 536 00:19:30,500 --> 00:19:32,500 SO THAT WILL SIMPLIFY, YOU KNOW 537 00:19:32,500 --> 00:19:33,800 SOME OF THE DECISION MAKING 538 00:19:33,800 --> 00:19:38,000 PROCESS, RELATED TO DETERMINING 539 00:19:38,000 --> 00:19:39,900 WHETHER A TRIAL, A PARTICULAR 540 00:19:39,900 --> 00:19:42,000 TRIAL IS INDEED AN APPLICABLE 541 00:19:42,000 --> 00:19:44,400 CLINICAL TRIAL. 542 00:19:44,400 --> 00:19:46,800 WE HAVE FURTHER ELABORATION BOTH 543 00:19:46,800 --> 00:19:47,800 WITHIN THE REGULATIONS AND 544 00:19:47,800 --> 00:19:50,800 PREAMBLE ABOUT THAT FIRST 545 00:19:50,800 --> 00:19:53,733 CRITERION OF STUDY TYPE AND IF 546 00:19:53,733 --> 00:19:54,833 YOU'RE ALREADY FAMILIAR WITH THE 547 00:19:54,833 --> 00:19:56,133 OPTIONS THAT ARE AVAILABLE RIGHT 548 00:19:56,133 --> 00:19:58,033 NOW FOR STUDY TYPE, WHEN YOU 549 00:19:58,033 --> 00:19:59,333 REGISTER THE STUDY, YOU'RE 550 00:19:59,333 --> 00:20:01,333 INDICATING WHETHER OR NOT IT IS 551 00:20:01,333 --> 00:20:05,033 INTERVENTIONAL, OBSERVATIONAL OR 552 00:20:05,033 --> 00:20:06,733 IF YOU'RE KRETTING AN EXPANDED 553 00:20:06,733 --> 00:20:07,933 ACCESS RECORD FOR THAT 554 00:20:07,933 --> 00:20:08,233 INFORMATION. 555 00:20:08,233 --> 00:20:09,933 SO WE WILL CONTINUE TO HAVE 556 00:20:09,933 --> 00:20:13,733 THOSE SAME OPTIONS AVAILABLE AND 557 00:20:13,733 --> 00:20:15,733 1 OF THE FIRST CRITERIA IS 558 00:20:15,733 --> 00:20:17,533 INDICATING WHETHER OR NOT THE 559 00:20:17,533 --> 00:20:19,033 STUDY FALLS INTO THESE 3, WHICH 560 00:20:19,033 --> 00:20:21,333 1 OF THESE 3 STUDY TYPES AND 561 00:20:21,333 --> 00:20:23,966 INTERVENTIONAL IS BASICALLY 562 00:20:23,966 --> 00:20:25,799 SYNONYMOUS WITH A CLINICAL 563 00:20:25,800 --> 00:20:27,300 TRIAL. 564 00:20:27,300 --> 00:20:28,500 ONE OF THE OTHER IMPORTANT 565 00:20:28,500 --> 00:20:30,800 CLARIFICATIONS THAT WE MADE 566 00:20:30,800 --> 00:20:33,000 WITHIN THE FINAL RULE ITSELF WAS 567 00:20:33,000 --> 00:20:36,700 THAT THOSE OTHER STUDY TYPES OF 568 00:20:36,700 --> 00:20:38,800 OBSERVAL AND EXPANDED ACCESS 569 00:20:38,800 --> 00:20:40,700 WOULD NOT BE GENERALLY 570 00:20:40,700 --> 00:20:42,100 CONSIDERED TO BE APPLICABLE 571 00:20:42,100 --> 00:20:43,600 CLINICAL TRIALS. 572 00:20:43,600 --> 00:20:46,700 IN THE NPRM WE INDICATE THAD IN 573 00:20:46,700 --> 00:20:48,100 CERTAIN CIRCUMSTANCES IT COULD 574 00:20:48,100 --> 00:20:49,600 BE POSSIBLE THAT AN EXPANDED 575 00:20:49,600 --> 00:20:53,300 ACCESS PROGRAM IF IT MEANT ALL 576 00:20:53,300 --> 00:20:54,900 THE OTHER CRITERIA MIGHT BE 577 00:20:54,900 --> 00:20:56,000 CONSIDERED AN APPLICABLE 578 00:20:56,000 --> 00:20:57,600 CLINICAL TRIAL, WE FURTHER 579 00:20:57,600 --> 00:21:00,133 CLARIFIED WITHIN THE PREAMBLE 580 00:21:00,133 --> 00:21:01,433 ITSELF BUT IN THIS CASE, 581 00:21:01,433 --> 00:21:03,433 EXPANDED ACCESS WILL NOT BE 582 00:21:03,433 --> 00:21:04,433 CONSIDERED APPLIC ANNUAL 583 00:21:04,433 --> 00:21:05,433 CLINICAL TRIAL. 584 00:21:05,433 --> 00:21:07,333 THE OTHER ASPECT WE CLARIFY IS 585 00:21:07,333 --> 00:21:09,033 THAT OBSERVATIONAL STUDIES ALSO 586 00:21:09,033 --> 00:21:10,433 WILL NOT BE CONSIDERED 587 00:21:10,433 --> 00:21:13,233 APPLICABLE CLINICAL TRIALS WITH 588 00:21:13,233 --> 00:21:16,933 1 POSSIBLE EXCEPTION. 589 00:21:16,933 --> 00:21:18,233 AGAIN, ON THE DETERMINE NATION 590 00:21:18,233 --> 00:21:20,033 SIDE THERE'S A FOOT NOTE 591 00:21:20,033 --> 00:21:21,833 INDICATING IF THERE IS A 592 00:21:21,833 --> 00:21:24,966 PEDIATRIC POST MARKET 593 00:21:24,966 --> 00:21:26,566 SURVEILLANCE OF A PRODUCT 594 00:21:26,566 --> 00:21:28,966 MANDATED BY THE FDA THAT THOSE 595 00:21:28,966 --> 00:21:30,666 THINGS ARE CONSIDERED TO BE 596 00:21:30,666 --> 00:21:32,299 APPLICABLE CLINICAL TRIALS AND 597 00:21:32,300 --> 00:21:34,800 IT IS POSSIBLE THAT A PEDIATRIC 598 00:21:34,800 --> 00:21:37,700 POST MARKET SURVEILLANCE OF A 599 00:21:37,700 --> 00:21:39,700 DEVICE PRODUCT WOULD BE AN 600 00:21:39,700 --> 00:21:40,600 OBSERVATIONAL STUDY. 601 00:21:40,600 --> 00:21:42,100 SO THAT WOULD BE THE 1 SITUATION 602 00:21:42,100 --> 00:21:45,400 IN WHICH A STUDY TYPE OF 603 00:21:45,400 --> 00:21:47,500 OBSERVATIONAL COULD FALL INTO 604 00:21:47,500 --> 00:21:49,800 THAT CATEGORY OF AN APPLICABLE 605 00:21:49,800 --> 00:21:51,100 CLINICAL TRIAL AND THEN THERE'S 606 00:21:51,100 --> 00:21:52,900 FURTHER ELABORATION IN THE 607 00:21:52,900 --> 00:21:57,400 PREAMBLE OF EACH ASPECT OF THIS. 608 00:21:57,400 --> 00:22:01,300 SO THE OTHER--NEXT CRITERIA IN 609 00:22:01,300 --> 00:22:02,600 THE DETERMINE NATION CHECK LIST 610 00:22:02,600 --> 00:22:03,900 IS WHETHER OR NOT THE STUDY IS 611 00:22:03,900 --> 00:22:07,333 EVALUATING A U.S. FDA REGULATED 612 00:22:07,333 --> 00:22:10,433 DRUG PRODUCT OR AN FDA REGULATED 613 00:22:10,433 --> 00:22:11,533 DEVICE PRODUCT. 614 00:22:11,533 --> 00:22:13,733 THERE ARE DEFINITIONS WITHIN THE 615 00:22:13,733 --> 00:22:15,233 REGULATIONS ABOUT THIS AS WELL 616 00:22:15,233 --> 00:22:17,733 AS FURTHER EXPLANATION IN THE 617 00:22:17,733 --> 00:22:20,633 PREAMBLE, BUT BASICALLY WHAT THE 618 00:22:20,633 --> 00:22:22,133 QUESTION IS GETTING AT IS 619 00:22:22,133 --> 00:22:23,866 WHETHER OR NOT, THE PRODUCT 620 00:22:23,866 --> 00:22:26,666 ITSELF WOULD REQUIRE A MARKETING 621 00:22:26,666 --> 00:22:28,866 APPLICATION TO BE APPROVED BY 622 00:22:28,866 --> 00:22:31,966 THE FDA, YOU KNOW, AN NDA, A 623 00:22:31,966 --> 00:22:34,866 BLA, A PMA, IN ORDER TO BE 624 00:22:34,866 --> 00:22:37,466 MARKETED WITHIN THE U.S. 625 00:22:37,466 --> 00:22:38,799 SO THAT'S REALLY WHAT THAT 626 00:22:38,800 --> 00:22:40,200 QUESTION IS GETTING AT IN TERMS 627 00:22:40,200 --> 00:22:42,300 OF WHETHER OR NOT THE PRODUCT 628 00:22:42,300 --> 00:22:44,900 EVALUATED IS INDEED SOMETHING 629 00:22:44,900 --> 00:22:48,500 THAT IS REGULATED BY THE FDA. 630 00:22:48,500 --> 00:22:50,100 THERE'S ADDITIONAL USEFUL 631 00:22:50,100 --> 00:22:52,400 ELABORATION WITHIN THE PREAMBLE, 632 00:22:52,400 --> 00:22:53,900 AGAIN THOSE PAGE NUMBERS ARE 633 00:22:53,900 --> 00:22:55,700 ALSO PROVIDED AT THE BOTTOM OF 634 00:22:55,700 --> 00:22:58,000 THE SLIDE. 635 00:22:58,000 --> 00:23:00,200 WE DIDN'T REALLY RECEIVE MANY 636 00:23:00,200 --> 00:23:01,400 COMMENTS ON THIS, AND WE 637 00:23:01,400 --> 00:23:03,100 ACTUALLY DIDN'T RECEIVE ANY 638 00:23:03,100 --> 00:23:04,800 COMMENTS ON THESE DATA ELEMENTS 639 00:23:04,800 --> 00:23:08,500 IN RESPONSE TO THE NPRM BUT WE 640 00:23:08,500 --> 00:23:10,900 HAVE YOU KNOW TRIED TO MAKE IT 641 00:23:10,900 --> 00:23:12,533 CLEAR ABOUT VARIOUS ASPECTS THAT 642 00:23:12,533 --> 00:23:14,433 MIGHT NEED TO BE TAKEN INTO 643 00:23:14,433 --> 00:23:16,333 CONSIDERATION WHEN RESPONDING TO 644 00:23:16,333 --> 00:23:19,133 THIS PARTICULAR QUESTION. 645 00:23:19,133 --> 00:23:20,433 AND WHAT THIS SLIDE IS GETTING 646 00:23:20,433 --> 00:23:21,833 AT IS THE THAT THERE MIGHT BE 647 00:23:21,833 --> 00:23:23,966 CASES IN WHICH, SAY YOU HAVE A 648 00:23:23,966 --> 00:23:26,566 STUDY OF A DEVICE PRODUCT AND 649 00:23:26,566 --> 00:23:28,666 SO, YOUR STUDY IS EVALLUALITYING 650 00:23:28,666 --> 00:23:39,166 A U.S. FDA REGULATED DEVICE 651 00:23:39,166 --> 00:23:40,466 PRODUCT AND SO IN THE BACKGROUND 652 00:23:40,466 --> 00:23:42,566 YOU MIGHT BE ADMINISTERING 653 00:23:42,566 --> 00:23:44,899 GENERAL ANESTHESIA BUT THIS DRUG 654 00:23:44,900 --> 00:23:46,500 IS USED IN THE CLINICAL TRIAL 655 00:23:46,500 --> 00:23:49,200 BUT THE CLINICAL TRIAL ITSELF IS 656 00:23:49,200 --> 00:23:50,600 NOT NECESSARILY STUDYING THAT 657 00:23:50,600 --> 00:23:52,700 FDA REGULATED DRUG PRODUCT. 658 00:23:52,700 --> 00:23:54,200 SO THAT WOULD BE A CONSIDERATION 659 00:23:54,200 --> 00:23:59,800 TO MAKE INTO ACCOUNT IN TERMS OF 660 00:23:59,800 --> 00:24:02,300 WHAT ABOUT THE TODAY ITSELF IS 661 00:24:02,300 --> 00:24:05,000 ACTUALLY EVALUATING. 662 00:24:05,000 --> 00:24:07,100 AND WE ALSO FURTHER ELABORATED 663 00:24:07,100 --> 00:24:08,100 ON THE RELATIONSHIP OF THIS 664 00:24:08,100 --> 00:24:09,700 PARTICULAR DATA ELEMENT TO 665 00:24:09,700 --> 00:24:11,700 ANOTHER DATA ELEMENT THAT IS 666 00:24:11,700 --> 00:24:14,800 REQUIRED TO BE SUBMITTED AS PART 667 00:24:14,800 --> 00:24:16,300 OF CLINICAL TRIAL REGISTRATION 668 00:24:16,300 --> 00:24:17,500 INFORMATION AND THAT'S THE 669 00:24:17,500 --> 00:24:20,433 INTERVENTION TYPE DATA ELEMENT. 670 00:24:20,433 --> 00:24:22,133 YOU MAY BE STUDYING OR 671 00:24:22,133 --> 00:24:24,566 EVALUATING AN INTERVENTION TYPE 672 00:24:24,566 --> 00:24:26,966 THAT IS LABELED AS A DIETARY 673 00:24:26,966 --> 00:24:28,166 SUPPLEMENT. 