>> GOOD AFTERNOON, THIS IS
REBECCA WILLIAMS
DIRECTOR AT CLEANICAL TRIALS
SO, WHAT I PLAN TO COVER TODAY
IS THE INFORMATION RELATED TO
CLINICAL TRIAL RESULTS
INFORMATION SUBMISSION AND THE
UPDATE REQUIREMENTS FOR CLINICAL
TRIAL RESULTS INFORMATION AND I
WILL BE TOUCHING ON THE POSTING
PROVISIONS, WHEN THE NIH IS
REQUIRED TO POST SUBMITTED
CLINICAL TRIAL INFORMATION AS
WELL AS TOUCHING ON QUALITY
CONTROL REVIEW PROCEDURES.
I WILL NOTE THAT THE SECOND
WEBINAR SLIDES AND RECORDINGS
ARE NOW AVAILABLE ON OUR WEB
SITE.
THE LINK FOR THAT IS AT THE
BOTTOM OF THE SLIDE, IF YOU'RE
FAMILIAR WITH THE WAY OUR WEB
SITE IS STRUCTURED IF YOU GO TO
THE SUBMIT STUDY SECTION IT'S
UNDER THE CAT GOREY OF TRAINING
MATERIALS.
AND EVEN THOUGH THIS IS THE LAST
OF THE WEBINARS PLANNED IN THIS
SERIES, AS WE CONTINUE TO ROLL
OUT ADDITIONAL INFORMATION ABOUT
THE FINAL RULE, IT IS LIKELY
THAT WE WILL PLAN ADDITIONAL
WEBINARS TO WALK THROUGH SOME OF
THOSE VARIOUS ASPECTS OF
IMPLEMENTATION SO STAY TUNED FOR
THAT.
WE DO PLAN TO ANNOUNCE THOSE
THROUGH THE UPDATE LIST SERVE.
WE HAVE INFORMATION ABOUT THAT
ON THE FADA 801 REQUIREMENTS AND
I BELIEVE I HAVE A LINK TO IT
THEA THE END OF THIS SLIDE ALSO.
AGAIN I'LL START WITH JUST THE
OVERVIEW OF THE FINAL RULE, FOLK
USING ON THE WHAT ASPECTS OF
FINAL RULE PROVISIONS I'LL BE
COVERING AND THEN AS CAN YOU SEE
HERE, GOING INTO A LOT OF DETAIL
ABOUT THE SUBMISSION
REQUIREMENTS AS WELL AS POSTING
AND QC PROCEDURES.
SO JUST A REMINDER, THERE IS
THIS PUBLICATION IN THE NEW
ENGLAND JOURNAL THAT PROVIDES
THE OVERVIEW OF THE REQUIREMENT
IN THE FINAL RULE AND IT'S A
USEFUL TOOL FOR COMMUNICATING
WITH OTHERS ABOUT THE GENERAL
REQUIREMENTS.
IN TERMS OF THE ACTUAL
REGULATIONS, THEMSELVES, AS
WE'VE DESCRIBED IN PREVIOUS
WEBINARS THEY'RE BROKEN UP INTO
VARIOUS SUBPARTS WITH THE
INTRODUCTORY SECTION TITLED
GENERAL PROVISION AND JUST TO
POINT OUT THAT EVEN THOUGH I'M
NOT FOCUSING ON THAT PART TODAY,
A LOT OF WHAT IS COVERED IN THE
RESULT SUBMISSION REQUIREMENTS
AND THE REGISTRATION SUBMISSION
REQUIREMENTS ARE ALSO--THEY ALSO
INTERSECT WITH THE DEFINITIONS
SECTION.
SO 1110 WHAT DEFINITIONS APPLY
TO THIS PART UNDER SUBPART A IS
A VITICAL SECTION BECAUSE IT HAS
A LOT OF DETAIL ABOUT
ELABORATIONS OF DEFINITIONS THAT
IMPACT OTHER PARTS OF THE
REQUIREMENTS.
I WILL BE LOOPING BACK TO
REGISTRATION, INFORMATION,
SUBPART B TODAY JUST TO TALK
ABOUT THE POSTING PROVISIONS IN
TERMS OF WHEN THE NIH DIRECTOR
WILL POST CLINICAL TRIAL
REGISTRATION INFORMATION AND
THEN AS CAN YOU SEE HERE, I'LL
BE FOCUSING ON THE RESULTS
INFORMATION SUBMISSION
REQUIREMENT.
MOST OF THE REQUIREMENTS UNDER
SUBPART C WILL BE COVERED IN
THIS TALK TODAY.
AS WELL AS 1164 WHICH ADDRESSES
WHEN BOTH INFORMATION MUST BE
UPDATED AS WELL AS WHEN IT MUST
BE CORRECTED AND THAT'S WHERE
THE ACTIONER DITIONAL
INFORMATION ABOUT QC PROCEDURE
SYSTEM DESCRIBED IN THE SECTION
11.64.
SO AGAIN JUST REVISITING WITH
THE GENERAL REQUIREMENTS ARE
THAT ARE OUTLINED IN THE FINAL
RULE.
THESE ALSO PARALLEL THE
REQUIREMENTS THAT ARE WITHIN THE
STATUTE ITSELF, IT'S IMPORTANT
TO POINT OUT JUST THE KEY TERMS
IN TERMS OF REALLY UNDERSTANDING
WHAT THE REQUIREMENTS AND THE
PROVISIONS ARE AND AGAIN IT'S
THE FACT THAT THE RESPONSIBLE
PARTY FOR AN APPLICABLE CLINICAL
TRIAL MUST DO THESE VARIOUS
ACTIVITIES FIRST THERE'S
REGISTERING IT WITHIN THE
TIMELINE SPECIFIED, KEEPING THE
INFORMATION UP TO DATE AND THEN
SUBMITTING SOME RESULTS
INFORMATION WITHIN 1 YEAR OF THE
TRIALS PRIMARY COMPLETION DATE
AND THERE ARE DELAYS ALLOWED IN
SOME CIRCUMSTANCES AND WE'LL BE
WALKING THROUGH VARIOUS ASPECTS
OF REALLY THAT LAST BULLET
TODAY.
SO IN TERMS OF WHO IS
RESPONSIBLE FOR SUBMITTING
CLINICAL TRIAL RESULTS
INFORMATION, IT'S THE SAME
INDIVIDUAL ORANTITY THAT'S
REQUIRED TO SUBMIT CLINICAL
TRIAL REGISTRATION INFORMATION.
SO IT'S THE RESPONSIBLE PARTY
THAT IS RESPONSIBLE FOR TAKING
OUT THESE ACTIONS.
WE DID COVER THIS TOPIC IN
GREATER DETAIL IN THE SECOND
WEBINAR AND I'LL JUST POINT YOU
TO SECTION 11.4 C, WHICH HAS
ELABORATIONS ON DETERMINING THE
RESPONSIBLE PARTY AND I'M NOT
GOING TO GO INTO ANYMORE DETAIL
HERE, TODAY, ABOUT THAT
PROVISION.
SO IN TERMS OF WHICH APPLICABLE
CLINICAL TRIALS, MUST HAVE
CLINICAL TRIAL RESULTS
INFORMATION, SUBMITTED, WE WENT
THROUGH IN THE FIRST WEBINAR THE
FACT THAT THERE'S REALLY 2
DIFFERENT CRITERIA THAT ARE
REALLY IMPORTANT FOR DETERMINING
WHAT THE REQUIREMENTS ARE FOR
SUBMISSION OF CLINICAL TRIAL
RESULTS INFORMATION AND THOSE 2
FACTORS RELATE FIRST TO 1, WHAT
WAS THE PRIMARY COMPLETION DATE
OF THAT APPLICABLE CLINICAL
TRIAL THAT WAS REQUIRED TO BE
REGISTERED AND THEN THE SECOND
FACTOR WAS WHAT WAS THE APPROVAL
STATUS OF THE PRODUCT AS OF THAT
PRIMARY COMPLETION DATE.
AND SO SECTION 11.42 LAYS OUT
THE DIFFERENT REQUIREMENTS FOR
THESE TYPES OF APPLICABLE
CLINICAL TRIALS BASED ON THESE
CATEGORIES.
SO THE FIRST 1 FOCUSES ON THE
CLINICAL TRIALS IN WHICH THESE
STUDY PRODUCT IS APPROVED
LICENSE OR CLEARED BY THE FDA.
AND SO, ALSO, THINKING BACK TO
THE EFFECTIVE DATE REQUIREMENTS,
THE FIRST REQUIREMENT HERE IS
FOCUSING ON THE PRIMARY
COMPLETION DATE.
SO THE PRIMARY COMPLETION DATE
WAS ON OR AFTER JANUARY18th
2017, THEN THE PROVISIONS
RELATED TO RESULTS INFORMATION
SUBMISSION THAT ARE DESCRIBED IN
THE FINAL RULE IN SECTION 11.48
MUST BE FOLLOWED IN TERMS OF THE
INFORMATION THAT'S REQUIRED TO
BE SUBMITTED.
IF THE PRIMARY COMPLETION DATE
IS BEFORE JANUARY18th, 2017,
THEN THE REQUIREMENTS ARE
BASICALLY WHAT THEY ARE NOW,
YOUR FOLLOWING THE REQUIREMENTS
THAT ARE DESCRIBED WITHIN THE
STATUTE.
THE SECOND CATEGORY OF
REQUIREMENTS RELATES TO
APPLICABLE CLINICAL TRIAL FOR
WHICH THE STUDIED PRODUCT IS NOT
APPROVED OR CLEARED BY FDA, AS
RECALLED THAT WAS 1 OF THE MAJOR
THINGS WE WERE ASKED TO CONSIDER
WITHIN THE FINAL RULE IS WHETHER
OR NOT RESULTS SUBMISSION
REQUIREMENT SHOULD BE EXPANDED
TO INCLUDE PRODUCTS THAT WERE
NOT PREVIOUSLY APPROVED BY
SENSOR CLEARED.
WE DESCRIBED THIS IN THE FIRST
WEBINAR ALSO THAT THE FINAL RULE
DID IN FACT TAKE THE STEP OF
REQUIREMENTING RESULTS
SUBMISSION FOR THESE CLINICAL
TRIALS BUT AGAIN TAKING INTO
ACCOUNT THE PRIMARY COMPLETION
DATE IN TERMS OF THE
APPLICABILITY OF THOSE
REQUIREMENTS.
SO IF THE PRIMARY COMPLETION
DATE WAS BEFORE JANUARY18th,
2017 AND THAT PRODUCT WAS NOT
APPROVED, LICENSE OR CLEARED BY
THAT PRIMARY COMPLETION DATE
THEN RESULTS INFORMATION IS NOT
REQUIRED TO BE SUBMITTED UNDER
THE FINAL RULE AND UNDER THE
STATUTE.
