FDA Expects Documents That Are Attributable, Legible, Contemporaneous, Organized, and Accurate

Stanford University
HRPP / Sponsor-Investigator Research (SIR)
Self-Assessment Checklist for Researchers [IND]
FDA Regulations 21 CFR 312 Investigational Drugs & Biologic Agents / AID-40m
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Protocol reviewed: / Review completed by:
Protocol #:
Title: / Name:
Date:

FDA expects documents that are attributable, legible, contemporaneous, organized, and accurate.

FDA expects you to obtain valid informed consent, maintain adequate case report forms (CRFs), and follow your IRB approved protocol. Review FDA GCP sections 8.2 and 8.3 before and during the study.

Suggestion: Organize documents in reverse chronologic order, with current documents on top.

Questions? Contact IRB Education or call 650-724-7141.

Required Documents inRegulatory Binder(and/or organized in electronic media) / Yes / No / N/A / IND SIR Training Checklist/Comments
1 / FDA IND Protocol Application
2 / Copy of each 1571form sent to FDA with IND Annual Reports / FDA Annual Report due:
2a / Has each FDA Annual Report (including the most recent) been submitted to the IRB? / If multi-site protocol, sponsor sends annual reports to each site.
3 / Copy of each 1571form sent to FDA with all IND correspondence, as indicated in 1571 Section 11 / File correspondence FROM the FDA with responses sent TO the FDA.
4 / IND acknowledgement letter, including clinical hold, and/or FDA safe to proceed correspondence
5 / Investigator Brochure (IB) and updated versions
6 / Clinicaltrials.gov certification - FDA Form 3674
7 / FDA Form 1572 (including subsequent changes)
8 / Financial disclosure form for each investigator / Use FDA form 3454, for investigators with NO financial interests or conflicts.
9 / Biographic sketch or CV for each investigator
10 / Current licenses for licensed investigators / Copy of wallet card, valid for all years IND is held
11 / Delegation of investigators’ responsibility log –signed and initialed by each investigator, with their study participation start/stop dates, etc.
12 / Initial and ongoing investigator training records
13 / Protocol deviation and adverse event records
14 / Safety reports (e.g., MedWatch 3500A)
15 / IRB approved consent forms and each revision
16 / All IRB approval letters
17 / All approved IRB protocol events, e.g., eProtocol (eP) modifications, renewals, reports, etc. / Print pdf with approval and expiration dates using eP Print View feature after each IRB approval.
18 / All IRB approved documents, e.g., recruitment ads, assents, phone scripts, questionnaires, etc.
19 / IRB Rosters and annual updated rosters
20 / Chronologic screening and/or enrollment log
21 / Drug acquisition, dispensing, and disposition records, e.g., detailed logs by lot #, expiration date, participants, returned drugs, etc.
22 / DSMB correspondence and reports, if applicable
23 / Laboratory certifications and normal values for tests included in the protocol
24 / Other correspondence relevant to the study

AID01040 rev1 02/14 Research Compliance Office CONFIDENTIAL Stanford University – For Internal Use Only