Master Regulatory File Checklist for Lead Site

Master Regulatory File Checklist for Lead Site* denotes items also applicable to minimal risk researchNote: DF/HCC investigators functioning as the sponsor should also refer to the Sponsor Regulatory File Checklist to determine whatadditional essential regulatory documentation must be maintained for that role.Protocol Current IRB approved protocol and all previously approved versions *Confidentiality agreementInformed Consent Current IRB approved informed consent document(s) and all previously approved versions *IRB /SRC Review DocumentsApproval/notification of Scientific ReviewSigned and dated submissions to IRB *Notification of IRB decisions and responses to IRB notifications *Notification of Activation for all DF/HCC and DF/PCC sites *Approved recruitment materials and educational materials/additional information distributedto subjects (e.g. drug diary) *Deviation/Violation TrackingSAEs/Unanticipated ProblemsMaster protocol deviations/exceptions/violations tracking log for all DF/HCC and DF/PCCsites *All serious adverse event (SAE) or unanticipated problem submissions to Sponsor and IRBSponsor and IRB notifications regarding SAEs or unanticipated problemsGeneral Correspondence Copies of significant communications with Sponsor for all DF/HCC and DF/PCC sites *Data & Safety MonitoringProtocol MonitoringCopies of Data and Safety Monitoring Board (DSMB), Data and Safety MonitoringCommittee (DSMC) or Scientific Progress Review Committee (SPRC) reports/summariesMonitoring Log (collect from all DF/HCC and DF/PCC sites at study close out)*Copies of monitoring reports *Form FDA 1572(if research under an IND)CVs(if research under an IND/IDE)Signed and dated Form FDA 1572 submission(s ) to SponsorSigned and dated CVs for all persons listed on Form FDA 1572Version: September 17, 2012

Licensure(if research under an IND/IDE)Financial DisclosureValid medical licenses and/or certifications for all persons listed on Form FDA 1572Current financial disclosure statements for all persons listed on Form FDA 1572 orInvestigator Agreement and others as required by institutional policyDelegation of Authority Master Delegation of Authority Log for all DF/HCC and DF/PCC sites *Protocol TrainingInitial protocol-specific training records (e.g. Site Initiation Visit (SIV) documentation) for allDF/HCC and DF/PCC sites *Ongoing protocol-specific training records for all DF/HCC and DF/PCC sites *Lab Documentation(if performing Lab procedures/tests)Current lab certification (e.g. CLIA, CAP) for all DF/HCC and DF/PCC sites and external labfacilities providing protocol-specific testing *Normal lab/reference values for all DF/HCC and DF/PCC sites and external lab facilitiesproviding protocol-specific testing *Lab Director’s CV for DF/HCC and DF/PCC sites only *Screening / Enrollment Screening Log (collect from all DF/HCC and DF/PCC sites at study close out) *Enrollment Log(collect from all DF/HCC and DF/PCC sites at study close out) *Drug / Device RecordsDrug/Device shipment and receipt records (collect from all DF/HCC and DF/PCC sites at studyclose out)Drug/Device accountability logs (collect from all DF/HCC and DF/PCC sites at study close out)Investigator Brochure/Device ManualIND Safety ReportsMost recent version of Investigator Brochure or Device Manual and all previous versionsAll IND Safety Reports received from SponsorOverall PI’s determination as to whether each IND Safety Report warrants IRB reviewIND Safety Report submissions to IRB and IRB notificationsTissue Samples Tissue Log (if collecting, sharing and/or transferring tissue samples) *Supervisory Plan Signed and dated Supervisory Plan Summary Form and any updates *All correspondence supporting the Overall PI’s supervision and oversight activities *OBA Communication & Reporting(if gene-transfer research under an IND)NIH OBA letter summarizing RAC review/recommendations and final IBC approvalSigned and dated safety, annual progress and final report submissions to NIH OBA and IBCVersion: September 17, 2012