IF THE PRIMARY COMPLETION DATE
WAS ON OR AFTER JANUARY18th
2017, THEN THE RESULTS
INFORMATION SUBMISSION
REQUIREMENTS THAT ARE DESCRIBED
IN SECTION 1148 WOULD APPLY AND
WILL BE TALKING THROUGH THE
REQUIREMENTS THAT ARE VIBED IN
11.48 LATER WITHIN THE WEBINAR
TODAY.
SO KEY TERM THEN FOR
UNDERSTANDING HOW THESE
REQUIREMENTS APPLY TO YOUR
APPLIC ANNUAL CLINICAL TRIAL IS
THE DEFINITION OF PRIMARY
COMPLETION DATE.
IN THE STATUTE, THE PHRASE
COMPLETION DATE WAS USED AND
WE'VE DESCRIBED IN THE
DEFINITION SECTION OF THE FINAL
RULE IN SECTION 11.10 A, AGAIN I
PROMISED THAT SECTION WOULD COME
INTO PLAY VERY OFTEN.
WE DESCRIBED THAT TERM
COMPLETION DATE WHICH IS USED IN
THE STATUTE IS REFERRED TO IN
THE FINAL RULE AS THE PRIMARY
COMPLETION DATE.
THIS HAD BEEN IN PRACTICE AT
CLINICALTRIALS.GOV WHICH THE LAW
WAS PASSED TO HELP DRAW PEOPLE'S
ATTENTION TO THE FACT THAT THE
DEFINITION OF COMPLETION DATE
REALLY REQUIRES FURTHER
CONSIDERATION IN TERMS OF HOW
IT'S DEFINED AND THE REASON IS,
THAT IT'S DEFINED AS--DEFINED
BASED ON FINAL COLLECTION OF
DATA FOR THE PRIMARY OUTCOME
MEASURE, SO THAT'S WHY WE PLACE
THAT TERM PRIMARY IN FRONT OF
COMPLETION DATE TO DRAW
ATTENTION TO THAT FACT.
ONE OF THE OTHER THINGS WE DID
WITHIN THE FINAL RULE TO CLARIFY
A SITUATION THAT SEEMED TO COME
UP OFTEN ENOUGH TO REQUIRE
CLARIFICATION IN THE FINAL RULE
WAS A CASE IN WHICH MORE THAN 1
PRIMARY OUTCOME MEASURE AND THE
DATES FOR FINAL DATA COLLECTION
VARY AMONG THOSE PRIMARY OUTCOME
MEASURES.
SO IF THERE'S MORE THAN 1 AND
THEY HAVE DIFFERENT DATES OF
FINAL COLLECTION OF DATA FOR
THAT PRIMARY OUTCOME MEASURE,
THEN HOW WOULD A RESPONSIBLE
PARTY DETERMINE WHICH IS THE
APPROPRIATE DATE FOR THE PRIMARY
COMPLETION DATE.
AND WHAT THE FINAL RULE
CLARIFIES IS THAT IF THERE ARE
MULTIPLE, IT'S DATA IN WHICH
DATA COLLECTION IS COMPLETED FOR
ALL OF THE PRIMARY OUTCOMES,
WHICH WOULD MEAN THAT IT WOULD
BE THE LATER OF THE--I'LL SAY IN
THIS CASE, 2 DAYS, IF THERE ARE
2 PRIMARY OUTCOME MEASURES IT
WOULD BE THE DATE ASSOCIATED
WITH THE FINAL COLLECTION OF
DATA.
11.10 B IN THE FINAL RULE
FURTHER ELABORATES IS THAT THE
IT MUST BE SUBMITTED AS PART OF
REGISTRATION INFORMATION, IF THE
DATA ELEMENT THAT'S EXPECTED TO
BE UPDATED THROUGHOUT THE COURSE
OF THE CLINICAL TRIAL.
THERE ARE SPECIFIC REQUIREMENTS
FOR UPDATING THAT DATA ELEMENT
IN SECTION 1164 WHICH OUTLINES
THE REGISTRATION INFORMATION
UPDATE REQUIREMENTS.
SO WHAT IS THE TIMINGS FOR WHICH
IT MUST BE SUBMITTED?
THE FINAL RULE DESCRIBE THIS IS
IN SECTION 34 AND THERE'S MANY
DIFFERENT SUBSECTIONS WITHIN
SECTION 11.44.
IT STARTS OUT DESCRIBING WHAT
THE STANDARD SUBMISSION DESIGN
IS, AND IT REFERS BACK TO
SECTION 11.42 WHICH IS WHERE IT
BROKE OUT WHICH APPLICABLE
CLINICAL TRIALS ARE REQUIRED TO
HAVE RESULTS SUBMITTED AND
ACCORDING TO WHICH REQUIREMENTS.
SO IT'S SAYING THAT THE STANDARD
DEFINITION, THE STANDARD
SUBMISSION DEADLINE APPLIES TO
THOSE APPLICABLE CLINICAL TRIALS
THAT ARE REQUIRED TO HAVE
RESULTS INFORMATION APPLY AS
DESCRIBED IN SECTION 11.42 AND
THAT RESULTS INFORMATION MUST BE
SUBMITTED NO LATER THAN 1 YEAR
AFTER THE PRIMARY COMPLETION
DATE.
THEN THE LITTLER ADDITIONAL
DECISION THAT'S IN 11.44
OUTLINED DIFFERENT WAYS IN WHICH
THOSE DEADLINES MIGHT SHIFT AND
SO THERE ARE PROVISIONS ALLOWING
FOR DELAYED SUBMISSION AND
VARIOUS CIRCUMSTANCES.
THREE OF THEM ARE OUTLINED HERE.
I ACTUALLY TALKED ABOUT THEM IN
A CERTAIN AMOUNT OF DETAIL IN
THE FIRST WEBINAR.
SO I'M NOT GOING TO BE COVERING
THESE IN GREAT DETAIL, WITHIN
THIS WEBINAR, BUT JUST NOTING
THAT THERE ARE CONDITIONS IN
WHICH A SPONSOR IS SEEKING
APPROVAL OF A USE OR SEEKING
INITIAL APPROVAL CLEARANCE THERE
ARE MECHANISMS TO DELAY
SUBCOMMISSION OF RESULTS
REPORTING AND THOSE ARE GRIEBED
IN 11.44 B AND 11.44 C AND THEY
WERE ALSO DESCRIBED IN THE FIRST
WEBINAR.
THERE'S ALSO A MECHANISM TO
DELAY RESULT SUBMISSION IF THERE
IS GOOD CAUSE FOR AN EXTENSION
AND THAT'S DESCRIBED IN 11.44 E.
I DIDN'T GO THROUGH THAT IN THE
FIRST WEBINAR AND THERE REALLY
ISN'T TIME TO GO THROUGH IT IN
DETAIL TODAY.
BUT IT IS SOMETHING THAT WOULD
BE IMPORTANTY IMPORTANT TO READ
OVER AND UNDERSTAND THE
CIRCUMSTANCES IN WHICH IT MAY
APPLY.
YOU'LL NOTE ON THIS SLIDE THAT
WE WENT A, B, C, AND E, SO THERE
MUST BE A D IN THERE SO THAT'S
WHAT I'M GOING TO FOCUS ON OVER
THE NEXT COUPLE OF SLIDES AND
1144 D RESER FERS TO THE
SUBMISSION OF PARTIAL RESULTS
INFORMATION SO WE TALKED BEEN
THE PRIMARY COMPLETION DATE
DEFINITION, NOW IT'S POSSIBLE
THAT THE PRIMARY OUTCOME
MEASURES, IF THERE'S MORE THAN 1
MIGHT HAVE DIFFERENT TIME
PERIODS FOR DATA COLLECTION.
WELL THE SAME THING MAY BE TRUE
FOR SECONDARY SUBMISSION.
ALL PRIMARY OUTCOME MEASURES AND
ALL SECONDARY OUTCOME MEASURES
ARE REQUIRED TO HAVE RESULTS
SUBMITTED.
BUT THE DEADLINE FOR SUBMITTING
IS BASED ON WHAT WHEN THAT IS
FOR THE FINAL OUTCOME MEASURE,
SO IF YOU HAVE A SITUATION IN
WHICH THE PRIMARY OUTCOME
MEASURE, COMPLETED AT YEAR 1 AND
YOUR SECONDARY OUTCOME MEASURE
DATA ISN'T OCCURRING UNTIL YEAR
2 IT WOULD BE DIFFICULT TO
REPORT RESULTS WITHIN THE 1 YEAR
TIME FRAME FROM THAT
PRIMARY--FOR DATA COLLECTION FOR
THAT PRIMARY OUTCOME MEASURE
BECAUSE YOU WOULD HAVE JUST
COMPLOATED THE DAILY BASIS DATA
COLLECTION FOR THE SECONDARY
OUTCOME MEASURE AT THE TIME THAT
THE RESULTS WERE ALREADY
SUBMITTED EMPLOYED SO THIS
SECTION IS ACKNOWLEDGING THAT
SITUATION AND ADDRESSING THE
FACT THAT THERE MIGHT BE
SITUATIONS IN WHICH SECONDARY
OUTCOME MEASURE SUBMISSION WILL
HAPPEN ON A ROLLING BASIS IF YOU
WILL.
AND IN IT OUTLINES THE TIME
FRAMES FOR WHEN THAT INFORMATION
MUST BE SUBMITTED.
AND IT INDICATES THAT THE
SECONDARY OUTCOME MEASURE
INFORMATION IS DUE NO LATER THAN
1 YEAR AFTER THE DATE ON WHICH
THE FINAL SUBJECT IS EXAMINED OR
RECEIVES AN INTERVENTION.
FOR PURPOSES OF FINAL COLLECTION
OF DATA FOR THAT SECONDARY
OUTCOMPREHEND MEASURE.
THAT EXPLANATION MAY SOUND VERY
SIMILAR BECAUSE IT'S BASICALLY
THE PRIMARY--PRIMARY COMPLETION
DATE DEFINITION BEING APPLIED TO
THE SECONDARY OUTCOME MEASURE
INFORMATION.
HOWEVER, FOR SECONDARY OUTCOME
MEASURES, THERE ISN'T A SPECIFIC
DATA ELEMENT THAT WE COLLECT
THAT ALLOWS FOR IDENTIFICATION
OF THAT DATE AND SO IT'S THE
RESPONSIBILITY OF THE
RESPONSIBLE PARTY TO INSURE THAT
THEY ARE MEETING THOSE TIME
FRAMES FOR SECONDARY OUTCOME
MEASURES, SUBMISSION IN
ACCORDANCE WITH THE FINAL
COLLECTION OF THE DATA OUTCOME
MEASURE.
SO SIMILARLY AS POSSIBLE, THE
ADVERSE EVENT INFORMATION MIGHT
BE COLLECTED AT A LONGER TIME
PERIOD THAN THE PRIMARY OUTCOME
MEASURE, MAYBE IT'S COLLECTED IN
THE SAME TIME FRAME AS THE
SECONDARY OUTCOME MEASURES OR
PERHAPS IT EXTENDS LONGER AS
PART OF THAT PROTOCOL AND SO
SIMILARLY, ANY ADDITIONAL
ADVERSE EVENT INFORMATION WOULD
BE DUE NO LATER THAN 1 YEAR
AFTER THAT PRESPECIFIED DATA,
DATA COLLECTION FOR THAT
INFORMATION.
