4.2. Investigator Regulatory Binder: Files, usually a binder, maintained by the investigator at the investigative site.

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1 POLICY #: RCO-203 Page: 1 of 7 1. POLICY STATEMENT: Essential regulatory documents will be on maintained for research sponsored by or conducted at Dana-Farber/Harvard Cancer Center (DF/HCC) to assure compliance with regulatory requirements. 2. BACKGROUND: Essential Documents are those documents that individually and collectively permit evaluation of the conduct of the research and the quality of data produced. These documents serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements. These documents should be maintained as required by the applicable regulatory requirement(s). Sponsors and institutions should take measures to prevent accidental or premature destruction of these documents. Upon request of the monitor, auditor, Institutional Review Board (IRB), or regulatory authority, the Sponsor or institution should make available for direct access all requested researchspecific documents. 3. RESPONSIBLE PERSONNEL: 3.1. Investigator acting as a Sponsor 3.2. Overall Principal Investigator (PI) 3.3. Site Responsible Investigator 3.4. Subinvestigator 3.5. Research Nurse 3.6. Study Coordinator 4. DEFINITIONS: 4.1. DF/PCC: Dana-Farber/Partners Cancer Care 4.2. Investigator Regulatory Binder: Files, usually a binder, maintained by the investigator at the investigative site Lead Site: The site at the same physical location as the DF/HCC Overall Principal Investigator Master Regulatory Binder: The files maintained by the Lead Site.

2 POLICY #: RCO-203 Page: 2 of Network Affiliate: Select New England area community hospitals that have a contractual agreement with DF/PCC and access to selected Phase II and Phase III trials Non-Lead Site: The site at the same physical location of the DF/HCC Site Responsible Investigator. This does not include Satellite or Network Affiliate sites Satellite Site: A site licensed and accredited under one of the DF/HCC institutions that functions under the wider umbrella of the parent institution Sponsor Regulatory File: The essential document files maintained by the Sponsor that are established at the beginning of the trial, as appropriate. A final closeout of a trial can only be performed when a monitor has reviewed the investigator files and assured that the sponsor files have all required documents collected and confirmed. 5. POLICY: 5.1. The contents of the regulatory files, whether maintained at the sponsor location or at the investigative site(s), need not be stored together in one location. Documents that are stored centrally or electronically must be referenced in a Note to File stating where the document(s) are kept The regulatory documents outlined in the below procedures will be collected and filed for all pending and active research (i.e., protocols which have not been completed). For research activated prior to September 17, 2012, these documents will not be retrospectively collected but collected moving forward. National Cancer Institute (NCI) National Clinical Trials Network (NCTN) trials are required to follow Clinical Trials Monitoring Branch (CTMB) requirements, which may differ from the document requirements outlined below Sponsor Regulatory File The Sponsor Regulatory File consists of items listed below that are applicable to a given project. These documents are subject to regulatory review Certificate of Analysis for all batches of investigational product(s) manufactured and shipped (where applicable)

3 POLICY #: RCO-203 Page: 3 of Clinical Trial Agreements - signed Correspondence all Curricula vitae (CV) - all persons listed on Form FDA 1572 or Enrollment Logs all FDA Documentation (where applicable) Form FDA 1572 cumulative for all sites Financial Disclosure all persons listed on Form FDA 1572 or {Note: these documents are required only if the PI holds the IND or IDE} Informed Consent Template Investigator Meeting materials Investigational Brochure/Device Manual all versions (where applicable) IRB Review Documents all approved IRB submissions and notifications Laboratory Documentation (central and local where applicable) Medical Licenses - all persons listed on Form FDA 1572 or Monitoring guidelines, reports, and master list of monitors Protocol all versions sent to participating sites Publications (where applicable) SAE/Unanticipated Problems cumulative Sample of label(s) attached to investigational product container(s) (where applicable)

