ELEMENT II.5.A.

ELEMENT II.5.A.: The IRB or EC maintains a complete set of materials relevant to the review of the research protocol or plan for a period of time sufficient to comply with legal and regulatory requirements, sponsor requirements, and organizational policies and procedures.

IRB or EC recordkeeping should follow legal and regulatory requirements, sponsor requirements, and organizational policies and procedures. IRB or EC records for a protocol or research plan should also be organized to allow a reconstruction of a complete history of all IRB or EC actions related to the review and approval of the protocol.

The IRB or EC should have a policy and procedure governing document retention that follows legal and regulatory requirements, sponsor requirements, and organizational policies and procedures. The method for record retention should allow access by authorized personnel and ensure that documents are kept safely and confidentially.

Regulatory and guidance references

DHHS: 45 CFR 115(a)-(b), OHRP Guidance on Written Institutional Review Board (IRB) Procedures
DoD: Instruction 3216.02 15.d
FDA: 21 CFR 56.115(a)(b), FDA Information Sheets: Frequently Asked Questions: IRB Records
ICH-GCP: 3.4, 4.4, 4.9
VA: VHA Directive 1200.05(3) section 16
AAHRPP Tip Sheet: Following the Guideline of the International Conference on Harmonisation – Good Clinical Practice (E6)

Required written materials

Essential requirements:
1. In order to allow a reconstruction of a complete history of IRB actions related to the review and approval of the protocol:
  1. Policies and procedures have IRB or EC records include copies of:
    1. Protocols or research plans.
    2. Investigator brochure, if any.
    3. Scientific evaluations, when provided by an entity other than the IRB or EC.
    4. Recruitment materials.
    5. Consent documents.
    6. Progress reports submitted by researchers.
    7. Reports of injuries to participants.
    8. Records of continuing review activities.
    9. Modifications to previously approved research.
    10. Unanticipated problems involving risks to participants or others.
    11. Documentation of non-compliance.
    12. Significant new findings.
    13. A resume for each IRB member.
    14. All previous membership rosters
    15. Data and safety monitoring reports, if any.
    16. All correspondence between the IRB or EC and researchers.
  2. Policies and procedures have IRB records for initial and continuing review of research by the expedited procedure include:
    1. The justification for using the expedited procedure.
    2. The rationale for conducting continuing review of research that otherwise would not require continuing review.
    3. The rationale for a determination that research appearing on the list of eligible expedited review categories is greater than minimal risk.
    4. Actions taken by the reviewer.
    5. Any findings required by laws, regulations, codes, and guidance to be documented.
  3. Policies and procedures have IRB or EC records document the justification for exempt determinations.
  4. Policies and procedures have IRB or EC records document determinations required by laws, regulations, codes, and guidance.
When following DoD requirements:
1. Records maintained by non-DoD organizations that document compliance or noncompliance with DoD requirements shall be made accessible for inspection and copying by representatives of the DoD.
When following VA requirements:
1. IRB records are the responsibility of the local research office. The local VA facility must designate how the records can be accessed and where the records will be maintained or stored. NOTE: Records of an IRB must be addressed in the MOU for the VA Facility’s use of another entity’s IRB (see section 16.a.(9) and VHA Directive 1058.03). The MOU must ensure that all applicable Federal and VA regulations are met.
2. For VA facilities:
  1. All records must be accessible for inspection and copying (by authorized representatives of VA, ORO, OHRP, FDA, and other authorized entities or Federal department or agencies at reasonable times and in a reasonable manner. Records constituting a Federal record in VA research must be retained in accordance with VHA RCS 10-1.

Outcomes

IRB or EC recordkeeping follows legal and regulatory requirements, sponsor requirements, and organizational policies and procedures.
Records of a research protocol or plan are organized to allow a reconstruction of a complete history of IRB or EC actions related to the review and approval of the research protocol or plan.
Records are retained for the required period of time.
Records are stored in a way that maintains confidentiality.

Proceed To: ELEMENT II.5.B.

Resources: For Accreditation - Evaluation Instrument

Evaluation Instrument for Accreditation

Table of Contents

ELEMENT II.5.A.