11.44 D OUTLINES SURFACES IN
WHICH IT WAS SUBMITTED UNDER
1144 B OR C AND IT'S SAYING THAT
IT WOULD BE THE LATER OF THE DUE
DATES WHICHEVER IN EACH OF THOSE
SITUATIONS WOULD BE CONSIDERED
LATER IS WHAT WOULD BE APPLIED
TO THAT PARTICULAR APPLICABLE
CLINICAL TRIAL.
ANOTHER THEN WE ELABORATED ON IN
THE CONFIXTURE, IS THE CONCEPT
OF THE STUDY COMPLETION DATE,
STUDY COMPLETION DATE IS
AICALITIA ELEMENT THAT WE'VE HAD
AVAILABLE IN CLINICAL TRIALS
.GOV BUT IT'S BEEN OPTIONAL.
WE ADDED THIS AS A REQUIRED DATA
ELEMENT AS PART OF REGISTRATION
INFORMATION AND AGAIN, I'VE
RESTATED THE DEFINITION OF THE
STUDY COMPLETION DATE HERE WHICH
TAKES INTO ACCOUNT FINALIDATE
DATA COLLECTION FOR PRIMARY,
SECONDARY AND ADVERSE EVENT
INFORMATION.
AND WHAT WE EXPLAINED IN THE
PREAMBLE TO THE FINAL RULE WAS
THAT COLLECTING THIS STUDY
COMPLETION DATE ALLOWS US TO
ADENTIFY KIND OF THE MAXIMUM
TIME PERIOD FOR WHICH ALL
CLINICAL TRIAL RESULTS
INFORMATION WOULD BE REQUIRED TO
BE SUBMITTED.
WE ACKNOWLEDGE THE FACT THAT THE
RESPONSIBLE PARTY MAY NEED TO
SUBMIT PARTIAL RESULTS
INFORMATION SEVERAL TIMES SO
AGAIN, IF THE SECONDARY OUTCOME
MEASURE MEASURE IS CONSIDER
OCCURRING AT DIFFERENT TIME
PERIODS THEN THAT MAY NEED TO BE
SUBMITTED AT DIFFERENT TIME
POINTS DEPENDING ON WHEN THAT
FINAL COLLECTION OCCURS.
THE OTHER BENEFIT OF ADDING THIS
STUDY COMPLETION DATE AS A
DEFINITION IS THAT IT HELPS
IDENTIFY WHEN THE OBLIGATION TO
SUBMIT RESULTS INFORMATION
CONTINUES THROUGH.
AND SO, IT'S BASICALLY THE
MAXIMUM PERIOD OF TIME BY WHICH
RESULTS INFORMATION SHOULD BE
SUBMITTED WHICH WOULD BE LATER
THAN 1 YEAR FOLLOWING THAT STUDY
COMPLETION DATE.
SO THE NEXT SECTION OF THE FINAL
RULE OUTLINES WHAT CONSITUTES
CLINICAL TRIAL RESULTS
INFORMATION.
THIS IS DESCRIBED IN SECTION
11.48 OF THE FINAL RULE AND IT'S
BROKEN UP INTO 2 SECTIONS.
I'M GOING TO BE FOCUSING ON
SECTION 11.48 A WHICH IS APPLIES
TO APPLICABLE CLINICAL TRIALS
THAT WERE REQUIRED TO REGISTER
AND HAVE A PRIMARY COMPLETION
DATE ON OR AFTER JANUARY18th
2017 MEANING AFTER THE EFFECTIVE
DATE OF THE FINAL RULE.
YOU'LL SEE A LITTLE RED ASTERISK
ON THE SCREEN THAT GOES TO THE
BOTTOM OF THE SLIDE.
THE SECOND PART OF 11.48 IS
11.48 B WHICH DESCRIBES
REQUIREMENTS FOR A CERTAIN TYPE
OF APPLICABLE CLINICAL TRIALS,
THAT IS A PEDIATRIC POST MARKET
SURVEILLANCE OF A DEVICE PRODUCT
BUT THAT IS NOT A CLINICAL
TRIAL.
SO THOSE REQUIREMENTS ARE
OUTLINED IN SECTION 11.48 B.
I WILL NOT BE DESCRIBING THOSE
TODAY BUT YOU HAVE THE REFERENCE
THERE FOR UNDERSTANDING WHAT
THOSE REQUIREMENTS MAY BE IF IT
APPLIES TO YOU.
AND SO THE RESULTS INFORMATION
MODULES ARE VERY SIMILAR TO WHAT
YOU'RE ALREADY FAMILIAR WITH FOR
THE RESULTS SUBMISSION
REQUIREMENTS.
THEY'RE COMPOSED OF SCIENTIFIC
MODULINGS, PARTICIPANT FLOWS,
DEMOGRAPHIC AND BASE LINE
CHARACTERISTICS OUTCOME AND
STATISTICAL ANALYSIS INFORMATION
AND ADVERSE EVENTSS INFORMATION.
ALSO ADMINISTRATIVE INFORMATION
IS VERY SIMILAR TO WHAT ALREADY
EXISTS.
NOEL NOTICE 2 NEW SECTIONS THAT
DIDN'T EXIST PRIOR TO THE FINAL
RULE.
ONE IS THE PROTOCOL AND
STATISTICAL ANALYSIS PLAN.
IT'S NOW REQUIRED TO BE
SUBMITTED AT THE TIME OF
SUBMISSION, I'LL BE TALKING
ABOUT THAT IN A BIT MORE DETAIL
AND THEN THE LAST 1 IS
ADDITIONAL CLINICAL TRIAL
RESULTS INFORMATION FOR
APPLICABLE DEVICE CLINICAL
TRIALS THAT ARE UNAPPROVED OR
UNCLEARED.
AND WHAT THIS IS REFERRING TO IS
WHAT WE'VE KIND OF GENERALLY
REFERRED TO AS THE LOCK BOX THAT
THERE ARE CERTAIN CLINICAL
TRIALS, DEVICE CLINICAL TRIALS,
THAT WE DON'T POST
LEDGEISTRATION INFORMATION FOR
BECAUSE THAT PRODUCT IS
UNAPPROVED OR UNCLEARED AND
THOSE WERE THE DIRECTIONS WITHIN
THE STATUTE.
ONE OF THE THINGS WE DESCRIBED
IN THE SECOND WEBINAR RELATED TO
REGISTRATION INFORMATION
REQUIREMENTS THOUGH WAS THAT A
RESPONSIBLE PARTY CAN AUTHORIZE
NIH TO POST THAT INFORMATION,
THAT REGISTRATION INFORMATION
FOR THESE APPLICABLE DEVICE
CLINICAL TRIALS, AT THE TIME OF
REGISTRATION IF THEY SO CHOOSE.
THAT'S AN OPTIONAL ITEM AND THEY
CONTINUE TO DO THAT BUT THE
REASON FOR HAVING THIS
ADDITIONAL REQUIREMENT WAS THAT
BY ADDING THE REQUIREMENT, THE
TO POST RESULTS INFORMATION FOR
THOSE TRIALS, THAT ARE
UNAPPROVED OR UNCLEARED AND ARE
STUDYING DEVICE PRODUCTS THAT
POSTING THE RESULTS INFORMATION
IN THE ABSENCE OF INFORMATION
THAT IS SIMILAR TO THE
REGISTRATION INFORMATION WOULD
MAKE THAT INFORMATION DIFFICULT
TO UNDERSTAND AND TO INTERPRET
AND SO THIS SECTION DESCRIBES
THE MECHANISM BY WHICH WE WILL
BASICALLY ALLOW A RESPONSIBLE
PARTY TO INDICATE THAT CERTAIN
REGISTRATION INFORMATION HAS
BEEN KEPT UP TO DATE AND TO
AUTHORIZE THE POSTING OF THAT
INFORMATION ALONG THE SIZE AND
RESULTS INFORMATION FOR THIS
PARTICULAR CATEGORY OF PRODUCT.
AGAIN, I'M NOT GOING ON TO GO
INTO THAT IN ANYMORE DETAILS IN
WHAT I ALREADY DID BUT THE
EXPLANATION I THINK WITHIN THE
FINAL RULE REAMBLE IS AS CLEAR
AS WE COULD MAKE IT.
I ALSO WANT TO POINT OUT THAT WE
HAVE A DOCUMENT AVAILABLE THAT
DESCRIBES CHANGES FROM CURRENT
PRACTICE, IN THE FINAL RULE.
SO BASICALLY IT'S A SUMMARY OF
THE CHANGES THAT WE'VE MADE
WITHIN THE FINAL RULE THAT ARE
DIFFERENT FROM CURRENT PRACTICES
AND IT INCLUDES 2 TABLES, 1 OF
REGISTRATION INFORMATION, AND
ANOTHER OF RESULTS INFORMATION
TAKEN--THEY WALKS THROUGH THE
STATUS OF DATA ELEMENTS BEFORE
THE FINAL RULE AND WHAT IT WILL
BE REQUIRING FOR THESE TRIALS
THAT ARE SUBJECT TO THE NEW
REQUIREMENT.
SO AGAIN I ALSO WANT TO
REITERATE AN ASPECT OF THE
RESULT INFORMATION, SUBMISSION
REQUIREMENTS, WE CONTINUE TO GET
A LOT OF QUESTIONS ABOUT HOW THE
REQUIREMENTS WILL APPLY WITHIN
THE PRS, I WALK THROUGH SOME OF
THIS INFORMATION, WHEN
DESCRIBING THE 11.42 SECTION BUT
WHAT I WANT TO ELABORATE ON JUST
A LITTLE BIT FURTHER WAS THAT
BECAUSE THESE RESULTS
INFORMATION REQUIREMENTS ARE
GOING TO BE DETERMINED, BY THE
PRIMARY COMPLETION DATE, THAT
THE PRS, THE SYSTEM BY WHICH YOU
SUBMIT THE INFORMATION WILL
SIMILARLY BE RELYINGOT PRIMARY
COMPLETION DATE TO DETERMINE
WHICH RESULTS INFORMATION
REQUIREMENTS SUPPLY.
THIS IS PARALENS LENS LENS LENS
TO WHAT WE DESCRIBED FOR
REGISTRATION INFORMATION WHEN
THE REGISTRATION INFORMATION
REQUIREMENTS ARE DEPENDENT ON
WHEN THE STUDY INITIATED OR WHAT
THAT STUDY START DATE IS AND
AGAIN THE PRS WILL RELY ON THAT
STEADY START DATE FOR IMPOSING
REQUIREMENTSOT FINAL RULE.
AND RESULTS STATES ELEMENT, SO
AGAIN THAT REQUIREMENT FOR
SUBMITTING THE RESULTS
INFORMATION SPEC JUSTIFIED IN
11.48 GOES INTO EFFECT IF THE
PRIMARY COMPLETION DATE IS ON OR
AFTER JANUARY18th 2017.