674 00:24:28,166 --> 00:24:30,866 AND THAT--THAT DIETARY 675 00:24:30,866 --> 00:24:32,666 SUPPLEMENT MAY BE USED IN A WAY 676 00:24:32,666 --> 00:24:36,766 THAT WOULD ACTUALLY REQUIRE A 677 00:24:36,766 --> 00:24:38,866 MARKETING APPLICATION IN ORDER 678 00:24:38,866 --> 00:24:40,566 TO BE MARKETED FOR THAT 679 00:24:40,566 --> 00:24:41,266 PARTICULAR USE. 680 00:24:41,266 --> 00:24:42,866 SO IT COULD ACTUALLY BE STUDYING 681 00:24:42,866 --> 00:24:46,766 A USFDA REGULATING DRUG PRODUCT 682 00:24:46,766 --> 00:24:47,766 EVEN THOUGH YOU THINK OF THATTED 683 00:24:47,766 --> 00:24:51,066 PROUCT AS A DIETARY SUPPLEMENT. 684 00:24:51,066 --> 00:24:53,099 AND SO AGAIN IN THE ELABORATION 685 00:24:53,100 --> 00:24:54,400 SECTION OF THE FINAL RULE, 686 00:24:54,400 --> 00:24:55,800 THERE'S SOME REALLY USEFUL 687 00:24:55,800 --> 00:24:57,800 EXPLANATIONS OF ADDITIONAL 688 00:24:57,800 --> 00:24:59,500 THINGS THAT TAKE--THAT YOU WANT 689 00:24:59,500 --> 00:25:00,900 TO TAKE INTO ACCOUNT WHEN 690 00:25:00,900 --> 00:25:01,900 CONSIDERING THESE VARIOUS 691 00:25:01,900 --> 00:25:05,700 ASPECTS OF THE DETERMINE NATION 692 00:25:05,700 --> 00:25:08,800 APPROACH. 693 00:25:08,800 --> 00:25:11,000 AND SO THEN IN TERMS OF WHICH 694 00:25:11,000 --> 00:25:12,400 APPLICABLE CLINICAL TRIALS MUST 695 00:25:12,400 --> 00:25:13,600 BE REGISTERED WITH THE 696 00:25:13,600 --> 00:25:15,400 REGULATIONS OUTLINED, IT'S 697 00:25:15,400 --> 00:25:18,400 GENERAL DESCRIPTION OF WHAT WAS 698 00:25:18,400 --> 00:25:19,600 ALSO DESCRIBED IN THE STATUTE 699 00:25:19,600 --> 00:25:20,800 THAT BASICALLY 1 YOU HAVE TO 700 00:25:20,800 --> 00:25:21,900 MEET THE DEFINITION OF AN 701 00:25:21,900 --> 00:25:23,500 APPLICABLE CLINICAL TRIAL AND 702 00:25:23,500 --> 00:25:25,233 THEN THERE ARE THESE DIFFERENT 703 00:25:25,233 --> 00:25:27,033 CRITERIA BASED ON DATES IN TERMS 704 00:25:27,033 --> 00:25:28,433 OF WHEN THE LAW ITSELF WAS 705 00:25:28,433 --> 00:25:29,633 ACTUALLY PASSED. 706 00:25:29,633 --> 00:25:31,633 THE LAW WAS PASSED IN SEPTEMBER 707 00:25:31,633 --> 00:25:34,933 OF 2007 AND SO IT APPLIED TO 708 00:25:34,933 --> 00:25:36,433 STUDIES THAT WERE INITIATED 709 00:25:36,433 --> 00:25:39,033 AFTER THE PASSAGE OF THE LAW OR 710 00:25:39,033 --> 00:25:41,533 IT APPLIED TO STUDIES THAT WERE 711 00:25:41,533 --> 00:25:45,033 ON-GOING AS OF THE DATE OF THE 712 00:25:45,033 --> 00:25:47,133 PASSAGE OF THE LAW AND THAT 713 00:25:47,133 --> 00:25:48,933 HADN'T YET COMPLETED BY THE END 714 00:25:48,933 --> 00:25:51,133 OF THAT SAME YEAR. 715 00:25:51,133 --> 00:25:52,933 AND SO IN TERMS OF DETERMINING 716 00:25:52,933 --> 00:25:55,133 WHAT THAT DATE OF INITIATION IS, 717 00:25:55,133 --> 00:25:57,233 THE REGULATIONS FURTHER EXPLAIN 718 00:25:57,233 --> 00:25:59,066 THAT THE DAT OF INITIATION IS 719 00:25:59,066 --> 00:26:01,566 THE DATE ON WHICH THE FIRST 720 00:26:01,566 --> 00:26:03,366 HUMAN SUBJECT IS ENROLLED AND WE 721 00:26:03,366 --> 00:26:04,566 CONSIDER THAT TO BE THE STEADY 722 00:26:04,566 --> 00:26:10,166 START DATA ELEMENT. 723 00:26:10,166 --> 00:26:12,166 SO THE NEXT THING TO TAKE INTO 724 00:26:12,166 --> 00:26:13,166 CONSIDERATION, YOU KNOW WE 725 00:26:13,166 --> 00:26:14,366 COVERED WHO IT IS THAT MUST BE 726 00:26:14,366 --> 00:26:18,666 DOING THIS. 727 00:26:18,666 --> 00:26:20,066 WHICH APPLICABLE TRIALS ARE 728 00:26:20,066 --> 00:26:21,966 COVERED AND THE NEXT ASPECT IS 729 00:26:21,966 --> 00:26:23,899 WHEN MUST THE INFORMATION BE 730 00:26:23,900 --> 00:26:24,600 SUBMITTED. 731 00:26:24,600 --> 00:26:27,200 THERE ARE OUTLINES WITHIN THE 732 00:26:27,200 --> 00:26:28,700 RULE ITSELF SO GENERALLY, 733 00:26:28,700 --> 00:26:30,300 CLINICAL TRIAL REGISTRATION AND 734 00:26:30,300 --> 00:26:32,533 INFORMATION MUST BE SUBMITTED 735 00:26:32,533 --> 00:26:34,633 WITHIN 21 CALENDAR DAYS AFTER 736 00:26:34,633 --> 00:26:41,433 THAT FIRST HUMAN RULE. 737 00:26:41,433 --> 00:26:42,833 ALTHOUGH THESE ARE REQUIREMENTS 738 00:26:42,833 --> 00:26:44,733 WITHIN THE REGULATIONS, THEY'RE 739 00:26:44,733 --> 00:26:46,833 ALSO DESCRIBED IN THE STATUTE, 740 00:26:46,833 --> 00:26:49,433 THAT IF YOU ARE INTENDING TO 741 00:26:49,433 --> 00:26:52,233 PUBLISH THE RESULTS OF THE 742 00:26:52,233 --> 00:26:57,033 CLINICAL TRIAL FOR THE JOURNAL 743 00:26:57,033 --> 00:27:00,133 EDITORS REQUIRES REGISTRATION TO 744 00:27:00,133 --> 00:27:02,633 OCCUR PRIOR TO THE ENROLLMENT OF 745 00:27:02,633 --> 00:27:03,633 FIRST PARTICIPANT. 746 00:27:03,633 --> 00:27:05,266 SO THAT'S ANOTHER ASPECT TO TAKE 747 00:27:05,266 --> 00:27:06,066 INTO CONSIDERATION WHEN 748 00:27:06,066 --> 00:27:07,966 DETERMINING THE TIMING OF WHEN 749 00:27:07,966 --> 00:27:11,866 YOU WILL BE REGISTERING CLINICAL 750 00:27:11,866 --> 00:27:12,166 TRIAL. 751 00:27:12,166 --> 00:27:13,466 BUT IN TERMS OF WHAT IT IS THAT 752 00:27:13,466 --> 00:27:16,466 THE STATUTE AND THE FINAL RULE 753 00:27:16,466 --> 00:27:20,666 REQUIRE, IT'S JUST 21 CALENDAR 754 00:27:20,666 --> 00:27:22,466 DAYS AFTER THE HUMAN SUBJECT IS 755 00:27:22,466 --> 00:27:23,599 ENROLLED AND AGAIN WE CONSIDER 756 00:27:23,600 --> 00:27:28,000 THIS TO BE THE STEADY START DATE 757 00:27:28,000 --> 00:27:28,600 ELEMENT. 758 00:27:28,600 --> 00:27:32,400 IN THE LAST WEBINAR, WEUC IN THE 759 00:27:32,400 --> 00:27:34,700 RULE DEFINITION SO I WON'T SPEND 760 00:27:34,700 --> 00:27:35,433 MUCH TIME ON IT HERE. 761 00:27:35,433 --> 00:27:35,899 762 00:27:35,900 --> 00:27:37,400 SO THE NEXT ASPECT IS WHAT 763 00:27:37,400 --> 00:27:39,000 CONSITUTES CLINICAL TRIAL 764 00:27:39,000 --> 00:27:42,600 REGISTRATION, INFORMATION? 765 00:27:42,600 --> 00:27:44,200 AND THIS RELATES TO WHAT ARE THE 766 00:27:44,200 --> 00:27:46,733 SPECIFIC DATA ELEMENTS MA MUST 767 00:27:46,733 --> 00:27:48,633 BE SUBMITTED UNDER THE FINAL 768 00:27:48,633 --> 00:27:49,833 RULE. 769 00:27:49,833 --> 00:27:52,133 SO THIS IS ALL DESCRIBED IN 770 00:27:52,133 --> 00:27:55,733 SECTION 11.28 OF THE REGULATIONS 771 00:27:55,733 --> 00:27:57,966 AND THE WAY THAT IT'S SEGMENTED 772 00:27:57,966 --> 00:27:59,766 IS THAT IT DESCRIBES THESE 2 773 00:27:59,766 --> 00:28:02,566 CONDITIONS SO 1 WE'RE ALWAYS 774 00:28:02,566 --> 00:28:03,766 TALKING ABOUT APPLICABLE 775 00:28:03,766 --> 00:28:05,166 CLINICAL TRIALS BUT THE WAY THAT 776 00:28:05,166 --> 00:28:06,766 IT'S LAID OUT IN THE REGULATIONS 777 00:28:06,766 --> 00:28:08,366 IN TERMS OF WHAT INFORMATION 778 00:28:08,366 --> 00:28:10,066 MUST BE SUBMITTED. 779 00:28:10,066 --> 00:28:12,666 IT'S BASED ON THE EFFECTIVE DATE 780 00:28:12,666 --> 00:28:14,966 OF THE RULE ITSELF. 781 00:28:14,966 --> 00:28:17,066 AND SO, AGAIN, THAT EFFECTIVE 782 00:28:17,066 --> 00:28:18,966 DATE, YOU MAY RECOGNIZE ON THIS 783 00:28:18,966 --> 00:28:22,099 SLIDE AS JANUARY18th 2017. 784 00:28:22,100 --> 00:28:25,100 SO IT'S A REGULATION STAKE IS 785 00:28:25,100 --> 00:28:27,400 THAT FOR ANY APPLICABLE CLINICAL 786 00:28:27,400 --> 00:28:29,100 TRIAL THAT HAD A ESTATE START 787 00:28:29,100 --> 00:28:34,000 DATE BEFORE JANUARY18th 2017, 788 00:28:34,000 --> 00:28:35,400 YOU ARE CONTINUING TO FOLLOW THE 789 00:28:35,400 --> 00:28:36,300 REQUIREMENTS THAT ARE DESCRIBED 790 00:28:36,300 --> 00:28:38,000 IN THE STATUTE AND ARE BASICALLY 791 00:28:38,000 --> 00:28:38,900 THE REQUIREMENTS THAT WE 792 00:28:38,900 --> 00:28:40,800 CURRENTLY HAVE IN PLACE AT 793 00:28:40,800 --> 00:28:45,700 CLINICAL TRIALS .GOV. 794 00:28:45,700 --> 00:28:46,900 THEY ARE DESCRIBED IN THE FINAL 795 00:28:46,900 --> 00:28:48,800 RULE IN THIS SECOND PART OF 796 00:28:48,800 --> 00:28:55,533 11.28, 11.28 A2 LISTS IT IS 797 00:28:55,533 --> 00:28:57,199 ELEMENTS SUBMITTED FOR THOSE 798 00:28:57,200 --> 00:29:00,666 TRIALS THAT STARTED ON OR AFTER 799 00:29:00,666 --> 00:29:02,166 THE EFFECTIVE DATE WHICH IS 800 00:29:02,166 --> 00:29:05,266 AGAIN JANUARY18th, 2017. 801 00:29:05,266 --> 00:29:06,966 AND IT DESCRIBES THESE DATA 802 00:29:06,966 --> 00:29:09,366 ELEMENTS BASED ON 4 CATEGORIES 803 00:29:09,366 --> 00:29:10,566 OF INFORMATION THAT YOU CAN SEE 804 00:29:10,566 --> 00:29:18,766 HERE, THAT ARE SIMILAR TO 805 00:29:18,766 --> 00:29:19,166 STATUTE. 