HRPP policies & procedures manual

303: Documentation and document management

1. Purpose

The purpose of this policy is to describe the requirements for document management, retention, and archiving.

2. Policy

The IRB files must be maintained in a manner that contains a complete history of all IRB actions related to review and approval of a protocol, including continuing reviews, amendments, and adverse event reports. All IRB records are retained as electronics copies; no paper files are kept.  All records regarding a submitted study (regardless of whether it is approved) must be retained in an appropriate manner as required by regulatory requirements and/or institutional policy, and be available for Freedom of Information Act requests.

Records must be accessible for inspection and copying by authorized representatives of the sponsor, funding departments, or agency, regulatory agencies, and institutional auditors at reasonable times and in a reasonable manner.

Required documents must be submitted to the appropriate funding entity as required.

3. Specific policies

3.1 Document retention

The Office of Research Assurances (ORA) must retain all electronic records regarding an application (regardless of whether it is approved) for at least 3 years.

For all applications that are approved and the research initiated, including studies that did not enroll any subjects, the ORA must retain all records regarding that research for at least 3 years after completion or cancellation of the research.

Applications that do not meet the definition of “research” and “human subject” as defined in DHHS regulations and do not meet the definition of “clinical investigation” in FDA regulations will maintained for 3 years.

Adequate documentation of the IRB activities will be prepared, maintained and retained in a secure location.  Retained documents include but are not limited to:

General office
  • Agendas and minutes of all IRB meetings
  • Protocols closed out or withdrawn without subject enrollment
Study files
  • Progress reports submitted by investigators
  • Records of continuing review activities
  • Copies of all correspondence between the IRB and investigator
  • Statements of significant new findings provided to subjects as submitted by the investigator
  • Approved consent documents, and reports of adverse events, unexpected adverse events, and unanticipated problems occurring to subjects and reported deviations or violations from the protocol
  • Copies of all submitted monitoring reports and site visit reports
  • Reports of any complaints received from subjects
  • For each protocol’s initial and continuing review, the frequency of the next review
  • Protocol violations submitted to the IRB
  • Unexpected adverse events submitted to the IRB
For initial and continuing review of research by the expedited procedure
  • Specific permissible category on Addendum 1
  • Reviewer’s comment sheet
For exempt studies
  • Specific exemption category
Determinations and protocol–specific findings supporting the determinations for the following
  • Waiver of alteration of the consent process
  • Waiver of documentation of consent
  • Research involving pregnant women, fetuses, and neonates
  • Research involving prisoners
  • Research involving children

3.2 IRB documents (accessibility, inspection and copying)

IRB records will be accessible for inspection and copying by authorized representatives of the OHRP, FDA and other authorized entities at reasonable times and in a reasonable manner.

3.3 IRB administration documents

The ORA must maintain and retain for at least three (3) years:

  • All records regarding IRB administrative activities that affect review activities: 3 years
  • All records regarding protocols that are approved and the research initiated: 3 years after completion of the research or termination of IRB approval

3.4 Destruction of copies

All materials received by the IRB, which are considered confidential and in excess of the required original documentation will be collected at the end of the meeting and destroyed.

3.5 Archiving and destruction

All documents and materials relevant to IRB determinations will be archived by the ORA.  After 3 years the documents and materials may be destroyed.

Current and obsolete membership rosters will remain in the ORA and then be archived according to University policy.

Records of member appointments, resignations and evaluations will be kept at least 7 years.

4. Applicable regulations and guidelines

45 CFR 46.103, 46.115

21 CFR 56.115

5. Forms


6. Procedures employed to implement this policy & assignment of responsibility

IRB coordinatorEnsure study information is entered in the database. Organize the submitted material.
ORA director, IRB coordinator Retain all records regarding a submitted study as required by regulatory requirements and/or institutional policy.