AND SO, EFFECTIVELY WHAT THAT
MEAN SYSTEM THAT THE EARLIEST
THAT RESULTS INFORMATION WOULD
BE DUE UNDER THE FINAL RULE
REQUIREMENT IS JANUARY18th,
2018.
SO BASICALLY 1 YEAR FOR THAT
STANDARD SUBMISSION AFTER THAT
PRIMARY COMPLETION DATE.
SO THIS IS INCLUDED IN EARLY
EARLY SLIDES BUT I JUST WANT TO
REITERATE THAT WE ARE TARGETING
TO HAVE A RELEASE TO PRS TESTS
BY LATE NOVEMBER THAT WILL HAVE
BASICALLY MOST OF THE RESULTS
DATA ELEMENTS INCORPORATED, A
DATA ELEMENT DEFINITION DOCUMENT
WITH THE RELATED XML SCHEMA.
THE NEW DATA ELEMENTS THAT ARE
PART OF THE SCHEMA WILL
BASICALLY BE ADAATIVE, MEANING
THAT OUR OVERALL GOAL IS TO
CONTINUE TO HAVE THE OLD XML
SCHEMA CONTINUE TO WORK
INDEFINITELY THAT THESE ARE
ADDITIONS AND IT SHOULDN'T
BREAK.
IT SHOULD BE THE KEY WORD BUT WE
DEFINITELY INTEND TO CONTINUE TO
BE ABLE TO ACCOMMODATE EXISTING
SUBMISSIONS IN THE SAME WAY.
TO NOTE THAT THAT THE
INFORMATION MAY BE AVAILABLE IN
THE PRS TEST AT THE END OF
NOVEMBER, IT SHOULDN'T BE USED
AS A STAGES AREA FOR SUBMISSION,
THE INFORMATION IS REALLY FOR
INFORMATIONAL PURPOSES TO ALLOW
FOR TESTING WITHIN THE YOUR OWN
SYSTEMS AND PROCESSES.
WE DO INTEND TO PUT THAT RELEASE
ON TO THE OPERATIONAL PRS SYSTEM
ON JANUARY18th WHICH IS THE
EFFECTIVE DATE AND AGAIN, THOSE
RESULTS DATA ELEMENTS THAT ARE
NEWLY REQUIRED BY THE FINAL RULE
WILL BE RELYING AGAIN ON THAT
PRIMARY COMPLETION DATE.
INITIALLY WHEN WE PUSH THAT
INFORMATION TO THE PRS, WE WILL
NOT BE TURNING THOSE NEW
REQUIREMENTS INTO ERRORS, THEY
WILL BE WARNINGS TO HELP PEOPLE
UNDERSTAND WHAT THE REQUIREMENTS
ARE WILL BE OR ARE AND TO HELP
INSURE THAT BY COMPLIANCE DATE
PEOPLE ARE READY AND AWARE OF
WHAT THOSE REQUIREMENTS FOR FOR
ANY PARTICULAR CLINICAL TRIAL.
AND THEN ON APRIL18th, THE
COMPLIANCE DATE, WE INTEND TO
HAVE THOSE NEW DATA ELEMENTS
THAT ARE REQUIRED BY THE FINAL
RULE SHOWING UP AS ERRORS, IF
THEY ARE REQUIRED, BUT AGAIN,
RELYING ON THAT PRIMARY
COMPLETION DATE TO DETERMINE
WHICH STUDIES IT APPLIES TO SO
EVEN THOUGH, THOSE WILL BE IN
EFFECT IN APRIL, WE RECOGNIZE
THAT THERE MAY BE
ADDITIONAL--STUDIES MAY NOT BE
ROLLING IN THAT ARE SUBJECT TO
THESE NEW REQUIREMENTS FOR A
LITTLE WHILE AFTER THAT.
SO NOW I'M GOING TO WALK THROUGH
EACH OF THE SPECIFIC RESULTS
INFORMATION MODULES.
AGAIN IF YOU'RE ALREADY FAMILIAR
WITH THE PROCESS OF SUBMITTING
RESULTS INFORMATION, MOST OF
THIS WILL LOOK VERY SIMILAR.
IN TERMS OF THE RESULTS
INFORMATION REQUIREMENTS,
OVERALL, THEY'RE NOT ALL THAT
DIFFERENT FROM WHAT IS ALREADY
AVAILABLE IN PRACTICE, RIGHT
NOW.
FOR EACH MODULE OF INFORMATION
BEING SUBMITTED, THE RESPONSIBLE
PARTY IS CONSTRUCTING A TABLE OF
INFORMATION.
SO FOR PARTICIPATE FLOW, THE
TABLE OR THE COLUMNS ARE
COMPOSED OF THE ARMS, THE
SPECIFIC ARMS THAT
PARTICIPANTS'RE ASSIGNED TOO ARE
DESCRIBED AS THOSE COLUMNS AND
THEN THE PARTICIPANT DATA IN
TERMS OF THE NUMBER OF
PARTICIPANTS THAT STARTED AND
COMPLETED THE CLINICAL TRIAL IN
EACH OF THOSE ARMS MAKE UP THE
ROWS.
ONE OF THE NEW REQUIREMENTS IS
THAT IF THERE IS ANY
PREASSIGNMENT INFORMATION THAT
IS ANY SIGNIFICANT EVENTS THAT
OCCUR AFTER ENROLLMENT BUT PRIOR
TO ASSIGNMENT TO AN ARM, SUCH AS
A RUN IN PERIOD, ANYTHING THAT
WOULD REALLY CAUSE THERE TO BE A
DIFFERENCE IN THE NUMBER OF
PARTICIPANTS THAT WERE ENROLLED
IN THE CLEANICAL TRIAL AND THOSE
THAT WERE ACTUALLY START INDEED
THAT PARTICIPANT FLOW MODULE, IS
THE TYPE OF INFORMATION THAT
WOULD BE DESCRIBED HERE.
THE PARTIC PACT PANT DATA IS
SIMILAR TO THE REQUIREMENTS, THE
NUMBER OF PARTICIPANTS THAT
STARTED AND COMPLETED THE
CLINICAL TRIAL BY AN ARM, WE'VE
ALSO ADDED A NEW REQUIREMENT TO
ALSO DESCRIBE IN CERTAIN
SITUATIONS, ADDITIONAL
INFORMATION ABOUT A--THE UNIT OF
ASSIGNMENT IF IT'S OTHER THAN
PARTICIPANTS.
THERE ARE MANY STUDIES THAT NOT
ONLY ARE EVALUATING PARTICIPANTS
BUT THEY'RE ALSO EVALUATING A
PARTICULAR ASPECT OF THAT
PARTICIPANT.
SO AN EXAMPLE MAY BE EYES, MAYBE
POSSIBLE THAT 1 EYE OR POAGHT
EYE OF THAT PARTICIPANT COULD BE
ASSIGNED TO A PARTICULAR
CLINICAL TRIAL ARM.
IN THE PAST WE HAVEN'T HAD A
MECHANISM TO ACCOMMODATE THIS
INFORMATION IN A STRUCTURED WAY.
WE DID JUST PUT A RELEASE OUT ON
PRS TEST THAT, IS SCHEDULED TO
GO TO PRS ON OCTOBER22nd THAT
ACTUALLY INCORPORATES THESE NEW
DATA ELEMENTS FOR PROVIDING
ADDITIONAL INFORMATION WHEN THE
UNIT OF ASSIGNMENT IS SOMETHING
OTHER THAN PARTIC PANNEDS.
THIS IS--THIS IS THE TYPE OF
DATA ELEMENT THAT IF YOU'RE
STUDY IS DESIGNED IN THIS WAY,
YOU WILL FIND IT USEFUL AND WILL
BE A MORE ACCURATE WAY TO
REPRESENT THE STUDY DESIGN BUT
IF IT DOESN'T APPLY TO YOUR
CLINICAL TRIAL THEN IT DOESN'T
NEED TO CONTINUE, THEN IT
DOESN'T IMPACT YOUR DATA
SUBMISSION, BASICALLY.
THE SECOND MODULE IS DEMOGRAPHIC
AND BASE LINE CHARACTERISTICS,
AGAIN THIS IS SIMILAR TO THE
INFORMATION REQUIREMENT THAT WE
ALREADY HAVE IN PLACE.
THE TABLE OF BASE LINE
CHARACTERISTIC SYSTEM COMPOSED
OF THE ARMS OR GROUPS OF
PARTICIPANTS THAT ANALYZE THAT
BASE LINE.
THERE ARE REQUIREMENTS FOR
PROVIDING INFORMATION ABOUT THE
ANALYSIS POPULATION.
THIS INCLUDES THE NUMBER OF BASE
LINE PARTICIPANTS THAT WERE
ANALYZED IN EACH ARM OF THE
CLINICAL TRIAL AND PARALLELLING
THAT NEW REQUIREMENT IN
PARTICIPANT FLOW, THERE IS NOW
THE REQUIREMENTS TO SPECIFY IF
THE UNIT OF ANALYSIS WAS
SOMETHING OTHER THAN
PARTICIPANT, AGAIN, AN EXAMPLE
WOULD BE EYES THAT THE
RESPONSIBLE PARTY CAN SPECIFY
THAT INFORMATION ABOUT OF UNITS
ANALYZED.
THERE'S ALSO THE OPPORTUNITY TO
PROVIDE A DESCRIPTION ABOUT THE
ANALYSIS POPULATION.
WE HAVE SPECIFIED IN THE FINAL
RULE THAT THE USE OF THIS
ANALYSIS POPULATION DESCRIPTION
DATA ELEMENTS IS REQUIRED IN
SITUATIONS IN WHICH THE OVERALL
NUMBER OF BASE LINE PARTICIPANT
SYSTEM DIFFERENT FROM THE NUMBER
OF HUMAN SUBJECTS ASSIGNED TO AN
ARM, MEANING THAT THE
PARTICIPANT ASSIGNED TO AN ARM
AND PARTICIPANT FLOW, ARE
DIFFERENT THAN WHAT'S ACTUALLY
BEING ANALYZED IN THE BASE LINE
CHARACTERISTICS MODULE.
SO THIS WOULD ALLOW USERS AND
READERS OF THE INFORMATION TO
UNDERSTAND HOW DECISIONS WERE
MADE ABOUT THAT ANALYSIS
POPULATION WHY IT MAY BE
DIFFERENT.
THE FINAL RULE ALTS FURTHER
DESCRIBES WHICH BASE LINE
MEASURES ARE REQUIRED TO BE
SUBMITTED.
PRIOR TO THE FINAL RULE, THE
PRS, THE SYSTEM ITSELF ENFORCED
A REQUIREMENT THAT EVERY
CLINICAL TRIAL HAVE INFORMATION
AVAILABLE ABOUT THE AGE OF THE
PARTICIPANT AND THE GENDER OF
THE PARTICIPANT.
