REBECCA WILLIAMS.
I'M THE ASSISTANT DIRECTOR AT
CLINICAL TRIALS.GOV.
AND YOU ARE CURRENTLY LOGGED
INTO OUR FINAL RULE WEBINAR
SERIES.
THIS IS THE SECOND OF 3 PLANNED
WEBINARS THAT WE HAVE, TO WALK
THROUGH VARIOUS REQUIREMENTS OF
THE FINAL RULE.
JUST A FEW HOUSEKEEPING ISSUES
BEFORE I GET STARTED.
WE DO HAVE THE--YOU DO HAVE THE
ABILITY TO ASK QUESTIONS THROUGH
THE Q&A PANEL ON THE WEBINAR
PAGE.
THE KEY IS TO HAVE THE QUESTIONS
ADDRESSED TO ALL PANELISTS.
WE WILL AIM TO ADDRESS QUESTIONS
AT THE END OF THE WEBINAR TODAY
BUT WHAT WE HAVE BEEN DOING IS
ACCUMULATING QUESTIONS AND WE
WILL AIM TO ANSWER THEM AT THE
NEXT WEBINAR OR AT--OR HAVE A
WAY TO ADDRESS THEM ON THE
CLINICAL TRIALS.GOV WEB SITE.
IF YOU DO HAVE QUESTIONS, AFTER
THE WEBINAR, YOU CAN SUBMIT THEM
TO OUR REGULAR E-MAIL ADDRESS
WHICH IS REGISTER
@CLINICALTRIALS .GOV.
AND WITH THAT I THINK THE AUDIO
SOUNDS OKAY, TODAY AND SO ALL OF
THOSE PROBLEMS ARE HOPEFULLY
RESOLVED FROM THE LAST TIME AND
I'LL GO AHEAD AND GET STARTED.
JUST A QUICK OVERVIEW ABOUT THE
WEBINAR SERIES ITSELF.
WE HELD THE FIRST IN THE SERIES
LAST WEEK ON SEPTEMBER27th.
WE DO NOW HAVE THE AUDIO
RECORDINGS AND THE SLIDES
AVAILABLE ON OUR WEB SITE.
YOU CAN SEE THE AT THE BOTTOM OF
THIS PARTICULAR SLIDE, THERE'S A
LINK THAT YOU CAN GO TO TO
ACCESS THAT INFORMATION.
IF YOU'RE FAMILIAR WITH THE
CLINICAL TRIALS.GOV WEB SITE.
YOU WOULD GO TO THE SUBMIT STUDY
SECTION AND THEN THERE'S ANOTHER
SECTION FOR TRAINING MATERIALS
AND THE FINAL RULE WEBINARS ARE
LOCATED UNDER THAT TRAINING
MATERIALS PAGE.
SO YOU CAN ACCESS THOSE WEBINARS
AT ANY TIME.
WITH THIS WEBINAR, WE WILL ALSO
POST IT IN THE SAME PLACE AND WE
WILL DO THE SAME THING FOR THE
SUBSEQUENT WEBINAR.
MOST LIKELY IT WILL TAKE US UP
TO 1 WEEK TO GET THE WEBINARS
POSTED AND YOU CAN CHECK BACK
THEN FOR MORE INFORMATION.
AND SO THE GENERAL SCHEDULE FOR
THE WEBINARS IS THAT WE'RE
AIMING TODAY TO COVER IN MORE
DETAIL, REGISTRATION INFORMATION
REQUIREMENTS AND ALSO SOME
CONTENT RELATED TO UPDATE
REQUIREMENTS.
AND THE NEXT WEBINAR, WILL FOCUS
ON CLINICAL TRIAL RESULTS
INFORMATION AND UPDATE
REQUIREMENTS RELATED TO THAT.
AS WELL AS TALKING A LITTLE BIT
MORE ABOUT THE QUALITY CONTROL
REVIEW PROCEDURES AND
IMPLICATIONS FOR POSTING
SUBMITTED INFORMATION ON
CLINICAL TRIALS.GOV.
SO THIS IS JUST A MORE DETAILED
LOOK AT TODAY'S AGENDA.
I WILL PROVIDE AGAIN JUST AN
OVERVIEW OF THE ENVIRONMENTS AND
THE STRUCTURE OF THE FINAL RULE
ITSELF TO ORIENT PEOPLE AGAIN IN
TERMS OF NAVIGATING THE CONTENT
THAT WE HAVE AVAILABLE AND THEN
WE'LL GO INTO A LOT OF THE
BASICS RELATED TO CLINICAL
TRIALS INFORMATION IN TERMS OF
WHO HAS TO DO IT, WHAT TRIALS
MUST BE REGISTERED, WHAT MUST BE
SUBMITTED, AND THEN WHEN MUST
THAT INFORMATION BE UPDATED.
AS WAS THE LAST WEBINAR, I'LL
MOSTLY BE FOCUSING ON THE NEW
REQUIREMENTS THAT WILL BE PLACED
ON THE FINAL RULE AND I'LL AIM
TO BE VERY CLEAR ABOUT
DISTINGUISHING BETWEEN FINAL
RULE REQUIREMENTS VERSUS THINGS
THAT WERE REQUIRED UNDER THE
STATUTE.
AND SO HOPEFULLY, ALL OF THAT
WILL SEEM STRAIGHT FORWARD.
SO IN TERMS OF OVERVIEW, I WANT
TO REMIND PEOPLE THAT 1 OF THE
ITEMS MADE AVAILABLE WILL BE
AVAILABLE WHEN WE PUBLISHED THE
FINAL RULE WAS THE ARTICLE IN
THE NEW ENGLAND JOURNAL OF
MEDICINE THAT HAD A HIGH LEVEL
OVERVIEW OF THE FINAL RULE
ITSELF, WITH THE SUMMARY OF MANY
OF THE KEY ISSUES.
THIS ARTICLE, I THINK IS
PROBABLY USEFUL WHEN
COMMUNICATING WITH INVESTIGATORS
AND OTHERS WITHIN YOUR OWN
INSTITUTION OR JUST OTHER PEOPLE
LOOKING FOR GENERAL KNOWLEDGE
ABOUT THE FINAL RULE ITSELF, AS
WITH EVERYTHING, YOU KNOW IT'S
COMPLICATED SO TO GET A LOT OF
DETAILS, YOU ACTUALLY HAVE TO
DELVE INTO THE CONTENT OF THE
FINAL RULE AND THAT'S WHAT WE'RE
AIMING TO DO HERE OVER THE
COURSE OF THESE WEBINARS.
SO JUST TO A REMINDER THAT IN
TERMS OF THE WAY THAT THE
REGULATIONS THEMSELVES ARE
STRUCTURED IT'S SEGMENTED INTO
DIFFERENT SUBPARTS, WHAT WE'RE
GOING TO BE FOCUSING ON TODAY,
IF YOU HAVE COLORS DISPLAYING OR
HIGHLIGHTED IN RED, BUT
BASICALLY WE'RE FOCUSING ON TO
WHOM DO THESE REGULATIONS APPLY
MEANING THE RESPONSIBILITY PARTY
AND THEN WHAT DEFINITIONS ARE
RELEVANT AS WELL AS MORE DETAILS
ABOUT WHICH INFORMATION MUST BE
SUBMITTED FOR REGISTRATION AND
WHEN IT MUST BE SUBMITTED.
IT IS OTHER PART, SUBPART C
FOCUSES ON INFORMATION AND
THAT'S GOING TO BE THE FOCUS OF
THE NEXT WEBINAR, SUBPART D IS
WHERE YOU FIND INFORMATION IN
SECTION 1164 ON UPDATE
REQUIREMENTS.
SO I'LL BE TALKING ABOUT UPDATE
REQUIREMENTS TODAY IN THE
CONTEXT OF REGISTRATION
INFORMATION.
AND SO GENERALLY SPEAKING IN
TERMS OF THE GENERAL
REQUIREMENTS, IN THE FINAL RULE
AND ACTUALLY REALLY UNDER THE
STATUTE, IT'S BASICALLY THE
SAME.
THERE'S A FEW KEY TERMS THAT YOU
NEED TO BE AWARE OF THAT REALLY
DICTATE WHEN CERTAIN INFORMATION
AND WHICH INFORMATION MUST BE
SUBMITTED.
SO GENERALLY SPEAKING IT'S
ALWAYS THE RESPONSIBLE PARTY
THAT IS RESPONSIBLE FOR
SUBMITTING INFORMATION AND WHAT
WE'RE FOCUSING ON ARE APPLICABLE
CLINICAL TRIALS.
SO THE RESPONSIBLE PARTY FOR AN
APPLICABLE TRIAL, MUST FIRST
REGISTER THAT TRIAL WITH
CLINICAL TRIALS.GOV AND THERE'S
A DEADLINE ASSOCIATED WITH THAT,
THAT SHOULD BE NO LATER THAN 21
DAYS AFTER THE ENROLLMENT OF THE
FIRST PARTICIPANT.
THAT'S PRETTY MUCH THE SAME AS
WHAT'S DESCRIBED IN THE STATUTE.
INFORMATION MUST BE UPDATE
OFFICE OF DIVERSITY CLINICAL
TRIALS.GOV FOR THAT REGISTRATION
INFORMATION AT LEAST ONCE EVERY
12 MONTHS WITH SOME ITEMS
REQUIRING A MORE FREQUENT UPDATE
THAT THAT INFORMATION NEEDS TO
BE UPDATED WITHIN 15 OR 30 DAYS
OF A CHANGE AND WE WILL GO INTO
MORE DETAIL ABOUT WHICH ELEMENTS
ARE SUBJECT TO THOSE 30 DAY
REQUIREMENTS.
THEN FINALLY THE LAST
REQUIREMENT IS TO SUBMIT SUMMARY
RESULTS INFORMATION WHICH
INCLUDES ADVERSE EVENTS
INFORMATION NO LATER THAN 1 YEAR
AFTER THE TRIAL COMPLETION DATE
WITH DELAYS ALLOWED IN CERTAIN
CIRCUMSTANCES SO AGAIN TO
REITERATE WHAT WE'RE FOCUSING ON
TODAY ARE REALLY THOSE FIRST 2
SUBBULLETS IN TERMS OF
REGISTRATION AND REQUIREMENTS.