806 00:29:19,166 --> 00:29:20,866 WE HAVE MADE THE DOCUMENT 807 00:29:20,866 --> 00:29:23,966 AVAILABLE, THE URL IS HERE, AND 808 00:29:23,966 --> 00:29:27,599 WE ATTEMPTED TO ATTEMPT THE DATA 809 00:29:27,600 --> 00:29:31,100 ELEMENTS AND THE TABLE HAVE 810 00:29:31,100 --> 00:29:32,800 EXPLAINED WHETHER OR NOT THOSE 811 00:29:32,800 --> 00:29:34,900 DATA ELEMENTS WERE ALREADY 812 00:29:34,900 --> 00:29:37,400 REQUIRED OR CONSIDERED OPTIONAL 813 00:29:37,400 --> 00:29:40,200 UNDER THE CURRENT--OR UNDER THE 814 00:29:40,200 --> 00:29:42,000 CURREQUIREMENTS AT CLINICAL 815 00:29:42,000 --> 00:29:44,200 TRIALS.GOV. 816 00:29:44,200 --> 00:29:46,400 SO HAVE YOU A BETTER VIEW OF 817 00:29:46,400 --> 00:29:47,700 WHAT WILL CHANGE FROM YOUR OWN 818 00:29:47,700 --> 00:29:49,400 CURRENT PRACTICES AND AS WE TALK 819 00:29:49,400 --> 00:29:50,600 THROUGH THE DATA ELEMENT 820 00:29:50,600 --> 00:29:51,600 REQUIREMENTS I'LL BE 821 00:29:51,600 --> 00:29:53,000 HIGHLIGHTING SOME OF THOSE 822 00:29:53,000 --> 00:30:05,066 CHANGES FOR YOU AS WELL. 823 00:30:05,066 --> 00:30:07,266 AND THEN THAT'S THE DATA EXISTS 824 00:30:07,266 --> 00:30:08,166 PRIOR TO THE RULE. 825 00:30:08,166 --> 00:30:09,366 AGAIN WHAT I WOULD LOAMACYIC TO 826 00:30:09,366 --> 00:30:11,066 REITERATE IS THE APPROACH THAT 827 00:30:11,066 --> 00:30:14,766 WE'RE GOING TO BE TAKING WITHIN 828 00:30:14,766 --> 00:30:16,766 THE PRA SIZE AND SO BECAUSE 829 00:30:16,766 --> 00:30:19,566 THERE'S THIS DIFFERENCE IN TERMS 830 00:30:19,566 --> 00:30:21,466 OF REQUIREMENTS FOR REGISTRATION 831 00:30:21,466 --> 00:30:23,566 INFORMATION BASED ON WHEN THE 832 00:30:23,566 --> 00:30:25,366 STEADY START DATE FOR THE STUDY 833 00:30:25,366 --> 00:30:28,166 WAS, THE PRS ITSELF WILL ALSO BE 834 00:30:28,166 --> 00:30:31,566 RELYING ON THE STUDY START DATE 835 00:30:31,566 --> 00:30:32,866 INFORMATION THAT'S SUBMITTED TO 836 00:30:32,866 --> 00:30:36,099 DETERMINE WHICH REGISTRATION 837 00:30:36,100 --> 00:30:37,400 INFORMATION ELEMENTS ARE 838 00:30:37,400 --> 00:30:39,400 CONSIDERED TO BE REQUIRED. 839 00:30:39,400 --> 00:30:41,100 SO I DID DISCUSS THIS IN THE 840 00:30:41,100 --> 00:30:43,300 LAST WEBINAR, BUT I JUST WANT TO 841 00:30:43,300 --> 00:30:44,800 REITERATE SOME OF OUR GENERAL 842 00:30:44,800 --> 00:30:53,600 PLANS HERE TO TRY TO MAKE SURE 843 00:30:53,600 --> 00:30:55,200 THIS IS AS CLEAR AS POSSIBLE. 844 00:30:55,200 --> 00:30:57,433 SO WE'RE AIMING AT THE END OF 845 00:30:57,433 --> 00:30:59,533 NOVEMBER TO MAKE SURE THE PRS 846 00:30:59,533 --> 00:31:01,333 SYSTEM IS THE TYPICAL PROCESS WE 847 00:31:01,333 --> 00:31:02,533 FOLLOW BEFORE WE MAKE SOMETHING 848 00:31:02,533 --> 00:31:03,633 AVAILABLE IN THE OPERATIONAL 849 00:31:03,633 --> 00:31:07,066 PRS, WE WILL PUT THAT ON 850 00:31:07,066 --> 00:31:09,566 PRSTEST, THAT ALLOWS US TO DO 851 00:31:09,566 --> 00:31:11,166 TESTING FOR POTENTIAL BUGS AND 852 00:31:11,166 --> 00:31:14,366 ALLOWS OUR DATA PROVIDER TO GET 853 00:31:14,366 --> 00:31:15,566 EXPERIENCE WITH THE NEXT SET OF 854 00:31:15,566 --> 00:31:16,566 INFORMATION THAT WILL BE IN THE 855 00:31:16,566 --> 00:31:20,466 OPERATIONAL SYSTEM. 856 00:31:20,466 --> 00:31:22,566 SO THAT RELEASE IN LATE NOVEMBER 857 00:31:22,566 --> 00:31:23,866 WILL HAVE THE REGISTRATION AND 858 00:31:23,866 --> 00:31:26,066 RESULTS DATA ELEMENTS THAT ARE 859 00:31:26,066 --> 00:31:35,866 REQUIRED BY THE FINAL RULE IT 860 00:31:35,866 --> 00:31:37,966 WILL ALSO INCLUDE DOCUMENTATION 861 00:31:37,966 --> 00:31:38,766 NEEDED TO UNDERSTAND THAT 862 00:31:38,766 --> 00:31:39,066 INFORMATION. 863 00:31:39,066 --> 00:31:40,999 I JUST WANT TO REITERATE THOUGH 864 00:31:41,000 --> 00:31:42,900 THAT THE PURPOSE OF PUTTING THAT 865 00:31:42,900 --> 00:31:44,500 INFORMATION ON PRS TEST SYSTEM 866 00:31:44,500 --> 00:31:47,800 TO GET IT READY FOR--FOR MOVING 867 00:31:47,800 --> 00:31:49,400 THAT RELEASE INTO THE 868 00:31:49,400 --> 00:31:52,100 OPERATIONAL PRS. 869 00:31:52,100 --> 00:31:53,500 IT'S REALLY FOR INFORMATION 870 00:31:53,500 --> 00:31:54,300 PURPOSES. 871 00:31:54,300 --> 00:31:57,633 WE NEVER RECOMMEND PEOPLE USE IT 872 00:31:57,633 --> 00:31:59,733 AS A STAGING AREA TO THEN BE 873 00:31:59,733 --> 00:32:01,133 ABLE TO SUBMIT INFORMATION TO 874 00:32:01,133 --> 00:32:06,433 THE OPERATIONAL PRS. 875 00:32:06,433 --> 00:32:07,433 IT'S REALLY JUST ANOTHER 876 00:32:07,433 --> 00:32:09,233 MECHANISM FOR BEDDING WHAT THOSE 877 00:32:09,233 --> 00:32:09,933 REQUIREMENTS ARE. 878 00:32:09,933 --> 00:32:11,033 WE WILL PLAN TO REMOVE THAT 879 00:32:11,033 --> 00:32:12,033 RELEASE THOUGH TO THE 880 00:32:12,033 --> 00:32:17,366 OPERATIONAL PRS. 881 00:32:17,366 --> 00:32:19,466 ON THE EFFECTIVE DATE WHICH IS 882 00:32:19,466 --> 00:32:22,066 JANUARY18 AND THERE IS A LAG 883 00:32:22,066 --> 00:32:23,566 TIME BETWEEN EFFECTIVE DATE AND 884 00:32:23,566 --> 00:32:25,366 COMPLIANT DANCE, MEANING THE 885 00:32:25,366 --> 00:32:26,566 DATE BY WHICH EVERYONE'S 886 00:32:26,566 --> 00:32:27,866 EXPECTED TO HAVE $INFORMATION 887 00:32:27,866 --> 00:32:29,166 SUBMITTED AND COMPLIANCE WITH 888 00:32:29,166 --> 00:32:39,466 THE FINAL RULE TO THE PRS WILL 889 00:32:39,466 --> 00:32:41,466 NOT HAVE THE ELEMENTS FOR THE 890 00:32:41,466 --> 00:32:43,966 DATA, WE WILL HAVE WARNINGS 891 00:32:43,966 --> 00:32:46,266 AVAILABLE FOR FOR INFORMATION 892 00:32:46,266 --> 00:32:47,499 REQUIRED FOR A PARTICULAR TRIAL 893 00:32:47,500 --> 00:32:49,000 WHEN THAT COMPLIANCE DATE OF 894 00:32:49,000 --> 00:32:50,800 APRIL18th COMES AROUND. 895 00:32:50,800 --> 00:32:52,500 BUT, IT'S REALLY THAT 896 00:32:52,500 --> 00:32:53,800 APRIL18th RELEASE INTO THE 897 00:32:53,800 --> 00:32:57,233 OPERATIONAL PRS IN WHICH WE WILL 898 00:32:57,233 --> 00:33:02,133 THEN MAKE IT REQUIRED TO HAVE 899 00:33:02,133 --> 00:33:05,333 THE FINAL DATA RULE ELEMENT BUT 900 00:33:05,333 --> 00:33:07,033 AGAIN WE WILL RELYOT STEADY 901 00:33:07,033 --> 00:33:09,133 START DATEOT SAME WAY THE RULE 902 00:33:09,133 --> 00:33:10,833 RELYS ON THE STEADY START DATE 903 00:33:10,833 --> 00:33:12,333 TO DETERMINE WHICH REGISTRATION 904 00:33:12,333 --> 00:33:14,733 DATA ELEMENTS ARE RELEVANT FOR 905 00:33:14,733 --> 00:33:21,666 ANY PARTICULAR TRIAL. 906 00:33:21,666 --> 00:33:22,766 SO NOW I'M GOING INTO MORE 907 00:33:22,766 --> 00:33:25,366 DETAIL ABOUT SOME OF THE 908 00:33:25,366 --> 00:33:27,166 REGISTRATION ELEMENTS THAT WILL 909 00:33:27,166 --> 00:33:28,966 BE REQUIRED TO BE SUBMITTED 910 00:33:28,966 --> 00:33:30,466 UNDER THE FINAL RULE SO THESE 911 00:33:30,466 --> 00:33:32,766 ARE FOR STUDIES THAT HAVE START 912 00:33:32,766 --> 00:33:35,466 DATES ON OR AFTER JANUARY18th 913 00:33:35,466 --> 00:33:38,666 2017. 914 00:33:38,666 --> 00:33:40,866 WHAT I INDICATED WITH A RED 915 00:33:40,866 --> 00:33:43,966 ASTERRIFIC ARE THOSE ELEMENTS 916 00:33:43,966 --> 00:33:45,266 THAT ARE REQUIRED BY THE FINAL 917 00:33:45,266 --> 00:33:45,566 RULE. 918 00:33:45,566 --> 00:33:47,266 SO THIS MAY EITHER BE AN 919 00:33:47,266 --> 00:33:49,166 EXISTING DATA ELEMENT OR MAYBE A 920 00:33:49,166 --> 00:33:51,466 COMPLETELY NEW DATA ELEMENT 921 00:33:51,466 --> 00:33:53,066 THAT'S NEWLY REQUIRED BY THE 922 00:33:53,066 --> 00:33:53,699 FINAL RULE. 923 00:33:53,700 --> 00:33:55,000 WE ATTEMPTED TO INDICATE IN 924 00:33:55,000 --> 00:33:56,800 THESE SLIDES WHEN SOMETHING IS 925 00:33:56,800 --> 00:33:59,433 CONSIDERED TO BE A NEW ITEM 926 00:33:59,433 --> 00:34:01,333 VERSUS WHETHER IT'S JUST 927 00:34:01,333 --> 00:34:02,933 SOMETHING THAT'S AN EXISTING 928 00:34:02,933 --> 00:34:10,733 ITEM AND TURNING INTO REQUIRED. 929 00:34:10,733 --> 00:34:12,933 I WILL JUST HIGHLIGHT SOME OF 930 00:34:12,933 --> 00:34:14,433 THESE WITHOUT GOING INTO EXTREME 931 00:34:14,433 --> 00:34:16,033 DETAIL ON EACH OF THEM. 932 00:34:16,033 --> 00:34:19,433 ONE THING I'LL NOTICE ON THIS 933 00:34:19,433 --> 00:34:21,233 SLIDE IT'S PRIMARY PURPOSE. 934 00:34:21,233 --> 00:34:23,133 WE WILL ADD A NEW OPTION TO THE 935 00:34:23,133 --> 00:34:24,933 PRIMARY PURPOSE OPTIONS FOR 936 00:34:24,933 --> 00:34:26,466 INDICATING WHETHER OR NOT A 937 00:34:26,466 --> 00:34:31,866 STUDY IS CONSIDERED TO BE A 938 00:34:31,866 --> 00:34:33,766 DEVICE FEASIBILITY WITH THE 939 00:34:33,766 --> 00:34:34,566 DEFINITIONS WITHIN THE 940 00:34:34,566 --> 00:34:37,966 REGULATIONS. 941 00:34:37,966 --> 00:34:38,966 THIS IS IMPORTANT TO REMEMBER 942 00:34:38,966 --> 00:34:40,766 FROM THE ATP DETERMINE NATION 943 00:34:40,766 --> 00:34:42,066 SLIDE FOR DETERMINING WHETHER OR 944 00:34:42,066 --> 00:34:43,566 NOT SOMETHING WOULD BE 945 00:34:43,566 --> 00:34:51,866 CONSIDERED AN ECT. 946 00:34:51,866 --> 00:34:53,566 ANOTHER CHAIRVELG THAT WILL BE 947 00:34:53,566 --> 00:34:55,666 EFFECTED IS FOR STUDY PHASE, 948 00:34:55,666 --> 00:34:57,366 ANOTHER THING WE CLARIFY IN THE 949 00:34:57,366 --> 00:34:58,766 PREAMBLE FOR THAT PARTICULAR DAT 950 00:34:58,766 --> 00:35:01,799 ELEMENT, 1 WAS THAT STUDY PHASE 951 00:35:01,800 --> 00:35:04,400 OOH PLIES TO CLINICAL TRIALS OF 952 00:35:04,400 --> 00:35:06,200 DRUGS, THESE ARE BASED ON FDA 953 00:35:06,200 --> 00:35:08,200 REGULATIONS AND THEY ARE IN THE 954 00:35:08,200 --> 00:35:11,100 CONTEXT OF INVESTIGATIONAL DRUG 955 00:35:11,100 --> 00:35:12,400 PRODUCTS. 956 00:35:12,400 --> 00:35:15,100 AND SO, 1 OF THE MODIFICATIONS 957 00:35:15,100 --> 00:35:16,800 AND EXPLANATIONS THAT WE'VE 958 00:35:16,800 --> 00:35:20,500 INDICATED IS THAT, PHASE 0 IS 959 00:35:20,500 --> 00:35:22,100 NOT A PHASE THAT'S RECOGNIZED IN 960 00:35:22,100 --> 00:35:26,000 THE FDA REGULATIONS THEMSELVES 961 00:35:26,000 --> 00:35:27,200 BUT IS CONSIDERED TO MEET THE 962 00:35:27,200 --> 00:35:30,600 DEFINITION OF A PHASE 1 CLINICAL 963 00:35:30,600 --> 00:35:31,200 TRIAL. 