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HELLO EVERYONE.I'M MARJORIE GOOD, MARGE GOOD.I'M A NURSE CONSULTANT WITH THEDIVISION OF CANCER PREVENTIONWITHIN NCI.I'M A NURSE CONSULTANT WORKINGWITH NCI GRANT FUNDED COMMUNITYBASED RESEARCH PERHAPS OFWHICH -- PROGRAMS OF WHICH THEREARE ABOUT 46 ACROSS TUESDAY, ONEIN PAT RILEY.AND I ACTUALLY CAME FROM ACOMMUNITY BASED PROGRAM WHICHHAS REALLY HELPED ME WITH THISNEW ROLE TO HELP NEW SITESCOMING ON BOARD.I WAS WITH THE PROGRAM INWICHITA, KANSAS ACTUALLY, ANDDID THE WORK FOR OVER 20RATHERS, MANAGED THE RESEARCHPROGRAM THERE WHICH WAS QUITEBUSY AND ACTIVE.WE AVERAGE USUALLY BETWEEN 600AND 800 PATIENTS ENROLLED IONCLINICAL TRIALS IN A YEAR'STIME.SO WE WERE BUSY.WE WERE HEAVRY INVOLVED INCLINICAL RESEARCH.WITH THAT, I CAME AWAY WITH ALOT OF KNOWLEDGE THAT I LIKE TOSHARE WITH AS MANY AS POSSIBLE.SO TODAY IS ONE OF THOSE EFFORTSTO LET YOU KNOW A LITTLE BITMORE DATA MANAGEMENT AND THEDEVELOPMENT OF CASE REPORTFORMS.I KNOW THERE IS A VARYING DEGREEOF EXPERTISE AS WELL JOB ROLES.I THINK THAT WE'LL BEENPARTICIPATING IN THIS TRAINING.I TRIED TO BASE THIS AROUNDTHAT, WITH THAT IN MIND.SO SOME OF IT MAY SEEM REALLYBASIC AT A OTHERS, AND MAYBE ALITTLE BIT ABOVE STANDARDS FOROTHERS AS WELL.SO I'M HAPPY TO TAKE QUESTIONSAT THE END.TODAY, I HOPE WE CAN DISCUSS THEIMPORTANCE OF THE PROPER DATACOLLECTION EFFORTS, IDENTIFYTYPES OF DATA CLOTHED, LISTPOTENTIAL SOURCE DOCUMENTS FORTHAT DATA COLLECTION.NAME KEY FACTORS TO CONSIDERDURING CASE REPORT FORMDEVELOPMENT.THINGS THAT ARE IMPORTANT TOCONSIDER WHEN YOU DEVELOP -- ANDI ADDED MORE INFORMATION FROM MYLAST INFORMATION AS A REQUEST OFSOME OF THE COMMENTS AFTER THEPRESENTATION SO HOPEFULLY THATADDITIONAL INFORMATION WILL BEFORMATIVE AS WELL.I WANT TO COVER WHAT CONSTITUTESA POORLY DESIGN CASE REPORTFORM.HOPEFULLY IT WILL INFORM YOU NOTTO GO DOWN THAT ROAD.THEN WE WANT TO TALK ABOUT DATAMANAGEMENT ITSELF, QUITE LARGE.WITHIN THAT, IT'S GOING TO -- ILIKE TO REVIEW THE AUDITPROCESSES THEMSELVES, DESCRIBETHAT FIRST EVENT REPORTING ANDDESCRIBE LIGHTLY ON REGULATORYREQUIREMENTS FOR DATACOLLECTION.THE USE OF DATA IS VERY, VERYIMPORTANT.DATA ANALYSIS AND REPORTING,ACTUAL CAPTURING OF THE DATA ISWHAT INFORMS THE ANALYSIS ANDTHE REPORTING, THE PUBLICATIONTHAT GOES ON AFTER THE STUDY ISCOMPLETED.IT'S A METHOD OF TRACKING THEPATIENT OR SUBJECTS.USED FOR FDA SAFETY MONITORING.IT'S USED IN NEW DRUGAPPLICATION SUBMISSIONS, SPORTSTHOSE LABELING CLAIMS FOR NEWDRUGS THAT ARE GOING THROUGH THEFDA PROCESS.REVIEWED BY DATA SAFETYMONITORING BOARDS TO ASSESS THETRIAL'S SAFETY AND ONGOINGACTIVITY.IT'S USED IN PUBLICATIONS ANDMEDICAL JOURNALS, AND DEFINITELYHELPS TO INFORM FUTUREDEVELOPMENT OF TRIALS.SO THE ACTUAL DATA MANAGEMENTREPORTING, THE OUTCOMES OF THECLINICAL TRIAL ARE DEPENDENT ONTHIS DATA COLLECTED, NEEDS TO BECOLLECTED CREATELY IN A TIMELYMANNER AND NEEDS TO BEVERIFIABLE.THOSE ARE THE KIND OF THINGSWE'RE GOING TO TALK ABOUT.IT MUST REFLECT THE ACTUAL AIMSOF THE CLINICAL TRIAL, AND ITMUST COMPLY WITH REGULATORYAGENCIES.AND REALLY, ALL THIS IS KEY.YOU'RE GOING TO GET ALL THISINFORMATION IF YOU HAVEADEQUATELY DESIGNED CASE REPORTFORMS.SO BASICALLY, THERE IS AN OLDADAGE THAT I HEAR STILLFREQUENTLY.BAR GARBAGE IN, GARBAGE OUT.I LISTED ON THE SLIDE THEPRINCIPAL INVESTIGATOR, CLINICALRESEARCH NURSE, CRA, THE DATAMANAGER, DATABASE ADMINISTRATORAND STATISTICIAN, ALL THESEPEOPLE PLAY A KEY ROLE.THERE ARE OTHER PEOPLE THAT CANPLAY AS WELL DEPENDING ON THETYPE OF STUDY.YOU ALSO MADE HEED TO INCLUDERADIATION ONCOLOGISTS,NUTRITIONISTS, CASE WORKERS,AGAIN, DEPENDS ON YOUR STUDYTHAT YOU'RE TRYING TO DEVELOP.PART -- THE PRINCIPLEINVESTIGATOR REALLY DOES PLAY AKEY ROLE.HE'S RESPONSIBLE, HE OR SHE ISRESPONSIBLE FOR ALL ASPETS OFTHE TRIAL, INCLUDING THE ETHICALCONDUCT OF THE RESEARCH, THEELIGIBILITY, PROTOCOL ADHERENCE,ADVERSE EVENT REPORTING ANDREPORTING OF TIMELY AND ADEQUATEDATA.A LOT TO CARRY AND PI.'S NEED TOBE AWARE.THEY DETERMINE THE RESPONSE TOTHERAPY AND INTERVENTION,DEPENDS WHETHER THE ADVERSEEVENT MUST BE ATTRIBUTED TO THEACTUAL AGENT OR DRUG USED INTRIAL.EACH MEMBER OF THE TEAM DOESPLAY A KEY ROLE ENCONDUCTINGRESEARCH ETHICALLY, MAINTAININGCONFIDENTIALITY AND FOLLOWINGTHE CODE OF FEDERAL REGULATIONS,AND COMPLYING WITH HIPAA.IN ORDER TO DO THAT, TRAINING ISESSENTIAL.THE PROTOCOL IS OFTEN CONSIDEREDA ROAD MAP, A DOCUMENT THATINCLUDES THE INFORMATION ANDHOPEFULLY WRITTEN CLEARLY SOEVERY ONE UNDERSTANDS THAT.BUT IT PROVIDES INFO REGARDINGWHY THE STUDY IS BEING DONE, THEHYPOTHESIS BEHIND IT, THE AIMSIN HOW THE STUDY IS GOING TO BECONDUCTED TO MEET THOSE AIMS.THE PROTOCOL SHOULD CONTAINSUFFICIENT DETAIL SO THAT THEREIS UNIFORMITY IN THE SELECTIONAND TREATMENT OF PATIENTS ANDUNIFORM DATA COLLECTION ANDSUBMISSION.SO THINGS TO CONSIDER WHEN YOUDEVELOP THE PROTOCOL.WHAT DATA AILMENTS GOING TO BECOLLECTING?WHAT IS THE STEIN AND THECONTENT OF THE DATA, COLLECTIONAS A RESULTS THAT NEED TO BECONSIDERED TO CAPTURE THAT DATA.THEM WHAT TYPE OF COMPUTERDATABASE ARE YOU UTILIZING?COMMON DATA ELEMENTS IS A TERMTHAT'S OFTEN USED.AND IT'S ACTUALLY QUITEIMPORTANT IN DEVELOPING YOURCASE REPORT FORMS.ELEMENTS THAT HAVE BEENDETERMINED TO BE IDENTICALBETWEEN PROJECTS AND CONTEXT,AND THE EXAMPLES MIGHT BE NAME,AGE, GENDER.THERE IS NOT TOO MANY WAYS TODEFINE THOSE.THERE TEND TO BE FAIRLY COMMONACROSS STUDIES.SO THEY'RE CONSIDERED COMMONDATA ELEMENTS.AND I'LL GO INTO A LITTLE BITMORE DETAIL AS WE GO FURTHERINTO THIS DISCUSSION.THEY REALLY HELP TO FACILITATETHE UNDERSTANDING AND SHARING OFTHAT INFORMATION ACROSS STUDIES.IF SOMEONE ELSE WANTS TOREPLICATE OR DO A SIMILAR TYPEOF STUDY, THEY'LL WANT TO USETHE SAME DATA ELEMENTS.THAT WOULD INFORM PAIN A FUTUREMETA-ANALYSIS THAT SOMEONE WOULDLIKE TO DO.METAANALYSIS ARE MUCH EASIER TODO WHEN COMMON DATA ARE BEINGUSED BETWEEN TRIALS.STUDY ENTRY, SOME DATA ELEMENTSTHAT COULD BE