SO GENERALLY SPEAKING THE
REGULATIONS OUTLINE WHO IT IS
THAT MUST SUBMIT CLINICAL TRIAL
REGISTRATION INFORMATION TO
CLINICAL TRIALS.GOV.
AND WITHIN THE REGULATIONS
THEMSELVES, THERE'S ACTUALLY 2
SECTIONINGS THAT ARE RELEVANT
FOR UNDERSTANDING THESE
REQUIREMENTS.
AND 11.4, WHERE IT HAS A LOT OF
DETAILS ABOUT WHO THIS PART
APPLIES TO.
AND THEN IN SECTION 11.20, IT
REITERATES WHO IT IS THAT MUST
SUBMIT CLINICAL TRIAL
REGISTRATION INFORMATION AND AS
I MENTIONED THE PREVIOUS SLIDE,
THE KEY TERM THAT'S IMPORTANT TO
UNDERSTAND IS THE RESPONSIBLE
PARTY.
IT'S THE RESPONSIBLE PARTY WHO
MUST PUB MITT CLINICAL TRIAL
INFORMATION.
THERE'S ONLY 1 RESPONSIBLE PARTY
AND ONLY 1 AND THAT'S CLARIFIED
BOTH OF THE FINAL RULE ITSELF.
IT'S CONSIDERED THE RESPONSIBLE
PARTY UNLESS THAT SPANSOR HAS
DESIGNATED A PRINCIPLE
INVESTIGATOR TO BE THE
RESPONSIBLE PARTY IS THERE'S
CRITERIA ASSOCIATED WITH THAT.
AND SO, THEN, IN TERMS OF
FIGURING OUT WHO IS--WHO IS THE
RESPONSIBLE PARTY, THE FIRST
THING YOU HAVE TO FIGURE OUT IS
WHO WOULD BE CONSIDERED THE
SPONSOR.
SO EACH APPLICABLE CLINICAL
TRIAL MUST HAVE 1 SPONSOR AND
IT'S OUTLINED IN SECTION 11.4 IN
THIS WAY.
AND IT'S VERY SIMILAR TO
ACTUALLY HOW THIS HAS BEEN
DEFINED PRIOR TO THE FINAL RULE,
SO THIS SHOULD ALL SEEM
RELATIVELY FAMILIAR IF YOU'RE
ALREADY FAMILIAR WITH THE
STATUTE ITSELF.
SO WHAT IT'S BASICALLY SAYING IS
THAT IF THE CLINICAL TRIAL IS
BEING CONDUCTED UNDER AN IND AND
THE IDE, THEN THE IND OR IDE
HOLDER WOULD BE CONSIDERED THE
SPONSOR FOR THAT CLINICAL TRIAL.
HOWEVER, THERE ARE MANY
CIRCUMSTANCES IN WHICH A
CLINICAL TRIAL MAY NOT BE
CONDUCTED UNDER AN IND OR AN
IDE, SO YOU NEED ANOTHER
CRITERIA TO DETERMINE WHO IT IS
THAT WOULD BE RESPONSIBLE.
THE THING THAT IS STATED IS THAT
IT'S AGAIN A SINGLE PERSON
ORANTITY, SO IT MUST BE AN
INDIVIDUAL OR AN ORGANIZATION
WHO IS CONSIDERED TO HAVE
INITIATED THE TRIAL AND THEN
THERE'S SOME ELABORATION ABOUT
WHAT THAT MEANS IN TERMS OF
PREPARING OR PLANNING THE TRIAL,
HAVING AUTHORITY AND CONTROL
OVER THE TRIAL ITSELF THAT IN
THAT CASE, WHOEVER IT IS, THAT
MEETS THOSE CRITERIA, WOULD BE
CONSIDERED THE SPONSOR.
AND FURTHER ARTICULATED WE
INDICATED THAT THE SPONSOR IN
TURN MAY DESIGNATE A PRINCIPLE
INVESTIGATOR TO BE THE
RESPONSIBLE PARTY.
A KEY ASPECT OF THE FINAL RULE,
AND THIS IS ALSO REFLECTED IN
THE STATUTE IS THAT THE
PRINCIPLE INVESTIGATOR MUST BE
ABLE TO MEET CERTAIN
REQUIREMENTS TO BE ELIGIBLE TO
BE THE RESPONSIBLE PARTY.
SO THAT IS ACCESS OR CONTROL
OVER THE DATA AND BE ABLE TO
PUBLISH THE TRIAL AND HAVE THE
ABILITY TO MEET ALL THE
REQUIREMENTS FOR SUBMITTING AND
UPDATING CLINICAL TRIAL
INFORMATION AS DESCRIBED IN THE
REGULATIONS ITSELF.
IT FURLER DESCRIBES HOW THE
PRINCIPLE INVESTIGATOR CAN BE
PART OF THE PARTY.
IT STATES THAT THE SPONSOR MUST
OBTAIN FROM THE PRINCIPLE
INVESTIGATOR AN ACKNOWLEDGMENT
OF THOSE RESPONSIBLE, OF THOSE
RESPONSIBILITIES AS THE
RESPONSIBLE PARTY AND THAT THE
PI MUST ALSO ACKNOWLEDGE THAT
DESIGNATION IN A FORMAT WE
SPECIFIED.
IN THE PREAMBLE ITSELF, WE GO
INTO MORE DETAIL ABOUT THIS, AND
TALK ABOUT CURRENT PRACTICE
WITHIN CLINICAL TRIALS.GOV FOR
DESIGNATING THE PI AS THE
RESPONSIBLE PARTY, CURRENTLY
WITHIN THE PRS, THE MECHANISM BY
WHICH THIS HAPPENS IS THAT THE
PRINCIPLE INVESTIGATOR WILL BE
GIVEN ACCESS TO SPONSORS
ORGANIZATION ACCOUNT WITHIN THE
PRS AND GIVE THEM ACCESS AND THE
INVESTIGATOR WOULD BE IDENTIFIED
IN THE DATA PARTY ELEMENT AS
BEING THE RESPONSIBLE PARTY AND
THAT PI WOULD THEN BE
RESPONSIBLE FOR RELEASING OR
SUBMITTING THE RECORD THROUGH
THE PRS, TO CLINICAL TRIALS.G
OV.
AND THE PREAMBLE FURTHER
REITERATES THAT WE INTEND TO
CONTINUE THAT APPROACH AND TO
CONTINUE TO SUPPORT THAT
MECHANISM FOR DESIGNATION WITHIN
THE PRS ITSELF.
THE REGULATIONS DISCUSS WHETHER
IT'S NECESSARY TO PULL THE
REQUIREMENTS AND IF THEY CAN'T
MEET THE REQUIREMENTS, THE
SPONSOR MUST WITHDRAW THE
DESIGNATION.
THE SPONSOR IN THAT RESPONSIBLE
PARTY DATA ELEMENT FIELD WOULD
BE ABLE TO CHANGE THE
DESIGNATION FROM PI BACK TO
SPONSOR.
AND THE SPONSOR WOULD HAVE THE
RESPONSIBILITY OF RELEASING OR
SUBMITTING THAT RECORD TO
CLINICAL TRIALS.GOV.
SO THOSE METHODS ARE AGAIN
DESCRIBED IN THE PREAMBLE OF
THIS SECTION FOR THE FINAL RULE.
SO THAT GENERALLY COVERS WHO IT
IS THAT'S RESPONSIBLE FOR
REGISTERING AN APPLICABLE
CLINICAL TRIAL AND I THINK IT'S
JUST REALLY IMPORTANT TO
REITERATE THAT AT THE OUTSET OF
A CLINICAL TRIAL, ESPECIALLY A
MULTISITE CLINICAL TRIAL THAT
MIGHT HAVE MANY DIFFERENT
ORGANIZATIONS INVOLVED AND MANY
DIFFERENT PARTIES INVOLVED THAT
IT'S ESPECIALLY IMPORTANT TO
MAKE CLEAR WITHIN--WITHIN ANY
CONSTRUCTING THAT EXISTS FOR THE
TRIAL, WHO IT IS THAT HAS
THAT--WHO HAS THAT RESPONSIBLE
PARTY, RESPONSIBILITY SO THAT
IT'S CLEAR TO EVERYONE WHO WILL
BE MANAGING THIS AND IN SOME
CASES, IT WILL BE DICTATED
BASICALLY BY WHO THE IND OR IDE
HOLDER IS, OR THERE NEEDS TO BE
CLEAR EVALUATION OF WHO IT WAS
THAT WAS CONSIDERED TO HAVE
INITIATED THAT CLINICAL TRIAL.
SO THEN IN TERMS OF WHICH
APPLICABLE TRIALS MUST BE
REGISTERED THIS, IS AGAIN
FURTHER DEFINED WITHIN
REGULATIONS.
THERE'S A COUPLE PLACES WHERE
THIS COMES INTO PLAY, THERE'S
THE DEFINITION SECTION OF THE
REGULATIONS WHICH IS 11.10.
THIS IS 11.10A, THE DEFINITION
IS A APPLICABLE TRIAL AND 2
TYPES OF APPLICABLE CLINICAL
TRIALS ARE DEFINED SO THERE'S
APPLICABLE DRUG CLINICAL TRIAL
AND APPLICABLE DEVICE CLINICAL
TRIAL.
I'VE INCLUDED THE EXAMPLE OF
DRUG APPLICABLE TRIAL AND YOU
CAN SEE THERE'S MULTIPLE
COMPONENTS TO UNDERSTANDING WHAT
IT IS THAT'S CONSIDERED TO BE AN
APPLICABLE DRUG TRIAL.