4 POLICY #: RCO-203 Page: 4 of Screening Log (if screening subjects to determine initial eligibility) Site Initiation Visit Records (where applicable) Transfer of Obligations (if using a Clinical Research Organization) 5.4. Investigator Regulatory File (maintained at investigator site) There is only one master regulatory binder for each protocol conducted at DF/HCC. The Lead Site is responsible for maintaining the essential regulatory documents for the protocol. The following items are present in a master regulatory binder depending on the specific protocol. These documents are subject to regulatory review Confidentiality Agreement (where applicable) Consent and/or Assent Forms all IRB approved versions Correspondence significant communications with the Sponsor or other DF/HCC sites (where applicable) Curricula vitae (CV) - all persons listed on Form FDA 1572 or Data and Safety Monitoring copies of reports or summaries (where applicable) Delegation of Authority Log - cumulative for all sites Deviation/Violation Log cumulative for all sites Drug & Device Accountability Records (where applicable) Enrollment Log all sites (if enrolling and consenting subjects; collect from all DF/HCC and DF/PCC sites at study close out) Financial Disclosure - all persons listed on Form FDA 1572 or and others as required by institutional policy Form FDA 1572 (where applicable)

5 POLICY #: RCO-203 Page: 5 of IND Safety Reports (where applicable) Investigational Brochure/Device Manual (where applicable) IRB Review Documents- all approved IRB submissions and notifications Laboratory Documentation (if performing lab procedures/tests) For DF/HCC and DF/PCC facilities: certifications, Lab Director s CV and normal lab/reference values For non-df/hcc or DF/PCC facilities: certifications and normal lab/reference values Medical Licenses - all persons listed on Form FDA 1572 or Monitoring Records logs and reports (where applicable) OBA Communication and Reporting (where applicable) Protocol - all versions Protocol Training records cumulative for all sites SAE/Unanticipated Problem report forms (where applicable) Scientific Review Documentation (where applicable) Screening Log (if screening subjects to determine initial eligibility) Site Initiation Visit Records (where applicable) Tissue Log (if collecting, sharing and/or transferring tissue samples and required by the Sponsor) Financial information (e.g. budget, contracts, billing records, funding notifications, grant applications, etc.) and Audit information are not subject to regulatory review and must be kept in a separate file.

6 POLICY #: RCO-203 Page: 6 of Each Non-Lead Site, Satellite Site, and DF/PCC Network Affiliate participating in the research maintains a subset of the essential regulatory documents necessary to demonstrate compliance with regulatory requirements. The following items are present in the other investigative site files depending on the specific protocol. These documents are subject to regulatory review Consent and/or Assent Forms all IRB approved versions Delegation of Authority Log for that site Enrollment Log for that site IRB Activation memo (where applicable) IRB Approval memo IRB documentation generated by that site (i.e. SAE reports, deviations, violations, etc.) Monitoring Log for that site Pertinent correspondence received or generated by that site Protocol all versions Protocol Training for that site Only copies of IND Safety reports that have met DFCI IRB reporting requirements will be filed at non-lead sites Screening Log for that site All versions of the Investigational Drug Brochure/Device manual (as applicable) must be filed at non-lead site During the course of the research, the essential regulatory documents will be kept at each investigative site in a secure location, accessible only to research team members, where the sponsor s confidential information will not be compromised.

7 POLICY #: RCO-203 Page: 7 of The regulatory essential documents will be updated and maintained on a continuous basis during the course of the research In general, the essential regulatory documents will be kept at each investigative site until the close out visit at which time the essential regulatory documents will be compacted and organized into easily searchable files and placed in boxes for ease of long-term storage The documents will be sent off-site to long term storage as soon as conveniently possible following the close out visit and completion with the IRB. If there is no close out visit, the essential regulatory documents will be sent off-site to long term storage as soon as conveniently possible after the research is terminated with the IRB. 6. APPLICABLE REGULATIONS & GUIDELINES: 21 CFR 50 Protection of Human Research Subjects 21 CFR 54 Financial Disclosure by Clinical Investigators 21 CFR 56 Institutional Review Boards 21 CFR Investigational New Drugs Drugs for Human Use 21 CFR 812 Investigational Device Exemption 45 CFR 46 Protection of Human Subjects FDA Industry Guidelines and Information Sheets FDA Compliance Policy Guidance Programs: , , and RELATED REFERENCES: International Conference on Harmonisation E6 DF/HCC Site Management Plan 8. RELATED RESOURCES: DF/HCC Master Regulatory File Checklist for Lead Site DF/HCC Regulatory File Checklist for Network Affiliates DF/HCC Regulatory File Checklist for Non-Lead and Satellite Sites DF/HCC Sponsor Regulatory File Checklist DF/HCC Guidance on Maintaining Regulatory Documents

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