CAPTURED,DEMOGRAPHIC, ELIGIBILITY, FAMILYAND PATIENT HISTORY, ALL OFTHESE ARE PIECES OF INFORMATIONTHAT ARE COLLECTED AT THE TIMETHE STUDY ENTRY.EACH OF THEM MAY HAVE MUTCH DATAELEMENTS WITHIN THEM.SO ON STUDY, EACH WORRY AGAINCAN CONTAIN MULTI DATA ELEMENTS.THEY MAY CONSIDER CAPTURING THETREATMENT, THE ASSESSMENTS OFRANS, RADIOLOGY, THINGS THATHAVE BEEN DONE IN THE INTERIMDURING TREATMENT.WHAT KIND OF CONCOMANT MEDS WERETAKEN, ADVERSE EVENTS,HOSPITALIZATIONS, TREATMENTRESPONSE.THERE ARE PATIENT REPORTEDOUTCOMES THAT MAY BE COMPLETEDAS WELL.THESE ARE ALL THINGS YOU WANT TOCONSIDER AS YOU DEVELOP YOURCASE REPORT FORMS.SOURCE DOCUMENTS ARE BASICALLYANY DOCUMENT WHERE THE DATA ISFIRST RECORDED.WITH THE INFORMATION FOR THEFORMS DATA, CASE REPORT FORMS ISCAPTURED FROM.THEY CONFIRM THE PROTOCOLADHERENCE.THEY CONFIRM -- AND VAL INDICATETHE DATA BEING SUBMITTED ISACTUALLY THERE AND REAL.IT ALSO SERVES AN AUDIT TRAILALLOWING THE RECREATION OF THESTUDY, AND IT ALSO CONFIRMS THEACTUAL EXISTENCE OF THE STUDYPARTICIPANTS.I THINK YOU HAVE OR WILL BEHAVING A LECT ON SCIENTIFICCONDUCT AND HOPEFULLY WITHINTHAT, THERE WAS EXAMPLES SHAREDREGARDING FRAUD.AND IT ACTUALLY DOES HAPPEN ANDSOME INVESTIGATORS MAKE UPPATIENTS AND DOING AN AUDIT ORACTUALLY HAVING SOURCE DOCUMENTSHELPS TO TRACK AND FIND THOSEISSUES.SO -- SOURCE DOCUMENT, EXAMPLESMEMBER SIMPLY AT THE HOSPITALRECORDS, THE CLINICAL, OFFICECHASER, VARIOUS REPORTS, ACTUALPROGRESS NOTES INCLUDINGSUFFICIENT AS WELL AS NURSENOTES.OTHER EXAMPLES MIGHT BE LETTERSFROM REFERRING PHYSICIANS.ACTUAL RADIOLOGICAL FILMS, TUMORMEASUREMENTS, PARTICIPANTDIARIES, PARTICIPANT INTERVIEWS,AND PHARMACY DISPENSING RECORDSAND PHOTOGRAPHS.SO ACTUAL DATA ABSTRACTION,THEN, IS FEELING THAT BASICALLYIS CONSIDERED -- ANYTHINGRECORDED ON THE CRF SHOULD BE INTHE SOURCE DOCUMENT.IF THERE IS SOMETHING RECORDEDON THE CRF, IT HAS TO BE TRACKEDBACK TO A SOURCE DOCUMENT.A COMMON STATEMENT OR COMMONPOST-IT NOTE, I WOULD PUT AROUNDOFTEN TIMES FOR MY STAFF,BASICALLY TO KEEP IT MIND IFIT'S NOT WRITTEN IT DIDN'THAPPEN.THAT'S HOW THE AUDITORS WILL SEETHAT.IT MAY HAVE HAPPENED.IF IT'S THOUGHT WRITTEN --ACTUALLY NOT REPLICATED OR FOUNDIN THE SOURCE DOCUMENT, THENTHEY'RE BASICALLY GOING TOCONSIDER IT FALSIFIEDINFORMATION POSSIBLY.ANY CORRECTION OR CHANGE SHOULDBE DATED, INITIALED ANDEXPLAINED AND SHOULD NOT -- THEORIGINAL INFORMATION SHOULD NOTBE OBSCURED.THIS APPLIES TO THE CRF AS WELLAS THE SOURCE DOCUMENT. ONLYPROVIDES THE REQUESTED DATA.SOME RESEARCH STAFF I'VE HADREEK TO WRITE A BOOK SOMETIMESOR A LOT OF INFORMATION.IT'S NOT NECESSARY.JUST CRF SHOULD BE DESIGNED WELLENOUGH TO CAPTURE THEINFORMATION THEY WANT.AND WHAT IS NEEDED.AND USE STANDARD MEDICALTERMINOLOGY AS WELL.AND AS FAR AS THE CORRECTIONSAND THE DATA EXTRACTION, TOO,THE THING TO KEEP IN MIND ISI'VE HAD OCCASIONALLY STAFF THATWOULD USE POST-IT NOTES.KIND OF AS A REMINDER FORTHEMSELVES TO GO BACK IN ANDMAKE THAT NOTE.THEY FORGET, OR THEY FORGET TOTAKE THE POST IT NOTE OUT, SO ITDOESN'T LOOK VERY GOOD.POST-IT NOTES SHOULD BE NOT USEDIN THIS CASES MATURE SO AGAIN,DATA ABSTRACTION.THE AUDITORS WHEN THEY COME INSHOULD BE ABLE TO RECONSTRUCTTHAT PATIENT'S STUDY COURSEPIECING TOGETHER ALL THE DATAOBTAINED FROM THOSE SOURCEDOCUMENTS.THE METHODS OF DATA COLLECTION,JUST TO GIVE YOU KIND OF A PICKTORELL VIEW -- PICTURAL VIEW,POSSIBLY ELECTRONIC CAPTURED ASWELL AS PAPER.THOSE ARE THE TWO MAIN TYPES OFFORMS IN USE.ACACY REPORT FORM IS BASICALLY APREPRINTS IF IT'S PAPER, BY THESPONSOR OR THE P.I. TO DETERMINETHE DATA ELEMENTS THAT WILL BEOUTLINED IN THE PROTOCOL.IT TRANSLATES THE PROTOCOLSPECIFIC ACTIVITIES INTO DATA.THEY ENSURE THERE IS ACTUALSTANDARDIZATION AND CONSISTENCYOF THE DATA CAPTURED ACROSSMUTCH SITES.SO -- MULTI SITES.THE DATA IN KANSAS IS THE SAMECOLLECTED IN CALL. COLORADO.THEY'RE SIGNED TO IMPACT THEQUALITY OF THE DATA COLLECTED,BASICALLY PROPERTY SIGNED CRFsSTREAMLINE AUDITS, MAKE THEMEASIER, AND ALSO HELP WITH THEDATA ANALYSIS AND REPORTING.SO I PUT TOGETHER A BIT OF APECT PICTURAL BASED ON APREVIOUS DEMONSTRATION OF ANACTUAL PROTOCOL.GOES THROUGH PURPOSES,OBJECTIVES AND OPERATIONAL, THENTHE ANALYSIS PLAN PART OF THEPROTOCOL DOCUMENT ALSO.THAT ANALYSIS, THEN, DESCRIBESDATA COLLECTED, KEY ENDPOINTTHAT WILL BE LOOKED FOR, AS WELLAS THE STATISTICAL METHOD USED.THE CASE REPORT FORM SUPPORTSALL THOSE TWO THINGS, THAT'S HOWVITAL A CASE REPORT FORM IS.SO I THINK THIS VIEW OF IT SAYSA LOT.SO THINGS YOU WANT TO C I WANTTO GO THROUGH SEVERAL LITTLETHINGS TO THINK ABOUT.WHEN YOU'RE DEVELOPING CASEREPORT FORMS.AGAIN, THE PROTOCOL DETERMINESWHAT DATA SHOULD BE COLLECTED.AND IF IT IS DOCUMENTED ORWRITTEN ON THE CASE REPORT FORMIT MUST BE COLLECTED.AS SPECIFIED IN THE PROTOCOL.THAT DATA WILL NOT BE ANALYZED.THE DATA THAT WILL NOT BEANALYZED SHOULD NOT BE ASKEDFOR.I CAN'T TELL YOU HOW MANYIES,MORE IN THE OLD DAYS OR EARLYYEARS OF BEING A RESEARCH NURSE,WE FILLED OUT HUMONGOUS AMOUNTSOF DATA, PAPER FORMS, CASE FLOWSHEETS WITH TYPY BOXES WHERE WEHAD TO FILL IN THINGS.I FOUND OUT YEARS LATER MUCH OFTHAT DATA WAS NEVER USE.REALLY VERY FRUSTRATING.SO KEEP THAT IN MIND AS YOUTHINK ABOUT WHAT DATA YOU WANTTO CAPTURE.CRAs AT THE OTHER END,RESEARCH NURSES REALLY DON'TWANT TO BE CAPTURING UNNECESSARYINFORMATION.ALSO ADDS EXTRA BURDEN TO THEPATIENTS AS WELL, BECAUSETHEY'RE COLLECTING EXTRAINFORMATION THAT MAYBE THEYWOULD YOU WANT BE COLLECTINGOTHERWISE.OTHER THOUGHTS, THE -- SORRY,MOVING ON HERE.AGAIN INVOLVES THE DEVELOPMENTSHOULD INVOLVE VARIOUS PEOPLEFROM THE RESEARCH TEAM.THEY ALL ARE INVOLVED INDIFFERENT ASPECTS.GETTING THEIR INPUT ISIMPORTANT.TECHNICALLY, THE STATISTICIANAND THE PROGRAMMER IF YOU'REGOING TO BE USE ELECTRONICFORMS.REVIEW THE ANALYSIS PLAN.WHAT'S BEING ASKED FOR?THAT DEFINITELY WILL INFORM YOURCRF, THEN LOOK AND SEE YOUROTHER PREVIOUS FORMS YOU COULDMODEL AFTER OR EVEN REPLICATEAND USE.SO AGAIN, WHAT