ONE IT'S A CONTROL CLINICAL
INVESTIGATION, OTHER THAN A
PHASE 1 CLINICAL INVESTIGATION
THAT HAS TO BE A DRUG PRODUCT
THAT'S SUBJECT TO SECTION 505 OF
THE FEDERAL FOOD, DRUG AND
COSMETICS ACT AND THEN THERE'S
FURTHER ELABORATION OF THE
MEANINGS OF CLINICAL
INVESTIGATION AND PHASE 1 IN
RELATIONSHIP TO FDA REGULATIONS
THAT COVER THE SAME TOPICS.
IN RECOGNITION OF COMPLEXITY OF
VARIOUS ASPECTS OF THIS
DEFINITION, ANOTHER SECTION OF
THE REGULATIONS FOCUSES ON HOW 1
WOULD DETERMINE WHETHER OR NOT A
PARTICULAR STUDY IS AN
APPLICABLE CLINICAL TRIAL AND
WOULD BE CONSISTENT WITH THIS
DEFINITION THAT YOU SEE HERE.
SO THAT'S WHAT'S DESCRIBED IN
SECTION 122, FROM'S AN
EXPLANATION OF HOW 1 WOULD
DETERMINE AN APPLICABLE CLINICAL
TRIAL WHETHER IT WAS INITIATED
ON OVER AFTER JANUARY18, 2017.
IF YOU HAD READ THE FIRST
WEBINAR OR READ THE RULES IN
DETAIL, YOU RECOGNIZE JANUARY18
AS THE EFFECTIVE DATE OF THE
REGULATIONS AND SO THAT'S WHY,
IN THIS CASE, WE ARE LIMITING
THIS EXPLANATION TO THOSE TRIALS
THAT ARE INITIATED ON OR AFTER
JANUARY18th, 2017 AND I'LL GO
INTO A LITTLE BIT MORE DETAIL
ABOUT THE IMPLICATIONS OF THAT
IESKTIVE DATE AND SUBSEQUENT
LIVES.
AND SO BASICALLY THE MAIN GOAL
OF THIS DETERMINE NATION OF THIS
APPROACH WAS TO IMP ELEMENT
SOMETHING CLOSER TO A CHECK
LIST.
YOU'LL SEE THAT WORD USED WITHIN
THE PREAMBLE ITSELF THAT YOU CAN
USE DATA ELEMENTS THAT ARE
REQUIREMENTED TO BE SUBMITTED AS
PART OF CLINICAL TRIAL
REGISTRATION INFORMATION TO MAKE
THIS DETERMINE NATION.
AND SO, 1 OF THE CRITERIA, IS
RELATED TO THE STUDY TYPE
ITSELF.
ANOTHER IS RELATED TO WHETHER OR
NOT IT'S STUDYING THE USDA
REGULATED DRUG PRODUCT OR DEVICE
PRODUCT BOTH OF THOSE ARE NEWLY
AVAILABLE WITHIN THE PRS AND I
WILL GO INTO DETAIL ABOUT EACH
OF THESE SO RIGHT NOW I'M JUST
SUMMARIZING IT.
THE STUDY PHASE, EXCLUDES PHASE
1 STUDIES AND SIMILARLY FOR
DEVICES IT EXCLUDES DEVICE
FEASIBILITY STUDIES.
AND AGAIN WE HAVE MORE DETAIL ON
EACH OF THESE.
THERE'S A FEW OTHER CRITERIA
THAT HELP DETERMINE WHETHER OR
NOT SOMETHING IS SUBJECT TO FDA
REGULATION AND THAT HAS TO DO
WITH THE LOCATION OF THE TRIALS
THAT TELL WHETHER OR NOT IT'S
CONDUCTED UNDER IND AND WHETHER
OR NOT IT'S STUDIED IN CLINICAL
TRIAL IS MANUFACTURED IN AND
EXPORTED FROM THE U.S.
AND THAT REALLY, THAT LAST
CRITERIA, ONLY COMES INTO PLAY
IF ANY OF THE OTHER THINGS
HAVEN'T YET APPLIED.
SO IF THEY'RE IN THE
[INDISCERNIBLE] IF IT'S
CONDUCTED UNDER AN IDE OR IND,
THAT LAST POINT ISN'T RELEVANT
THAT WAY.
SO 1 THING THAT MANY OF YOU MAY
BE AWARE OF IN THE ORIGINAL
PROPOSAL IN THE NOTICE OF
PROPOSED RULE MAKING RELATED TO
HOW WE ARE GOING TO IMPLEMENT
THIS DETERMINE NATION OF AN
APPLICABLE CLINICAL
TRIAL--DETERMINATION OF AN
APPLICABLE CLINICAL TRIAL WE
OFFER ASPECTS OF CONTROL.
AND WHAT WE PROPOSED IN THE NPRM
IS THAT THERE WOULD BE A
SPECIFIC DATA ELEMENT FOR
IDENTIFYING WHETHER A STUDY HAD
A SINGLE ARM AND WAS CONSIDERED
TO BE CONTROLLED BECAUSE IN THE
NPRM WE DEFINED ANY 2 ARM STUDY
AS BEING CONTROLLED.
WHAT YOU MAY HAVE NOTICED IS
THAT DATA ELEMENT IS THEN
PRESENT AND THAT'S BECAUSE OF
THE ADDITIONAL ELABORATION THAT
WE INCLUDED IN THE FINAL RULE
THAT BASICALLY SAYS THAT FOR THE
PURPOSES OF THIS PART, ALL
CLINICAL TRIALS MEANING ANY THAT
WOULD BE CONSIDERED TO BE
INTERVENTIONAL THAT HAS 1 OR
MORE ARMS AND PRESPECIFIED
OUTCOME MEASURES WILL BE
CONSIDERED CONTROL FOR THE
PURPOSE OF THIS RULE.
SO THAT WILL SIMPLIFY, YOU KNOW
SOME OF THE DECISION MAKING
PROCESS, RELATED TO DETERMINING
WHETHER A TRIAL, A PARTICULAR
TRIAL IS INDEED AN APPLICABLE
CLINICAL TRIAL.
WE HAVE FURTHER ELABORATION BOTH
WITHIN THE REGULATIONS AND
PREAMBLE ABOUT THAT FIRST
CRITERION OF STUDY TYPE AND IF
YOU'RE ALREADY FAMILIAR WITH THE
OPTIONS THAT ARE AVAILABLE RIGHT
NOW FOR STUDY TYPE, WHEN YOU
REGISTER THE STUDY, YOU'RE
INDICATING WHETHER OR NOT IT IS
INTERVENTIONAL, OBSERVATIONAL OR
IF YOU'RE KRETTING AN EXPANDED
ACCESS RECORD FOR THAT
INFORMATION.
SO WE WILL CONTINUE TO HAVE
THOSE SAME OPTIONS AVAILABLE AND
1 OF THE FIRST CRITERIA IS
INDICATING WHETHER OR NOT THE
STUDY FALLS INTO THESE 3, WHICH
1 OF THESE 3 STUDY TYPES AND
INTERVENTIONAL IS BASICALLY
SYNONYMOUS WITH A CLINICAL
TRIAL.
ONE OF THE OTHER IMPORTANT
CLARIFICATIONS THAT WE MADE
WITHIN THE FINAL RULE ITSELF WAS
THAT THOSE OTHER STUDY TYPES OF
OBSERVAL AND EXPANDED ACCESS
WOULD NOT BE GENERALLY
CONSIDERED TO BE APPLICABLE
CLINICAL TRIALS.
IN THE NPRM WE INDICATE THAD IN
CERTAIN CIRCUMSTANCES IT COULD
BE POSSIBLE THAT AN EXPANDED
ACCESS PROGRAM IF IT MEANT ALL
THE OTHER CRITERIA MIGHT BE
CONSIDERED AN APPLICABLE
CLINICAL TRIAL, WE FURTHER
CLARIFIED WITHIN THE PREAMBLE
ITSELF BUT IN THIS CASE,
EXPANDED ACCESS WILL NOT BE
CONSIDERED APPLIC ANNUAL
CLINICAL TRIAL.
THE OTHER ASPECT WE CLARIFY IS
THAT OBSERVATIONAL STUDIES ALSO
WILL NOT BE CONSIDERED
APPLICABLE CLINICAL TRIALS WITH
1 POSSIBLE EXCEPTION.
AGAIN, ON THE DETERMINE NATION
SIDE THERE'S A FOOT NOTE
INDICATING IF THERE IS A
PEDIATRIC POST MARKET
SURVEILLANCE OF A PRODUCT
MANDATED BY THE FDA THAT THOSE
THINGS ARE CONSIDERED TO BE
APPLICABLE CLINICAL TRIALS AND
IT IS POSSIBLE THAT A PEDIATRIC
POST MARKET SURVEILLANCE OF A
DEVICE PRODUCT WOULD BE AN
OBSERVATIONAL STUDY.
SO THAT WOULD BE THE 1 SITUATION
IN WHICH A STUDY TYPE OF
OBSERVATIONAL COULD FALL INTO
THAT CATEGORY OF AN APPLICABLE
CLINICAL TRIAL AND THEN THERE'S
FURTHER ELABORATION IN THE
PREAMBLE OF EACH ASPECT OF THIS.
SO THE OTHER--NEXT CRITERIA IN
THE DETERMINE NATION CHECK LIST
IS WHETHER OR NOT THE STUDY IS
EVALUATING A U.S. FDA REGULATED
DRUG PRODUCT OR AN FDA REGULATED
DEVICE PRODUCT.
THERE ARE DEFINITIONS WITHIN THE
REGULATIONS ABOUT THIS AS WELL
AS FURTHER EXPLANATION IN THE
PREAMBLE, BUT BASICALLY WHAT THE
QUESTION IS GETTING AT IS
WHETHER OR NOT, THE PRODUCT
ITSELF WOULD REQUIRE A MARKETING
APPLICATION TO BE APPROVED BY
THE FDA, YOU KNOW, AN NDA, A
BLA, A PMA, IN ORDER TO BE
MARKETED WITHIN THE U.S.
SO THAT'S REALLY WHAT THAT
QUESTION IS GETTING AT IN TERMS
OF WHETHER OR NOT THE PRODUCT
EVALUATED IS INDEED SOMETHING
THAT IS REGULATED BY THE FDA.
