Sample IND/IDE Responsibility Checklist

DF/HCC Version: February 1, 2011Sample IND/IDE Responsibility ChecklistThe following checklist is created based on the Sponsor and Investigator responsibilities outlinedin the FDA Code of Federal Regulations 21 CFR 312 (drugs/biologics) and 812 (devices). Thepurpose of this checklist is to clarify which documents can provide evidence that the physicianIND/IDE holder (i.e. Sponsor – Investigator) has fulfilled his/her responsibility.The checklist is divided into the following sections:1. Sponsor responsibilities2. Investigator responsibilities3. Drug/Device responsibilities4. Record Retention5. FDA InspectionDocuments (listed in the right column) correspond to the regulations written in 21 CFR 312 and812. Depending on the specific study, additional documents may be needed.Consider using this checklist during the study start up phase and/or as an internal review toolprior to an inspection.The following table is provided for internal tracking:Principal Investigator:DFCI IRB Protocol #:IND/IDE #:IND/IDE holder:Date:

1.2 Select qualified investigators and monitors(312.53, 312.57(b), 812.43, 812.140(b)(3))• Select PIs qualified by training and experience• Ship investigational product only to thoseinvestigators participating in the trial• Accurate records of financial disclosureaccording to 21 CFR 54• Select monitors qualified by training andexperience(bullets 1 & 2 apply to multicenter trials)Signed FDA form 1572 /InvestigatorAgreement (IA)Investigator CV and licensureIRB approvalFDA form 3455 for PI and sub – investigatorslisted on 1572 or IA• For multicenter studies, Investigatorinformation is required for each site• FDA form 1572 & PI CV is provided to FDAMonitor of study:PIOther: _____________________________CV and training experience of monitorEnsure monitor is trained on protocol1.3 Ensure ongoing monitoring investigations(312.56, 812.46)• Ensure proper monitoring• Ensure PI compliance or discontinue shipmentsof the investigational drug/device• Review and evaluate drug/device safety andeffectiveness• Discontinue investigation within 5 working dayswhen unreasonable and significant risk to subjectare identified• Ensure IRB & FDA approval to resume aterminated study1.4 Informing Investigators (312.55, 812.45)• Provide all clinical investigators with Investor’sBrochure (IB) or Device Manual (DA)• Inform investigators of new observationsdiscovered by or reported to the sponsor on theinvestigational productDocumentation of safety monitoring planWho will be reviewing safety data:PI DSMB/DSMCMedical Monitor Other ____________Reports/meeting minutes from DSMB and/orMedical monitorDocumentation of data monitoring planResearch team has been trained on datacollection sheets and/or CRFsCorrespondence with monitorDocumentation of monitoring (monitoring log)Notify all investigators, IRB, and FDA ifinvestigation is discontinuedIRB approval prior to resuming a terminatedstudyCurrent Investigator’s Brochure/DeviceManualFor Multi-center studyDocumentation that all sites have receivedIB/DADocumentation of communication withinvestigators regarding new observations andadverse events.DF/HCC Version: February 1, 20113

2.0 INVESTIGATOR RESPONSIBILITIES (312.60, 812.100)2.1 Assure IRB review and approval (312.66,812.110, 812.150(a))IRB documentation:Initial reviewContinuing reviewAmendmentsAdverse event reportsUnanticipated eventsProtocol deviations/violationsCurrent IB/Device ManualOther IRB correspondence2.2 Maintain adequate and accurate casehistories on each subject’s participation in thetrial (312.62 (b), 812.140(a)(3))*DF/HCC policy requires all IRB correspondence(hard copy or electronic) on file at lead study site.Informed consent for all subjectsDocumentation that informed consent wasobtained prior to study proceduresDocumentation that subject was given a copyof signed and dated consent formSubject eligibility documentedSource dataProgress notesCRFsConcomitant medications recordedSignature/date of staff obtaining data2.3 Conduct study according to signedinvestigator statement, protocol, and applicableregulations (312.60, 812.100)2.4 Personally conduct and supervise theinvestigation (312.60, 812.100)Ensure:• Appropriate delegation• Adequate training• Adequate supervision2.5 Protect the rights, safety, and welfare ofstudy subjects (312.60, 812.100)Report violations/deviations to IRBPromptly report to IRB any “on-site” adverseevents/unanticipated adverse device effects inaccordance with institutional requirementsObtain informed consent in accordance withprovisions in 21 CFR 50Delegation logStaff training logRoutine research team meeting to review trialprogress, AEs, protocol changesMeeting minutesRoutine meetings with study monitorProcedures for internal review of dataProvide reasonable medical care for AEsInform subject when medical care is needed forconditions unrelated to researchInvestigator is available to subjects duringconduct of studyAppropriate delegation to Co – Investigator ifPI is not availableDF/HCC Version: February 1, 20114

2.6 The Investigator is responsible forproviding Sponsor with reports (312.64,812.150(a))• Progress reports• Safety reports• Deviations from investigational plan• Final Reports• Financial disclosure reports3.0 DRUG/DEVICE ACCOUNTABILITY3.1 The Sponsor is responsible for record ofdrug/device disposition (312.57, 312.59,812.43(b), 812.140(b)(2))• Maintain adequate record of receipt andshipment of investigational drug/device• Assure return of all unused investigationaldrug/device from individual investigatorsparticipating in trial or authorize alternativedisposition of unused product• Maintain written records of any disposition ofthe drug/device3.2 The Investigator is required to maintainadequate records of the disposition of thedrug/device (312.62, 812.140(a)(2))The Investigator has provided sponsor withpertinent correspondence (enrollment numbers,adverse events, financial information and anychanges in financial information)N/A, single center studyDrug/device ReceiptDrug/device received from IndustryDrug/device accountability log includes:Receipt dateQuantityLot #Return/dispositionMethod of disposalDrug/device manufactured onsiteDrug/device ShipmentSingle center study – no drug/device shipmentDrug/device shipped to multiple sitesDrug/device accountability log includes:DateDestinationWho shippedQuantityLot #Return/dispositionMethod of disposalDrug/device dispensing record including:Research Pharmacy will manage drugDateLot #/ device #QuantityID of subject administered/implantedDisposition/record of returnID of person dispensingReturn of drug/device, count & reasonDF/HCC Version: February 1, 20115

3.3 The Investigator is responsible to ensurecontrol of investigational drug/device (312.61,812.110(c))• Drug/device will be administered only to thosesubjects enrolled in the clinical study and underinvestigator or designee’s supervisionEnrollment log/ Randomization logDelegation of Responsibility log4.0 RECORD RETENTION (312.57(C), 312.62(C), 812.140(D))4.1 Sponsor and Investigator: Retain records for Records are on file2 years after marketing or 2 years afterinvestigational use is discontinued and FDA isnotified5.0 FDA INSPECTION (312.58, 312.68, 812.145)5.1 Sponsor and Investigator: Inspection ofInvestigators records and reportsUpon request, permit FDA officer to access, copyand verify any records or reports made by theinvestigatorDF/HCC Version: February 1, 20116