DATA IS NEEDED?IN RELATIONSHIP TO WHEN THE DATAWILL BE AVAILABLE SOME THINKABOUT THAT. HOW MANY PEOPLE AREGOING TO BE INVOLVED ENCAPTURINGTHAT INFORMATION.IF YOU HAVE A DATA, INFORMATIONTHAT YOU NEED FROM PERHAPS THEPATIENT LEVEL OR PATIENT CHARTLEVEL, BUT YOU ALSO HAVE OTHERINFORMATION THAT MAYBE YOU WANTTO CAPTURE FROM A RAIDATIONONCOLOGIST, THOSE ARE OFTENTIMES TWO DIFFERENT AREAS SOMAYBE YOU WANT TO DEVELOP TWODIFFERENT FORMS, ONE FOR THATPATIENT FOCUS INFORMATION ANDTHEN ANOTHER FORM FOR THERADIOLOGIST TO COMPLETE.SO IT'S ALL ONE FORM ISN'T LOSTBY IT BEING INFORMATION BEINGOBTAINED FROM ANOTHER SITE.THINGS TO THINK ABOUT.AND THEN, AGAIN, WHO IS GOING TOBE COMPLETING THOSE FORMS?THIS ARE VARCRISIS DEGREES OFEXPERTISE OUT THERE.VARIOUS DEGREES OF EXPERTISE,CRAs AND RESEARCH IN YOURS AREVERY SAVVY.OTHERS HAVE NOT AS MUCHEXPERIENCE SO YOU WANT TO THINKABOUT, THAT ESPECIALLY WITH THETERMINOLOGY YOU USE AND HOWYOU'RE CAPTURING THE INFORMATIONON THE FORM.I'LL GIVE YOU JOYS ORSUGGESTIONS ON THAT AS WELL. --IDEAS OR SUGGESTIONS.THE DATA TO BE COLLECTED ANDFORMS YOU SHOULD BE CLEARLYOUTLINED TIN PROTOCOL ONTIMINGS, PROTOCOL DOCUMENTS USEDTO HAVE A SPECIFIC SECTION THATDESCRIBES WHAT FORMS ARE DUEWHEN.AND ALSO, EVEN A CALENDAR OFEVENTS THAT IS A ONE PAGE FORMTHAT PEOPLE CAN REFER TO, ANDYOU HAVE MOORE LIKELIHOOD OFGETTING THE INFORMATION BACK INA TIMELY MANNER AND ACCURATELYIF THAT'S UTILIZED.AGAIN, CLEARLY STATED,SELF-EXPLANATORY AND IT SHOULDCORRELATE WITH THE STATISTICALSOFTWARE YOU'RE USING.MULTIPLE WAYS.GENERATE FRIENDRY -- USERFRIENDLY FORMSING ABOUT YOURAUDIENCE.AVOID ASKING FOR LENGTHY TEXTINFORMATION.TRY TO GET IT IN SPECIFIC --WHAT INFORMATION YOUSPECIFICALLY WANT.AND AGAIN COLLECTING ONLYESSENTIAL AND VERY IMPORTANT TONUMBER YOUR -- OR KEEP TRACK OFWHAT VERSION YOU'RE USING,NOTHING WORSE THAN GETTING ANOLD VERSION INTO A PROTOCOLDOCUMENT AND CAPTURING THE WRONGINFORMATION.OTHER POINTS THAT I FOUND IN ARECENT PUBLICATION ARE TO USECONSISTENT FORMATS, FONT SIZE,AND STYLE.THROUGHOUT THE PROTOCOL.DON'T USE ONE VERSION WITH ONEFORM, ANOTHER WITH ANOTHER.USE CLEAR AND CONCISE QUESTIONS,PROMPTS AND INSTRUCTS.AND USE THE OPTION OF CIRCLINGANSWERS IS PROBABLY NOT A GOODIDEA.INSTEAD, CHECK BOXES AREPROBABLY GOING TO GET YOU MOREACCURATE INFORMATION.AS I SAID, BOXES OR SEPARATELINES TO HOLD THE ANSWERS.AGAIN, THIS HELPS TO INFORM THEPERSON THAT IS RECORDING IT ORPROVIDING YOU INFORMATION.AND HE'LL GIVE YOU AN EXAMPLEHERE IN A BIT.SEPARATE THE COLUMNS WITH THEYCAN LIENS.PROVIDE BOLD AND ITTALLIZEDINSTRUCTIONS SO IT STANDS OUTSEPARATORY SO PEOPLE KNOW WHATTHEY'RE LOOKING AT AND READING.MINIMIZE THE FREE TEXT RESPONSESAND AVOID COLLECTION OF DERIVEDDATA TO DECREASE CALCULATIONERRORS.AN EXAMPLE WOULD BE ASKING FORTHE PERSON THAT'S CAPTURES THEDATA TO CALCULATE A BMI, SOTHEY'LL USE HEIGHT WEIGHT ANDAGE.IT'S BETTER TO COLLECT ITYOURSELF AND THEN CALCULATE THEINFORMATION YOURSELF.IF YOU'RE RELYING TOTALLY ONTHAT PERSON TO CALCULATE THATYOU MAY COME UP WITH ERRONEOUSINFORMATION.JUST A SUGGESTION.AVOID USING ALL THAT APPLY.THAT FORCES THAT PERSON TO MAKEASSUMPTIONS.SPECIFY THE UNIT OF MEASURE.AND HE'LL SHOW YOU AN EXAMPLE OFWHETHER THERE IS HE -- WHAT'S AGOOD CASE, NOT SO G INDICATE THENUMBER OF DECIMAL PLACES YOUWANT RECORDED.STANDARD DATA FORMAT, FOREXAMPLE, FOR YOUR YEAR OR DATAOF BIRTH, BDMMYYY, VERY COMMONLYUSED.USE PRECODED ANSWER SETSWHENEVER POSSIBLE.THIS HELPS AND MAKES IT EASIERFOR THE DATA TO BE COLLECTED.SO SIMPLE YES, NO, MALE, FEMALE,AND IF YOU'RE GOING TO HAVEGRADING OR LEVELS OF INFORMATIONYOU'RE TRYING TO CAPTURE, MAKETHAT CONSISTENT, SO FOR LIKENURSE EVENTS, CHOOSE BETWEENMILD, MODERATE OR SEVERE.AGAIN, CONSIDER USING COMMONDATA ELEMENTS, MINIHAS DONE ALOT OF WORK ON BUILDING AREPOSITORY OR LIKE WE OFTEN CALLIT A WAREHOUSE OF INFORMATION --OF COMMONLY USED COMMON DATAELEMENTS THAT WE REALLY STRONGLYSUGGEST ARE RESEARCH PROGRAMS ONPEOPLE TO USE.AND INVESTIGATORS AS THEYPRESENT TRIALS FOR US TOEVALUATE, WE WANT TO SEE COMMONDATA ELEMENTS ACROSS THEM.WE ALSO REALLY ENCOURAGE, IFIT'S SPECIFICRY A NEW FORM, TOUSE -- TO CONSIDER PILOTING THEFORMS AMONG YOUR OUTLINE SITESOR RESEARCH STAFF TO SEE DO THEYMAKE SENSE, THEY WRECKING HOMETHE INFORMATION THAT YOU'RE --WRECKING HOME THE INFORMATION --BRINGING HOME THE INFORMATION ORARE THEY MISSING THE BOAT?AND COMPLETE THAT CRFDEVELOPMENT PRIOR TO STUDYACTIVATION IS REALLY IMPORTANT.NOTHING MORE FRUSTRATING FORSTAFF TO HAVE A STUDY THEY'REANXIOUS TO START WITH BUTTHEY'RE WAITING ON YOUR CRFFORMS.THEY HELP TO INFORM THE RESEARCHSITE TO KNOW HOW COMPLEX ANDDETAILED THE STUDY WILL BE ANDHELP THEM TO DECIDE WHAT KIND OFSTAFFING TO ADDRESS TOWARD THATTRIAL.THERE ARE SECTIONS OF POORLYDESIGNED STUDIES, USUALLYTHEY'RE NOT ASKING FOR THE DATATHAT YOU REALLY WANT TO HAVECOLLECTED.IT MIGHT REQUIRE MODIFICATIONDOWN THE LINE OR DOWN THE ROADAS -- AFTER THE STUDY ISACTIVATED, WHICH ADDSDIFFICULTLY AND COMPLEXITY TOTHE ANALYSIS PROCESS.ACTUALLY IMPEDES THE PROCESS.REQUIRES REVIEWING AND SCREENING -- CLEANI NG THE DATATHROUGH THE PROCESS OF FALSE.IT MIGHT LEAD TO YOU ACTUALLYMISSING TARGET DATES THAT YOUNEED, REALLY INFORM YOUR ENDOPPONENTS POSSIBLY.AND AGAIN, IF YOU'RE COLLECTINGTOO MUCH DATA YOU'RE REALLYWASTING THE RESOURCES OF THECOLLECTION AND PROCESSING.ANY KIND OF DELAY IN GETTINGTHANK ACCOMPLISHED YOU'REDELAYING THE ABILITY TO GET THEANSWERS THAT YOU WANT WITHINYOUR STUDY.SO HERE IS JUST KIND OF A SIMPLETO THE LEFT IS AN EXAMPLE OF APOORLY DESIGNED CRF.THERE ARE JUST -- YOU'RE ASKINGTORE THE FOREPAW THERE IS ASIMPLE LINE THAT -- FOR THEINFORMATION BUT YOU'RE EXPECTINGEVERY ONE TO UNDERSTAND WHATNUMBERS AND DATA YOU WANT.ON THE RIGHT, THE WELL DESIGNED,THERE IS ACTUALLY BOXES PROVIDEDFOR THEM TO FILL IN.FOLLOWED BY AN EXPLANATION OFWHAT THE BOXES SHOULD BE.FOR EXAMPLE, FOR YOUR DATE OFVISIT, THE DAY -- WELL, IN