THERE'S ADDITIONAL USEFUL
ELABORATION WITHIN THE PREAMBLE,
AGAIN THOSE PAGE NUMBERS ARE
ALSO PROVIDED AT THE BOTTOM OF
THE SLIDE.
WE DIDN'T REALLY RECEIVE MANY
COMMENTS ON THIS, AND WE
ACTUALLY DIDN'T RECEIVE ANY
COMMENTS ON THESE DATA ELEMENTS
IN RESPONSE TO THE NPRM BUT WE
HAVE YOU KNOW TRIED TO MAKE IT
CLEAR ABOUT VARIOUS ASPECTS THAT
MIGHT NEED TO BE TAKEN INTO
CONSIDERATION WHEN RESPONDING TO
THIS PARTICULAR QUESTION.
AND WHAT THIS SLIDE IS GETTING
AT IS THE THAT THERE MIGHT BE
CASES IN WHICH, SAY YOU HAVE A
STUDY OF A DEVICE PRODUCT AND
SO, YOUR STUDY IS EVALLUALITYING
A U.S. FDA REGULATED DEVICE
PRODUCT AND SO IN THE BACKGROUND
YOU MIGHT BE ADMINISTERING
GENERAL ANESTHESIA BUT THIS DRUG
IS USED IN THE CLINICAL TRIAL
BUT THE CLINICAL TRIAL ITSELF IS
NOT NECESSARILY STUDYING THAT
FDA REGULATED DRUG PRODUCT.
SO THAT WOULD BE A CONSIDERATION
TO MAKE INTO ACCOUNT IN TERMS OF
WHAT ABOUT THE TODAY ITSELF IS
ACTUALLY EVALUATING.
AND WE ALSO FURTHER ELABORATED
ON THE RELATIONSHIP OF THIS
PARTICULAR DATA ELEMENT TO
ANOTHER DATA ELEMENT THAT IS
REQUIRED TO BE SUBMITTED AS PART
OF CLINICAL TRIAL REGISTRATION
INFORMATION AND THAT'S THE
INTERVENTION TYPE DATA ELEMENT.
YOU MAY BE STUDYING OR
EVALUATING AN INTERVENTION TYPE
THAT IS LABELED AS A DIETARY
SUPPLEMENT.
AND THAT--THAT DIETARY
SUPPLEMENT MAY BE USED IN A WAY
THAT WOULD ACTUALLY REQUIRE A
MARKETING APPLICATION IN ORDER
TO BE MARKETED FOR THAT
PARTICULAR USE.
SO IT COULD ACTUALLY BE STUDYING
A USFDA REGULATING DRUG PRODUCT
EVEN THOUGH YOU THINK OF THATTED
PROUCT AS A DIETARY SUPPLEMENT.
AND SO AGAIN IN THE ELABORATION
SECTION OF THE FINAL RULE,
THERE'S SOME REALLY USEFUL
EXPLANATIONS OF ADDITIONAL
THINGS THAT TAKE--THAT YOU WANT
TO TAKE INTO ACCOUNT WHEN
CONSIDERING THESE VARIOUS
ASPECTS OF THE DETERMINE NATION
APPROACH.
AND SO THEN IN TERMS OF WHICH
APPLICABLE CLINICAL TRIALS MUST
BE REGISTERED WITH THE
REGULATIONS OUTLINED, IT'S
GENERAL DESCRIPTION OF WHAT WAS
ALSO DESCRIBED IN THE STATUTE
THAT BASICALLY 1 YOU HAVE TO
MEET THE DEFINITION OF AN
APPLICABLE CLINICAL TRIAL AND
THEN THERE ARE THESE DIFFERENT
CRITERIA BASED ON DATES IN TERMS
OF WHEN THE LAW ITSELF WAS
ACTUALLY PASSED.
THE LAW WAS PASSED IN SEPTEMBER
OF 2007 AND SO IT APPLIED TO
STUDIES THAT WERE INITIATED
AFTER THE PASSAGE OF THE LAW OR
IT APPLIED TO STUDIES THAT WERE
ON-GOING AS OF THE DATE OF THE
PASSAGE OF THE LAW AND THAT
HADN'T YET COMPLETED BY THE END
OF THAT SAME YEAR.
AND SO IN TERMS OF DETERMINING
WHAT THAT DATE OF INITIATION IS,
THE REGULATIONS FURTHER EXPLAIN
THAT THE DAT OF INITIATION IS
THE DATE ON WHICH THE FIRST
HUMAN SUBJECT IS ENROLLED AND WE
CONSIDER THAT TO BE THE STEADY
START DATA ELEMENT.
SO THE NEXT THING TO TAKE INTO
CONSIDERATION, YOU KNOW WE
COVERED WHO IT IS THAT MUST BE
DOING THIS.
WHICH APPLICABLE TRIALS ARE
COVERED AND THE NEXT ASPECT IS
WHEN MUST THE INFORMATION BE
SUBMITTED.
THERE ARE OUTLINES WITHIN THE
RULE ITSELF SO GENERALLY,
CLINICAL TRIAL REGISTRATION AND
INFORMATION MUST BE SUBMITTED
WITHIN 21 CALENDAR DAYS AFTER
THAT FIRST HUMAN RULE.
ALTHOUGH THESE ARE REQUIREMENTS
WITHIN THE REGULATIONS, THEY'RE
ALSO DESCRIBED IN THE STATUTE,
THAT IF YOU ARE INTENDING TO
PUBLISH THE RESULTS OF THE
CLINICAL TRIAL FOR THE JOURNAL
EDITORS REQUIRES REGISTRATION TO
OCCUR PRIOR TO THE ENROLLMENT OF
FIRST PARTICIPANT.
SO THAT'S ANOTHER ASPECT TO TAKE
INTO CONSIDERATION WHEN
DETERMINING THE TIMING OF WHEN
YOU WILL BE REGISTERING CLINICAL
TRIAL.
BUT IN TERMS OF WHAT IT IS THAT
THE STATUTE AND THE FINAL RULE
REQUIRE, IT'S JUST 21 CALENDAR
DAYS AFTER THE HUMAN SUBJECT IS
ENROLLED AND AGAIN WE CONSIDER
THIS TO BE THE STEADY START DATE
ELEMENT.
IN THE LAST WEBINAR, WEUC IN THE
RULE DEFINITION SO I WON'T SPEND
MUCH TIME ON IT HERE.
CONSITUTES CLINICAL TRIAL
REGISTRATION, INFORMATION?
AND THIS RELATES TO WHAT ARE THE
SPECIFIC DATA ELEMENTS MA MUST
BE SUBMITTED UNDER THE FINAL
RULE.
SO THIS IS ALL DESCRIBED IN
SECTION 11.28 OF THE REGULATIONS
AND THE WAY THAT IT'S SEGMENTED
IS THAT IT DESCRIBES THESE 2
CONDITIONS SO 1 WE'RE ALWAYS
TALKING ABOUT APPLICABLE
CLINICAL TRIALS BUT THE WAY THAT
IT'S LAID OUT IN THE REGULATIONS
IN TERMS OF WHAT INFORMATION
MUST BE SUBMITTED.
IT'S BASED ON THE EFFECTIVE DATE
OF THE RULE ITSELF.
AND SO, AGAIN, THAT EFFECTIVE
DATE, YOU MAY RECOGNIZE ON THIS
SLIDE AS JANUARY18th 2017.
SO IT'S A REGULATION STAKE IS
THAT FOR ANY APPLICABLE CLINICAL
TRIAL THAT HAD A ESTATE START
DATE BEFORE JANUARY18th 2017,
YOU ARE CONTINUING TO FOLLOW THE
REQUIREMENTS THAT ARE DESCRIBED
IN THE STATUTE AND ARE BASICALLY
THE REQUIREMENTS THAT WE
CURRENTLY HAVE IN PLACE AT
CLINICAL TRIALS .GOV.
THEY ARE DESCRIBED IN THE FINAL
RULE IN THIS SECOND PART OF
11.28, 11.28 A2 LISTS IT IS
ELEMENTS SUBMITTED FOR THOSE
TRIALS THAT STARTED ON OR AFTER
THE EFFECTIVE DATE WHICH IS
AGAIN JANUARY18th, 2017.
AND IT DESCRIBES THESE DATA
ELEMENTS BASED ON 4 CATEGORIES
OF INFORMATION THAT YOU CAN SEE
HERE, THAT ARE SIMILAR TO
STATUTE.
WE HAVE MADE THE DOCUMENT
AVAILABLE, THE URL IS HERE, AND
WE ATTEMPTED TO ATTEMPT THE DATA
ELEMENTS AND THE TABLE HAVE
EXPLAINED WHETHER OR NOT THOSE
DATA ELEMENTS WERE ALREADY
REQUIRED OR CONSIDERED OPTIONAL
UNDER THE CURRENT--OR UNDER THE
CURREQUIREMENTS AT CLINICAL
TRIALS.GOV.
SO HAVE YOU A BETTER VIEW OF
WHAT WILL CHANGE FROM YOUR OWN
CURRENT PRACTICES AND AS WE TALK
THROUGH THE DATA ELEMENT
REQUIREMENTS I'LL BE
HIGHLIGHTING SOME OF THOSE
CHANGES FOR YOU AS WELL.
AND THEN THAT'S THE DATA EXISTS
PRIOR TO THE RULE.
AGAIN WHAT I WOULD LOAMACYIC TO
REITERATE IS THE APPROACH THAT
WE'RE GOING TO BE TAKING WITHIN
THE PRA SIZE AND SO BECAUSE
THERE'S THIS DIFFERENCE IN TERMS
OF REQUIREMENTS FOR REGISTRATION
INFORMATION BASED ON WHEN THE
STEADY START DATE FOR THE STUDY
WAS, THE PRS ITSELF WILL ALSO BE
RELYING ON THE STUDY START DATE
INFORMATION THAT'S SUBMITTED TO
DETERMINE WHICH REGISTRATION
INFORMATION ELEMENTS ARE
CONSIDERED TO BE REQUIRED.