964 00:35:31,200 --> 00:35:33,833 AND SO, 1 OF THE MODIFICATIONS 965 00:35:33,833 --> 00:35:36,133 WILL BE RELATED TO THE OPTIONS 966 00:35:36,133 --> 00:35:42,433 FOR PHASE THAT ARE AVAILABLE. 967 00:35:42,433 --> 00:35:44,233 STUDY DESIGN IS ANOTHER ELEMENT 968 00:35:44,233 --> 00:35:45,833 THAT IS NOT NECESSARILY NEWLY 969 00:35:45,833 --> 00:35:46,833 REQUIRED THE WAY IT'S 970 00:35:46,833 --> 00:35:48,733 IMPLEMENTED NOW IS THAT AT LEAST 971 00:35:48,733 --> 00:35:50,933 1 OF THE SUBELEMENTS HAD TO BE 972 00:35:50,933 --> 00:35:52,933 PROVIDED UNDER STUDY DESIGNS, 973 00:35:52,933 --> 00:35:54,533 WHAT IS NEW IS THAT WILL BE 974 00:35:54,533 --> 00:35:57,766 REQUIRING ALL THE ELEMENTS UNDER 975 00:35:57,766 --> 00:35:58,666 STUDY DESIGN. 976 00:35:58,666 --> 00:36:00,066 I WILL POINT OUT THAT UNDER 977 00:36:00,066 --> 00:36:01,966 INTERVENTIONAL STUDY MODEL WHICH 978 00:36:01,966 --> 00:36:03,366 IS WHERE YOU DESCRIBE THE BASIC 979 00:36:03,366 --> 00:36:05,066 DESIGN OF THE STUDY, SO WHETHER 980 00:36:05,066 --> 00:36:07,599 OR NOT IT'S PARALLEL, FACTORIAL, 981 00:36:07,600 --> 00:36:10,300 WE'VE ADDED A NEW OPTION, CALLED 982 00:36:10,300 --> 00:36:13,200 SEQUENTIAL AND THE PRIMARY GOAL 983 00:36:13,200 --> 00:36:15,200 OF THAT NEW OPTION IS TO BE ABLE 984 00:36:15,200 --> 00:36:17,800 TO BETTER ACCOMMODATE CERTAIN 985 00:36:17,800 --> 00:36:21,500 STUDIES THAT PROGRESS BASED ON 986 00:36:21,500 --> 00:36:23,200 MILESTONES OCCURRING PREVIOUS TO 987 00:36:23,200 --> 00:36:23,500 THAT. 988 00:36:23,500 --> 00:36:25,700 SO AN EXAMPLE WOULD BE A DOSE 989 00:36:25,700 --> 00:36:28,200 ESCALATION STUDY WHICH IN SOME 990 00:36:28,200 --> 00:36:30,500 CASES, YOU KNOW MAY BE 991 00:36:30,500 --> 00:36:32,700 CONSIDERED ALSO A PHASE 1 STUDY, 992 00:36:32,700 --> 00:36:34,900 WOULDN'T BE REQUIRED BY THE RULE 993 00:36:34,900 --> 00:36:37,400 BUT THE WAY THAT IT'S APPROACHED 994 00:36:37,400 --> 00:36:39,300 IS THAT OFTEN TIMES YOU HAVE 1 995 00:36:39,300 --> 00:36:42,633 COHORT OR PARTICIPANT. 996 00:36:42,633 --> 00:36:44,133 YOU FIND THE RESULTS FROM THAT 997 00:36:44,133 --> 00:36:45,733 COHORT AND YOU ADD IN A SECOND 998 00:36:45,733 --> 00:36:47,633 COHORT OR PARTICIPANT. 999 00:36:47,633 --> 00:36:49,833 THAT ALSO HAPPENS IN AN ADAPTIVE 1000 00:36:49,833 --> 00:36:51,833 DESIGN TYPE STUDY. 1001 00:36:51,833 --> 00:36:53,433 SO THE SEQUENTIAL OPTION IS 1002 00:36:53,433 --> 00:36:55,133 DESIGNED TO BETTER ACCOMMODATE 1003 00:36:55,133 --> 00:36:58,066 THOSE DESIGNS THAT AREN'T EASILY 1004 00:36:58,066 --> 00:36:59,466 ACCOMMODATED BY THE EXISTING 1005 00:36:59,466 --> 00:37:00,466 OPTIONS. 1006 00:37:00,466 --> 00:37:02,366 ALSO NOTE THERE WILL BEING 1007 00:37:02,366 --> 00:37:03,566 ADDITIONAL FREE RADICALS TEXT 1008 00:37:03,566 --> 00:37:04,466 FIELDS ASSOCIATESSED WITH THE 1009 00:37:04,466 --> 00:37:06,566 DATA ELEMENTS SO INTERVENTIONAL 1010 00:37:06,566 --> 00:37:08,766 STUDY MODEL WILL HAVE A FREE 1011 00:37:08,766 --> 00:37:09,966 TEXT FIELD ASSOCIATE WIDE IT 1012 00:37:09,966 --> 00:37:11,166 THAT IF YOU WANT TO THE PROVIDE 1013 00:37:11,166 --> 00:37:13,066 MORE DETAILS ABOUT THE STUDY 1014 00:37:13,066 --> 00:37:14,999 MODEL ITSELF, YOU WILL HAVE A 1015 00:37:15,000 --> 00:37:16,300 PLACE RIGHT NEXT TO THE 1016 00:37:16,300 --> 00:37:17,300 INFORMATION TO BE ABLE TO 1017 00:37:17,300 --> 00:37:18,300 PROVIDE THAT. 1018 00:37:18,300 --> 00:37:19,900 AND THAT'S TRUE, MANY OTHER 1019 00:37:19,900 --> 00:37:22,600 PLACES, AND AGAIN THAT'S KIND OF 1020 00:37:22,600 --> 00:37:24,500 CLEAR IN VARIOUS ASPECTS OF THE 1021 00:37:24,500 --> 00:37:26,600 PREAMBLE WHERE IT DESCRIBES EACH 1022 00:37:26,600 --> 00:37:31,500 OF THESE DATA ELEMENTS. 1023 00:37:31,500 --> 00:37:33,100 SOME OF THE THINGS MARKED AS NEW 1024 00:37:33,100 --> 00:37:34,500 IN THIS SLIDE ARE AGAIN RELATED 1025 00:37:34,500 --> 00:37:36,300 TO DETERMINING WHETHER OR NOT A 1026 00:37:36,300 --> 00:37:38,000 PARTICULAR STUDY IS AN 1027 00:37:38,000 --> 00:37:40,400 APPLICABLE CLINICAL TRIAL. 1028 00:37:40,400 --> 00:37:44,400 AN INDICATION OF WHETHER A STUDY 1029 00:37:44,400 --> 00:37:46,200 IS A PEDIATRIC POST MARKET 1030 00:37:46,200 --> 00:37:47,933 SURVEILLANCE OF A DEVICE PRODUCT 1031 00:37:47,933 --> 00:37:50,733 IS AGAIN 1 OTHER ASPECTS OF 1032 00:37:50,733 --> 00:37:51,833 DETERMINING WHETHER SOMETHING 1033 00:37:51,833 --> 00:37:55,533 S&P AN ACT, SO THAT'S A NEW DATA 1034 00:37:55,533 --> 00:37:57,866 ELEMENT THAT'S BEING ADADDED. 1035 00:37:57,866 --> 00:38:02,466 A NEW REQUIREMENT IS THE STUDY 1036 00:38:02,466 --> 00:38:03,166 START DATE. 1037 00:38:03,166 --> 00:38:04,766 WE HAVE THIS ELEMENT WITHIN 1038 00:38:04,766 --> 00:38:06,766 CLINICAL TRIALS .GOV AND IT WILL 1039 00:38:06,766 --> 00:38:09,066 BE REQUIRED UNDER THE FINAL RULE 1040 00:38:09,066 --> 00:38:11,866 AND AS YOU ARE AWARE, BECAUSE OF 1041 00:38:11,866 --> 00:38:13,766 THE EFFECTIVE DATE, RELYING ON 1042 00:38:13,766 --> 00:38:16,366 THAT STUDY, START DATE IT'S MORE 1043 00:38:16,366 --> 00:38:17,866 IMPORTANT IN THE CONTEXT OF 1044 00:38:17,866 --> 00:38:19,466 IMPLEMENTING VARIOUS ASPECTS OF 1045 00:38:19,466 --> 00:38:23,699 THE RULE ITSELF. 1046 00:38:23,700 --> 00:38:24,700 ANOTHER THING THAT IS NEW WITHIN 1047 00:38:24,700 --> 00:38:27,400 THE CONTEXT OF THAT DATA ELEMENT 1048 00:38:27,400 --> 00:38:28,400 IS THAT ALTERNATES REQUIRED TO 1049 00:38:28,400 --> 00:38:31,400 PROVIDE THE DAY THAT THE STUDY 1050 00:38:31,400 --> 00:38:33,700 STARTED WHEN THAT STEADY START 1051 00:38:33,700 --> 00:38:35,900 DATE IS CONSIDERED TO BE ACTUAL 1052 00:38:35,900 --> 00:38:37,700 AND THAT'S ANOTHER ASPECT OF 1053 00:38:37,700 --> 00:38:39,300 BEING ABLE TO IMPLEMENT PART OF 1054 00:38:39,300 --> 00:38:41,800 THE REGULATIONS BECAUSE THE 1055 00:38:41,800 --> 00:38:44,400 REQUIREMENTS REGISTERS WITHIN 21 1056 00:38:44,400 --> 00:38:47,100 DAYS OF PARTICIPANT--OF THAT 1057 00:38:47,100 --> 00:38:48,800 FIRST PARTICIPANT BEING ENROLL 1058 00:38:48,800 --> 00:38:50,000 INTERESTED SO, THE KEY TO BEING 1059 00:38:50,000 --> 00:38:52,200 ABLE TO DETERMINE THAT WOULD BE 1060 00:38:52,200 --> 00:38:55,133 TO HAVE A SPECIFIC DATA 1061 00:38:55,133 --> 00:38:56,633 AVAILABLE FOR THAT. 1062 00:38:56,633 --> 00:38:58,066 WE'VE ALSO ADDED A REQUIREMENT 1063 00:38:58,066 --> 00:39:00,366 FOR STEADY COMPLETION DATE. 1064 00:39:00,366 --> 00:39:01,666 I WILL BE TALKING MORE ABOUT 1065 00:39:01,666 --> 00:39:02,966 THIS ASPECT IN THE THIRD 1066 00:39:02,966 --> 00:39:04,766 WEBINAR, PARTICULARLY IN THE 1067 00:39:04,766 --> 00:39:07,466 CONTEXT OF RESULTS INFORMATION 1068 00:39:07,466 --> 00:39:08,666 BECAUSE OF THE DEFINITION OF 1069 00:39:08,666 --> 00:39:11,066 PRIMARY COMPLETION DATA AND HOW 1070 00:39:11,066 --> 00:39:12,266 IT DIFFERS FROM THE STUDY 1071 00:39:12,266 --> 00:39:14,866 COMPLETION DATE, THE STUDY 1072 00:39:14,866 --> 00:39:17,566 COMPLETION DATE ITSELF PROVIDES 1073 00:39:17,566 --> 00:39:20,466 BASICALLY, THE MAXIMUM PERIOD OF 1074 00:39:20,466 --> 00:39:22,466 TIME OVER WHICH WE WOULD EXPECT 1075 00:39:22,466 --> 00:39:24,166 THE RESULTS INFORMATION TO BE 1076 00:39:24,166 --> 00:39:25,966 SUBMITTED BECAUSE BY THAT POINT 1077 00:39:25,966 --> 00:39:27,599 IN TIME, BY THE TIME YOU REACHED 1078 00:39:27,600 --> 00:39:30,800 THE STUDY COMPLETION DATE, YOU 1079 00:39:30,800 --> 00:39:35,200 WOULD HAVE HAD DATA COMPLETION 1080 00:39:35,200 --> 00:39:37,200 FOR THE PRIMARY OR SECONDARY 1081 00:39:37,200 --> 00:39:39,200 OUTCOMES AND THE ADVERSE 1082 00:39:39,200 --> 00:39:39,600 INFORMATION. 1083 00:39:39,600 --> 00:39:41,300 BUT GANNA I KNOW THIS MAY NOT 1084 00:39:41,300 --> 00:39:41,900 SOUND FAMILIAR. 1085 00:39:41,900 --> 00:39:44,000 WE'LL GO INTO MORE DETAILS ABOUT 1086 00:39:44,000 --> 00:39:45,800 THIS IN THE NEXT WEBINAR, MORE 1087 00:39:45,800 --> 00:39:47,300 IN THE CONTEXT OF THE 1088 00:39:47,300 --> 00:39:48,800 REQUIREMENTS. 1089 00:39:48,800 --> 00:39:50,600 AND THEN FINALLY, ENROLLMENT, 1090 00:39:50,600 --> 00:39:52,000 THE TOTAL NUMBER OF PEOPLE THAT 1091 00:39:52,000 --> 00:39:53,300 WERE ENROLL INDEED THE CLINICAL 1092 00:39:53,300 --> 00:39:56,000 TRIAL. 1093 00:39:56,000 --> 00:39:57,000 OTHER THINGS THAT ARE MARKED 1094 00:39:57,000 --> 00:39:59,933 WITH RED ASTERISKS ON THIS SLIDE 1095 00:39:59,933 --> 00:40:01,666 FOR DESCRIPTIVE INFORMATION ARE 1096 00:40:01,666 --> 00:40:06,666 AGAIN FOCUSED ON BEING ABLE TO 1097 00:40:06,666 --> 00:40:09,066 DETERMINE WHETHER A STUDY IS 1098 00:40:09,066 --> 00:40:10,466 INDEED A CLINICAL TRIAL AND SO 1099 00:40:10,466 --> 00:40:12,166 YOU CAN SEE THOSE DATA ELEMENTS 1100 00:40:12,166 --> 00:40:13,366 THAT WE ALREADY TALKED ABOUT IN 1101 00:40:13,366 --> 00:40:15,966 TERMS OF STUDYING USFDA 1102 00:40:15,966 --> 00:40:18,866 REGULATED DEVICE PRODUCT, DRUG 1103 00:40:18,866 --> 00:40:20,466 PRODUCT AND WHETHER OR NOT IT'S 1104 00:40:20,466 --> 00:40:21,466 MANUFACTURED OR EXPORTED FROM 1105 00:40:21,466 --> 00:40:22,566 THE U.S. 1106 00:40:22,566 --> 00:40:25,266 ANOTHER DATA ALIMENT THAT IS 1107 00:40:25,266 --> 00:40:26,966 MARKED AS BEING NEWLY REQUIRED 1108 00:40:26,966 --> 00:40:29,566 AND IS CONSISTENT WITH THE DATA 1109 00:40:29,566 --> 00:40:31,166 ELEMENT THAT WE ALREADY HAVE, IS 1110 00:40:31,166 --> 00:40:32,666 WHETHER OR NOT THAT DEVICE 1111 00:40:32,666 --> 00:40:34,399 PRODUCT IS APPROVED OR CLEARED 1112 00:40:34,400 --> 00:40:38,000 BY THE USFDA. 