WE REQUESTED COMMENTS OR INVITED
PUBLIC COMMENTS ON OTHER TYPES
OF BASE LINE MEASURES THAT WE
SHOULD OR COULD REQUIRE UNDER
THE FINAL RULE IF THEY WERE
ELEMENTS THAT WERE COMMON ACROSS
CLINICAL TRIALS AND THAT WOULD
ALSO HAVE SOME UTILITY AND BEING
REPORTED BROADLY.
WE DID RECEIVE A LOT OF COMMENTS
IN RESPONSE TO THIS INVITATION
AND THERE WERE MANY COMMENTS
THAT SUPPORTEDAD AILING A
REQUIREMENT FOR RACE AND
ETHNICITY INFORMATION AS PART OF
BASE LINE INFORMATION.
WE DIDN'T INITIALLY INCLUDE THIS
REQUIREMENT BECAUSE WE'RE
CONCERNED IT MIGHT NOT BE
ROUTINELY COLLECTED ACROSS
CLINICAL TRIALS BUT SOME
COMMENTERS SUGGEST THAD THERE
COULD BE A MECHANISM OR A WAY TO
INDICATE THAT IT WASN'T
COLLECTED UNDER THE PROTOCOL AS
A WAY TO BE FAIR FOR PROTOCOLS
ACROSS CLINICAL STUDIES SO WE
END UP AGREES WITH THAT APPROACH
AND ARE NOWADDING A REQUIREMENT
TO SUBMIT INFORMATION ABOUT RACE
AND ETHNICITY IF IT WAS
COLLECTED UNDER THE PROTOCOL.
MECHANISM FOR DOING SO IS GOING
TO BE VERY SIMILAR TO WHAT WE
ALREADY HAVE IN PLACE, AND THAT
WE HAVE ALREADY HAD STRUCTURED
DATA ELEMENTS AVAILABLE FOR
REPORTING, FOR IDENTIFYING WHEN
BASE LINE MEASURES ARE
EVALUATING RACE OR ETHNICITY AND
ADOPTING THE NIH AND OMB
STANDARDS IN IN CATEGORY.
IT'S NOT REQUIRED TO USE THOSE
STANDARDS BUT IF YOU HAVE, YOU
CAN SPECIFY THAT YOU'VE DONE SO.
THE FINAL RULE ALSO, FURTHER
ELABORATES ON THE FACT THAT IT'S
ALSO EXPECTED THAT ANY OTHER
MEASURES THAT WERE ASSESSED AT
BASE LINE AND USED IN THE
ANALYSIS OF THE PRIMARY OUTCOME
MEASURES SHOULD ALSO BE REPORTED
IN THE BASE LINE CHARACTERRITICS
MODULE.
SO IT'S FURTHER ELABORATING ON
THE TYPES OF BASE LINE MEASURES
THAT ARE REQUIRED TO BE
REPORTED.
AND THEN IN TERMS OF ACTUALLY
PROVIDING THAT INFORMATION, FOR
EACH BASE LINE SUBMITTED,
THERE'S INFORMATION THAT MUST BE
PROVIDED AND THERE'S A NAME AND
DESCRIPTION OF THE MEASURE.
THIS IS SIMILAR IN NATURE TO
INFORMATION THAT WE DESCRIBED
FOR OUTCOME MEASURES AND
REGISTRATION INFORMATION.
IT ALSO MUST BE IDENTIFIED WHAT
THE MEASURE TYPE IS, IS IT A
MEAN, IS IT A MEDIAN, OR IS IT A
COUNT OF PARTICIPANTS INDICATING
WHAT TYPE OF SUMMARY DATA ARE
GOING TO BE REPORTED.
WE ELABORATED IN THE PREAMBLE
THAT THE CURRENT LIST OF MEASURE
TYPE OPTIONS THAT WE'RE USING IN
THE PRS NOW, IS GOING TO BE
MODIFIED TO INCLUDE ADDITIONAL
OPTIONS THAT WERE REQUESTED FROM
COMMENTERS AND/OR THAT BASED ON
OUR OWN ANALYSIS, SEEM TO BE
IMPORTANT TO HAVE ADDITIONAL
INFORMATION ABOUT, AND THESE
INCLUDED ACCOUNTS OF
PARTICIPANTS OR IF IT'S
ACCOUNTED UNITS AND THE
GEOMETRIC SQUARES.
FOR EACH MEASURE IT'S ALSO
IMPORTANT TO IDENTIFY THE
SPECIFIC UNIT OF MEASURE THAT'S
USED.
THE UNIT OF MEASURE IS
PARTICIPANTS.
IF IT WAS SOMETHING LIKE BLOOD
PRESSURE, THE UNIT OF MEASURE
WOULD BE MILL PLETTERS AND THE
ACTUAL BASE LINE MEASURE DAT
ATHE SUMMARY DATA MEASURE THAT
WAS CALCULATED FOR THAT MEAN OR
FOR THAT COUNT.
WE'VE ALSO INCLUDED ADDITIONAL
OPTIONS FOR RESPONSIBLE PARTIES
TO SPECIFY WHEN BASE LINE
MEASURE DATA IF THEY'RE
CATEGORICAL ARE MULTIUALLY
EXCLUSIVE AND EXHAUSTIVE
CATEGORIES AND WE DESCRIBED THIS
IN THE PREAMBLE AND THE RELEASE
THAT'SOT TEST NOW AND THAT WILL
BE IN THE PRS THE END OF
OCTOBER, ALSO ENCLOUDS THESE
OPTIONS SO THIS IS SOMETHING YOU
CAN EXPLORE NOW.
SOMETHING THAT'S UNIQUE TO THE
BASE LINE CHARACTERISTICS TABLE
IS THAT BECAUSE THE OVERALL
NUMBER OF PARTICIPANT IS
PROVIDED OVERALL, FOR THE ENTIRE
BASE LINE MEASURE TABLE BUT THEN
MANY OR MULTIPLE BASE LINE
MEASURES ARE PROVIDED WITHIN
EACH ROW OF THAT TABLE.
IT'S ACTUALLY POSSIBLE THAT
THERE CAN BE CASES WHERE THE
NUMBER OF BASE LINE PARTICIPANTS
THAT'S ANALYZED FOR ANY
PARTICULAR MEASURE MIGHT BE
DIFFERENT FROM THAT OVERALL
NUMBER OF BASE LINE
PARTICIPANTS.
AND SO WE'VE ADDED A REQUIREMENT
AND THE ABILITY FOR RESPONSIBLE
PARTIES TO SPECIFY AT THE
MEASURE LEVEL, WHEN THE ANALYSIS
POPULATION DIFFERS FROM THAT
OVERALL ANALYSIS POPULATION.
THIS IS A FEATURE THAT WE'VE
ALSO ADDED INTO THE LATEST
RELEASE ON PRS TEST THAT WILL BE
IN THE OPERATIONAL SYSTEM AT THE
END OF OCTOBER.
AND THEN SIMILAR TO THE
PARTICIPANT FLOW MODULE WHERE WE
ADDED ADDITIONAL REQUIREMENTS TO
SPECIFICATIONS, THE DIFFERENT
REQUIREMENTS ARE FOLDED OVER
BASE LINE MEASURES AS WELL, TO
ALLOW WHEN THE UNIT OF ANALYSIS
IS SOMETHING OTHER THAN
PARTICIPANTS.
THE THIRD OUTCOME IS STATISTICAL
ANALYSIS, AS WITH REGISTRATION
INFORMATION, IT IS REQUIRED TO
REPORT EACH PRIMARY OUTCOME
MEASURE AND EACH OUTCOME
MEASURE.
EACH OUTCOME MEASURE IS REPORTED
SEPARATELY AND WE PROVIDED
ADDITIONAL ELABORATION ABOUT
THOSE REQUIREMENTS ALSO KIND OF
CARRYING OVER MUCH OF THE
DESCRIPTION THAT IS DESCRIBED
FOR THE OUTCOME MEASURE AND
INFORMATION AND REGISTRATION
INFORMATION.
AS WITH THE OTHER MODULES, THE
COLUMNS FOR THE TABLE ARE
COMPOSED OF INFORMATION ABOUT
THE ARM OR GROUP THAT'S USED FOR
COMPARISON, AS A BASE LINE
INFORMATION, ADDITIONAL
INFORMATION IS PROVIDED ABOUT
THE ANALYSIS POPULATION, BUT
THIS IS BUT THIS IS A PERMEASURE
BASIS SO PROVIDING THE NUMBER OF
PARTICIPANTS ANALYZED IF IT'S
RELEVANT, THE NUMBER OF UNITS
ANALYZED.
I DIDN'T--THIS WAS A REQUIREMENT
THAT HAS ALREADY BEEN AVAILABLE
IN THE OUTCOME MEASURES MODULE
FOR A WHILE AND IT WAS SOMETHING
THAT WAS ALREADY INCORPORATED IN
THE NPRM WHEN WE FIRST ISSUED
THAT.
AND SO, THIS ISN'T A CHANGE FROM
WHAT'S ALREADY THERE.
WE JUST CARRIED FORWARD THE
ABILITY TO REPORT INFORMATION
ABOUT THESE OTHER UNITS IN THE
MODULES OUT OUTCOME MEASURES.
AND BASE LINE MEASURES, AS A
REQUIREMENT, IF IT'S APPLICABLE
TO PROVIDE INFORMATION ABOUT THE
ANALYSIS POPULATION.
PROVIDING A DESCRIPTION ABOUT
THE ANALYSIS POPULATION.
WE DESCRIBED THIS IN THE DETAIL
IN THE SECOND WEBINAR ABOUT WHAT
MAKES UP A GOOD OUTCOME MEASURE
IN TERMS OF HAVING SPECIFICS
ABOUT THE METHODS THAT WERE USED
TO CHARACTERIZE IT.
YOU CAN SEE EXAMPLES WITHIN THE
PREAMBLE FOR THE FINAL RULE AS
WELL AS CURRENTLY ON OUR WEB
SITE.
ALSO DESCRIBING THE TIME
POINTINGS AT WHICH THE OUTCOME
MEASURE WAS ASSESSED, WE
INDICATED IN THE ELABORATION FOR
OUTCOME MEASURE INFORMATION THAT
TYPICALLY IF AN OUTCOME MEASURE,
BLOOD PRESSURE IS ASSESSED AT
MULTIPLE TIME POINTS, EACH OF
THOSE TIME POINTS IS REPORTED AT
DIFFERENT POINTS AND TIMES, 3
MONTHS, 6 MONTHS, 9 MONTHS,
THOSE UNIQUE ASSESSMENTS IS
CONSIDERED TO BE A UNIQUE
OUTCOME MEASURE AND SO CAN YOU
FIND ADRYINGSAL INFORMATION
ABOUT THAT IN THE PREAMBLE AS
WELL.
WE'VE MADE SIMILAR MODIFICATIONS
TO THE LIST OF THE MEASURE TYPE
AS WERE DESCRIBED IN THE BASE
LINE MEASURES MODULE.