SO I DID DISCUSS THIS IN THE
LAST WEBINAR, BUT I JUST WANT TO
REITERATE SOME OF OUR GENERAL
PLANS HERE TO TRY TO MAKE SURE
THIS IS AS CLEAR AS POSSIBLE.
SO WE'RE AIMING AT THE END OF
NOVEMBER TO MAKE SURE THE PRS
SYSTEM IS THE TYPICAL PROCESS WE
FOLLOW BEFORE WE MAKE SOMETHING
AVAILABLE IN THE OPERATIONAL
PRS, WE WILL PUT THAT ON
PRSTEST, THAT ALLOWS US TO DO
TESTING FOR POTENTIAL BUGS AND
ALLOWS OUR DATA PROVIDER TO GET
EXPERIENCE WITH THE NEXT SET OF
INFORMATION THAT WILL BE IN THE
OPERATIONAL SYSTEM.
SO THAT RELEASE IN LATE NOVEMBER
WILL HAVE THE REGISTRATION AND
RESULTS DATA ELEMENTS THAT ARE
REQUIRED BY THE FINAL RULE IT
WILL ALSO INCLUDE DOCUMENTATION
NEEDED TO UNDERSTAND THAT
INFORMATION.
I JUST WANT TO REITERATE THOUGH
THAT THE PURPOSE OF PUTTING THAT
INFORMATION ON PRS TEST SYSTEM
TO GET IT READY FOR--FOR MOVING
THAT RELEASE INTO THE
OPERATIONAL PRS.
IT'S REALLY FOR INFORMATION
PURPOSES.
WE NEVER RECOMMEND PEOPLE USE IT
AS A STAGING AREA TO THEN BE
ABLE TO SUBMIT INFORMATION TO
THE OPERATIONAL PRS.
IT'S REALLY JUST ANOTHER
MECHANISM FOR BEDDING WHAT THOSE
REQUIREMENTS ARE.
WE WILL PLAN TO REMOVE THAT
RELEASE THOUGH TO THE
OPERATIONAL PRS.
ON THE EFFECTIVE DATE WHICH IS
JANUARY18 AND THERE IS A LAG
TIME BETWEEN EFFECTIVE DATE AND
COMPLIANT DANCE, MEANING THE
DATE BY WHICH EVERYONE'S
EXPECTED TO HAVE $INFORMATION
SUBMITTED AND COMPLIANCE WITH
THE FINAL RULE TO THE PRS WILL
NOT HAVE THE ELEMENTS FOR THE
DATA, WE WILL HAVE WARNINGS
AVAILABLE FOR FOR INFORMATION
REQUIRED FOR A PARTICULAR TRIAL
WHEN THAT COMPLIANCE DATE OF
APRIL18th COMES AROUND.
BUT, IT'S REALLY THAT
APRIL18th RELEASE INTO THE
OPERATIONAL PRS IN WHICH WE WILL
THEN MAKE IT REQUIRED TO HAVE
THE FINAL DATA RULE ELEMENT BUT
AGAIN WE WILL RELYOT STEADY
START DATEOT SAME WAY THE RULE
RELYS ON THE STEADY START DATE
TO DETERMINE WHICH REGISTRATION
DATA ELEMENTS ARE RELEVANT FOR
ANY PARTICULAR TRIAL.
SO NOW I'M GOING INTO MORE
DETAIL ABOUT SOME OF THE
REGISTRATION ELEMENTS THAT WILL
BE REQUIRED TO BE SUBMITTED
UNDER THE FINAL RULE SO THESE
ARE FOR STUDIES THAT HAVE START
DATES ON OR AFTER JANUARY18th
2017.
WHAT I INDICATED WITH A RED
ASTERRIFIC ARE THOSE ELEMENTS
THAT ARE REQUIRED BY THE FINAL
RULE.
SO THIS MAY EITHER BE AN
EXISTING DATA ELEMENT OR MAYBE A
COMPLETELY NEW DATA ELEMENT
THAT'S NEWLY REQUIRED BY THE
FINAL RULE.
WE ATTEMPTED TO INDICATE IN
THESE SLIDES WHEN SOMETHING IS
CONSIDERED TO BE A NEW ITEM
VERSUS WHETHER IT'S JUST
SOMETHING THAT'S AN EXISTING
ITEM AND TURNING INTO REQUIRED.
I WILL JUST HIGHLIGHT SOME OF
THESE WITHOUT GOING INTO EXTREME
DETAIL ON EACH OF THEM.
ONE THING I'LL NOTICE ON THIS
SLIDE IT'S PRIMARY PURPOSE.
WE WILL ADD A NEW OPTION TO THE
PRIMARY PURPOSE OPTIONS FOR
INDICATING WHETHER OR NOT A
STUDY IS CONSIDERED TO BE A
DEVICE FEASIBILITY WITH THE
DEFINITIONS WITHIN THE
REGULATIONS.
THIS IS IMPORTANT TO REMEMBER
FROM THE ATP DETERMINE NATION
SLIDE FOR DETERMINING WHETHER OR
NOT SOMETHING WOULD BE
CONSIDERED AN ECT.
ANOTHER CHAIRVELG THAT WILL BE
EFFECTED IS FOR STUDY PHASE,
ANOTHER THING WE CLARIFY IN THE
PREAMBLE FOR THAT PARTICULAR DAT
ELEMENT, 1 WAS THAT STUDY PHASE
OOH PLIES TO CLINICAL TRIALS OF
DRUGS, THESE ARE BASED ON FDA
REGULATIONS AND THEY ARE IN THE
CONTEXT OF INVESTIGATIONAL DRUG
PRODUCTS.
AND SO, 1 OF THE MODIFICATIONS
AND EXPLANATIONS THAT WE'VE
INDICATED IS THAT, PHASE 0 IS
NOT A PHASE THAT'S RECOGNIZED IN
THE FDA REGULATIONS THEMSELVES
BUT IS CONSIDERED TO MEET THE
DEFINITION OF A PHASE 1 CLINICAL
TRIAL.
AND SO, 1 OF THE MODIFICATIONS
WILL BE RELATED TO THE OPTIONS
FOR PHASE THAT ARE AVAILABLE.
STUDY DESIGN IS ANOTHER ELEMENT
THAT IS NOT NECESSARILY NEWLY
REQUIRED THE WAY IT'S
IMPLEMENTED NOW IS THAT AT LEAST
1 OF THE SUBELEMENTS HAD TO BE
PROVIDED UNDER STUDY DESIGNS,
WHAT IS NEW IS THAT WILL BE
REQUIRING ALL THE ELEMENTS UNDER
STUDY DESIGN.
I WILL POINT OUT THAT UNDER
INTERVENTIONAL STUDY MODEL WHICH
IS WHERE YOU DESCRIBE THE BASIC
DESIGN OF THE STUDY, SO WHETHER
OR NOT IT'S PARALLEL, FACTORIAL,
WE'VE ADDED A NEW OPTION, CALLED
SEQUENTIAL AND THE PRIMARY GOAL
OF THAT NEW OPTION IS TO BE ABLE
TO BETTER ACCOMMODATE CERTAIN
STUDIES THAT PROGRESS BASED ON
MILESTONES OCCURRING PREVIOUS TO
THAT.
SO AN EXAMPLE WOULD BE A DOSE
ESCALATION STUDY WHICH IN SOME
CASES, YOU KNOW MAY BE
CONSIDERED ALSO A PHASE 1 STUDY,
WOULDN'T BE REQUIRED BY THE RULE
BUT THE WAY THAT IT'S APPROACHED
IS THAT OFTEN TIMES YOU HAVE 1
COHORT OR PARTICIPANT.
YOU FIND THE RESULTS FROM THAT
COHORT AND YOU ADD IN A SECOND
COHORT OR PARTICIPANT.
THAT ALSO HAPPENS IN AN ADAPTIVE
DESIGN TYPE STUDY.
SO THE SEQUENTIAL OPTION IS
DESIGNED TO BETTER ACCOMMODATE
THOSE DESIGNS THAT AREN'T EASILY
ACCOMMODATED BY THE EXISTING
OPTIONS.
ALSO NOTE THERE WILL BEING
ADDITIONAL FREE RADICALS TEXT
FIELDS ASSOCIATESSED WITH THE
DATA ELEMENTS SO INTERVENTIONAL
STUDY MODEL WILL HAVE A FREE
TEXT FIELD ASSOCIATE WIDE IT
THAT IF YOU WANT TO THE PROVIDE
MORE DETAILS ABOUT THE STUDY
MODEL ITSELF, YOU WILL HAVE A
PLACE RIGHT NEXT TO THE
INFORMATION TO BE ABLE TO
PROVIDE THAT.
AND THAT'S TRUE, MANY OTHER
PLACES, AND AGAIN THAT'S KIND OF
CLEAR IN VARIOUS ASPECTS OF THE
PREAMBLE WHERE IT DESCRIBES EACH
OF THESE DATA ELEMENTS.
SOME OF THE THINGS MARKED AS NEW
IN THIS SLIDE ARE AGAIN RELATED
TO DETERMINING WHETHER OR NOT A
PARTICULAR STUDY IS AN
APPLICABLE CLINICAL TRIAL.
AN INDICATION OF WHETHER A STUDY
IS A PEDIATRIC POST MARKET
SURVEILLANCE OF A DEVICE PRODUCT
IS AGAIN 1 OTHER ASPECTS OF
DETERMINING WHETHER SOMETHING
S&P AN ACT, SO THAT'S A NEW DATA
ELEMENT THAT'S BEING ADADDED.
A NEW REQUIREMENT IS THE STUDY
START DATE.
WE HAVE THIS ELEMENT WITHIN
CLINICAL TRIALS .GOV AND IT WILL
BE REQUIRED UNDER THE FINAL RULE
AND AS YOU ARE AWARE, BECAUSE OF
THE EFFECTIVE DATE, RELYING ON
THAT STUDY, START DATE IT'S MORE
IMPORTANT IN THE CONTEXT OF
IMPLEMENTING VARIOUS ASPECTS OF
THE RULE ITSELF.