1113 00:40:38,000 --> 00:40:39,700 ONE ASPECT OF POSTING 1114 00:40:39,700 --> 00:40:40,100 INFORMATION ON 1115 00:40:40,100 --> 00:40:42,600 CLINICALTRIALS.GOV, IS THAT THE 1116 00:40:42,600 --> 00:40:46,300 STATUTE ITSELF RESTRICTED NIH 1117 00:40:46,300 --> 00:41:06,233 FROM POSTING--WE NEED TO KNOW 1118 00:41:06,233 --> 00:41:08,366 THE APPROVAL STATUS OF THE 1119 00:41:08,366 --> 00:41:10,966 DEVICE PRODUCT ITSELF. 1120 00:41:10,966 --> 00:41:13,566 BUT BECAUSE THERE ARE VARIOUS 1121 00:41:13,566 --> 00:41:16,866 REASONS, THAT SPONSORS AND 1122 00:41:16,866 --> 00:41:18,266 RESPONSIBLES PARTIES MAY WANT TO 1123 00:41:18,266 --> 00:41:22,066 MAKE REGISTRATION INFORMATION 1124 00:41:22,066 --> 00:41:23,166 AVAILABLE FOR CLINICAL TRIALS 1125 00:41:23,166 --> 00:41:25,266 THAT EVALUATING THESE PRODUCTS 1126 00:41:25,266 --> 00:41:26,766 THAT ARE NOT YET APPROVED, THE 1127 00:41:26,766 --> 00:41:28,466 FINAL RULE DOES INCLUDE AN 1128 00:41:28,466 --> 00:41:30,066 OPTION FOR A RESPONSIBLE PARTY, 1129 00:41:30,066 --> 00:41:33,866 TO INDICATEICATE THAT THEY'RE 1130 00:41:33,866 --> 00:41:36,666 AUTHORIZING THE NIH TO POST THE 1131 00:41:36,666 --> 00:41:38,266 REGISTRATION INFORMATION BEFORE 1132 00:41:38,266 --> 00:41:40,366 THAT DEVICE PRODUCT HAS BEEN 1133 00:41:40,366 --> 00:41:41,799 APPROVED OR CLEARED. 1134 00:41:41,800 --> 00:41:43,700 THAT'S NOT A REQUIREMENT, IT'S 1135 00:41:43,700 --> 00:41:45,300 AN OPTION IF THE RESPONSIBLE 1136 00:41:45,300 --> 00:41:46,900 PARTY WANTS THAT INFORMATION TO 1137 00:41:46,900 --> 00:41:54,300 BE MADE AVAILABLE TO THE PUBLIC. 1138 00:41:54,300 --> 00:41:55,600 ANOTHER IMPORTANT ASPECT OF THE 1139 00:41:55,600 --> 00:41:57,100 REGISTRATION DATA ELEMENT IS 1140 00:41:57,100 --> 00:41:59,233 THAT THERE'S FURTHER ELABORATION 1141 00:41:59,233 --> 00:42:01,233 IN THE PRIMARY OUTCOME MEASURES 1142 00:42:01,233 --> 00:42:03,133 AND SECONDARY OUTCOME MEASURES. 1143 00:42:03,133 --> 00:42:04,733 THERE ARE 3 COMPONENTS TO HAVING 1144 00:42:04,733 --> 00:42:06,333 A FULL DESCRIPTION OF AN OUTCOME 1145 00:42:06,333 --> 00:42:07,733 MEASURE AND THAT INCLUDES THE 1146 00:42:07,733 --> 00:42:09,633 NAME AND DESCRIPTION OF IT AS 1147 00:42:09,633 --> 00:42:11,233 WELL AS TIME FRAME. 1148 00:42:11,233 --> 00:42:13,233 BUT WHAT WASN'T CLEAR FROM THE 1149 00:42:13,233 --> 00:42:14,766 STATUTE ITSELF WAS WHAT THE 1150 00:42:14,766 --> 00:42:17,566 DEFINITION OF A PRIMARY OUTCOME 1151 00:42:17,566 --> 00:42:18,466 MEASURE IS AND WHAT THE 1152 00:42:18,466 --> 00:42:19,966 DEFINITION OF A SECONDARY 1153 00:42:19,966 --> 00:42:22,266 OUTCOME MEASURE IS, AND SO 1 1154 00:42:22,266 --> 00:42:23,566 BENEFIT OF THE FINAL RULE IS 1155 00:42:23,566 --> 00:42:24,866 THAT IT BRAININGS MORE CLARITY 1156 00:42:24,866 --> 00:42:27,466 TO THE SPECIFIC DEFINITIONS. 1157 00:42:27,466 --> 00:42:29,166 AND BEFORE I DESCRIBED THAT, I 1158 00:42:29,166 --> 00:42:32,266 ALSO JUST WANT TO CLARIFY, THAT 1159 00:42:32,266 --> 00:42:35,566 THE STATUTE AND THE REGULATIONS 1160 00:42:35,566 --> 00:42:37,566 REQUIRE THAT EACH PRIMARY AND 1161 00:42:37,566 --> 00:42:39,766 SECONDARY OUTCOME MEASURE BE 1162 00:42:39,766 --> 00:42:41,366 SUBMITTED, SOMETIMES WE GET 1163 00:42:41,366 --> 00:42:42,566 QUESTIONS ABOUT WHETHER OR NOT 1164 00:42:42,566 --> 00:42:43,966 SECONDARY OUTCOME MEASURES ARE 1165 00:42:43,966 --> 00:42:46,566 LIMITED TO KEY SECONDARY OUTCOME 1166 00:42:46,566 --> 00:42:48,799 MEASURES, THAT LANGUAGE DOESN'T 1167 00:42:48,800 --> 00:42:53,000 EXIST WITHIN THE [INDISCERNIBLE] 1168 00:42:53,000 --> 00:42:55,200 IN TERMS OF LIMITING TO THE 1169 00:42:55,200 --> 00:42:57,100 SECONDARY OUTCOME MEASURES SO 1170 00:42:57,100 --> 00:42:58,633 THE INTERPRETATION HAS BEEN THAT 1171 00:42:58,633 --> 00:43:00,733 THIS SHOULD BE EACH PRIMARY 1172 00:43:00,733 --> 00:43:03,033 OUTCOME MEASURE THAT'S SPECIFIED 1173 00:43:03,033 --> 00:43:03,833 IN THE PROTOCOL. 1174 00:43:03,833 --> 00:43:05,333 THE DEFINITIONS WE PROVIDED FOR 1175 00:43:05,333 --> 00:43:06,733 PRIMARY OUTCOME MEASURE AND 1176 00:43:06,733 --> 00:43:08,233 SECONDARY OUTCOME MEASURE ARE 1177 00:43:08,233 --> 00:43:12,533 AVAILABLE IN SECTION 11.10. 1178 00:43:12,533 --> 00:43:14,133 IT DESCRIBES THE PRIMARY OUTCOME 1179 00:43:14,133 --> 00:43:16,033 MEASURES AS BEING THE OUTCOME 1180 00:43:16,033 --> 00:43:18,033 MEASURE OF GREATEST IMPORTANCE 1181 00:43:18,033 --> 00:43:19,533 THAT'S SPECIFIED IN THE PROTOCOL 1182 00:43:19,533 --> 00:43:21,766 AND AUTOMOBILELY IT'S LABELED AS 1183 00:43:21,766 --> 00:43:23,866 SUCH AND IT'S THE 1 THAT'S 1184 00:43:23,866 --> 00:43:25,666 TYPICALLY USED IN THE POWER 1185 00:43:25,666 --> 00:43:27,166 CALCULATION ITSELF SO IT MAY 1186 00:43:27,166 --> 00:43:29,966 ALSO BE CLEAR FROM THE 1187 00:43:29,966 --> 00:43:31,566 STATISTICAL ANALYSIS PLAN FOR 1188 00:43:31,566 --> 00:43:32,866 THAT CLINICAL TRIAL WHICH IS 1189 00:43:32,866 --> 00:43:34,466 CONSIDERED TO BE THE PRIMARY 1190 00:43:34,466 --> 00:43:35,766 OUTCOME MEASURE. 1191 00:43:35,766 --> 00:43:37,866 AND MOST CASES THERE IS USUALLY 1192 00:43:37,866 --> 00:43:39,866 ONLY 1 PRIMARY OUTCOME MEASURE 1193 00:43:39,866 --> 00:43:41,066 BUT THE RULE ACKNOWLEDGES THAT 1194 00:43:41,066 --> 00:43:42,366 THERE MIGHT BE CASES IN WHICH 1195 00:43:42,366 --> 00:43:44,066 THERE IS MORE THAN 1 PRIMARY 1196 00:43:44,066 --> 00:43:47,266 OUTCOME MEASURE. 1197 00:43:47,266 --> 00:43:49,366 THE RULE ALSO FURTHER DESCRIBES 1198 00:43:49,366 --> 00:43:51,066 THE DEFINITION FOR SECONDARY 1199 00:43:51,066 --> 00:43:51,966 OUTCOME MEASURE AND IN 1200 00:43:51,966 --> 00:43:53,466 COMPARISON TO THE PRIMARY IS 1201 00:43:53,466 --> 00:43:54,899 CONSIDERED TO BE AN OUTCOME 1202 00:43:54,900 --> 00:43:58,633 MEASURE, BUT IT'S SOMETHING THAT 1203 00:43:58,633 --> 00:44:00,433 WOULD BE PART OF THE 1204 00:44:00,433 --> 00:44:04,133 PRESPECIFIED ANALYSIS PLAN AND 1205 00:44:04,133 --> 00:44:06,233 IT BASICALLY EXCLUDES THINGS 1206 00:44:06,233 --> 00:44:07,433 THAT ARE SPECIFIED AS 1207 00:44:07,433 --> 00:44:08,433 EXPLORATORY. 1208 00:44:08,433 --> 00:44:10,533 AND EXPLORATORY OUTCOME MEASURE 1209 00:44:10,533 --> 00:44:11,733 WOULD NUMBER OF PATIENTS BE 1210 00:44:11,733 --> 00:44:13,533 CONSIDERED SECONDARY OUTCOME 1211 00:44:13,533 --> 00:44:17,533 MEASURE IN THAT GENERAL SENSE. 1212 00:44:17,533 --> 00:44:19,733 THE PREAMBLE ALSO HAVE FURTHER 1213 00:44:19,733 --> 00:44:20,933 COLLABORATION ABOUT THE NATURE 1214 00:44:20,933 --> 00:44:21,933 OF THE INFORMATION THAT'S 1215 00:44:21,933 --> 00:44:23,433 EXPECTED TO BE SUBMITTED AS PART 1216 00:44:23,433 --> 00:44:26,133 OF OUTCOME MEASURE INFORMATION 1217 00:44:26,133 --> 00:44:28,066 AND I'VE ALREADY INDICATE THAD 1218 00:44:28,066 --> 00:44:29,666 THE 3 COMPONENTS ARE THE NAME 1219 00:44:29,666 --> 00:44:31,166 AND THE DESCRIPTION IN THE TIME 1220 00:44:31,166 --> 00:44:35,366 POINTS AND SO, HERE YOU CAN SEE 1221 00:44:35,366 --> 00:44:38,366 AN EXAMPLE OF HOW EACH OF THIS 1222 00:44:38,366 --> 00:44:39,766 PLAYS OUT SO GENERALLY SPEAKING 1223 00:44:39,766 --> 00:44:41,066 YOU WOULD HAVE AN ATTRIBUTE YOU 1224 00:44:41,066 --> 00:44:42,166 WANT TO BE MEASURING, IT COULD 1225 00:44:42,166 --> 00:44:45,966 BE SOMETHING LIKE SYSTOLIC BLOOD 1226 00:44:45,966 --> 00:44:47,466 PRESSURE AND THE DESCRIPTION 1227 00:44:47,466 --> 00:44:48,566 WOULD INCLUDE MORE INFORMATION 1228 00:44:48,566 --> 00:44:52,466 ABOUT HOW YOU INTEND TO DESCRIBE 1229 00:44:52,466 --> 00:44:54,166 THE RESULTS FOR THAT SPECIFIC 1230 00:44:54,166 --> 00:44:55,066 OUTCOME MEASURE. 1231 00:44:55,066 --> 00:44:57,566 SO IN THIS CASE THE EXAMPLE 1232 00:44:57,566 --> 00:44:59,066 WOULD BE THE MEAN VALUE OF THAT 1233 00:44:59,066 --> 00:45:00,266 SIS TOLL-LIKE RECEPTORIC BLOOD 1234 00:45:00,266 --> 00:45:01,799 PRESSURE, BUT THAT IN ITSELF 1235 00:45:01,800 --> 00:45:03,000 WOULD NOT BE COMPLETE WITHOUT 1236 00:45:03,000 --> 00:45:04,900 KNOWING AT WHAT TIME POINTS 1237 00:45:04,900 --> 00:45:08,200 YOU'RE INTENDING TO SUMMARIZE 1238 00:45:08,200 --> 00:45:09,500 THE SPECIFIC METRIC THAT WAS 1239 00:45:09,500 --> 00:45:10,400 USED. 1240 00:45:10,400 --> 00:45:11,900 A SPECIFIC ASPECT OF THAT COULD 1241 00:45:11,900 --> 00:45:15,300 BE 24 WEEKS AFTER THE INITIATION 1242 00:45:15,300 --> 00:45:18,800 OF THAT PARTICULAR INTERVENTION 1243 00:45:18,800 --> 00:45:20,300 THAT'S BEING EVALUATED. 