THISCASE THE DATA DAY, DAY, MONTH, MONTH,YEAR.BLOOD PRESSURE, PULSE, BEATS PERMINUTE.THIS IS -- THAT'S CLEAR FORANYONE WHO IS GOING TO BEFELLING OUT THANK FORM SO YOU'LLGET CONSISTENT INFORMATION BACK,WHEREAS THE -- THE EXAMPLE ONTHE LEFT, YOU MAY GET ALL KINDSOF INFORMATION BACK THAT YOU'RENOT GOING TO BE ABLE TO USE ORYOU HAVE TO QUERY THE SITES TOGET MORE INFORMATION FOR THEM.THAT WILL FRUSTRATE EVERY ONE.SO TO TALK ABOUT ELECTRONICCRFS, THIS IS A MODE THAT ITHINK MORE AND MORE SPONSORS ANDRESEARCHERS ARE GOING TO.AND THERE ARE MANY COMMERCIALPROGRAMS OUT THERE. I'VE ONLYLISTED A FEW.THERE ARE MANY MORE THAN THIS.ORACLE, RAVE, eCLINICAL, THEYALL HAVE SIMILAR NAMES BUTDIFFERENT.AND THE ADVANTAGES OF ELECTRONICDATA CAPTURE ARE IT ACTUALLY ISA MUCH FASTER MODE.RESEARCH PERSON OR CRF CAN SITAT THE COMPUTER AND ENTER THEDATA.ELECTRONICALLY SUBMITTED.FATHERLY QUICKLY.IT ACTUALLY, I THINK -- PROMOTESCLEANER DATA COLLECTION BECAUSEOFTEN TIMES THEY'RE PROGRAMMEDQUERY OR QUESTION IMMEDIATELYERREASONIOUS INFORMATION AS THEYSUBMIT A NUMBER THAT'S WAY OUTOF RANGE FOR WHAT THEY'REEXPECTING.IT WILL QUERY THE PERSONIMMEDIATELY AND SAY DID YOU PUTTHAT IN RIGHT, OR MANY THEY JUSTTRANSCRIBED IT INCORRECTLY.IT'S EASIER FOR MONITORS ANDMONITORING AUDITING BECAUSE THEINFORMATION IS MORE CLEAR.YOU DON'T HAVE HANDWRITTEN TYPETHINGS.IT'S ESSENTIAL DATABASE FORSTORAGE FOR ALL TRIAL DATA.AND AGAIN ALLOWS FOR REAL TIMEDATA ACCESS.THERE ARE SOME DRAWBACKS TO IT.OFTEN TIMES THERE IS LACK ONONSITE TECHNOLOGY.I THINK THIS IS IMPROVING, BUTSEE IT PARTICULARLY IN SOME OFTHE COMMUNITY BASED PROGRAMS IFTHEY'RE IN INSTITUTIONS THATTHEY'RE COMPUTER I.T. SYSTEMSARE NOT QUITE UP TO THE LEVELTHAT THEY HEED TO BE TO ADOPT ORTO ADAPT TO THE ELECTRONIC FORMSTHAT ARE COMING OVER THE SYSTEMTHAT IS BEING USED.THERE IS A HIGH COST INVESTMENTINITIALLY FOR SPONSORS TODEVELOP THESE ELECTRONIC CRF,THESE COMPANIES ARE OUT TO MAKEMONEY, THAT'S PART OF WHYTHEY'RE IN THE BUSINESS.SO IT CAN BE QUITE EXPENSIVE.THERE IS THIS ALSO COMPLEXITY OFINSTALLATION AND MAINTENANCE OFTHE SOFTWARE THAT GOES WITHCOST.AND SOMETIMES INVESTIGATORS ARENOT TERRIBLY MOTIVATED AND THEREIS A LOT OF TRAINING THAT NEEDSTO BE DONE.HERE IS AN EXAMPLE OF MAYBE WHATA WEB VIEW OF A FORM MAY LOOKLIKE.IT LOOKS PRETTY SIMPLE.THESE BOXES SEEM LIKE THEY'REPRETTY SIMPLE TO FILL IN ANDTHEY ARE.THESE ARE -- THIS IS A GOODEXAMPLE OF WHAT A CRF SHOULDLOOK LIKE.THERE IS A LOT OF WORK BEHINDBUILDING THIS.ALL THESE BOXES HAVE TO BEPREFILLED, USUALLY THE EXALSPREADSHEET THE SCENES.THERE IS WHERE YOU NEEDPROGRAMMERS AND PEOPLE TO HELPYOU DESIGN THAT.I'M AMASSED BY THE COMPLEXITY,HINDTHE SCENES WORK.I'M HAPPY SOMEONE ELSE DOESTHAT, NOT ME.YOU HAVE TO THINK ABOUT, THEREIS MORE BEHIND IT.THIS IS WHERE THE COMMON DATAELEMENTS COMES IN, THAT IF YOUUSE THAT WAREHOUSE, YOU CAN PULLTHAT INFORMATION INTO THIS TYPEOF THING, MAKES IT MUCH EASIERFOR YOU.JUST A FEW THINGS TO THINKABOUT.SO AGAIN, DESIGNING THEELECTRONIC CRF IS SIMILAR TOPAPER.THE METHOD OF DATA COLLECTIONWILL IMPACT THE STEIN OF HOWTHOSE SCREENS WILL LOOK.THE SAME CONSIDERATIONS FORDESIGNING THESE FORMS SHOULD BETHE SAME AS WHAT YOU'VE DONE FORPAPER FORMS.AGAIN, CONSIDER THE VOLUME ANDTHE FREQUENCY OF THE DATA THATYOU'RE COLLECTING.AVOID EXCESS DETAIL ON THESCREENS.REALLY IMPORTANT TO THOROUGHLYTEST THESE.WE'VE HAD A FEW OCCURRENCESWHERE THE STUDY HAS BEEN OPENED,ACTIVATED, AND THERE IS SOMEGLITCH WHEN THE ELECTRONIC DATAFORMS AND SIGHTS CAN'T USE IT SOWE HAVE TO GET THAT FIXEDQUICKLY OR ELSE PUT THE STUDY ONHOLD UNTIL WE CAN GET IT FIXED.AND AGAIN, I THINK MANY OF THESEAND MANY RESEARCHERS HAVEDEVELOPED USER INSTRUCTIONS FORTHESE.I THINK THEY ARE VITAL.SO CHOOSING ELECTRONIC DATASYSTEMS, YOU THINK ABOUT THESCOPE, THE SCALABILITY, HOW ISIT GOING TO BE USED OVER THELONG TERM.IS IT A -- DOES HAVE HAVETHABILITY TO ADAPT AND CHANGE.IS IT -- DOES HAVE ITINTEROPERABILITY BETWEEN OTHERSYSTEMS.HOW SECURE IS IT?DOES IT HAVE AN UNDERHIGHINGSTRUCTURE THAT -- UNDER LININGSTRUCTURE BUILT WELL ENOUGH?IS IT USER FRIENDLY.THE CODE OF FEDERAL REGULATIONSDOES ADDRESS ELECTRONIC RECORDSAS WELL AS SIGNATURES, ANDREADING THESE CODES IS IMPORTANTFOR ANYONE THAT WANTS TOCONSIDER DEVELOPING THESE, BUTTHEY BASICALLY REQUIRE VARIOUSMECHANISMS TO BE EMPLOYED, SUCHAS ENSURING THAT THE DATA ISACCURATE, RELIABLE, HAS NOT BEENALTERED.DOES THE SYSTEM ALLOW YOU TOCHECK FOR THAT.DOES -- CAN YOU CREATE ACCURATEAND COMPLETE COPIES OF THERECORDS?FOR INSPECTION OR REVIEW?ARE THERE RECORDS PROTECTED?AND RETRIEVABLE WHEN NECESSARY?AND IS THERE THE ABILITY TOLIMIT ACCESS TO THE SYSTEM.USUALLY BY USER NAMES ANDPASSWORDS SO NOT EVERY ONE CANACCESS IT.ANOTHER MORE ON THE CROWED OFFEDERAL REGULATIONS -- CODE OFFEDERAL REGULATIONS.CAN THEY IDENTIFY WHO HASENTERED THE INFORMATION.CAN THAT BE TRACKED?AND HAS THAT DATA BEEN MODIFIEDOR CHANGED ACROSS THE TIME?THIS IS, AGAIN, TRYING TO ASSESSFOR NOT NECESSARILY FRAUD, BUT ACHANGE.I THINK IT'S IMPORTANT IN THESTUDIES TO BE ABLE TO TRACKTHAT, MONITORS AND AUDITORS WILLBE INTERESTED IN IT.IT NEEDS TO HOLD INDIVIDUALSACCOUNTABLE AND RESPONSIBLE FORTHE DATA UNDER AN ELECTRONICSIGNATURE.THAT IN ITSELF IS A -- I FOUNDTHROUGH EXPERIENCE WITH SOME OFTHE RESEARCH SITES VARIOUSPROGRAMS, VARIOUS ELECTRONICSYSTEMS THAT SITES HAVE.SOME HAVE THE ABILITY TO PROVIDEELECTRONIC SIGNATURES, OTHERSDON'T.AND THEY ALSO HAVE TO BECERTIFIED PROGRAMS.SO CHECK IN TO THAT WHEN YOU'RECONSIDERING DEVELOPING THESE ANDCONSIDERING YOUR RESEARCH SITESSELECTION.DO THEY HAVE THAT CAPABILITY.AND AGAIN, TRAINING.TRAINING, TRAINING, THAT'S WHYYOU'RE HERE TODAY, TRAINING.SO IT SEEMS TO BE AN ONGOINGTHING WITH CLINICAL RESEARCH.SO ACTUAL DATA TRANSER, PAPERCRFS ARE USUALLY COMPLETED ATTHE SITE, SUBMITTED TO THESPONSOR AND ELECTRONICALLYENTERED BY THE SPONSOR AT THEIRSITE.SO IT'S A LOT OF EXTRA WORK.AND EXPENSE.ELECTRONIC, AGAIN