ANOTHER THING THAT IS NEW WITHIN
THE CONTEXT OF THAT DATA ELEMENT
IS THAT ALTERNATES REQUIRED TO
PROVIDE THE DAY THAT THE STUDY
STARTED WHEN THAT STEADY START
DATE IS CONSIDERED TO BE ACTUAL
AND THAT'S ANOTHER ASPECT OF
BEING ABLE TO IMPLEMENT PART OF
THE REGULATIONS BECAUSE THE
REQUIREMENTS REGISTERS WITHIN 21
DAYS OF PARTICIPANT--OF THAT
FIRST PARTICIPANT BEING ENROLL
INTERESTED SO, THE KEY TO BEING
ABLE TO DETERMINE THAT WOULD BE
TO HAVE A SPECIFIC DATA
AVAILABLE FOR THAT.
WE'VE ALSO ADDED A REQUIREMENT
FOR STEADY COMPLETION DATE.
I WILL BE TALKING MORE ABOUT
THIS ASPECT IN THE THIRD
WEBINAR, PARTICULARLY IN THE
CONTEXT OF RESULTS INFORMATION
BECAUSE OF THE DEFINITION OF
PRIMARY COMPLETION DATA AND HOW
IT DIFFERS FROM THE STUDY
COMPLETION DATE, THE STUDY
COMPLETION DATE ITSELF PROVIDES
BASICALLY, THE MAXIMUM PERIOD OF
TIME OVER WHICH WE WOULD EXPECT
THE RESULTS INFORMATION TO BE
SUBMITTED BECAUSE BY THAT POINT
IN TIME, BY THE TIME YOU REACHED
THE STUDY COMPLETION DATE, YOU
WOULD HAVE HAD DATA COMPLETION
FOR THE PRIMARY OR SECONDARY
OUTCOMES AND THE ADVERSE
INFORMATION.
BUT GANNA I KNOW THIS MAY NOT
SOUND FAMILIAR.
WE'LL GO INTO MORE DETAILS ABOUT
THIS IN THE NEXT WEBINAR, MORE
IN THE CONTEXT OF THE
REQUIREMENTS.
AND THEN FINALLY, ENROLLMENT,
THE TOTAL NUMBER OF PEOPLE THAT
WERE ENROLL INDEED THE CLINICAL
TRIAL.
OTHER THINGS THAT ARE MARKED
WITH RED ASTERISKS ON THIS SLIDE
FOR DESCRIPTIVE INFORMATION ARE
AGAIN FOCUSED ON BEING ABLE TO
DETERMINE WHETHER A STUDY IS
INDEED A CLINICAL TRIAL AND SO
YOU CAN SEE THOSE DATA ELEMENTS
THAT WE ALREADY TALKED ABOUT IN
TERMS OF STUDYING USFDA
REGULATED DEVICE PRODUCT, DRUG
PRODUCT AND WHETHER OR NOT IT'S
MANUFACTURED OR EXPORTED FROM
THE U.S.
ANOTHER DATA ALIMENT THAT IS
MARKED AS BEING NEWLY REQUIRED
AND IS CONSISTENT WITH THE DATA
ELEMENT THAT WE ALREADY HAVE, IS
WHETHER OR NOT THAT DEVICE
PRODUCT IS APPROVED OR CLEARED
BY THE USFDA.
ONE ASPECT OF POSTING
INFORMATION ON
CLINICALTRIALS.GOV, IS THAT THE
STATUTE ITSELF RESTRICTED NIH
FROM POSTING--WE NEED TO KNOW
THE APPROVAL STATUS OF THE
DEVICE PRODUCT ITSELF.
BUT BECAUSE THERE ARE VARIOUS
REASONS, THAT SPONSORS AND
RESPONSIBLES PARTIES MAY WANT TO
MAKE REGISTRATION INFORMATION
AVAILABLE FOR CLINICAL TRIALS
THAT EVALUATING THESE PRODUCTS
THAT ARE NOT YET APPROVED, THE
FINAL RULE DOES INCLUDE AN
OPTION FOR A RESPONSIBLE PARTY,
TO INDICATEICATE THAT THEY'RE
AUTHORIZING THE NIH TO POST THE
REGISTRATION INFORMATION BEFORE
THAT DEVICE PRODUCT HAS BEEN
APPROVED OR CLEARED.
THAT'S NOT A REQUIREMENT, IT'S
AN OPTION IF THE RESPONSIBLE
PARTY WANTS THAT INFORMATION TO
BE MADE AVAILABLE TO THE PUBLIC.
ANOTHER IMPORTANT ASPECT OF THE
REGISTRATION DATA ELEMENT IS
THAT THERE'S FURTHER ELABORATION
IN THE PRIMARY OUTCOME MEASURES
AND SECONDARY OUTCOME MEASURES.
THERE ARE 3 COMPONENTS TO HAVING
A FULL DESCRIPTION OF AN OUTCOME
MEASURE AND THAT INCLUDES THE
NAME AND DESCRIPTION OF IT AS
WELL AS TIME FRAME.
BUT WHAT WASN'T CLEAR FROM THE
STATUTE ITSELF WAS WHAT THE
DEFINITION OF A PRIMARY OUTCOME
MEASURE IS AND WHAT THE
DEFINITION OF A SECONDARY
OUTCOME MEASURE IS, AND SO 1
BENEFIT OF THE FINAL RULE IS
THAT IT BRAININGS MORE CLARITY
TO THE SPECIFIC DEFINITIONS.
AND BEFORE I DESCRIBED THAT, I
ALSO JUST WANT TO CLARIFY, THAT
THE STATUTE AND THE REGULATIONS
REQUIRE THAT EACH PRIMARY AND
SECONDARY OUTCOME MEASURE BE
SUBMITTED, SOMETIMES WE GET
QUESTIONS ABOUT WHETHER OR NOT
SECONDARY OUTCOME MEASURES ARE
LIMITED TO KEY SECONDARY OUTCOME
MEASURES, THAT LANGUAGE DOESN'T
EXIST WITHIN THE [INDISCERNIBLE]
IN TERMS OF LIMITING TO THE
SECONDARY OUTCOME MEASURES SO
THE INTERPRETATION HAS BEEN THAT
THIS SHOULD BE EACH PRIMARY
OUTCOME MEASURE THAT'S SPECIFIED
IN THE PROTOCOL.
THE DEFINITIONS WE PROVIDED FOR
PRIMARY OUTCOME MEASURE AND
SECONDARY OUTCOME MEASURE ARE
AVAILABLE IN SECTION 11.10.
IT DESCRIBES THE PRIMARY OUTCOME
MEASURES AS BEING THE OUTCOME
MEASURE OF GREATEST IMPORTANCE
THAT'S SPECIFIED IN THE PROTOCOL
AND AUTOMOBILELY IT'S LABELED AS
SUCH AND IT'S THE 1 THAT'S
TYPICALLY USED IN THE POWER
CALCULATION ITSELF SO IT MAY
ALSO BE CLEAR FROM THE
STATISTICAL ANALYSIS PLAN FOR
THAT CLINICAL TRIAL WHICH IS
CONSIDERED TO BE THE PRIMARY
OUTCOME MEASURE.
AND MOST CASES THERE IS USUALLY
ONLY 1 PRIMARY OUTCOME MEASURE
BUT THE RULE ACKNOWLEDGES THAT
THERE MIGHT BE CASES IN WHICH
THERE IS MORE THAN 1 PRIMARY
OUTCOME MEASURE.
THE RULE ALSO FURTHER DESCRIBES
THE DEFINITION FOR SECONDARY
OUTCOME MEASURE AND IN
COMPARISON TO THE PRIMARY IS
CONSIDERED TO BE AN OUTCOME
MEASURE, BUT IT'S SOMETHING THAT
WOULD BE PART OF THE
PRESPECIFIED ANALYSIS PLAN AND
IT BASICALLY EXCLUDES THINGS
THAT ARE SPECIFIED AS
EXPLORATORY.
AND EXPLORATORY OUTCOME MEASURE
WOULD NUMBER OF PATIENTS BE
CONSIDERED SECONDARY OUTCOME
MEASURE IN THAT GENERAL SENSE.
THE PREAMBLE ALSO HAVE FURTHER
COLLABORATION ABOUT THE NATURE
OF THE INFORMATION THAT'S
EXPECTED TO BE SUBMITTED AS PART
OF OUTCOME MEASURE INFORMATION
AND I'VE ALREADY INDICATE THAD
THE 3 COMPONENTS ARE THE NAME
AND THE DESCRIPTION IN THE TIME
POINTS AND SO, HERE YOU CAN SEE
AN EXAMPLE OF HOW EACH OF THIS
PLAYS OUT SO GENERALLY SPEAKING
YOU WOULD HAVE AN ATTRIBUTE YOU
WANT TO BE MEASURING, IT COULD
BE SOMETHING LIKE SYSTOLIC BLOOD
PRESSURE AND THE DESCRIPTION
WOULD INCLUDE MORE INFORMATION
ABOUT HOW YOU INTEND TO DESCRIBE
THE RESULTS FOR THAT SPECIFIC
OUTCOME MEASURE.
SO IN THIS CASE THE EXAMPLE
WOULD BE THE MEAN VALUE OF THAT
SIS TOLL-LIKE RECEPTORIC BLOOD
PRESSURE, BUT THAT IN ITSELF
WOULD NOT BE COMPLETE WITHOUT
KNOWING AT WHAT TIME POINTS
YOU'RE INTENDING TO SUMMARIZE
THE SPECIFIC METRIC THAT WAS
USED.
A SPECIFIC ASPECT OF THAT COULD
BE 24 WEEKS AFTER THE INITIATION
OF THAT PARTICULAR INTERVENTION
THAT'S BEING EVALUATED.