1244 00:45:20,300 --> 00:45:22,300 THE PREAMBLE FURTHER CLARIFIES 1245 00:45:22,300 --> 00:45:23,600 THAT IF THERE'S A SINGLE 1246 00:45:23,600 --> 00:45:25,800 ATTRIBUTE LIKE SYSTOLIC BLOOD 1247 00:45:25,800 --> 00:45:27,100 PRESSURE, BUT THAT ASSESS THE 1248 00:45:27,100 --> 00:45:28,300 MULTIPLE POINTS IN TIME THAT 1249 00:45:28,300 --> 00:45:29,700 THAT IS GENERALLY CONSIDERED TO 1250 00:45:29,700 --> 00:45:33,100 BE DIFFERENT OUTCOME MEASURES, 1251 00:45:33,100 --> 00:45:36,133 SO IF YOU'RE EVALUATING SYSTOLIC 1252 00:45:36,133 --> 00:45:37,433 BLOOD PRESSURE AT 3 DIFFERENT 1253 00:45:37,433 --> 00:45:40,033 TIME POINTS, SAY 3 MONTHS, 6 1254 00:45:40,033 --> 00:45:41,833 MONTHS, 12 MONTHS EACH OF THOSE 1255 00:45:41,833 --> 00:45:43,333 TIME POINTS OF ASSESSMENT WOULD 1256 00:45:43,333 --> 00:45:44,633 BE CONSIDERED TO BE A UNIQUE 1257 00:45:44,633 --> 00:45:46,233 OUTCOME MEASURE, EACH OF THOSE 1258 00:45:46,233 --> 00:45:53,633 LOOKS AT THE DATA IF YOU WILL. 1259 00:45:53,633 --> 00:45:54,833 OTHER INFORMATION BEYOND THE 1260 00:45:54,833 --> 00:45:56,433 DESCRIPTIVE INFORMATION THAT'S 1261 00:45:56,433 --> 00:45:57,666 REQUIRED IS INFORMATION RELATED 1262 00:45:57,666 --> 00:46:00,066 TO RECRUITMENT, EVERYONE IS 1263 00:46:00,066 --> 00:46:02,266 GENERALLY FAMILIES WITH THE 1264 00:46:02,266 --> 00:46:03,866 CRITERIA WHICH INCLUDES 1265 00:46:03,866 --> 00:46:05,166 INCLUSION AND EXCLUSION 1266 00:46:05,166 --> 00:46:06,166 CRITERIA. 1267 00:46:06,166 --> 00:46:07,699 THERE ARE SOME STRUCTURED DATA 1268 00:46:07,700 --> 00:46:09,900 ELEMENTS TO GET ASTERISKS THE 1269 00:46:09,900 --> 00:46:12,000 AGE LIMITS OF PEOPLE THAT ARE 1270 00:46:12,000 --> 00:46:14,100 ELIGIBLE FOR THE CLINICAL TRIAL. 1271 00:46:14,100 --> 00:46:15,900 IS THERE A MINIMUM OR MAXIMUM 1272 00:46:15,900 --> 00:46:18,500 AGE AT WHICH ELIGIBILITY IS CUT 1273 00:46:18,500 --> 00:46:20,800 OFF AND IF THE TRIAL ITSELF IS 1274 00:46:20,800 --> 00:46:24,000 LIMITING PER TISIPATION, BASED 1275 00:46:24,000 --> 00:46:27,000 ON A PARTICIPANT SEX OR GENDER 1276 00:46:27,000 --> 00:46:28,400 AND WHETHER OR NOT THE STUDY 1277 00:46:28,400 --> 00:46:30,700 ITSELF IS ACCEPTING HEALTHY 1278 00:46:30,700 --> 00:46:32,000 VOLUNTEERS. 1279 00:46:32,000 --> 00:46:33,400 WE ALSO THEN COLLECT INFORMATION 1280 00:46:33,400 --> 00:46:35,200 ABOUT RECRUITMENT STATUS. 1281 00:46:35,200 --> 00:46:37,000 AND WHETHER OR NOT THE CURRENT 1282 00:46:37,000 --> 00:46:41,333 CLINICAL TRIAL IS CURRENTLY 1283 00:46:41,333 --> 00:46:43,433 RECRUITING OR IF IT HAS 1284 00:46:43,433 --> 00:46:46,333 COMPLETED RECRUITMENT AND 1285 00:46:46,333 --> 00:46:47,633 ONGOING AND WHETHER OR NOT IT'S 1286 00:46:47,633 --> 00:46:49,333 COMPLETED, THIS HAPPENS AT THE 1287 00:46:49,333 --> 00:46:51,133 INDIVIDUAL SITE STATUS LEVEL SO 1288 00:46:51,133 --> 00:46:54,733 THAT INDIVIDUAL PARTICIPANTS WHO 1289 00:46:54,733 --> 00:46:56,833 MAY BE INTERESTED IN A CLINICAL 1290 00:46:56,833 --> 00:46:58,766 STUDY CAN SEE IT AT ANY LOCATION 1291 00:46:58,766 --> 00:47:01,866 THAT MAY BE NEAR THEM, WHETHER 1292 00:47:01,866 --> 00:47:03,266 NOT THAT PARTICULAR LOCATION MAY 1293 00:47:03,266 --> 00:47:05,266 BE RECRUITING AS WELL. 1294 00:47:05,266 --> 00:47:07,066 THE PREAMBLE OF THE FINAL RULE 1295 00:47:07,066 --> 00:47:09,066 ALSO FURTHER ELABORATES ON THAT 1296 00:47:09,066 --> 00:47:10,766 SECTION GENDER BETA ELEMENT, 1297 00:47:10,766 --> 00:47:14,366 THAT THE REQUIREMENT IS 1298 00:47:14,366 --> 00:47:17,899 BASICALLY TO INDICATE WHETHER OR 1299 00:47:17,900 --> 00:47:21,700 NOT THEORY KRUTMENT IS INDICATE 1300 00:47:21,700 --> 00:47:22,900 BIDE THE SEX OF THE INDIVIDUAL, 1301 00:47:22,900 --> 00:47:24,200 YOU CAN SEE THE DEFINITION HERE, 1302 00:47:24,200 --> 00:47:25,700 BUT IF NECESSARY, IF THE TRIAL 1303 00:47:25,700 --> 00:47:28,200 ITSELF IS ALSO TAKING INTO 1304 00:47:28,200 --> 00:47:29,100 CONSIDERATION A PERSON 1305 00:47:29,100 --> 00:47:30,900 SELF-REPRESENTATION OF THEIR 1306 00:47:30,900 --> 00:47:32,500 GENDER IDENTITY. 1307 00:47:32,500 --> 00:47:33,700 THERE'S NOW GOING TO BE A 1308 00:47:33,700 --> 00:47:35,700 STRUCTURED AND EASIER PLACE TO 1309 00:47:35,700 --> 00:47:37,200 IDENTIFY THAT INFORMATION WITHIN 1310 00:47:37,200 --> 00:47:39,300 THE CONTEXT OF RECRUITMENT 1311 00:47:39,300 --> 00:47:43,800 INFORMATION. 1312 00:47:43,800 --> 00:47:46,000 ANOTHER KEY DATA ELEMENT IS THE 1313 00:47:46,000 --> 00:47:48,733 AVAILABILITY OF EXPANDED ACCESS. 1314 00:47:48,733 --> 00:47:51,033 THIS PERTAINS TO APPLICABLE DRUG 1315 00:47:51,033 --> 00:47:53,333 CLINICAL TRIALS THAT INCLUDE 1316 00:47:53,333 --> 00:47:56,133 INVESTIGATIONAL DRUG PRODUCTS. 1317 00:47:56,133 --> 00:47:58,066 IN THE NOTICE OF PROPOSED RULE 1318 00:47:58,066 --> 00:48:01,566 MAKING THERE IS A MORE GENERAL 1319 00:48:01,566 --> 00:48:02,666 REQUIREMENT ABOUT WHO WOULD BE 1320 00:48:02,666 --> 00:48:03,866 REQUIRED TO PROVIDE INFORMATION 1321 00:48:03,866 --> 00:48:05,366 ABOUT THE AVAILABILITY OF 1322 00:48:05,366 --> 00:48:06,566 EXPANDED ACCESS. 1323 00:48:06,566 --> 00:48:08,066 WE RECEIVED A LOT OF COMMENTS 1324 00:48:08,066 --> 00:48:09,466 ABOUT THIS, AND THERE WERE 1325 00:48:09,466 --> 00:48:12,766 CONCERNS THAT THERE MAY BE CASES 1326 00:48:12,766 --> 00:48:14,066 IN WHICH THE RESPONSIBILITY 1327 00:48:14,066 --> 00:48:16,566 PARTY MAY OR MAY NOT BE AWARE OF 1328 00:48:16,566 --> 00:48:18,166 WHETHER OR NOT THERE IS EXPANDED 1329 00:48:18,166 --> 00:48:20,066 ACCESS AVAILABLE TO A PARTICULAR 1330 00:48:20,066 --> 00:48:22,599 PRODUCT AND SO, THE APPROACH 1331 00:48:22,600 --> 00:48:25,500 TAKEN IN THE FINAL RULE IS TO 1332 00:48:25,500 --> 00:48:27,900 LIMIT THE REQUIREMENT FOR 1333 00:48:27,900 --> 00:48:29,000 PROVIDING INFORMATION ON 1334 00:48:29,000 --> 00:48:31,600 EXPANDED ACCESS, THE SITUATIONS 1335 00:48:31,600 --> 00:48:33,700 IN WHICH THE RESPONSIBLE PARTY 1336 00:48:33,700 --> 00:48:35,800 IS BOTH THE MANUFACTURE AND THE 1337 00:48:35,800 --> 00:48:37,600 SPONSOR OF THAT APPLICABLE 1338 00:48:37,600 --> 00:48:39,400 CLINICAL TRIAL BECAUSE IN THAT 1339 00:48:39,400 --> 00:48:42,300 CASE, THEY WOULD BE IN A 1340 00:48:42,300 --> 00:48:44,100 POSITION TO KNOW ABOUT THE 1341 00:48:44,100 --> 00:48:46,700 AVAILABILITY OF EXPANDED ACCESS 1342 00:48:46,700 --> 00:48:50,200 FOR THAT DRUG PRODUCT. 1343 00:48:50,200 --> 00:48:51,700 THE OTHER THING WE CLARIFIED IN 1344 00:48:51,700 --> 00:48:53,500 THE CONTEXT OF EXPANDED 1345 00:48:53,500 --> 00:48:54,733 ACSESSION AND PROVIDING 1346 00:48:54,733 --> 00:48:55,633 INFORMATION ABOUT IT IS THAT 1347 00:48:55,633 --> 00:48:59,266 IT'S--IT COVERS ALL ASPECTS OF 1348 00:48:59,266 --> 00:49:01,166 THE REGULATIONS RELATED TO 1349 00:49:01,166 --> 00:49:03,566 EXPANDED ACCESS PROGRAMS SO 1350 00:49:03,566 --> 00:49:05,366 THERE'S 3 DIFFERENT TYPES OF 1351 00:49:05,366 --> 00:49:06,566 EXPANDED ACCESS THAT ARE 1352 00:49:06,566 --> 00:49:08,066 DESCRIBE INDEED FDA REGULATIONS 1353 00:49:08,066 --> 00:49:09,866 AND THOSE INCLUDE FOR INDIVIDUAL 1354 00:49:09,866 --> 00:49:11,766 PATIENTS, INTERMEDIATE SIZE 1355 00:49:11,766 --> 00:49:13,066 POPULATIONS AND THE THIRD 1356 00:49:13,066 --> 00:49:15,566 CATEGORY OF UNDERTREATMENT IND 1357 00:49:15,566 --> 00:49:18,266 OR PROTOCOL AND THE FINAL RULE 1358 00:49:18,266 --> 00:49:20,166 ITSELF CLARIFIES THAT ALL 3 OF 1359 00:49:20,166 --> 00:49:24,566 THESE TYPES OF EXPANDED ACCESS 1360 00:49:24,566 --> 00:49:27,999 ARE CONSIDERED TO BE COVERED 1361 00:49:28,000 --> 00:49:29,000 WHEN YOU'RE ANSWERING THE 1362 00:49:29,000 --> 00:49:30,200 QUESTION ABOUT AVAILABILITY OF 1363 00:49:30,200 --> 00:49:32,500 EXPANDED ACCESS. 1364 00:49:32,500 --> 00:49:33,800 THEN THE NEXT LEVEL REQUIREMENT 1365 00:49:33,800 --> 00:49:38,600 WHICH IS ALSO CURRENTLY 1366 00:49:38,600 --> 00:49:39,400 SOMETHING THAT HAPPENS ON 1367 00:49:39,400 --> 00:49:43,200 CLINICALTRIALS.GOV IS THAT THE 1368 00:49:43,200 --> 00:49:44,800 PARTY MUST CREATE A EXPANDED 1369 00:49:44,800 --> 00:49:46,100 ACCESS RECORD TO PROVIDE 1370 00:49:46,100 --> 00:49:47,200 INFORMATION ABOUT THE 1371 00:49:47,200 --> 00:49:48,700 AVAILABILITY OF THAT 1372 00:49:48,700 --> 00:49:50,600 INVESTIGATIONAL DRUG PRODUCT. 1373 00:49:50,600 --> 00:49:52,200 SO AFTER THAT EXPANDED ACCESS 1374 00:49:52,200 --> 00:49:55,200 RECORD IS CREATED BY THE SPONSOR 1375 00:49:55,200 --> 00:49:57,233 OF THE APPLICABLE CLINICAL 1376 00:49:57,233 --> 00:49:59,533 TRIAL, THEN THE NCT NUMBER FOR 1377 00:49:59,533 --> 00:50:01,666 THAT EXPABDED ACCESS RECORD MUST 1378 00:50:01,666 --> 00:50:03,466 BE ADDED TO THE APPLICABLE 1379 00:50:03,466 --> 00:50:06,966 CLINICAL TRIAL RECORD ITSELF. 1380 00:50:06,966 --> 00:50:09,666 THE REGULATIONS IN SECTION 1128 1381 00:50:09,666 --> 00:50:11,766 C HAVE MORE DETAILS ABOUT THE 1382 00:50:11,766 --> 00:50:13,266 SPECIFIC DATA ELEMENTS THAT ARE 1383 00:50:13,266 --> 00:50:15,566 REQUIRED FOR AN EXPANDED ACCESS 1384 00:50:15,566 --> 00:50:16,666 RECORD. 