AND THEN AGAIN UNIT OF MEASURE
IS REQUIRED FOR EACH OUTCOME
MEASURE AND THEN OF COURSE THE
DATA THAT GO ALONG WITH THE
ANALYSIS.
ONE OF THE ASPECTS OF THE FINE
RULE THAT WE RECEIVED COMMENTS
ON WAS RELATED TO THE
REQUIREMENTS FOR STATISTICAL
ANALYSIS ASSOCIATE WIDE THOSE
PRIMARY AND SECONDARY OUTCOME
MEASURES.
THE STATUTE ITSELF HAD REQUIRED
THAT 4 OUTCOME MEASURES THAT THE
RESULTS OF TESTS OF STATISTICAL
SIGNIFICANCE BE REPORTED.
WE ATTEMPTED WITHIN THE NFRM AND
THEN HAVE FINALIZED WITHIN THE
FINAL RULE AND ELABORATION OF
VARIOUS TYPES OF STATISTICAL
ANALYSIS THAT MAY MEET THESE
REQUIREMENTS.
FIRST AND MOST LEERILY WOULD BE
IF THESE WERE PRESPECIFIED IN
THE PROTOCOL AND/OR STATISTICAL
ANALYSIS PLAN, FOR THE PRIMARY
OR THE SECONDARY AND WE RECEIVED
INFORMATION WITH THERE MIGHT BE
ANALYSISOT OUTCOME MEASURE BUT
THERE MAY BE ADDITIONAL ANALYSIS
THAT ARE CONSIDERED EXPLORATORY
EVEN THOUGH THEY'RE BEING
CONDUCTED IN RELATION TO THAT
PRIMARY OUTCOME MEASURE.
WE DID CLARIFY WITHIN THE
PREAMBLE THAT THE INTENT WOULD
BE TO EXCLUDE THOSE STATISTICAL
ANALYSIS THAT ARE CONSIDERED
EXPLORATORY EVEN IF THEY'RE
RELATING TO THE PRIMARY OUTCOME
MEASURE.
ANOTHER CATEGORY IS WHETHER THE
INFORMATION HAD BEEN MADE
PUBLIC, IF IT HAD BEEN MADE
PUBLIC BY THE SPONSORROR
RESPONSIBLE PARTY PRIOR TO THE
DATE ON WHICH INFORMATION WAS
SUBMITTED FOR THE PRIMARY
OUTCOME MEASURES BUT THAT
REPORTING OF THAT INFORMATION BY
THE SPONSOR OR RESPONSIBLE PARTY
IS AN INDICATION TO SOME EXTENT
THAT THAT INFORMATION IS DEEMED
TO BE SCIENTIFICALLY APPROPRIATE
BY THOSE PARTYS.
THE THIRD CATEGORY WAS
WHETHER--WAS IF AN ANALYSIS WAS
CONDUCTED ON A PRIMARY OUTCOME
MEASURE IN RESPONSE TO REQUEST
BY THE FDA AGAIN PUTTING A TIME
LIMITATION ON IT SO IT WOULD BE
ANYTHING REQUESTED PRIOR TO THE
DAY ON WHICH CLINICAL TRIAL
RESULTS INFORMATION WAS
SUBMITTED FOR THAT PRIMARY
OUTCOME MEASURE.
THE PREAMBLE FURTHER CLARIFIED
THAT IT DOESN'T NECESSARILY
REFLECT THOSE AT THE AGENCY'S
AGREEMENT.
YOU KNOW THAT THE ANALYSIS ARE
CONSIDERED TO BE VALID.
SO IN TERMS OF STATISTICAL
ANALYSIS INFORMATION THAT MUST
BE PROVIDED, THE REQUIREMENTS
ARE VERY SIMILAR TOW WHAT IS
ALREADY IN PLACE WITHIN CLINICAL
TRIALS.GOV IF YOU ARE SUBMITTING
INFORMATION ON THE STATISTICAL
ANALYSIS.
A KEY ASPECT IS IDENTIFYING
WHICH ARMS ARE INVOLVED IN THE
ANALYSIS OF THAT INFORMATION.
SOMETIMES THE STUDY MAY HAVE
MULTIPLE ARMS BUT THERE ARE PAIR
WISE COMPARISONS BEING DONE
ACROSS SOME OF THOSE ARMS AND
THOSE ARE IMPORTANT TO IDENTIFY
WHICH ARMS FROM THAT SUMMARY
OUTCOME MEASURE DATA ARE BEING
COMPARED IN THE STATISTICAL
ANALYSIS.
THERE IS A MECHANISM TO INDICATE
THE TYPE OF STATISTICAL TEST
THAT'S BEING CONDUCTED.
THESE ARE A NEW OPTIONS AND A
LITTLE BIT DIFFERENT FROM WHAT'S
CURRENTLY IMPLEMENTED, AND IT
WAS BASED ON SOME OF THE
FEEDBACK THAT WE HAD RECEIVE
FRIDAY COMMENTS IN TERMS OF
BETTER IDENTIFYING.
THE DIFFERENT ASPECTS OF
STATISTICAL ANALYSIS THAT CAN
CONSIDER.
SO INDICATING WHETHER IT'S
SUPERIORITY, NONINFORIORITY,
EQUIVALENT OR OTHER.
WE HAD CASES IN WHICH THERE
MIGHT BE ANALYSIS OR SUMMARY
DESCRIPTIVE STATISTICS BEING
PROVIDED AS PART OF THE
STATISTICAL ANALYSIS MODULE IN
WHICH NONE OF THE OTHER OPTIONS
APPLIED.
SO WE DID INCORPORATE ANOTHER
OPTION WITHIN THAT LIST OF
OPTIONS.
IF THE STATISTICAL TEST IS
NONINFORIORITY OR EQUIVALENT.
THERE SHOULD BE A DESCRIPTION
THAT INCLUDES INFORMATION ABOUT
THE POWER CALCULATION AND THE
MARGINS ASSOCIATE WIDE THAT
ANALYSIS.
AND THEN AS IN THE SYSTEM NOW, 1
OF THE FOLLOWING WOULD BE
REQUIRED EITHER THE ESTIMATION
PARAMETER OR IF THERE'S A
CONFIDENCE ROLE IT CAN BE
PROVIDED AND THE P-VALUE TO
CALCULATE THAT.
WE ALSO DESCRIBE IN THE PREAMBLE
THAT IF NEITHER OF THE ABOVE
MECHANISMS FOR ESTIMATION MA RAM
TEROR P-VALUE WOULD APPLY TO THE
STUDY THAT THERE WILL BE A
GENERAL OTHER OPTION EMPLOYED
THERE WILL BE A GENERAL OTHER
OPTION AVAILABLE FOR SUBMITTING
INFORMATION WHEN IT DOESN'T FIT
INTO THOSE CLEAR CUT CATEGORIES.
WE ALSO FURTHER ELABORATED ON
CONSIDERATIONS FOR TERMINATED
TRIALS.
THIS WAS AN ASPECT WITHIN THE
NFRMTHAT WE INVITED COMMENTS ON
AND WE OUTLINED 2 DIFFERENT
SITUATIONS THAT WE HAVE OBSERVED
TO HAVE OCCURRED.
AND THAT WERE IMPORTANT FOR
CONSIDERATION.
THE FIRST CASE IS A TRIAL THAT'S
TERMINATED BEFORE DATA ARE
COLLECTED FOR PRIMARY OR
SECONDARY OUTCOME MEASURES.
SO THERE AREN'T DATA TO REPORT
BASED ON THE TIMING OF THAT TERM
NATION.
FIRST AND FOREMOST, IF A TRIAL
ACTUALLY DIDN'T ENROLL ANY
PARTICIPANTS IF THERE ARE 0
PARTICIPANTS ENROLLED IN THIS
STUDY, THAT STUDY WOULD CARRY A
STATUS OF WITHDRAWN IN OUR
SYSTEM, RATHER THAN TERMINATED
AND THERE WOULD BE NO
REQUIREMENT TO EVEN INITIATE
RESULTS REPORTING.
BUT IN THIS CASE, WITH THE
TRIALS TERMINATED AND THERE MAY
BE RESULTS OBLIGATIONS IN PLACE,
WE OUTLINE THE SCENARIO IN WHICH
IT'S APPROPRIATE TO SPECIFY THE
THERE WERE 0 DATA TO ANALYZE
WHEN THEY'RE COLLECTED AND THE
SUBSEQUENT OUTCOME DATA WOULD BE
SUBMITTED.
WE FURTHER EXPLAIN THAT THE
ADDITIONAL MODULES RELATED TO
REPORTING INFORMATION,
PARTICIPANT FLOW,
CHARACTERISTICS AND ADVERSE
EVENTS WOULD STILL BE REQUIRED
TO BE REPORTED.
THE OTHER SITUATION WAS A CASE
IN DHS OUTCOME MEASURE DATA WERE
COLLECTED FOR THOSE PRIMARY
AND/OR SECONDARY OUTCOME
MEASURES AND IT WAS BELOW THE
TEARINGET AND BELOW WHAT WAS
EXPECTED.
WE DID CLARIFY THAT IT IS
EXPECTED THAT OUTCOME MEASURE
INFORMATION AND THE ASSOCIATED
DATA FOR THOSE OUTCOME MEASURES
WOULD BE SUBMITTED.
HOWEVER, WE WOULD NOT EXPECT
THAT A STATISTICAL ANALYSIS
WOULD BE SUBMITTED ALONGSIDE
THAT IF IT WAS STILL DEEMED TO
BE IMPORTANT, SCIENTIFICALLY
APPROPRIATE WOULD BE ACCEPTABLE
TO SUBMIT IT AND THIS WOULD BE A
SITUATION IN WHICH IT'S NOT
NECESSARILY EXPECTED.
SOME PEOPLE DID RAISE SOME
CONCERNS ABOUT POTENTIAL PRIVACY
CONSIDERATIONS.
IN OUR GENERAL EXPERIENCE AND
WHAT WE DESCRIBED IN THE
PREAMBLE WAS THAT BECAUSE OF THE
LEVEL OF INFORMATION THAT'S
BEING PROVIDED IN TERMS OF
SUMMARY RESULTS INFORMATION, WE
DON'T EXPECT THERE TO BE PRIVACY
CONSIDERATIONS BUT THERE MAY BE
SOME EXCEPTIONS TO THAT.
AND IF THERE ARE, THEN THE
PROVISIONS AND 11.54 WHICH
RELATE TO WAIVERS MAY APPLY.
WE DID FURTHER INDICATE BECAUSE
WE HAVEN'T REALLY SEEN MANY
CASES WHERE THIS SEEMS TO BE
RELEVANT THAT WE WOULD EXPECT
THAT THERE WOULD BE A VERY
LIMITED NUMBER OF SITUATIONS IN
WHICH SUCH WAIVERS WOULD BE
REQUIRED AND THEN FURTHER MORE
GRANTED.
SO THE NEXT MODULE FOR RESULTS
INFORMATION ADVERSE EVENTS
INFORMATION.
MOST OF THE REQUIREMENTS IN THAT
ELEMENTS AT LEAST ARE SIMILAR TO
WHAT IS ALREADY AVAILABLE WITHIN
THE PRS.