THE PREAMBLE FURTHER CLARIFIES
THAT IF THERE'S A SINGLE
ATTRIBUTE LIKE SYSTOLIC BLOOD
PRESSURE, BUT THAT ASSESS THE
MULTIPLE POINTS IN TIME THAT
THAT IS GENERALLY CONSIDERED TO
BE DIFFERENT OUTCOME MEASURES,
SO IF YOU'RE EVALUATING SYSTOLIC
BLOOD PRESSURE AT 3 DIFFERENT
TIME POINTS, SAY 3 MONTHS, 6
MONTHS, 12 MONTHS EACH OF THOSE
TIME POINTS OF ASSESSMENT WOULD
BE CONSIDERED TO BE A UNIQUE
OUTCOME MEASURE, EACH OF THOSE
LOOKS AT THE DATA IF YOU WILL.
OTHER INFORMATION BEYOND THE
DESCRIPTIVE INFORMATION THAT'S
REQUIRED IS INFORMATION RELATED
TO RECRUITMENT, EVERYONE IS
GENERALLY FAMILIES WITH THE
CRITERIA WHICH INCLUDES
INCLUSION AND EXCLUSION
CRITERIA.
THERE ARE SOME STRUCTURED DATA
ELEMENTS TO GET ASTERISKS THE
AGE LIMITS OF PEOPLE THAT ARE
ELIGIBLE FOR THE CLINICAL TRIAL.
IS THERE A MINIMUM OR MAXIMUM
AGE AT WHICH ELIGIBILITY IS CUT
OFF AND IF THE TRIAL ITSELF IS
LIMITING PER TISIPATION, BASED
ON A PARTICIPANT SEX OR GENDER
AND WHETHER OR NOT THE STUDY
ITSELF IS ACCEPTING HEALTHY
VOLUNTEERS.
WE ALSO THEN COLLECT INFORMATION
ABOUT RECRUITMENT STATUS.
AND WHETHER OR NOT THE CURRENT
CLINICAL TRIAL IS CURRENTLY
RECRUITING OR IF IT HAS
COMPLETED RECRUITMENT AND
ONGOING AND WHETHER OR NOT IT'S
COMPLETED, THIS HAPPENS AT THE
INDIVIDUAL SITE STATUS LEVEL SO
THAT INDIVIDUAL PARTICIPANTS WHO
MAY BE INTERESTED IN A CLINICAL
STUDY CAN SEE IT AT ANY LOCATION
THAT MAY BE NEAR THEM, WHETHER
NOT THAT PARTICULAR LOCATION MAY
BE RECRUITING AS WELL.
THE PREAMBLE OF THE FINAL RULE
ALSO FURTHER ELABORATES ON THAT
SECTION GENDER BETA ELEMENT,
THAT THE REQUIREMENT IS
BASICALLY TO INDICATE WHETHER OR
NOT THEORY KRUTMENT IS INDICATE
BIDE THE SEX OF THE INDIVIDUAL,
YOU CAN SEE THE DEFINITION HERE,
BUT IF NECESSARY, IF THE TRIAL
ITSELF IS ALSO TAKING INTO
CONSIDERATION A PERSON
SELF-REPRESENTATION OF THEIR
GENDER IDENTITY.
THERE'S NOW GOING TO BE A
STRUCTURED AND EASIER PLACE TO
IDENTIFY THAT INFORMATION WITHIN
THE CONTEXT OF RECRUITMENT
INFORMATION.
ANOTHER KEY DATA ELEMENT IS THE
AVAILABILITY OF EXPANDED ACCESS.
THIS PERTAINS TO APPLICABLE DRUG
CLINICAL TRIALS THAT INCLUDE
INVESTIGATIONAL DRUG PRODUCTS.
IN THE NOTICE OF PROPOSED RULE
MAKING THERE IS A MORE GENERAL
REQUIREMENT ABOUT WHO WOULD BE
REQUIRED TO PROVIDE INFORMATION
ABOUT THE AVAILABILITY OF
EXPANDED ACCESS.
WE RECEIVED A LOT OF COMMENTS
ABOUT THIS, AND THERE WERE
CONCERNS THAT THERE MAY BE CASES
IN WHICH THE RESPONSIBILITY
PARTY MAY OR MAY NOT BE AWARE OF
WHETHER OR NOT THERE IS EXPANDED
ACCESS AVAILABLE TO A PARTICULAR
PRODUCT AND SO, THE APPROACH
TAKEN IN THE FINAL RULE IS TO
LIMIT THE REQUIREMENT FOR
PROVIDING INFORMATION ON
EXPANDED ACCESS, THE SITUATIONS
IN WHICH THE RESPONSIBLE PARTY
IS BOTH THE MANUFACTURE AND THE
SPONSOR OF THAT APPLICABLE
CLINICAL TRIAL BECAUSE IN THAT
CASE, THEY WOULD BE IN A
POSITION TO KNOW ABOUT THE
AVAILABILITY OF EXPANDED ACCESS
FOR THAT DRUG PRODUCT.
THE OTHER THING WE CLARIFIED IN
THE CONTEXT OF EXPANDED
ACSESSION AND PROVIDING
INFORMATION ABOUT IT IS THAT
IT'S--IT COVERS ALL ASPECTS OF
THE REGULATIONS RELATED TO
EXPANDED ACCESS PROGRAMS SO
THERE'S 3 DIFFERENT TYPES OF
EXPANDED ACCESS THAT ARE
DESCRIBE INDEED FDA REGULATIONS
AND THOSE INCLUDE FOR INDIVIDUAL
PATIENTS, INTERMEDIATE SIZE
POPULATIONS AND THE THIRD
CATEGORY OF UNDERTREATMENT IND
OR PROTOCOL AND THE FINAL RULE
ITSELF CLARIFIES THAT ALL 3 OF
THESE TYPES OF EXPANDED ACCESS
ARE CONSIDERED TO BE COVERED
WHEN YOU'RE ANSWERING THE
QUESTION ABOUT AVAILABILITY OF
EXPANDED ACCESS.
THEN THE NEXT LEVEL REQUIREMENT
WHICH IS ALSO CURRENTLY
SOMETHING THAT HAPPENS ON
CLINICALTRIALS.GOV IS THAT THE
PARTY MUST CREATE A EXPANDED
ACCESS RECORD TO PROVIDE
INFORMATION ABOUT THE
AVAILABILITY OF THAT
INVESTIGATIONAL DRUG PRODUCT.
SO AFTER THAT EXPANDED ACCESS
RECORD IS CREATED BY THE SPONSOR
OF THE APPLICABLE CLINICAL
TRIAL, THEN THE NCT NUMBER FOR
THAT EXPABDED ACCESS RECORD MUST
BE ADDED TO THE APPLICABLE
CLINICAL TRIAL RECORD ITSELF.
THE REGULATIONS IN SECTION 1128
C HAVE MORE DETAILS ABOUT THE
SPECIFIC DATA ELEMENTS THAT ARE
REQUIRED FOR AN EXPANDED ACCESS
RECORD.
IT'S VERY SIMILAR TO THE DATA
ELEMENTS THAT ARE REQUIRED UNDER
1128 OR AN APPLICABLE CLINICAL
TRIAL BUT IT'S LIMITED TO THE
DATA ELEMENTS THAT ARE MOST
RELEVANT TO EXPANDED ACCESS.
I JUST WANT TO MENTION THAT 1 OF
THE THINGS THAT WE'VE ADDED IS
THE ABILITY TO INDICATE THE TYPE
OF EXPANDED ACCESS THAT IS
AVAILABLE CORRESPONDING TO THOSE
3 TYPES UNDER THE EXPANDED
ACCESS REGULATIONS.
THE EXPECTATION IS THAT THERE
WOULD STILL BE JUST 1 EXPANDED
ACCESS RECORD FOR EACH
INVESTIGATIONAL DRUG PRODUCT BUT
THE SPONSOR WOULD INDICATE THE
TYPE OF EXPANDED ACCESS THAT IS
AVAILABLE FOR THAT
INVESTIGATIONAL DRUG PRODUCT IN
THAT RECORD AND MORE THAN 1 TYPE
COULD BE MENTIONED.
THE TYPE BECOMES IMPORTANT AGAIN
BECAUSE IF IT IS JUST INDIVIDUAL
PATIENT ACCESS, THEN THERE ARE
EVEN A MORE LIMITED SET OF DATA
ELEMENTS THAT ARE REQUIRED TO BE
PROVIDED WITHIN THAT EXPANDED
ACCESS RECORD.
THE FINAL SECTION IS--OR THE
NEXT SECTION LOCATION AND
CONTACT INFORMATION.
MANY OF THESE DATA ELEMENTS ARE
PRACTICALLY, THEY ARE THE SAME
AS WHAT'S CURRENTLY AVAILABLE IN
CLINICALTRIALS.GOV AND IN THE
FIRST PART WHAT WE'RE TALKING
ABOUT RESPONSIBLE PARTY AND THAT
DESIGNATION OF THE PRINCIPLE
INVESTIGATOR, IT'S LOCATED UNDER
THIS RESPONSIBLE PARTY BY
OFFICIAL TITLES DATA ELEMENT BUT
THAT'S WHERE THAT DESIGNATION
OCCURS.
THEN FINALLY THE LAST PIECE OF
ADMINISTRATIVE DATA ARE LISTED
HERE.
AGAIN THESE ARE ARE ALL VERY
SIMILAR TO WHAT IS CURRENTLY
AVAILABLE WITHIN
CLINICALTRIALS.GOV.
THE HUMAN SUBJECTS REVIEW BOARD
STATUS WHETHER OR NOT THAT TRIAL
HAS BEEN APPROVED OR NOT BY A
HUMAN SUBJECTS REVIEW BOARD WILL
NOW BE MADE PUBLIC, IT WASN'T A
PIECE OF INFORMATION THAT WE
MADE AVAILABLE IN THE PAST BUT
THAT WILL NOW BE POSTED ON THE
CLINICALTRIALS.GOV RECORD.
THERE IS ALSO ADDITIONAL
INFORMATION REQUIRED FOR THE
RESPONSIBLE PARTY AND THEIR
CONTACT INFORMATION BUT
GENERALLY THAT INFORMATION IS
NOT GOING TO BE MADE PUBLIC.