1385 00:50:16,666 --> 00:50:17,966 IT'S VERY SIMILAR TO THE DATA 1386 00:50:17,966 --> 00:50:21,966 ELEMENTS THAT ARE REQUIRED UNDER 1387 00:50:21,966 --> 00:50:25,266 1128 OR AN APPLICABLE CLINICAL 1388 00:50:25,266 --> 00:50:26,866 TRIAL BUT IT'S LIMITED TO THE 1389 00:50:26,866 --> 00:50:28,666 DATA ELEMENTS THAT ARE MOST 1390 00:50:28,666 --> 00:50:31,266 RELEVANT TO EXPANDED ACCESS. 1391 00:50:31,266 --> 00:50:32,766 I JUST WANT TO MENTION THAT 1 OF 1392 00:50:32,766 --> 00:50:34,899 THE THINGS THAT WE'VE ADDED IS 1393 00:50:34,900 --> 00:50:37,300 THE ABILITY TO INDICATE THE TYPE 1394 00:50:37,300 --> 00:50:40,300 OF EXPANDED ACCESS THAT IS 1395 00:50:40,300 --> 00:50:41,900 AVAILABLE CORRESPONDING TO THOSE 1396 00:50:41,900 --> 00:50:43,600 3 TYPES UNDER THE EXPANDED 1397 00:50:43,600 --> 00:50:45,400 ACCESS REGULATIONS. 1398 00:50:45,400 --> 00:50:47,100 THE EXPECTATION IS THAT THERE 1399 00:50:47,100 --> 00:50:49,500 WOULD STILL BE JUST 1 EXPANDED 1400 00:50:49,500 --> 00:50:52,300 ACCESS RECORD FOR EACH 1401 00:50:52,300 --> 00:50:55,100 INVESTIGATIONAL DRUG PRODUCT BUT 1402 00:50:55,100 --> 00:50:56,900 THE SPONSOR WOULD INDICATE THE 1403 00:50:56,900 --> 00:50:59,533 TYPE OF EXPANDED ACCESS THAT IS 1404 00:50:59,533 --> 00:51:00,533 AVAILABLE FOR THAT 1405 00:51:00,533 --> 00:51:02,233 INVESTIGATIONAL DRUG PRODUCT IN 1406 00:51:02,233 --> 00:51:04,433 THAT RECORD AND MORE THAN 1 TYPE 1407 00:51:04,433 --> 00:51:08,566 COULD BE MENTIONED. 1408 00:51:08,566 --> 00:51:10,366 THE TYPE BECOMES IMPORTANT AGAIN 1409 00:51:10,366 --> 00:51:12,466 BECAUSE IF IT IS JUST INDIVIDUAL 1410 00:51:12,466 --> 00:51:14,066 PATIENT ACCESS, THEN THERE ARE 1411 00:51:14,066 --> 00:51:16,366 EVEN A MORE LIMITED SET OF DATA 1412 00:51:16,366 --> 00:51:17,666 ELEMENTS THAT ARE REQUIRED TO BE 1413 00:51:17,666 --> 00:51:19,266 PROVIDED WITHIN THAT EXPANDED 1414 00:51:19,266 --> 00:51:22,566 ACCESS RECORD. 1415 00:51:22,566 --> 00:51:25,066 THE FINAL SECTION IS--OR THE 1416 00:51:25,066 --> 00:51:26,866 NEXT SECTION LOCATION AND 1417 00:51:26,866 --> 00:51:28,866 CONTACT INFORMATION. 1418 00:51:28,866 --> 00:51:31,366 MANY OF THESE DATA ELEMENTS ARE 1419 00:51:31,366 --> 00:51:32,766 PRACTICALLY, THEY ARE THE SAME 1420 00:51:32,766 --> 00:51:34,366 AS WHAT'S CURRENTLY AVAILABLE IN 1421 00:51:34,366 --> 00:51:37,266 CLINICALTRIALS.GOV AND IN THE 1422 00:51:37,266 --> 00:51:38,166 FIRST PART WHAT WE'RE TALKING 1423 00:51:38,166 --> 00:51:39,866 ABOUT RESPONSIBLE PARTY AND THAT 1424 00:51:39,866 --> 00:51:42,799 DESIGNATION OF THE PRINCIPLE 1425 00:51:42,800 --> 00:51:45,300 INVESTIGATOR, IT'S LOCATED UNDER 1426 00:51:45,300 --> 00:51:46,800 THIS RESPONSIBLE PARTY BY 1427 00:51:46,800 --> 00:51:49,000 OFFICIAL TITLES DATA ELEMENT BUT 1428 00:51:49,000 --> 00:51:50,500 THAT'S WHERE THAT DESIGNATION 1429 00:51:50,500 --> 00:51:53,800 OCCURS. 1430 00:51:53,800 --> 00:51:55,200 THEN FINALLY THE LAST PIECE OF 1431 00:51:55,200 --> 00:51:57,166 ADMINISTRATIVE DATA ARE LISTED 1432 00:51:57,166 --> 00:51:57,932 HERE. 1433 00:51:57,933 --> 00:51:59,533 AGAIN THESE ARE ARE ALL VERY 1434 00:51:59,533 --> 00:52:00,933 SIMILAR TO WHAT IS CURRENTLY 1435 00:52:00,933 --> 00:52:01,533 AVAILABLE WITHIN 1436 00:52:01,533 --> 00:52:03,033 CLINICALTRIALS.GOV. 1437 00:52:03,033 --> 00:52:04,933 THE HUMAN SUBJECTS REVIEW BOARD 1438 00:52:04,933 --> 00:52:07,733 STATUS WHETHER OR NOT THAT TRIAL 1439 00:52:07,733 --> 00:52:09,733 HAS BEEN APPROVED OR NOT BY A 1440 00:52:09,733 --> 00:52:11,633 HUMAN SUBJECTS REVIEW BOARD WILL 1441 00:52:11,633 --> 00:52:13,833 NOW BE MADE PUBLIC, IT WASN'T A 1442 00:52:13,833 --> 00:52:16,366 PIECE OF INFORMATION THAT WE 1443 00:52:16,366 --> 00:52:17,566 MADE AVAILABLE IN THE PAST BUT 1444 00:52:17,566 --> 00:52:18,966 THAT WILL NOW BE POSTED ON THE 1445 00:52:18,966 --> 00:52:21,966 CLINICALTRIALS.GOV RECORD. 1446 00:52:21,966 --> 00:52:24,566 THERE IS ALSO ADDITIONAL 1447 00:52:24,566 --> 00:52:26,866 INFORMATION REQUIRED FOR THE 1448 00:52:26,866 --> 00:52:27,666 RESPONSIBLE PARTY AND THEIR 1449 00:52:27,666 --> 00:52:29,066 CONTACT INFORMATION BUT 1450 00:52:29,066 --> 00:52:31,366 GENERALLY THAT INFORMATION IS 1451 00:52:31,366 --> 00:52:33,166 NOT GOING TO BE MADE PUBLIC. 1452 00:52:33,166 --> 00:52:35,566 THAT WILL BE KEPT INTERNALLY FOR 1453 00:52:35,566 --> 00:52:39,766 ADMINISTRATIVE PURPOSES ONLY. 1454 00:52:39,766 --> 00:52:41,066 SO THE FINAL SECTION I WANT TO 1455 00:52:41,066 --> 00:52:42,466 COVER TODAY AND I REALIZE WE'RE 1456 00:52:42,466 --> 00:52:45,566 ABOUT 7 MINUTES FROM THE END, IS 1457 00:52:45,566 --> 00:52:46,966 ABOUT WHEN CLINICAL TRIAL 1458 00:52:46,966 --> 00:52:48,799 REGISTRATION INFORMATION MUST BE 1459 00:52:48,800 --> 00:52:50,500 UPDATED. 1460 00:52:50,500 --> 00:52:54,200 THE UPDATE REQUIREMENTS ARE NOT 1461 00:52:54,200 --> 00:52:56,500 DESCRIBED IN PUB PART B WITH THE 1462 00:52:56,500 --> 00:52:58,233 REGISTRATION REQUIREMENTS 1463 00:52:58,233 --> 00:52:59,833 THEY'RE DESCRIBED IN SECTION 1464 00:52:59,833 --> 00:53:02,433 1164 WHICH COVERS UPDATE 1465 00:53:02,433 --> 00:53:04,633 REQUIREMENTS BOTH FOR CLINICAL 1466 00:53:04,633 --> 00:53:05,933 TRIAL REGISTRATION INFORMATION 1467 00:53:05,933 --> 00:53:08,033 AND CLINICAL TRIAL RESULTS 1468 00:53:08,033 --> 00:53:08,933 INFORMATION. 1469 00:53:08,933 --> 00:53:10,733 AND AS WITH OTHER SECTIONS OF 1470 00:53:10,733 --> 00:53:13,633 THE RULE, IT DISTINGUISHES 1471 00:53:13,633 --> 00:53:16,233 BETWEEN TRIALS THAT STARTED 1472 00:53:16,233 --> 00:53:18,133 BEFORE JANUARY18th OR THE 1473 00:53:18,133 --> 00:53:22,466 EFFECTIVE DATE OF THE FINAL RULE 1474 00:53:22,466 --> 00:53:23,666 AND THOSE THAT WERE STARTED ON 1475 00:53:23,666 --> 00:53:24,966 OR AFTER THE EFFECTIVE DATE OF 1476 00:53:24,966 --> 00:53:25,866 THE FINAL RULE. 1477 00:53:25,866 --> 00:53:27,266 I WILL JUST FOCUS ON THOSE 1478 00:53:27,266 --> 00:53:28,966 ASPECTS HERE. 1479 00:53:28,966 --> 00:53:31,066 IN GENERAL, THE CLINICAL TRIAL 1480 00:53:31,066 --> 00:53:32,766 REGISTRATION INFORMATION MUST BE 1481 00:53:32,766 --> 00:53:34,966 UPDATED AT LEAST ONCE PER YEAR. 1482 00:53:34,966 --> 00:53:36,866 AND THERE ARE OTHER MORE 1483 00:53:36,866 --> 00:53:38,966 DETAILED REQUIREMENTS FOR 1484 00:53:38,966 --> 00:53:40,866 CERTAIN DATA ELEMENTS THAT NEED 1485 00:53:40,866 --> 00:53:43,166 TO BE UPDATED IN A MORE TIMELY 1486 00:53:43,166 --> 00:53:44,666 FASHION. 1487 00:53:44,666 --> 00:53:46,566 ALL OF THE UPDATE REQUIREMENTS 1488 00:53:46,566 --> 00:53:47,666 BECAUSE ALL OF THE INFORMATION 1489 00:53:47,666 --> 00:53:50,566 ON CLINICAL TRIALS.GOV, OR MOST 1490 00:53:50,566 --> 00:53:51,866 OF THE TRIAL INFORMATION ON 1491 00:53:51,866 --> 00:53:55,699 PUBLIC TRIALS, THE PURPOSE AND 1492 00:53:55,700 --> 00:53:58,033 INTENT OF HAVING UPDATE 1493 00:53:58,033 --> 00:53:59,133 REQUIREMENTS IS TO INSURE THAT 1494 00:53:59,133 --> 00:54:00,833 THE PUBLIC INFORMATION THAT IS 1495 00:54:00,833 --> 00:54:02,733 SUBMITTED TO US AND AVAILABLE IS 1496 00:54:02,733 --> 00:54:04,633 ACTUALLY UP TO DATE AND 1497 00:54:04,633 --> 00:54:06,333 ACCURATE. 1498 00:54:06,333 --> 00:54:08,233 THAT'S AT LEAST 1 OF THE GENERAL 1499 00:54:08,233 --> 00:54:09,533 PURPOSES. 1500 00:54:09,533 --> 00:54:11,333 ON THIS SLIDE, I LISTED ALL OF 1501 00:54:11,333 --> 00:54:15,333 THE DATA ELEMENTS THAT ARE 1502 00:54:15,333 --> 00:54:17,033 SUBJECT TO THE SUBJECT 30 DAY 1503 00:54:17,033 --> 00:54:18,033 UPDATE REQUIREMENTS. 1504 00:54:18,033 --> 00:54:19,733 MEANING IF THERE ARE CHANGES AS 1505 00:54:19,733 --> 00:54:21,833 DESCRIBED HERE, THAT THEY MUST 1506 00:54:21,833 --> 00:54:25,233 OCCUR WITHIN 30 DAYS OF THOSE 1507 00:54:25,233 --> 00:54:26,033 CHANGES. 1508 00:54:26,033 --> 00:54:27,566 AND YOU CAN SEE THAT MANY OF 1509 00:54:27,566 --> 00:54:31,266 THESE DATA ELEMENTINGS ARE DATA 1510 00:54:31,266 --> 00:54:32,866 ELEMENTS THAT ARE REALLY KEY TO 1511 00:54:32,866 --> 00:54:34,666 IMPLEMENTING VARIOUS ASPECTS OF 1512 00:54:34,666 --> 00:54:35,666 THE FINAL RULE. 1513 00:54:35,666 --> 00:54:37,066 FOR EXAMPLE, THE PRIMARY 1514 00:54:37,066 --> 00:54:38,666 COMPLETION DATE, THE PRIMARY 1515 00:54:38,666 --> 00:54:40,166 COMPLETION DATE IS WHAT 1516 00:54:40,166 --> 00:54:43,266 DETERMINES WHEN THE RESULTS AND 1517 00:54:43,266 --> 00:54:44,666 INFORMATION IS REQUIRED TO BE 1518 00:54:44,666 --> 00:54:46,466 SUBMITTED SO HAVING AN ACCURATE 1519 00:54:46,466 --> 00:54:47,966 AND UP TO DATE PRIMARY 1520 00:54:47,966 --> 00:54:51,866 COMPLETION DATE WITHIN A 1521 00:54:51,866 --> 00:54:52,866 REASONABLE TIME PERIOD AFTER IT 1522 00:54:52,866 --> 00:54:54,866 IS KNOWN IS CRITICAL FOR 1523 00:54:54,866 --> 00:54:56,966 IMPLEMENTING VARIOUS ASPECTS OF 1524 00:54:56,966 --> 00:55:00,366 THE RULE. 1525 00:55:00,366 --> 00:55:02,199 SOME OTHER THINGS I'LL MENTION 1526 00:55:02,200 --> 00:55:03,700 THOUGH IS THAT IN GENERAL, THE 1527 00:55:03,700 --> 00:55:06,000 RECORD VERIFICATION DATE IS 1528 00:55:06,000 --> 00:55:08,700 SOMETHING THAT MUST BE UPDATED 1529 00:55:08,700 --> 00:55:12,400 ANYTIME THE RESPONSIBLE PARTY 1530 00:55:12,400 --> 00:55:14,600 REVIEWS THE COMPLETE SET OF 1531 00:55:14,600 --> 00:55:15,700 CLINICAL TRIAL INFORMATION AND 1532 00:55:15,700 --> 00:55:18,300 NOT LESS THAN EVERY 12 MONTHS. 