THE 1 NOTABLE ADDITION TO
INFORMATION THAT WE DON'T
CURRENTLY COLLECT OR HAVE A
STRUCTURED WAY TO COLLECT IS THE
ADDITION OF A THIRD TABLE OF
INFORMATION RELATED TO ALL CAUSE
MORTALITY.
THIS WAS ANOTHER TOPIC THAT WE
HAD INVITED PUBLIC COMMENT ON
AND HAD REQUESTED FEEDBACK ON,
AND THERE WERE MANY COMMENTERS
WHO WERE SUPPORTIVE OF THE
ADDITION OF INFORMATION OF THIS
ALL-CAUSE MORTALITY TABLE AND SO
IT IS INCLUDED IN THE FINAL RULE
REQUIREMENT.
A COUPLE OTHER THINGS THAT ARE
CURRENTLY AVAILABLE WITHIN
CLINICALTRIALS.GOV FOR PROVIDING
INFORMATION ABOUTAZ VERSE EVENT
INFORMATION REFERS TO THE METHOD
OF DATA COLLECTION.
THIS WAS THE TIME FRAME PER
REPORTING INFORMATION AS WELL AS
COLLECTION APPROACH AND IF
THERE'S ANYTHING ABOUT THE
METHODS THAT ARE DIFFERENT FROM
WHAT WOULD BE EXPECTED TO BE
REPORTED IN THOSE TABLES FOR
EXAMPLE, IT'S A DIFFERENT
DEFINITION OF ADVERSE EVENT OR
SERIOUS ADVERSE EVENT WAS USED
THAT WOULD BE IMPORTANT TO
CONVEY WITHIN THIS ADVERSE EVENT
RECORDING DESCRIPTION; THE
INFORMATION THAT WOULD BE
REQUIRED FOR EACH OF THE 3
TABLES WOULD AGAIN BE
INFORMATION THAT FORM THE
COMUMKCS OR ARMS OR GROUPS THAT
ARE BEING REPORTED ON.
FOR REACH TABLE, IT'S REQUIRED
TO PROVIDE THE TOTAL NUMBER OF
PARTICIPANTS EFFECTED SO EACH OF
THOSE TABLES ARE SERIOUS ADVERSE
EVENT TABLES, THE OTHER ADVERSE
EVENT TABLES WHICH COVERED
ADVERSE EVENTS AND 5% WITHIN ANY
ARM AND NOW THE ADDITION OF THE
ALL-CAUSE MORTALITY TABLE SO
THIS IS THE TOTALLY NUMBER OF
PARTIC PACTS EFFECTED AND YOU
NEED THE NUMBER FOR THOSE 3
TABLES, AND SIMILARLY TO GET THE
DENOMINATOR FOR THAT FREQUENCY
WOULD BE THE TOTAL NUMBER OF
PARTICIPANTS AT RISK OR THAT
WERE EVALUATED FOR THAT
PARTICULAR ADVERSE EVENT
ACCORDING TO THE TABLE IN WHICH
IT WAS BEING REPORTED.
EACH TABLE EXCEPT FOR THE
ALL-CAUSE MORTALITY TABLE WOULD
HAVE DETAILED INFORMATION ABOUT
THE SPECIFIC ADVERSE EVENTS THAT
WERE OBSERVED WITH INFORMATION
ABOUT THE ORGAN SYSTEM CLASS
THAT RELATES TO THE SPECIFIC
ADVERSE EVENTS.
AND THEN FOR EACH ADVERSE EVENT
TERMS, ROUGH ATOM VIEDING
PREQUENCY WHICH IS AGAIN THE
NUMBER OF PARTICIPANTS EFFECTED
AND THE NUMBER OF PARTICIPANTS
AT RISK.
>> A NEW COPY OF THE STATISTICAL
ANALYSIS PLAN, THIS WAS
SOMETHING SPECIFICALLY THAT THE
STATUTE ASKED US TO CONSIDER AS
PART OF THE RULE MAKING PROCESS,
IN TERMS OF DETERMINING WHETHER
OR NOT THE PROTOCOL WILL BE
NECESSARY FOR UNDERSTANDING THE
RESULTS AND INFORMATION
SUBMITTED.
AND AGAIN WE DID RECEIVE A LOT
OF COMMENTS AND SUPPORT AND
REQUIREMENTS THAT WERE NOT IN
SUPPORT OF THE REQUIREMENTS THAT
POINTED MORE TO CONCERNS ABOUT
PERSONALLY IDENTIFIABLE
INFORMATION AND POTENTIALLY
COMMERCIAL CONFIDENTIAL
INFORMATION.
THE COMMENTERS AND SUPPORT CITED
THE RECENT I. O. M. REPORT
RELATED TO VARIOUS ASPECTS OF
DISCLOSURE OF CLINICAL TRIAL
INFORMATION AND BASED ON KIND OF
THOSE TIMES AND OVERALL GOALS OF
MAKING THOSE PROTOCOL
INFORMATION SUBMITTED WE DID ADD
THIS AS A REQUIREMENT TO THE
FINAL RULE.
TO HELP MITIGATE SOME OF THOSE
CONCERNS ABOUT PERSONALLY
IDENTIFIABLE INFORMATION OR
TRADE SECRET INFORMATION, THE
RESPONSIBLE PARTY MAY REDACT
CERTAIN ASPECTS OF OF THE
PROTOCOL.
KNOW WE INDICATE IN THE PROTOCOL
THAT WE DON'T PHSLY INTEND TO
EVALUATE THOSE REDACTIONS THAT
ARE SUBMITTED BUT WE DO SPECIFY
SOME VERY CLEAR REQUIREMENTS IN
THE INFORMATION IF IT'S
SUBMITTED AS PART OF
REGISTRATION INFORMATION OR
RESULTS INFORMATION THAT WOULD
NOT BE SOMETHING THAT WOULD MEET
THE REQUIREMENTS FOR REDACTION
AND LITTLE POSSIBLE THAT THE
AGENT MAY CONTACT THE
RESPONSIBLE PARTY WHEN THERE ARE
CONCERNS ABOUT THAT REDACTION.
YOWL NOTICE THAT THE LANGUAGE
WITHIN THE REGULATIONS
THEMSELVES MAY INDICATE THEY MAY
REDACT.
IT'S NOT A NECESSARILY A
REQUIREMENT TO MAKE REDACTIONS
IN THE PROTOCOL IF THE
RESPONSIBLE PARTY DOESN'T SEE
ANY NEED TO BE DOING SO.
WE ALSO INDICATED IT WILL BE A
COMMON ELECTRONIC DOCUMENT
FORMAT, AND SPECIFY PRS CLINICAL
TRIAL INFO .GOV AND EACH THOUGH
WE'RE INTENDING TO MAKE THOSE
REQUIREMENTS AVAILABLE, RELATED
TO RESULTS, REQUIREMENTS
SUBMISSIONS IN THAT PRS TEST
RELEASE AT THE END OF NOVEMBER,
YOU CAN EXPECT THAT THE
INFORMATION RELATED TO PROTOCOL
SUBMISSION REQUIREMENTS WILL
LIKELY TAKE US A BIT LONGER IN
TERMS OF HOSTING ADDITIONAL
INFORMATION ABOUT PROTOCOL
SUBMISSION AS SPECIFIED HERE.
I WILL SKIP THROUGH THIS 1 BUT
THIS IS SIMILAR TO THE COLLECT,
THIS IS NEXT AGREEMENT AND THE
NEXT ASPECT IS KLINEICAL TRIALS
RESULTS INFORMATION, THESE
REQUIREMENTS ARE DESCRIBED IN
SECTION 1164 OF THE FINAL RULE.
AND WE TALKED THROUGH THE
REAMINGISTRATION UPDATE
REQUIREMENTS, THOSE ARE COVERED
IN A 1 AND 2 COVERS IN CLINICAL
TRIAL RESULTS INFORMATION.
GENERALLY THE REQUIREMENTS ARE
TO GET INFORMATION PER YEAR, BUT
1 THING I'LL COVER IN TERMS WHEN
THE OBLIGATION TO UPDATE ENDS
AND THAT'S COVERED ALSO IN
11.64.
BUT BEFORE JUMPING TO THAT.
I WANTED TO TOUCH ON THE ASPECTS
OF HOSTING CLINICAL TRIAL
INFORMATION THAT WE DIDN'T COVER
IN THE PREVIOUS WEBINARS.
THE POSTING REQUIREMENTS FOR
CLINICAL TRIAL REGISTRATION
INFORMATION ARE DESCRIBED IN
SECTION 37.35.
AND BASICALLY IT INDICATES THE
REQUIREMENTS BASED ON THE TYPE
OF APPLICABLE CLINICAL TRIAL
THAT IT IS.
AND APPLICABLE DRUG CLINICAL
TRIAL AND APPLICABLE DEVICE
CLINICAL TRIAL.
AND GENERALLY THE RHYMES FOR
DRUG CLINICAL TRIALS ARE THAT WE
WILL HOST THAT INFORMATION NO
LATER THAN 30 DAYS AFTER IT WAS
SUBMITTED EXCEPT FOR CERTAIN
ADMINISTRATIVE DATA THAT WE
DESCRIBED THAT WE WILL NOT MAKE
PUBLIC.
FOR APPLICABLE DEVICE CLINICAL
TRIALS, WHAT WE REFER TO AS LOCK
BOX PROVISION AND DEVICE
PRODUCTS THAT ARE NOT PREVIOUSLY
APPROVED OR CLEARS MUST NOT BE
POSTED UNTIL THAT APPROVAL OR
CLEARANCE A'RE OCCURS BUT AGAIN
A NEW ADDITION TO THE FINAL RULE
IS THAT WE HAVE ADDED THE
ABILITY FOR THE RESPONSIBLE
PARTY TO AUTHORIZE POSTING OR TO
OPTICAL IMAGES OUT OF HAVING
THAT INFORMATION WITH HELD FROM
THE PUBLIC SITE.
FOR CLINICAL TRIAL RESULTS
INFORMATION, THE POSTING
PROVISIONS ARE A BIT LESS
COMPLICATED.
THESE ARE IN SECTION 1152, WE
INDICATE THAT THE INFORMATION
WILL BE POSTED NOT LATER THAN 30
CALENDAR DAYS AFTER THE
RESPONSIBLE PARTY SUBMITS THE
INFORMATION.
AS SOME OF YOU MAY BE FAMILIAR
WITH WE CURRENTLY HAVE QUALITY
CONTROL MEASURES IN PLACE OF
CLINICAL TRIALS .GOV.
WHAT WE DESCRIBE AS A FORM OF
CALL CONTROL REVIEW THAT IS A 2
STEP PROCESS, THAT THERE ARE
AUTOMATED VALIDATION RULES THAT
WE'RE ABLE TO BUILD INTO THE PRS
BAGSED ON BASIC LOGIC, WE CAN
HAVE THE SYSTEM REQUIRE THAT
DATA ELEMENT AND INSURE THAT ANY
SUBMISSION THAT COMES TO US
INCLUDES THE REQUIRED DATA EARL
MENTORSHIP SKILL BEFORE
IT'S--ELEMENT BEFORE IT'S
SUBMITTED.