THAT WILL BE KEPT INTERNALLY FOR
ADMINISTRATIVE PURPOSES ONLY.
SO THE FINAL SECTION I WANT TO
COVER TODAY AND I REALIZE WE'RE
ABOUT 7 MINUTES FROM THE END, IS
ABOUT WHEN CLINICAL TRIAL
REGISTRATION INFORMATION MUST BE
UPDATED.
THE UPDATE REQUIREMENTS ARE NOT
DESCRIBED IN PUB PART B WITH THE
REGISTRATION REQUIREMENTS
THEY'RE DESCRIBED IN SECTION
1164 WHICH COVERS UPDATE
REQUIREMENTS BOTH FOR CLINICAL
TRIAL REGISTRATION INFORMATION
AND CLINICAL TRIAL RESULTS
INFORMATION.
AND AS WITH OTHER SECTIONS OF
THE RULE, IT DISTINGUISHES
BETWEEN TRIALS THAT STARTED
BEFORE JANUARY18th OR THE
EFFECTIVE DATE OF THE FINAL RULE
AND THOSE THAT WERE STARTED ON
OR AFTER THE EFFECTIVE DATE OF
THE FINAL RULE.
I WILL JUST FOCUS ON THOSE
ASPECTS HERE.
IN GENERAL, THE CLINICAL TRIAL
REGISTRATION INFORMATION MUST BE
UPDATED AT LEAST ONCE PER YEAR.
AND THERE ARE OTHER MORE
DETAILED REQUIREMENTS FOR
CERTAIN DATA ELEMENTS THAT NEED
TO BE UPDATED IN A MORE TIMELY
FASHION.
ALL OF THE UPDATE REQUIREMENTS
BECAUSE ALL OF THE INFORMATION
ON CLINICAL TRIALS.GOV, OR MOST
OF THE TRIAL INFORMATION ON
PUBLIC TRIALS, THE PURPOSE AND
INTENT OF HAVING UPDATE
REQUIREMENTS IS TO INSURE THAT
THE PUBLIC INFORMATION THAT IS
SUBMITTED TO US AND AVAILABLE IS
ACTUALLY UP TO DATE AND
ACCURATE.
THAT'S AT LEAST 1 OF THE GENERAL
PURPOSES.
ON THIS SLIDE, I LISTED ALL OF
THE DATA ELEMENTS THAT ARE
SUBJECT TO THE SUBJECT 30 DAY
UPDATE REQUIREMENTS.
MEANING IF THERE ARE CHANGES AS
DESCRIBED HERE, THAT THEY MUST
OCCUR WITHIN 30 DAYS OF THOSE
CHANGES.
AND YOU CAN SEE THAT MANY OF
THESE DATA ELEMENTINGS ARE DATA
ELEMENTS THAT ARE REALLY KEY TO
IMPLEMENTING VARIOUS ASPECTS OF
THE FINAL RULE.
FOR EXAMPLE, THE PRIMARY
COMPLETION DATE, THE PRIMARY
COMPLETION DATE IS WHAT
DETERMINES WHEN THE RESULTS AND
INFORMATION IS REQUIRED TO BE
SUBMITTED SO HAVING AN ACCURATE
AND UP TO DATE PRIMARY
COMPLETION DATE WITHIN A
REASONABLE TIME PERIOD AFTER IT
IS KNOWN IS CRITICAL FOR
IMPLEMENTING VARIOUS ASPECTS OF
THE RULE.
SOME OTHER THINGS I'LL MENTION
THOUGH IS THAT IN GENERAL, THE
RECORD VERIFICATION DATE IS
SOMETHING THAT MUST BE UPDATED
ANYTIME THE RESPONSIBLE PARTY
REVIEWS THE COMPLETE SET OF
CLINICAL TRIAL INFORMATION AND
NOT LESS THAN EVERY 12 MONTHS.
SO EVEN IF NO UPDATED
INFORMATION IS PROVIDED, THAT
RECORD VERIFICATION DATE MUST BE
KEPT UP TO DATE AT LEAST ONCE
EVERY 12 MONTHS.
IN THE NEXT WEBINAR I'LL HAVE
TIME TO GO INTO MORE DETAIL
ABOUT WHEN THE OBLIGATION TO
UPDATE ENDS.
THIS ISN'T INTO PURPLE TUITY
WHERE WE HAVE KEEP THE
RECOMMENDATION UPDATED FOREVER,
THERE IS BASICALLY A CUT OFF IN
THE REGULATIONS IN TERMS OF WHEN
THE OBLIGATION TO UPDATE ENDS.
THE OTHER THING THAT'S EXPLAINED
IS THAT IF THERE ARE PROTOCOL
AMENDMENTS THAT IMPACT
REGISTRATION INFORMATION, THAT
THOSE MUST ALSO BE UPDATED IN A
TIMELY FASHION ON CLINICAL
TRIALS.GOV WITHIN THE 30 DAY
TIMELINE.
AND THEN THE FINAL UPDATE
REQUIREMENT FOR REGISTRATION
INFORMATION IS THAT THAT MUST BE
UPDATE AT A TIME TAKEN--THEY
RESULTS INFORMATION IS INITIALLY
SUBMITTED.
IT MAY BE THE CASE THAT NO
UPDATES ARE NEEDED BUT THE
GENERAL CONCEPT IS THAT IT
SHOULD BE UPTO DATE AT THE TIME
RESUMMITS INFORMATION IS NEEDED
AND AGAIN THE REQUIREMENTS FOR
WHICH REGISTRATION INFORMATION
IS REQUIRED IS BASED ON THE
EFFECTIVE DATE.
SO EVEN IF YOUR RESULTS,
SUBMISSION REQUIREMENTS ARE
HAPPENING AFTER THE EFFECTIVE
DATE, IT DOESN'T MEAN THAT
SUDDENLY YOUR CLINICAL TRIAL
REGISTRATION INFORMATION ARE
CHANGING.
IT'S STILL BASED ON THE STUDY
START DATE FOR THAT APPLICABLE
TRIAL.
I WANT TO HIGHLIGHT A FEW
RESOURCES AGAIN THE RECORDING
FROM THE FIRST WEBINAR IS NOW
AVAILABLE AND ON ONLINE USING
THE URL THAT'S AT THE BOTTOM OF
THE SLIDE.
WE WILL BE POSTING THIS
RECORDING AS WELL AS SOON AS
POSSIBLE.
IT WILL LIKELY BE EARLY NEXT
WEEK.
AND THEN JUST A REMINDER IF YOU
HAVE NOT YET REGISTERED FOR THE
THIRD WEBINAR WHICH IS
OCTOBER11th, PLEASE GO AHEAD
AND DO SO.
YOU CAN EXCESS THAT
INFORMATIONISTRATION INFORMATION
AGAIN WITH THE LINK THAT'S ON
THIS SLIDE, IT'S AGAIN UNDER THE
SUBMIT STUDIES AND TRAINING
MATERIAL SECTION OF THE CLINICAL
TRIALS.GOV WEB SITE.
AND JUST A REMINDER THERE ARE
OTHER NIH RESOURCES AVAILABLE
BOTH ON THE FINAL RULE AND NIH
POLICY, ON CLINICAL TRIAL
REGISTRATION AND RESULTS
SUBMISSION THAT WE DID NOT
DISCUSS TODAY BUT WE BRIEFLY
MENTIONED IN THE FIRST WEBINAR,
IF YOU HAVE ANY QUESTIONS ABOUT
THAT POLICY, THERE'S AN E-MAIL
ADDRESS AVAILABLE HERE AS WELL
AS ADDITIONAL INFORMATION IN THE
NIH GID NOTICE.
--GUIDE NOTICE.
AND THEN ADDITIONAL RESOURCES
THAT WE HAVE ON THE CLINICAL
TRIALS.GOV WEB SITE.
--CLINICALTRIALS.GOV WEB SITE.
I KNOW PEOPLE HAVE BEEN
SUBMITTING QUESTIONS THROUGHOUT
THE WEBINAR AND IT SEEMS LIKE
THERE'S MAYBE A FEW THAT ARE
RECURRING EEL SEE IF WE CAN TAKE
A LOOK AND GET A FEW OF THEM
ANSWERED NOW.
IF NOT, AS LIKE THE LAST
WEBINAR, WHAT WILL AIM TO DO IS
FOLLOW UP IN THE SUBSEQUENT
WEBINAR AND/OR POST INFORMATION
ON OUR WEB SITE THAT MIGHT BE
ABLE TO APPROPRIATELY RESPOND TO
THE QUESTIONS.
SOME OF THESE ARE DIFFICULT
QUESTIONS AND MAY NOT BE THINGS
WE CAN ANSWER ON THE WEBINAR
TODAY.
SOME OF THEM RELATE TO RESULTS
REQUIREMENT SO WE WILL BE ABLE
TO DISCUSS MANY OF THEM IN THE
NEXT WEBINAR AND A LOT OF THEM
ACTUALLY ARE ALSO IN THE
CONTICKETS OF UPDATE
REQUIREMENTS SO I'LL PLAN TO
REVISIT THAT TOPIC BECAUSE IT'S
RELEVANT FOR RESULTS INFORMATION
AND HOPEFULLY WE CAN ADDRESS
THOSE SPECIFIC QUESTIONS IN THE
CONTEXT THERE.
OTHERWISE IT LOOKS LIKE MOST OF
THE QUESTIONS AREN'T SOMETHING
WEE WILL BE ABLE TO ANSWER AT
THIS MOMENT.
THANK YOU FOR THE QUESTIONS.
THEY KEEP US ON OUR TOES AND
HOPEFULLY CREATE MORE
INFORMATIVE RESOURCES GOING
FORWARD.
SO THANK YOU EVERYONE WILL FOR
ATTENDING TODAY.
WE WILL CONCLUDE THE WEBINAR NOW
AND PLEASE DO REGISTER FOR THE
NEXT 1 ON OCTOBER11th AND WE
LOOK FORWARD TO SEEING YOU
THERE.
THANK YOU.