MUCH ETHICINVEST -- LOG IN AND ACTUALLYENTER THE DATA CORRECTLY AT THESITE. -- DIRECTLY AT THE SITE.IT ALLOWS FOR REAL TIME DATAREVIEW.THERE ARE OTHER MEDS OR THINGSCOLLECTED, THOUGH, AND IT MIGHTBE MORE RELATED TO PATIENTREPORTED OUTCOMES OR FORMS WHERETHE PATIENTS FILL OUT THINGS ONPAPER AND THEY'RE SENT IN, ORTRANSCRIBED INTO AN ELECTRONICSYSTEM.THOSE MIGHT INCLUDE YOUR DIARIESAND CALENDARS THEY MIGHTCOMPLETE, QUESTIONNAIRES,QUALITY OF LIFE TYPE FORMS.AND ANY DATA SUPPORTING SOURCEDOCUMENTS.SO LET'S TALK ABOUT ACTUALLYMANAGING THE DATA.IT REALLY BECOMES A SYSTEM THATIS A CONTINUOUS SYSTEM.DATA IS COLLECTED, ACCORDING TOTHE PROTOCOL.HOPEFULLY THERE IS INTERNALQUALITY AUDIT CHECK POINTS ATTHE SITE.THE DATA IS SUBMITTED ACCORDINGTO THE PROTOCOL, IT'S REVIEWEDAT THE DATA CENTER.WHERE QUERIES ARE OFTENGENERATED, CAN BE GENERATED.WE'LL TALK ABOUT THAT.AND THEN DATA IS COLLECTED ANDRESUBMITTED.THIS IS JUST THIS ONGOING CYCLEOF DATA SUBMISSION.AND I THINK THIS SAYS A LOT.BUT JUST GOING TO GIVE ANEXAMPLE FOR PHASE 3 TRIAL.THIS ARE PROBABLY CLOSE TO 7500TO 9,000 PIECES OF DATA THATMIGHT BE COLLECTED FOR A SINGLEPATIENT.SO IF YOU TAKE THAT TIMES ASTUDY THAT MAY HAVE A SAMPLESIZE OF 500 PATIENTS, THAT'SGOING TO BE OVER 4 MILLIONPIECES OF DATA.SO KIND OF GIVES YOU APERSPECTIVE OF THE AMOUNT OFWORK AND THE IMPORTANCE OFCOLLECTING ACCURATE DATA WHEN ITCOMES TO THAT LEVEL OF EFFORT.SO AGAIN I WANT TO TALK ABOUTTHE INVESTIGATORRESPONSIBILITIES, AS FAR ASRELATING TO COMPLETION OF THECRF.GOOD CLINICAL PRACTICE, THERE ISGCP GUIDELINES, REALLYSPECIFICALLY STATE THATINVESTIGATOR SHOULD ENSURE THEACCURACY, COMPLETENESS,LEDGABILITY AND TIMELINESS OFTHE DATA.THAT INCLUDES ALL SECTIONS ARECOMPLETED, ANY ALTERATIONS HAVEBEEN MADE AND ALL ADVERSE EVENTSARE FULLY RECORDED AND REPORTEDACCORDINGING TO REGULATORYBODIES.I TRY TO INCOOKER MY STAFF TOCOMPLETE THE DATA FORMS ASCLOSELY AFTER THE VISIT ASPOSSIBLE.THIS IS WHERE YOU PICK UP ONMAYBE SOMETHING WAS MISSED.MAYBE YOU KNOW IT TOOK PLACE,INFORMATION WAS STATED, BUT ITWASN'T DOUBTED COMPLETELY --DOCUMENTED COMPLETELY.THEY'LL REMEMBER TO COMPLETETHAT AND KNOW THE INFORMATION ORRECORD IT CLOSER TO THE VISITTHAN IF A STAFF PERSON ISWAITING TO GO BACK IN 3 MONTHSLATER AND FILL OUT THE DATAFORM.IT'S A LITTLE TOO LATE TOCAPTURE THE INFORMATION THATMIGHT HAVE BEEN MISSED.IT ALSO ENSURES THAT THEINFORMATION CAN BE RETRIEVED ORFOLLOWED UP ON WHILE THAT VISITIS STILL FRESH IN THEIR MIND.THERE ARE PROBLEMS THAT AREENCOUNTERED WHEN CRFS ARECOMPLETED.THIS IS VERY COMMON SOMETIMES.THERE MEMBER A LACK OF SOURCEDOCUMENTATION.I THINK ONE THING THAT WECONTINUALLY FOUND IN OUR SITEWERE PHYSICIANS FAILING TOREPORT IN THE SOURCE DOCUMENTWHAT THE PATIENTS ACTUALPERFORMANCE STATUS WAS.SIMPLE, BUT OFTEN OUR AUDITORSREQUIRE THAT NUMBER INSTEAD OFJUST A DESCRIPTION OF THEACTIVITY OF THE PATIENT.IT WAS FRUSTRATING.SO WE DEVELOPED A SOURCEDOCUMENT THAT CAPTURED THAT.SO WE COULD HAVE THEINFORMATION.THERE CAN BE ERRORS IN THEPROTOCOL, ADHERING TO THEPROTOCOL.MISSING DATA, TRANSCRIPTIONERRORS, LAG IN DATA ENTRY, POORPATIENT RECALL AFTER ADVERSEEVENTS, AND ALSO JUST POORPATIENT COMPLIANCE.QUERIES ARE DAY TO DAY ACTIVITY,IF YOU'VE BEEN INVOLVED INCLINICAL RESEARCH MUCH AT ALL,PARTICULARLY AS A RESEARCHASSOCIATE OR CRF OR RESEARCHNURSE.THEY BASICALLY REVIEW THE --THEY REVIEW THE ACTIVITY WITHINTHE DATA THAT'S COLLECTED.IT HELPS TO CLEAN THE DATA.AND IT HELPS TO ASSESS ANDESOLVE SOME INCONSISTENT DATAMISSING ORANGE DESCRIPTION, --OR RANGE DESCRIPTION.AND THEY'RE SENT TO THEINVESTIGATOR FOR RESOLUTION.AGAIN, THIS IS MORE PROBABLYCOMMON WITH THE PAPER FORM THANTHE ELECTRONIC, AS I SAID,ELECTRONIC FORMS -- THEOPPORTUNITY TO COLLECT AND OR TOCLARIFY AND CORRECT ISSUES ISUSUALLY PROVIDED AT THE TIME OFDATA ENTRY.NOT ALL THE TIME.I REALLY HOPE THAT ANY RESEARCHSITES DO HAVE SOME SORT OFINTERNAL PROCESS TO REVIEW. THEIR RESEARCH BEFORE THEY HAVEAN EXTERNAL AUDITOR COME INTO -- TO WAIT TO FIND YOURPROBLEMS IS NOT A GOOD IDEA.TO BE PROACTIVE, SELF-IDENTIFYYOUR ERRORS, DEVELOP CORRECTIVEACTION PLANS, CORRECT YOURSOPs OR UPDATE YOUR SOPs.AND THEN THIS IS JUST REALLY KEYTO PREVENTING NON COMPLIANCE,AND IT HELPS TO, THEN, TRAINYOUR STAFF MORE APPROPRIATELY ASWELL.SO HOPEFULLY THOSE ISSUES ARERESOLVED AT THE TIME AND NOTONGOING.A LITTLE BIT DATA SAFETYMONITORING BOARDS.I SEE IN YOUR -- ALL YOUR TOPICSFOR DISCUSSION THAT THERE IS ADISCUSSION ON DATA SAFETYMONITORING BOARDS.I THINK IT DOES PLAY ANIMPORTANT ROLE WHEN YOU'RETALKING ABOUT DATA MANAGEMENT.THE DATA SAFETY MONITORINGBOARDS ARE BOARDS MADE UP OFEXPERTS THAT -- FOR SPECIFIC --USUALLY DISEASE CATEGORIES THATREVIEW TRIAL DATA.AND LOOK AT RECRUEL RATES, LOOKAT ADVERSE EVENTS, AND LOOK ATTHE DATA REPORTS AS FAR AS WHATIS THE INTERIM ANALYSIS SHOWING?THEY ALSO, THEN, BY DOING THAT,MIGHT CAPTURE ISSUES -- FORTRIALS, IF THE ACCRUAL RATE ISREALLY SLOW.THEY'LL ENCOURAGE THEINVESTIGATOR TO FIGURE OUT WHY.DEVELOP METHODS OR LOOK AT WHATTHE PROBLEMS MIGHT BE.AND PERHAPS AN AMENDMENT NEEDSTO BE MADE TO THE STUDY TOCHANGE SOMETHING, AN ELIGIBILITYTHAT'S PROHIBITING ACRAL.ADVERSE EVENTS, TWO ARM STUDY,ONE ARM IS MORE TOXIC, THE DATAMONITORING BOARD MIGHT SUGGESTDEPENDING HOW VEER THEDIFFERENCES MIGHT BE, OFSHUTTING DOWN ONE OF THE ARMS ORSHUTTING DOWN THE STUDY.AND DOING THE INTERIM ANALYSISHELPS TO ASSESS OUR -- IS ONEARM POSSIBLY GIVING BETTERRESULTS?ARE PATIENTS -- THEY USUALLYWRITE THIS OUT IN THEIR DATAANALYSIS PLAN OF WHAT THEY WILLACCEPT AS A LEVEL OF CHANGEBETWEEN ARMS.IF ONE ARM HAS REACHED THATTHRESHOLD, THEY MAY ACTUALLYSHUT A STUDY ARM DOWN ANDCONTINUE ANOTHER ARM.SO THE SAFETY DATA MOTORINGBOARDS PLAY A CLEAR ROLE IN ASAYING TRIALS.MONITORING AND AUDITING ARE TWOTERMS THAT GET INTERSPERSEDQUITE REGULARLY.MONITORING IS MORE THEOVERSEEING OF THE PROGRESS OFTHE CLINICAL TRIAL, KIND OF MOREOF A LOOK AT THE PROCESSES