SO WE DO INTEND TO CONTINUE THE
SAME FORM WHERE WE WILL HAVE AN
AUTOMATED SYSTEM BASE CHECK AND
THEN 2 IT WILL BE FOLLOWED BI A
MANUEL REVIEW WHICH IS CONDUCTED
BY OUR CLINICAL TRIALS .GOV
STAFF HERE.
ONE OF THE THINGS THAT WAS
UNIQUE ABOUT THE FINAL RULE IN
WHICH WE ALSO RECEIVED MANY
COMMENTS ON IN THE CONTEXT OF
THE NPRM IS WAS HOW THE POSTING
DEADLININGS THAT I JUST
DESCRIBED INTERSECT WITH QUALITY
CONTROL PROCEDURES.
AND WHAT WE INDICATE INDEED THE
PREAMBLE IS THAT THE STATORY
POSTING LINE HAS BEEN DELINEATED
BETWEEN SUBMISSION AND POSTING.
SO WHAT THAT MEAN SYSTEM THAT
THERE'S THE POTENTIAL FOR
INFORMATION TO BE POSTED EVEN IF
THE QC REVIEW PROCESS HAS NOT
COMPLETED.
FOR REGISTRATION INFORMATION WE
DID NOT TYPICALLY IN THE PAST
PROVIDE AN NCT NUMBER UNTIL THAT
QC REVIEW PROCESS WAS CONCLUDED.
WE INDICATE INDEED THE PREAMBLE
THAT THAT PROCESS THAT UNTIL
THAT QC PROCESS IS CONCLUDED THE
REGISTRATION INFORMATION WILL
NOT RECEIVE AN NCT NUMBER AND
THAT THE POSTED RECORD IF IT'S
RELEVANT WILL CONTAIN
INFORMATION TO MAKE CLUER THAT
THAT QC PROCESS HAD NOT
CONCLUDED.
WE ALSO INDICATE THAD WE WILL
EVALUATE ADDITIONAL WAYS IN
WHICH WE MIGHT SPECIFY THE
SPECIFIC DATA ELEMENTS THAT MAY
CONTAIN POTENTIAL ERRORS,
INSUFFICIENCIES AND
CONSISTENCIES AND SO HOW THIS IS
ALL DISCUSSED IN THE CONTEXT OF
THE FINAL RULE IS UNDER 11.64 B
WHICH ADDRESSINGS DIRECTIONS AND
THE FIRST SECTION OF CORRECTION
IS RELATED TO QUALITY CONTROL
REVIEW.
SO WE INDICATE THAT WE WILL
ESTABLISH PROCEDURES FOR QUALITY
CONTROL REVIEW AND WILL MAKE
INFORMATION AVAILABLE ABOUT THAT
AT PRS INFO.CLINICALTRIALS.GOV.
WE DON'T CURRENTLY HAVE THE
ASSOCIATION RULE REQUIREMENT
WITH PRS INFO AND THAT IS
SOMETHING THAT AGAIN WILL BE
COMING OUT AS SOON AS WE CAN
MAKE IT AVAILABLE AND AGAIN IT'S
NOT CLEAR WHAT THE TIMELINE
SPECIFICALLY FOR THAT WILL BE.
BUT AGAIN WE WOULD PLAN TO SEND
OUT NOTIFICATIONS THROUGH THE
FADA LIST SERVE WHEN THE IT'S
BEEN POSTED AND WE WILL PROVIDE
MORE DETAILS ABOUT IT BUT
SIMILAR TO HOW WE CONDUCT THE
PROCESS NOW IS THAT IF THERE ARE
POTENTIAL ISSUES IDENTIFIED
DURING THAT QC PROCESS WE
PROICIDE AN ELECTRONIC
NOTIFICATION TO THE
RESPONSIBILITY PARTY NOTIFYING
THEM OF WHAT WE IDENTIFIED A
PARENT ERRORS DEFICIENCIES OR
INCONSISTENCIES AND THAT WE
WOULD CONTINUE TO PLAN TO DO
THAT BRO SEASES.
NOW, WHAT IS CODIFIED WITHIN THE
FINAL RULE IS THAT THE
RESPONSIBILITY PARTY HAS A VERY
SPECIFIC TIMELINE IN WHICH THEY
MUST REPLY TO THOSE QC ISSUES
IDENTIFIED DURING THE REVIEW AND
FOR KLINEICAL TRIAL REGISTRATION
INFORMATION IT'S 15 DAYS AND FOR
CLINICAL TRIAL RESULTS
INFORMATION IT'S 25 CALENDAR
DAYS AND IT'S KIND OF
RECOGNIZING THE INCREASED
COMPLEXITY OF THE CLINICAL TRIAL
RESULTS INFORMATION ITSELF.
I REALIZE I AM AT THE END OF THE
HOUR WE PLANNED FAR THE WEBINAR
SO I WILL CONTINUE.
AND THE REST OF THE THINGS RIEL
BE ADDRESSING ARE OTHER
CORRECTIONS THAT ARE IDENTIFIED
OUTSIDE OF THE QC PROCESS AS
WELL AS WHEN THE OBLIGATION TO
UPDATE OR CORRECT ENDS.
SO THE FINAL RULE OF KNOWLEDGE
IS THE FACT THAT A RESPONSIBLE
PARTY MAY ALSO BECOME AWARE OF
ERRORS OUTSIDE OF THE QUALITY
CONTROL REVIEW PROCESS.
AND THAT THERE IS AN OBLIGATION
TO CORRECT OR ADDRESS THOSE
ERRORS AGAIN WITHIN THE SAME
TIME FRAMES THAT WERE OUTLINED
IN SECTION B-1, 15 DAYS FOR
REGISTRATION INFORMATION AND 25
DAYS FOR RESULTS INFORMATION.
IN TERMS OF WHEN THE OPERATING
GLOBALLY LIGATION TO SUBMIT
UPDATES ENDS, THIS WAS SOMETHING
WE RECEIVED A LOT OF COMMENTS ON
THAT RESPONSIBLE PARTIES HAD A
DESIRE TO KNOW WHEN THEY CAN
STOP HAVING TO KEEP A RECORD
UPDATED AND WHEN THIS OBLIGATION
ENDS AND SO 1164 OUTLINES, IN
MORE DETAIL, WHAT THESE
REQUIREMENTS ARE.
AND SO, IT'S BASING IT ONLET
TIME POINT AT WHICH ALL OF THE
CLINICAL TRIAL INFORMATION HAS
BEEN SUBMITTED AND SO IN A CASE
IN WHICH A TRIAL IS REQUIRED TO
SUBMIT CLINICAL TRIAL RESULTS
INFORMATION, IT'S WHEN ALL OF
THAT CLINICAL TRIAL RESULTS
INFORMATION LAS BEEN SUBMITTED
AND THE CORRECTIONS HAVE BEEN
MADE OR ADDRESSED IN RESPONSE TO
THAT NOTIFICATION THAT WAS
RECEIVED AS PART OF THAT QUALITY
CONTROL REVIEW PROCESS.
AND ONCE ALL OF THOSE ISSUES ARE
ADDRESSED.
THEN THE OBLIGATION TO SUBMIT
UPDATES ENDS.
BECAUSE THERE'S CASE INFORMATION
IN WHICH IT ENDS IS NOT REQUIRED
TO BE SUBMITTED, THE FINAL RULE
OUTLINE SAYS WHEN THE
REQUIREMENT TO UPDATE ENDS BASED
ON THAT AND AGAIN IT'S JUST
BASICALLY WHEN ALL THE REQUIRED
CLINICAL TRIAL REGISTRATION HAS
BEEN SUBMITTED AND THEN INCLUDE
IT OVER TIME AND THEN RESPONSE
TO ANY NOTICE RECEIVED DURING
THAT QC PROCESS.
IN TERMS OF WHEN THE OBLIGATION
TO CORRECT ENDS, THIS SLIDE IS
ACTUALLY STRUCTURE INDEED A VERY
SIMILAR WAY TO THE PREVIOUS
SLIDE AND THE OBLIGATION TO
CORRECT OR ADDRESS THOSE ERRORS
IS VERY SIMILAR IN TIMELINES IN
TERMS OF WHEN THE OBLIGATION TO
UPDATE ENDS.
SO THE TERMS OR RESOURCES WE
HAVE AVAILABLE ON OUR WEB SITE
THAT CAN YOU REFER TO, THERE IS
THE NOIRKS H NEWS RELEASE THAT
HAD INFORMATION NOT ONLY ON THE
FINAL RULE BUT ALSO ON THE NIH
POLICY ON DISSEMINATION OF
CLINICAL TRIAL INFORMATION,
THERE'S A WEB RESOURCE HERE AND
AN E-MAIL ADDRESS IF HAVE YOU
QUESTIONS ABOUT THAT POLICY, IN
TERMS OF NEVERGZ ON OUR WEB
SITE, WE HAVE INFORMATION UNDER
THAT SUBMIT STUDY SECTION, UNDER
THE FDAAA801, IF YOU ARE
INTERESTED IT IN RECEIVING
NOTIFICATIONS RELATED TO THAT
REAL.
WE ALSO HAVE THE ARCHIVED
VERSION OF THIS WEBINAR SERIES,
THE FIRST 2 WEB FLAIRS HAVE BEEN
POSTED AND WE INTEND TO HAVE
THIS 1 POSTED WITHIN A WEEK OF
TODAY.
YOU CAN ALSO SEND QUESTIONS TO
US AT THE E-MAIL ADDRESS HERE
AFTER--AFTER THE WEBINAR ITSELF,
AND AS I MENTIONED AT THE
BEGINNING AS WE CONTINUE TO ROLE
OUT MORE DETAILED INFORMATION
ABOUT VARIOUS ASPECTS OF
IMPLEMENTATION, IT IS LIKELY WE
WILL OFFER FUTURE WEBINARS AND
WILL MAKE INFORMATION AVAILABLE
ABOUT THAT AS IT BECOMES
AVAILABLE.
SO WE REALLY APPRECIATE EVERYONE
SUBMITTING QUESTIONS DURBING THE
WEBINAR TODAY.
WE WILL DO OUR BEST TO ADDRESS
THEM.
EITHER IN FUTURE WEBINARS OR
THROUGH Qs AND As OR
ADDITIONAL TYPE OFS INFORMATION
ON OUR WEB SITE SO THOSE
QUESTIONS ARE VERY USEFUL TO US
AND UNDERSTANDING WHAT SOME OF
TED CHALLENGES AND UNDERSTANDING
VARIOUS ASPECTS OF THE FINAL
RULE ARE.
SO I THINK EVERYONE WHO PAR TIS
PARTICIPATE IN A TRIALED IN THE
WEBINARY TODAY AND WE WILL CLOSE
THERE.
THANK YOU.