1533 00:55:18,300 --> 00:55:19,700 SO EVEN IF NO UPDATED 1534 00:55:19,700 --> 00:55:21,200 INFORMATION IS PROVIDED, THAT 1535 00:55:21,200 --> 00:55:23,700 RECORD VERIFICATION DATE MUST BE 1536 00:55:23,700 --> 00:55:25,100 KEPT UP TO DATE AT LEAST ONCE 1537 00:55:25,100 --> 00:55:26,400 EVERY 12 MONTHS. 1538 00:55:26,400 --> 00:55:29,200 IN THE NEXT WEBINAR I'LL HAVE 1539 00:55:29,200 --> 00:55:30,400 TIME TO GO INTO MORE DETAIL 1540 00:55:30,400 --> 00:55:31,800 ABOUT WHEN THE OBLIGATION TO 1541 00:55:31,800 --> 00:55:34,200 UPDATE ENDS. 1542 00:55:34,200 --> 00:55:37,433 THIS ISN'T INTO PURPLE TUITY 1543 00:55:37,433 --> 00:55:38,333 WHERE WE HAVE KEEP THE 1544 00:55:38,333 --> 00:55:40,133 RECOMMENDATION UPDATED FOREVER, 1545 00:55:40,133 --> 00:55:41,533 THERE IS BASICALLY A CUT OFF IN 1546 00:55:41,533 --> 00:55:45,433 THE REGULATIONS IN TERMS OF WHEN 1547 00:55:45,433 --> 00:55:47,533 THE OBLIGATION TO UPDATE ENDS. 1548 00:55:47,533 --> 00:55:48,833 THE OTHER THING THAT'S EXPLAINED 1549 00:55:48,833 --> 00:55:50,433 IS THAT IF THERE ARE PROTOCOL 1550 00:55:50,433 --> 00:55:51,633 AMENDMENTS THAT IMPACT 1551 00:55:51,633 --> 00:55:53,133 REGISTRATION INFORMATION, THAT 1552 00:55:53,133 --> 00:55:57,466 THOSE MUST ALSO BE UPDATED IN A 1553 00:55:57,466 --> 00:55:59,866 TIMELY FASHION ON CLINICAL 1554 00:55:59,866 --> 00:56:02,966 TRIALS.GOV WITHIN THE 30 DAY 1555 00:56:02,966 --> 00:56:05,966 TIMELINE. 1556 00:56:05,966 --> 00:56:07,366 AND THEN THE FINAL UPDATE 1557 00:56:07,366 --> 00:56:08,599 REQUIREMENT FOR REGISTRATION 1558 00:56:08,600 --> 00:56:09,900 INFORMATION IS THAT THAT MUST BE 1559 00:56:09,900 --> 00:56:11,800 UPDATE AT A TIME TAKEN--THEY 1560 00:56:11,800 --> 00:56:13,400 RESULTS INFORMATION IS INITIALLY 1561 00:56:13,400 --> 00:56:14,500 SUBMITTED. 1562 00:56:14,500 --> 00:56:15,800 IT MAY BE THE CASE THAT NO 1563 00:56:15,800 --> 00:56:17,300 UPDATES ARE NEEDED BUT THE 1564 00:56:17,300 --> 00:56:18,400 GENERAL CONCEPT IS THAT IT 1565 00:56:18,400 --> 00:56:20,000 SHOULD BE UPTO DATE AT THE TIME 1566 00:56:20,000 --> 00:56:21,400 RESUMMITS INFORMATION IS NEEDED 1567 00:56:21,400 --> 00:56:23,200 AND AGAIN THE REQUIREMENTS FOR 1568 00:56:23,200 --> 00:56:25,900 WHICH REGISTRATION INFORMATION 1569 00:56:25,900 --> 00:56:29,000 IS REQUIRED IS BASED ON THE 1570 00:56:29,000 --> 00:56:30,000 EFFECTIVE DATE. 1571 00:56:30,000 --> 00:56:31,600 SO EVEN IF YOUR RESULTS, 1572 00:56:31,600 --> 00:56:32,900 SUBMISSION REQUIREMENTS ARE 1573 00:56:32,900 --> 00:56:34,700 HAPPENING AFTER THE EFFECTIVE 1574 00:56:34,700 --> 00:56:36,500 DATE, IT DOESN'T MEAN THAT 1575 00:56:36,500 --> 00:56:38,700 SUDDENLY YOUR CLINICAL TRIAL 1576 00:56:38,700 --> 00:56:40,600 REGISTRATION INFORMATION ARE 1577 00:56:40,600 --> 00:56:41,333 CHANGING. 1578 00:56:41,333 --> 00:56:47,333 IT'S STILL BASED ON THE STUDY 1579 00:56:47,333 --> 00:56:49,733 START DATE FOR THAT APPLICABLE 1580 00:56:49,733 --> 00:56:50,033 TRIAL. 1581 00:56:50,033 --> 00:56:51,333 I WANT TO HIGHLIGHT A FEW 1582 00:56:51,333 --> 00:56:53,533 RESOURCES AGAIN THE RECORDING 1583 00:56:53,533 --> 00:56:55,433 FROM THE FIRST WEBINAR IS NOW 1584 00:56:55,433 --> 00:56:57,466 AVAILABLE AND ON ONLINE USING 1585 00:56:57,466 --> 00:57:00,766 THE URL THAT'S AT THE BOTTOM OF 1586 00:57:00,766 --> 00:57:01,466 THE SLIDE. 1587 00:57:01,466 --> 00:57:04,266 WE WILL BE POSTING THIS 1588 00:57:04,266 --> 00:57:06,566 RECORDING AS WELL AS SOON AS 1589 00:57:06,566 --> 00:57:06,866 POSSIBLE. 1590 00:57:06,866 --> 00:57:08,366 IT WILL LIKELY BE EARLY NEXT 1591 00:57:08,366 --> 00:57:10,166 WEEK. 1592 00:57:10,166 --> 00:57:11,866 AND THEN JUST A REMINDER IF YOU 1593 00:57:11,866 --> 00:57:14,766 HAVE NOT YET REGISTERED FOR THE 1594 00:57:14,766 --> 00:57:15,899 THIRD WEBINAR WHICH IS 1595 00:57:15,900 --> 00:57:17,700 OCTOBER11th, PLEASE GO AHEAD 1596 00:57:17,700 --> 00:57:18,400 AND DO SO. 1597 00:57:18,400 --> 00:57:20,500 YOU CAN EXCESS THAT 1598 00:57:20,500 --> 00:57:23,000 INFORMATIONISTRATION INFORMATION 1599 00:57:23,000 --> 00:57:24,000 AGAIN WITH THE LINK THAT'S ON 1600 00:57:24,000 --> 00:57:25,600 THIS SLIDE, IT'S AGAIN UNDER THE 1601 00:57:25,600 --> 00:57:27,000 SUBMIT STUDIES AND TRAINING 1602 00:57:27,000 --> 00:57:28,100 MATERIAL SECTION OF THE CLINICAL 1603 00:57:28,100 --> 00:57:32,200 TRIALS.GOV WEB SITE. 1604 00:57:32,200 --> 00:57:33,700 AND JUST A REMINDER THERE ARE 1605 00:57:33,700 --> 00:57:35,600 OTHER NIH RESOURCES AVAILABLE 1606 00:57:35,600 --> 00:57:37,500 BOTH ON THE FINAL RULE AND NIH 1607 00:57:37,500 --> 00:57:39,700 POLICY, ON CLINICAL TRIAL 1608 00:57:39,700 --> 00:57:41,300 REGISTRATION AND RESULTS 1609 00:57:41,300 --> 00:57:42,500 SUBMISSION THAT WE DID NOT 1610 00:57:42,500 --> 00:57:44,300 DISCUSS TODAY BUT WE BRIEFLY 1611 00:57:44,300 --> 00:57:45,800 MENTIONED IN THE FIRST WEBINAR, 1612 00:57:45,800 --> 00:57:46,900 IF YOU HAVE ANY QUESTIONS ABOUT 1613 00:57:46,900 --> 00:57:49,533 THAT POLICY, THERE'S AN E-MAIL 1614 00:57:49,533 --> 00:57:50,833 ADDRESS AVAILABLE HERE AS WELL 1615 00:57:50,833 --> 00:57:52,733 AS ADDITIONAL INFORMATION IN THE 1616 00:57:52,733 --> 00:57:55,733 NIH GID NOTICE. 1617 00:57:55,733 --> 00:57:57,133 --GUIDE NOTICE. 1618 00:57:57,133 --> 00:57:58,666 AND THEN ADDITIONAL RESOURCES 1619 00:57:58,666 --> 00:57:59,966 THAT WE HAVE ON THE CLINICAL 1620 00:57:59,966 --> 00:58:04,566 TRIALS.GOV WEB SITE. 1621 00:58:04,566 --> 00:58:07,266 --CLINICALTRIALS.GOV WEB SITE. 1622 00:58:07,266 --> 00:58:08,466 I KNOW PEOPLE HAVE BEEN 1623 00:58:08,466 --> 00:58:09,466 SUBMITTING QUESTIONS THROUGHOUT 1624 00:58:09,466 --> 00:58:10,866 THE WEBINAR AND IT SEEMS LIKE 1625 00:58:10,866 --> 00:58:12,066 THERE'S MAYBE A FEW THAT ARE 1626 00:58:12,066 --> 00:58:15,566 RECURRING EEL SEE IF WE CAN TAKE 1627 00:58:15,566 --> 00:58:16,966 A LOOK AND GET A FEW OF THEM 1628 00:58:16,966 --> 00:58:17,566 ANSWERED NOW. 1629 00:58:17,566 --> 00:58:21,666 IF NOT, AS LIKE THE LAST 1630 00:58:21,666 --> 00:58:23,499 WEBINAR, WHAT WILL AIM TO DO IS 1631 00:58:23,500 --> 00:58:25,100 FOLLOW UP IN THE SUBSEQUENT 1632 00:58:25,100 --> 00:58:28,800 WEBINAR AND/OR POST INFORMATION 1633 00:58:28,800 --> 00:58:30,800 ON OUR WEB SITE THAT MIGHT BE 1634 00:58:30,800 --> 00:58:33,900 ABLE TO APPROPRIATELY RESPOND TO 1635 00:58:33,900 --> 00:58:35,566 THE QUESTIONS. 1636 00:58:35,566 --> 00:58:39,599 THE QUESTIONS. 1637 00:58:39,600 --> 00:58:40,600 SOME OF THESE ARE DIFFICULT 1638 00:58:40,600 --> 00:58:41,900 QUESTIONS AND MAY NOT BE THINGS 1639 00:58:41,900 --> 00:58:43,600 WE CAN ANSWER ON THE WEBINAR 1640 00:58:43,600 --> 00:58:46,600 TODAY. 1641 00:58:46,600 --> 00:58:48,333 SOME OF THEM RELATE TO RESULTS 1642 00:58:48,333 --> 00:58:49,733 REQUIREMENT SO WE WILL BE ABLE 1643 00:58:49,733 --> 00:58:51,466 TO DISCUSS MANY OF THEM IN THE 1644 00:58:51,466 --> 00:58:53,166 NEXT WEBINAR AND A LOT OF THEM 1645 00:58:53,166 --> 00:58:54,566 ACTUALLY ARE ALSO IN THE 1646 00:58:54,566 --> 00:58:55,766 CONTICKETS OF UPDATE 1647 00:58:55,766 --> 00:58:59,966 REQUIREMENTS SO I'LL PLAN TO 1648 00:58:59,966 --> 00:59:01,766 REVISIT THAT TOPIC BECAUSE IT'S 1649 00:59:01,766 --> 00:59:03,066 RELEVANT FOR RESULTS INFORMATION 1650 00:59:03,066 --> 00:59:04,566 AND HOPEFULLY WE CAN ADDRESS 1651 00:59:04,566 --> 00:59:08,766 THOSE SPECIFIC QUESTIONS IN THE 1652 00:59:08,766 --> 00:59:14,166 CONTEXT THERE. 1653 00:59:14,166 --> 00:59:16,666 OTHERWISE IT LOOKS LIKE MOST OF 1654 00:59:16,666 --> 00:59:17,766 THE QUESTIONS AREN'T SOMETHING 1655 00:59:17,766 --> 00:59:19,166 WEE WILL BE ABLE TO ANSWER AT 1656 00:59:19,166 --> 00:59:20,266 THIS MOMENT. 1657 00:59:20,266 --> 00:59:21,399 THANK YOU FOR THE QUESTIONS. 1658 00:59:21,400 --> 00:59:22,900 THEY KEEP US ON OUR TOES AND 1659 00:59:22,900 --> 00:59:24,300 HOPEFULLY CREATE MORE 1660 00:59:24,300 --> 00:59:26,400 INFORMATIVE RESOURCES GOING 1661 00:59:26,400 --> 00:59:26,633 FORWARD. 1662 00:59:26,633 --> 00:59:28,999 SO THANK YOU EVERYONE WILL FOR 1663 00:59:29,000 --> 00:59:29,600 ATTENDING TODAY. 1664 00:59:29,600 --> 00:59:31,100 WE WILL CONCLUDE THE WEBINAR NOW 1665 00:59:31,100 --> 00:59:32,600 AND PLEASE DO REGISTER FOR THE 1666 00:59:32,600 --> 00:59:34,700 NEXT 1 ON OCTOBER11th AND WE 1667 00:59:34,700 --> 00:59:35,700 LOOK FORWARD TO SEEING YOU 1668 00:59:35,700 --> 00:59:36,100 THERE. 1669 00:59:36,100 --> 00:59:37,100 THANK YOU.