INPLACE.AND IT DOES ENSURE THAT THETRIAL IS BE CONDUCTED, REPORTEDACCORDING TO THE PROTOCOL.THE AUTOING IS MORE -- AUDITINGIS LOOKING AT THE DATA CARRYINGTHEM TO SOURCE DOCUMENTSSUBMITTED.IS IT ACCURATE?IS THE INFORMATION THERE THEYNEED TO SEE?THERE ARE VARIOUS AGENCIES THATCONDUCT AUDITS.THE NCI, WE HAVE RESEARCHPROGRAMS THAT PROVIDE RESEARCHTRIALS AND STUDIES FOR US TO --THAT ARE AVAILABLE, THEN TO OURRESEARCH PROGRAMS.SITES OUT IN THE COMMUNITIES.AND THE NCI CHARGES THESEPROGRAMS, THE ONES THAT GENERATETHE TRIALS, TO GO OUT ANDCONDUCT AUDITS ON A REGULARBASIS ON OUR RESEARCH SITESTISMFOOD AND DRUG ADMINISTRATION HASCONDUCTED AUDITS, WHEN SOMEBODYSAYS THEY'RE HAVING AN FDA AUDITTHEY'RE INSTANTLY STRESSED.I'LL GIVE YOU INFORMATION ABOUTAN FDA AUDIT BUT THEY'REIMPORTANT.FDA HAS -- CARRIES A HUGE ROLEOF TRYING TO DECIDE IF A DRUG ISACTIVE OR NOT, THEY WENT TO LOOKAT THE DATA TO ENSURE THAT ITACTUALLY IS.THE OFFICE OF HUMAN RESEARCHPROTECTION, OHRP THAT CONDUCTSAUDITS OF IRBS AND REGULATORYPORTIONS OF THE RESEARCH.THE SPONSOR ITSELF IN TRIAL WILLBOO AUDITS.AND THEN THERE SHOULD BE THOSEINTERIM SITE AUDITS DONELOCALLY.THE PURPOSE IS TO LOOK AT NUMBERONE, DETERMINE IF THE RIGHTSAFETY AND WELL FATHER OF THOSESTUDY -- WELFARE OF THOSE STUDYPARTICIPANTS HAVE BEEN UPHELD.TO EVALUATE THE CONDUCT OF THETRIAL, VAULT THE SITE'S STANDARDOPERATING PROCEDURES AND HELPVERIFY THE INTEGRITY ANDRELIABILITY OF THE DATA.THEY HELP TO DETERMINE THAT ALLTHE REGULATORY PROCEDURES HAVEBEEN FOLLOWED.FOR CAUSE AUDITS DO RAISE THEHAIRS ON THE BACK OF YOUR NECKSOMETIMES WHEN YOU THINK ABOUTTHOSE, BECAUSE YOU DON'T WANT TO -- THEY'R E USUALLY RELATED TOSITES THAT MAY BE COMPARED TOEVERY ONE ELSE PARTICIPATING INSTUDY, FOR SOME REASON THEY'REHAVING FAVORABLE RESULTSCOMPARED TO OTHERS.MIGHT FLAG A FOR CAUSE AUDIT.SITES WITH UP EXPECTED HIGHENROLLMENT VERSES OTHER.THE INVESTIGATOR CONDUCTING ALARGE NUMBER OF TRIALS, IFTHEY'RE OUTSIDE OF HIS OR HERAREA OF EXPERTISE, MAY RAISE ABIT OF A RED FLAG FOR A SITEAUDIT AND IF THERE HAS BEEN ANUNEXPECTED DEATH OR DEATHS AT APARTICULAR SITE, THAT, AGAIN,MAY TRIGGER A FOR CAUSE AUDIT.SO WHAT DO AUDITORS LOOK FOR IFI THINK HELPING TO KNOW THATWILL HELP INPROVE THE QUALITY OFANY PROGRAM.YOU LOOK AT THE REGULATORY IRBINFORMATION.THEY WANT DOCUMENTATION OF FULLREVIEW, INITIAL REVIEW AS WELLAS ANNUAL.THEY'LL LOOK AT YOUR CONSENTDOCUMENTS.THEY'LL LOOK AT THE PHARMACY,DRUG ACCOUNTABILITY.THEY WANT VERIFICATION OF THERECEIPT AND THE STORAGE ANDSECURITY AS WELL AS THEINVENTORY CONTROL.AND THE BIGGEST PIECE OR PORTIONTHAT THEY REVIEW ARE THE PATIENTCASE REVIEWS.AGAIN THEY'LL BE LOOKING AT THECONSENT, MOSTLY FOR SIGNATURE OFTHE PATIENT THAT THEY'RECOMPLETED PROPERLY.THEY'LL LOOK AT ELIGIBILITYCRITERIA, WHETHER CORRECTTREATMENT WAS ADMINISTRATORED,WHAT THE DISEASE OUTCOME ANDTUMOR RESPONSE WERE, ANY ADVERSEVOLUNTEERS, AND THEY LOOK ATGENERAL DATA QUALITY.INFORMED CONSENT, THEY'LL MAKESURE ALL THE REQUIRED ELEMENTSARE THERE.MOST OF OUR TRIALS PROVIDE THESITES WITH TEMPLATES, CONSTANTTEMPLATES.THEY SOMETIMES HAVE TO MODIFYTHEM TO FIT LOCAL CONTEXT.SOMETIMES IN THE PROCESS OFTRANSFERRING AND WORRYING WITHWORD DOCUMENT -- WORKING WITHWORD DOCUMENTS, SOME OF THEINFORMATION MAY BE DELETED,COPIED, PASTED INTO THE WRONGSECTION.THEY'RE ALL WHAT AUDITORS LOOKAT.THEY USUALLY DON'T COMPLAINABOUT ADDING INFORMATION, IFTHEY FEEL IT'S GOING TO HELPINFORM THE PATIENT, HOWEVER,REMOVING INFORMATION THAT WASTHERE FOR INFORMATION PURPOSESWILL RESULT IN USUALLY A MAJORDEVIATION.WAS APPROPRIATE VERSION OF THECONCEPT USED FOR ALL PATIENTS ATTHE CORRECT TIME?WAS RECONSENT -- CONSENT ORTRIAL CHANGED SIGNIFICANTLY THATREQUIRED ALL PATIENTS THAT WERECURRENTLY ON TRIAL TO BERE- CONSENTED, WERE THOSEPATIENTS RE-CONSENTS DONE?WAS THE CONSENT OBTAINED PRIORTO TESTS OR ASSESSMENTS?AND WAS IT OBTAINED DEFINITELYBEFORE ANY STUDY MEDICATION WASGIVEN?ELIGIBILITY, DID THE PATIENTMEET THE CRITERIA.THEY'LL GO THROUGH EVERY ONE OFTHE CRITERIA AND COMPARE IT TOWHAT THE CASE REPORT FORM SHOWS.AND IT NEEDS TO BE THERE.AS FAR AS THE -- LOOKING AT THEPROTOCOL ASSESSMENTS, ACCORDINGTO THE PROTOCOL THEY'LL LOOK ATTHE EXAM, PERFORMANCE,LABORATORY TESTS, TUMORMEASUREMENTS,ALITIES QUALITY OFLIFE MEASUREMENTS.TREATMENT WHERE THE DRUG DOSE,DRUG OR AGENT ADMINISTERED AS ITWAS DESIGNED OR -- SAID TO BEGIVEN WITHIN THE PROTOCOL?IF IT'S AN ORAL AGENT, WAS ADIARY OR PILL COUNT PROVIDED?AND THEY'LL ALSO, THEM, COMPARETHIS INFORMATION TO THE PHARMACYLOG.WAS IT THE DRUG ADMINISTERED INTIMELY -- ACCORDING TO THE TIMEOF ADMINISTRATION, ACCORDING TOTHE PROTOCOL, ANY DOSEMODIFICATIONS FOLLOWED ACCORDINGTO THE STUDY, AND AGAIN, THEY'LLLOOK TO SEE IF ANYCONTRAINDICATED DRUGS WEREPROVIDED OR GIVEN.DRUG ACCOUNTABILITY, WERE THEAGENTS PROPERLY STORE IN ASECURED PHARMACY AREA?WERE THEY STORED BY PROTOCOL ANDBY STUDY.THEY DIDN'T -- DO NOT WANT TOPUT THE SAME DRUG FROM DIFFERENTSTUDIES IN THE SAME BOX ORCONTAINER IN THE PHARMACY.IT REALLY ALLOWS ERROR, HUGEERRORS TO OCCUR SO THEY USUALLYWANT THOSE THINGS SEPARATED PIETRIAL.IF SOME AGENTS ARE REQUIRED TOBE REFRIGERATED OR FROZEN,THEY -- THE PHARMACY SHOULD BEABLE TO PROVIDE IT WILL LOGS TOMAKE SURE THAT THOSETEMPERATURES WERE -- STAYCONSISTENT ACCORDING TO THENEEDS OF THE DRUG.A HUGE ISSUE THAT I -- WE RUNINTO FREQUENTLY, THE DRUGACCOUNTABILITY FORMS.THEY'RE BUSY PEOPLE, THEPHARMACISTS SO THEY'LL WRITE ITDOWN, OH, THEY MADE A MISTAKE,SCRATCH IT OUT AND TRY TO FIXIT.AND THAT'S CONSIDERED INCORRECT.A SINGLE LINE, DATE, INITIAL,AND -- IS CONSIDERED A WAY TOCOMPLETE AN ERROR THAT MIGHTOCCUR ON ONE OF THOSE FORMS.MOST OF THE DARFs ARE STILL INPAPER FORM.THEY'RE TRYING TO CONVERT THEMTO ELECTRONICS WHICH HOPEFULLYELIMINATE SOME OF THE PROBLEMS.WAS THE INVESTIGATIONAL AGENTPROPERLY DISPOSED OF?WAS THE STUDY BLIND MAINTAINED?HOPEFULLY COMMERCIAL AGENTS WERENOT USED.THE THE DRUG INVENTORY COMPLETEDON A REGULAR BASIS.WE ENCOURAGE OUR PHARMACIES TODO MONTHLY CZECHS TO CONFIRMWHAT'S ON STOCK IS WHAT'S ON THEDRUG ACCOUNTABILITY FORM.COMMON AUDIT DEFICIENCIES.FAILURE TO FOLLOW THE PLAN,INVESTIGATIONAL PLAN.NOT DOCUMENTING INFORMATIONPROPERLY.ANY PROTOCOL DEVIATIONS THEYDIDN'T FOLLOW THE PROTOCOLACCORDING TO PLAN.FAILURE TO ENSURE THAT THECONSENT FORM WAS OBTAINED ISKIND OF A -- I DON'T SEE THAT ASMUCH.I THINK ONE ISSUE WE SEE MOREFREQUENTLY ARE THE RE-CONSENTSNOT DONE IN A TIMELY MANNER.FAILURE TO MAINTAIN ACCURATECOMPLETE AND CURRENT RECORDS.LACK OF APPROPRIATEACCOUNTABILITY FOR THE DRUGS ANDPROVIDED AGENTS.AND THEN A FAILURE TO OBTAIN IRBAPPROVAL.NOT SO MUCH THE INITIAL BUTMAYBE AMENDMENTS, IRB APPROVALSWITHIN A TIMELY MANNER OFTENTIMES IS A DEFICIENCY WE SEEWITHIN OUR SITES.AUDIT DETERMINATIONS.USUALLY, THEY'RE CLASSIFIED INTOTWO DIFFERENT CATEGORIES, LESSEROR MINOR DEFICIENTS VERSESMAJOR.MAJOR DERBIES ARE THOSE THAT --DEFISH SAYS CAN IMPACT THEENDPOINTS OF THE STUDY.AND IF A SITE GETS MANY, COULDPUT THEM AT RISK FOR CONTINUINGRESEARCH IN THE FUTURE.SO WE REALLY WORK TOWARDEDUCATING AND INFORMING SITESNOT TO DO -- TO TO THE BEST THEYCAN TO BUILD PROGRAMS ANDDEVELOP TRAINING SO THAT DOESN'THAPPEN.FINAL AUDIT DETERMINATIONS,USUALLY ARE -- WITHIN 3CATEGORIES.ACCEPTABLE, ACCEPTABLE NEEDSFOLLOW UP OR UNACCEPTABLE.ACCEPTABLE, THERE WERE VERY FEWDEVIATIONS FOUND.ACCEPTABLE MEANS FOLLOW-UP,PROBABLY SOME DEVIATIONS, NOTENOUGH TO BE OF CONCERN.IF A SITE IS DOING MUCHRESEARCH, THEY WILL HAVE SOMEMAJORS.IT'S INEVITABLE.IT'S DIFFICULT TO BE 100%CORRECT AT ALL TIMES.UNACCEPTABLE, HOWEVER, AREFINDINGS RELATED TO LOTS OFMAJOR DEVIATIONS, A LARGE% OFTHEM COMPARED TO WHAT WOULD BEEXPECTED.AND WITH THOSE, KEEPING ON THEIRSEVERITY, USUALLY THAT REQUIRESA REAUDIT WITHIN A YEAR.AND IF IT'S SEVERELY -- A SEVEREPROBLEM, THE SPONSOR MAYPROHIBIT THEM FROM CONDUCTINGFUTURE REQUEST.FOR A TIME OR FOREVER, REALLYDEPENDS ON THE DEGREE OFCOMPLEXITY OR FREEOF MAJORISSUES THAT WERE FOUND.SO AGAIN LOOKING AT THE FDAINSPECTION, THE FDA WILL COMEIN.THEY HAVE A HUGE LIST OF THANKSTHEY HIKE TO LOOK AT -- THINGSTHAT THEY LIKE TO REVIEW.IT'S LABOR INTENSIVE AND WORKFOR THE RESEARCH SITE.AND THEY'LL REVIEW AND THENTHEY'LL PROVIDE SITE WITH WHAT'SCALLED AN FDA FORM 483.YOU'LL HEAR A SITE SAY WHAT DIDYOUR 483 SAY.THIS IS WHAT THEY'RE REFERRINGTO.IT PROVIDES A LIST OFOBSERVATIONS THAT THE FDA FOUND.AND INVESTIGATOR HAS TO RESPONDWITHIN A CERTAIN TIMEFRAME.IT'S REVIEWED AT THE FDA.THE FDA MAKES A FINALDETERMINATION AND THEM ISSUES ARESPONSE LETTER.AND THAT LETTER CAN BE ANYTHINGFROM THOUGHT THAT MANY ISSUES,AND THEY OBSERVED BASICCOMPLIANCE WITH PERTINENTREGULATIONS.BASICALLY DIDN'T FIND MANYISSUES AT ALL, TO ALL THE WAY UPTO A NOTICE OF INITIATION OFDISQUALIFICATION AND PROCEEDINGSAND OPPORTUNITY TO EXPLAIN WHEREBASICALLY THAT SITE HAS BEENSHUT DOWN.AND THEY HAVE THE OPPORTUNITY TOAPPEAL OR TO REFUTE IT, BUT ITTAKES A LOT OF WORK AND EFFORTTO GET TO THAT POINT.SO -- THEY DO CARRY A PRETTYHEAVY STICK.SO TALK ABOUT ADVERSE EVENTREPORTING AN MONITORING.I HAD TO THROW A LITTLE BIT OFFA FUNNY IN.BASICALLY ADVERSE EVENTREPORTING IS IMPORTANT.VERY VITAL PIECE TO CONDUCTINGCLINICAL RESEARCH.IT'S BASICALLY AN ADVERSE EVENT,ANY UNTOWARD MEDICAL OCCURRENCETHAT MAY PRESENT ITSELF DURINGTHE TREATMENT OR ADMINISTRATIONWITH A PHARMACEUTICAL PRODUCT,AND WHICH MAY OR MAY NOT HAVE ACAUSAL RELATIONSHIP TO THEAGENT.THAT'S THE EVENT.A TOXICITY IS ACTUAL ADVERSEEVENT THAT DOES HAVE CAUSALRELATIONSHIPS, BASICALLY THEAGENT ITSELF HAS CAUSEDTOXICITY, FOR EXAMPLE, EGFRAGENTS CAUSE SKIN RASH.WE KNOW SKIN RASH IS A TOXICITY.THERE ARE SERIOUS ADVERSE EVENTSAS WELL.OR SAEs IS A TERM YOU WILLHEAR.THIS IS BASICALLY ANY MEDICALOCCURRENCE THAT RESULTS IN DEATHOR A LIFE THREATENING EVENT,REQUIRES HOSPITALIZATION, MAYRESULT IN A DISABILITY ORINCAPACITY OR CONGENITAL ANOMALYOR BIRTH DEFECT.ALL SAEs NEED TO BE REPORTED,AND THEY NEED TO BE REPORTED ASQUICKLY AS POSSIBLE TO THESPONSOR.THEY ALSO SHOULD BE -- COMPLYWITH REGULATORY REQUIREMENTSWHICH IS TO REPORT THEM TOREGULATORY AUTHORITIES INCLUDING INCLUDINGTHE IRB.ADVERSE EVENT REPORTING, THE HINIHAS COMMON TERMINOLOGY,CRITERIA FOR ADVERSE EVENTS ORCTCAE.SOME OF YOU ARE PROBABLYFAMILIAR WITH THAT.THIS IS BASICALLY A RATHER LARGEDOCUMENT NOW THAT ALLOWS LISTSMULTI TYPES OF ADVERSE EVENTSAND PROVIDING GRADING CRITERIATO HELP YOU DETERMINE WHATSEVERITY THAT ADVERSE EVENTWOULD BE.IT HELPS TO DETERMINE IF THEEVENT WAS EXPECTED ORUNEXPECTED, AND IT HELPS TO,THEN, RELATE THAT INFORMATIONWITHIN -- IS IT RELATED TO THESTUDY INTERVENTION.THERE ARE WAYS THAT THESE -- THEINFORMATION CAN BE EXPEDITED ANDREPORTED.THE NCI NOW HAS ROACHES OR ACOMMON SYSTEM THAT THEY USE FORTHEIR TRIALS THAT INFORMATION ISREPORTED WITHIN.THE IRB SPONSOR AND FDA ALSONEED TO BE INCLUDED IN THE --AGAIN, THE REPORTING OF THEINFORMATION.THIS IS JUST A QUICK SCREEN SHOTOF KIND OF AN OLDER VERSIONRIGHT NOW.THIS IS STILL VERSION 4. O BUTYOU CAN SEE WHERE IT LISTS THEADVERSE EVENT AND PROVIDES THEGRADING OF -- FROM 1-4 -- 1-5,ACTUALLY.5 IS ALMOST ALWAYS DEATH.AS BEING THE MOST SEVERE.A POINT TO MAKE WITH THE CTCAE,THEY ARE -- IT IS A BIT OF ANITERATIVE PROCESS.VERSIONS ARE CHANGING ON AFAIRLY REGULAR BASIS.WHEN YOU DESIGN YOUR PROTOCOL,YOU WANT TO INDICATE IN IT WHICHVERSION OF THE CTCAE ARE YOUEXPECTING THE RESEARCH SITE TOUSE THEN BE ABLE TO STICK WITHTHAT.FYI, THEY ARE LOOKING ATACTUALLY HOPEFULLY -- IT'S INTHE REVIEW ROW SAYS RIGHT NOW OFA VERSION 5.0.I DON'T THINK IT WILL LOOK A LOTDIFFERENT FROM THIS, BUT IT'S INTHE WORKS, SO BE AWARE OF THAT.ASSIGNING ATTRIBUTION CAN BECHALLENGING SOMETIMES, DEPENDINGON THE HEAVILY OF UNDERSTANDINGAND EXPERTISE AT THE CRF ORNURSING LEVEL.THEY RANGE FROM UNRELATED UP TODEFINITE, WITH IN BETWEENUNLIKELY, POSSIBLE AND PROBABLY.UNRELATED AND DEFINITE IS EASYTO FIGURE OUT.THE LEVELS IN BETWEEN MIGHT BECHALLENGIS, THIS IS WHERE IENCOURAGE THE INVESTIGATOR TO BEPULLED IN AND HELP TO MAKE THESEDECISIONS, SO THE ACCURATEINFORMATION IS PROVIDED.THERE ARE LEGAL A REGULATORYISSUES.I THINK YOU'LL GET SEVERAL OFTHESE OTHER PRESENTATIONS,YOU'LL HAVE WILL COVER THESE INMORE DETAIL.BUT JUST TO BE AWARE THAT THEREARE VARIOUS REGULATORY AGENCIESAND I'M GOING TO PROVIDE SOMESLIDES THAT PROVIDE THE ACTUALLINKS TO THESE.TO BE AWARE OF THEM, TO GO IN,CHECK THEM OUT.THERE IS A LOT OF INFORMATION TOLEARN.REGULATORY DOCUMENTS ARE OFTENBASED ON THE BELMONT REPORT.THE -- WHICH IS AN IMPORTANTDOCUMENT.THERE IS THE CODE OF REGULATIONSWHICH I ADDRESSED, AND SHAREDWITH YOU ON PREVIOUS SITES.THEN ANOTHER IMPORTANT DOCUMENTIS THE INTERNATIONAL CONFERENCEOF HARMONIZATION OR GOODCLINICAL PRACTICE GUIDELINES,GCP.AS FAR AS THE CODE OFREGULATIONS, I TRIED TO NARROWDOWN HAPPY BIRTHDAY SOME MORESPECIFIC ONES TO LOOK -- DOWNMAYBE SOME MORE SPECIFIC ONESINSTEAD OF DID HE GOING MIGHTTHE ENTIRE CODE WHICH CAN BEQUITE OVERWHELMING.I PROVIDE THOSE ON THIS SLIDE.AND THEN THE GCP IS FAIRLY LARGEDOCUMENT, SO I THINK IF YOU CANHONE IN ON THE SECTION LABELEDE6, I PROVIDE THE WEB LINK FORYOU AS WELL.THESE -- THIS E6 QUESTIONSTHROUGH THE BASICS, PRINCIPLESOF GCP, GOES THROUGH TRIALMANAGEMENT, SAFETY REPORTING,QUALITY ASSURANCE AND RECORD,RECORD REPORTS.THIS IS THE BACK BONE OFINFORMATION PROVIDED THE SITESTO BE EDUCATED AS WELL ASUNDERSTAND.INVESTIGATORS AND RESEARCHERSSHOULD BE VERY FAMILIAR WITH GCPGUIDELINES.MANY ARE PROBABLY ALSO FAMILIARWITH THE REGULATORY DOCUMENTS.MANY SPONSORS REQUIRE THESE TOBE CAPTURED WITHIN AN ACTUALSTUDY BINDER OR A CONFINEDDOCUMENT.THEY MAY INCLUDE THE STUDY ISAID, AS WELL AS ANY AMENDMENTS.THE DRUG BROCHURE THAT FORMS1572, A REALLY IMPORTANT FORMFOR INVESTIGATORS TO COMPLETE.ALL THE CDs OF THE -- CVs OFTHE PERM LISTED ON THE 1572.ANY IRB APPROVAL, CORDONS, ALLTHE IND SAFETY REPORTS AND SITESAFETY REPORTS SUBMITTED TO THEIRB.SHOULD INCLUDE THE IRB APPROVEDCONSENT DOCUMENTS,ADVERTISEMENTS USED, THEMEMBERSHIP LIST, DRUGINVENTORIES, TELEPHONE LOGS THATMAY HAVE BEEN USED TO DOCUMENTTHE TRACKING OF WHAT'S GONE ONWITH 2 STUDY.COPIES OF LAB CERTIFICATIONS,HOGS DOCUMENTING CRF VISITS ASWELL AS SIGNATURE LOGS, THEN THECLOSEOUT LETTER WITH ALL THEDOCUMENTS WOULD BE INCLUDEDWITHIN THE REGULATORY DOCUMENTSOR THE BINDER.NIH ALSO DOES HAVE DOCUMENTSTHAT THEY LIKE TO HAVE.MANY OF YOU ARE NIH EMPLOYEES,YOU'D BE FAMILIAR WITH THESE.HUMAN SUBJECTS PROTECTIONTRAINING, CONFLICT OF INTERESTDOCUMENTS, DISCLOSING FINANCEINTERESTS AS WELL AS THE SAFETYMONITORING BOARD PLAN ISINCLUDED WITH ANY GRANTAPPLICATIONS THAT WE HAVE ASWELL AS ALL THE RESEARCHPROGRAMS ARE REQUIRED TO HAVETHAT.WHAT IS THE DATA SHARING POLICY,AS WELL AS HOW TO ADEQUATELYINCLUDE A PLAN FOR AND INCLUDEMINORITIES, WOMEN AND CHILDRENWITHIN YOUR RESEARCH.RECORD RETENTION.HOW LONG TO DETERMINE TO KEEPRECORDS IS A QUESTION I OFTENRECEIVE.WHEN SOME OF THESE STUDIES GO ONFOR YEARS AND YEARS, THESERESEARCH SITES CAN HAVE A LOT OFDATA, A LOT OF RECORDS THAT THEYHAVE ON AND STORAGE, AND IT CANBE QUITE EXPENSIVE.MANY OF MY SITES ARETRANSFERRING THAT INFORMATIONINTO ELECTRONIC CAPTURE SYSTEMBY SCANNING IN, TRYING TO REDUCETHE BURDEN.BUT IT IS DIFFICULT TO FINDCONCRETE INFORMATION ON WHATTIMELINE RECORDS SHOULD BERETAINED.THERE ARE SOME MINIMUMS, THOUGH,AND USUALLY, THE SPONSOR WILLDEFINE THAT.BUT FOR MINIMUMS, TWO YEARSFOLLOWING THE DATA, THEMARKETING APPLICATION ISAPPROVED FOR ANY INVESTIGATIONALNEW DRUG IS STANDARD.AND IF THE APPLICATION ISDISAPPROVED, DATA SHOULD BEMAINTAINED FOR TWO YEARS AFTERSHIPMENT AND DELIVERY OF THEDRUG FOR INVESTIGATIONAL USE.IF THIS CONTINUED AND THE FDA ISNOTIFIED, ALL IRB RECORDS SHOULDBE MAINTAINED FOR AT LEAST 3YEARS AFTER THE STUDY ISCOMPETED.SOME OF THESE STUDIES GO ON FOURMANY YEARS SO THAT'S A LONG TIMETO MAINTAIN.AS FAR AS TOLUP AND ANALYSIS --FOLLOW UP AND ANALYSIS, NOFURTHER PARTICIPANT ENROLLENROLLMENT -- A TIME POINT THATFOLLOW-UP IS -- NEEDS TO BEDETERMINED.HOW LONG DOES IT NEED TO GO OUT.HOW MUCH DATA NEEDS TO BECOLLECTED DURING THIS SPACE.THE FUNDING IS FAR LESS AT THISTIME POINT.THINK ABOUT DATA QUERIES, ANDPREPARATION FOR THE FINALANALYSIS, ONCE THIS ISCOMPLETED, THE DATA IS FROZEN.AND YOU CAN'T ENTER -- SITESCAN'T ENTER MORE INFORMATIONINTO THE DATA SYSTEM.SO THEY WANT TO GET THATINFORMATION IN BEFORE THAT TIMEPOINT.AND THEN THE STUDY CLOSEOUT ISAN INTENSE REVIEW THAT AGAIN ISDONE BY SPONSOR IN WHICH THEYREVIEW THE REGULATORY DOCUMENTS,THEY LOOK OUTSTANDING CRFS ANDQUERIES, THEY LOOK AT THE DRUGINVENTORY.THEY VERIFY ALL CRFS HAVE BEENREPORTED TO THE -- AND ANY DRUGIS RETURNED AND ARRANGEMENTSWITH RECORD STORAGE AREDISCUSSED AND DETERMINED.SO BASICALLY, THERE ARE SOME KEYPIECES TO KEEP IN MIND AS FAR ASGUIDING PRINCIPLES OF DATAMANAGEMENT.AGAIN, DESIGNING CRFS INACCORDANCE WITH THE PROTOCOL ANDDOING THEM IN A METHOD THATMAKES SENSE AND USER FRIENDLYARE KEY.STANDARDIZED DATA ENTRYPROCEDURES AND PROCESSES.STAY ORGANIZED.BEING A COMPULSIVE I THINK IS AKEY ATTRIBUTE FOR PEOPLEINVOLVED IN RESEARCH.THEY TEND TO BE THE ONES THATWANT TO PAY IT REALLY -- STRONGATTENTION TO DETAIL.DON'T GET BEHIND, IT'S SODIFFICULT TO GET CAUGHT UP.EASIER SAID THAN DONE.AND THOROUGH AND COMPLETEDOCUMENTATION IS KEY.I'LL PROVIDE SOME RESOURCEWEBSITES YOU CAN USE AS WELL ASSOME ADDITIONAL REFERENCES FORSOME OF THE INFORMATION PROVIDEDWITHIN THE SLIDES, YOU CAN GO TOTHESE AND REVIEW IT IN MOREDETAIL IF YOU LIKE.SO WITH THAT, I'D BE HAPPY TOTAKE ANY QUESTIONS ANYONE MIGHTHAVE.OKAY.I'M NOT SEEINGIFY QUESTIONSWHICH IS JUST FINE.WE'RE RIGHT AT THE END OF THETIME PERIOD.THANK YOU TORYOUR ATTENTION ANDI THINK IF YOU COME UP WITHQUESTIONS LATER, THERE IS THEOPPORTUNITY TO SEND THEM TO ME.I'LL SEE WHAT I CAN DO TOHAPPILY ANSWER THOSE AS WELL ASAS I CAN OR FIND THE ANSWERS FORYOU.THANK YOU.