1.16 ORA Record Keeping Requirements

1.0 Purpose

The purpose of this policy and procedure is to describe the Organization’s requirements for maintenance of documentation of IRB and ORA activities. Retention of records by the investigator is described in HRPP policy 1.17 (Retention of Research Records).

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2.0 Policy

It is the policy of the Organization that the ORA will maintain documentation of all IRB activities in accordance with 45 CFR 46.115 and 21 CFR 56.115 as applicable. Records for each protocol will be organized to allow a reconstruction of a complete history of all IRB actions related to the review and approval of the protocol.

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3.0 Procedures

• 3.1. Format of Protocol Files:
  ProtocolIn filesaccordance maywith be45 eitherCFR 46.115 and 21 CFR 56.115, the ORA will maintain, in paper or electronic format. The format is dependent upon the year of initial review, the type of review, and the current status of the study.format:
  • 3.1.1. In general, research initially reviewed by the full IRB after January 16, 2012 is in electronic format accessed through RSS, and research initially reviewed by the full IRB prior and closed prior to January 16, 2012 is in paper files. Research initially reviewed by the full IRB prior to January 16, 2012 and either still active, or closed after that date may be partially in paper format and partially in electronic format.
• 3.2. Requirements for maintenance of protocol files: Each protocol file will include:
  • 3.2.1. The submitted IRB application which must contain all information necessary for the Board to make all the determinations required by 45 CFR 46.111 and 21 CFR 56.111.
  • 3.2.2. Detailed protocol (if required)
  • 3.2.3. Investigators Brochure (if required)
  • 3.2.4. Federal grant applications (if required)
  • 3.2.5. ICF/information sheets (if required). HIPAA authorization are included in this document as per HRPP policy 5.1 (Obtaining Informed Consent from Research Subjects).
  • 3.2.6. Documentation of scientific and scholarly merit review and approval of proposals by the Fred & Pamela Buffett Cancer Center Scientific Review Committee (SRC) for cancer-related studies.
  • 3.2.7. Documentation of review and approval of proposals by the Pharmacy and Therapeutics Committee (P&T Committee) (if required).
  • 3.2.8. Documentation of review and approval by the Institutional Biosafety Committee (IBC) (if required).
  • 3.2.9. Copies of Clinicalall Trialresearch Masterproposals Matrixreviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent forms, progress reports submitted by investigators, and Coverage Analysis findings (if required).
  • 3.2.10. Copiesreports of any written reviews from consultants.
  • 3.2.11. Review letters to the PI. Review letters include determinations in accordance with HRPP policy that the research satisfies, as applicable, all requirements of the following:
    • 3.2.11.1. Subparts of 45 CFR 46 (Subparts B, C, and D)
    • 3.2.11.2. 21 CFR 50 (Subpart D)
    • 3.2.11.3. Categories under which research is approved under expedited review
    • 3.2.11.4. Waiver or alteration of informed consent under applicable HHS regulations
    • 3.2.11.5. Waiver or alteration of HIPAA authorization under 45 CFR 164.512
    • 3.2.11.6. Waiver of documentation of consent under applicable HHS and FDA regulations.
    • 3.2.11.7. The category of research approved as exempt in accordance with HHS and FDA regulations.
      Note: The basis upon which the IRB determined that the specific findings required by applicable HHS and FDA regulations were met is found in the specific IRB application that was reviewed.
  • 3.2.12. PI responses to review letters and any other IRB correspondence to PIs.
  • 3.2.13. Documentation of approval of recruitment materials and copies of the approval materials.
  • 3.2.14. Requests for Change and correspondence pertaining to the request, including copies of the modified IRB approved and stamped ICF(s)/information sheets and/or protocols associated with the request.
  • 3.2.15. Copies of any new significant information providedinjuries to subjects.
  • 3.1.2.16. ApplicationsMinutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for Continuingrequiring Reviewchanges in or disapproving research; and correspondencea pertainingwritten to the request, including copiessummary of the ICF(s)/informationdiscussion sheetsof approvedcontroverted inissues conjunctionand withtheir continuing review.resolution.
  • 3.2.17.1.3. Interim progress reports and Data Safety Monitoring Board (DSMB) reports.
  • 3.2.18. ReportsRecords of Internalcontinuing adversereview events and adverse device effects.
  • 3.2.19. Reports of any non-physical injury to a subject.
  • 3.2.20. Reports of unanticipated problems involving risk to the subject or others
  • 3.2.21. Significant new findings provided by the investigator or discovered through other means.
  • 3.2.22. Requests for Single subject protocol deviations and violations.
  • 3.2.23. Reports of Protocol Violations
  • 3.2.24. Reports of Subject complaints
  • 3.2.25. Reports of incidents of noncompliance,activities, including documentation of investigation, correspondence, and reports to institutional officials, OHRP, and FDA where appropriate.
  • 3.2.26. Results from Post Approval Monitoring reviews and correspondence regarding the findings.
  • 3.2.27. IRB Review Checklists documenting:
    • 3.2.27.1. The justification for using the expedited review procedure.
    • 3.2.27.2. The rationale for conducting continuing review of research that otherwise would not require continuing review.review as described in §46.109(f)(1).
    • 3.2.27.1.4. Copies of all correspondence between the IRB and the investigators.
    • 3.1.5. A list of IRB members in the same detail as described in §46.108(a)(2).
    • 3.1.6. Written procedures for the IRB in the same detail as described in §46.108(a)(3) and (4).
    • 3.1.7. Statements of significant new findings provided to subjects, as required by §46.116(c)(5).
    • 3.1.8. The rationale for aan expedited reviewer's determination under §46.110(b)(1)(i) that research appearing on the list of eligible expedited review categorieslist described in §46.110(a) is greatermore than minimal risk.
    • 3.2.27.4.1.9. ActionsDocumentation taken byspecifying the reviewer.
    responsibilities
    • 3.2.27.5.that Anyan documentation for determinationsinstitution and justificationsan requiredorganization byoperating laws,an regulations,IRB codes,each andwill guidance
    undertake
    • 3.2.27.6.to Exemptensure determinations
    compliance
    with the requirements of this policy, as described in §46.103(e).
• 3.3.2. Long-Term Record Storage
  • 3.3.1. Paper copiesRecords of protocol recordsrelated activities submitted electronically through RSS are maintained indefinitely in RSS.
  • 3.3. Records of non-exemptprotocol researchrelated activities submitted on paper are maintained in UNMC storage in either CD-ROM (prior to 2012) or paper formatformat. (after 2012). CD-ROM discs or hard copyFiles will be stored indefinitely for future reference or inspectionmaintained by HHS,the FDAORA oras other sponsor representatives.
  • 3.3.2. All protocol submitted electronically through RSS (after 2012) are maintained indefinitelydescribed in RSSHRPP for1.17 future(Retention referenceof orResearch inspection by HHS, FDA, or other sponsor representatives.
  Records).
• 3.4. UNMCRecords of protocol related activities will be retained by the investigator as described in HRPP 1.17 (Retention of Research Administration Database:
  • 3.4.1. The ORA maintains a password protected database with full access by all members of the ORA. The database includes the characteristics of the research including the classification of the research, the study population, the designated risk level, type of review, funding source, and other information necessary to allow the IRB staff to track and monitor the status of protocols, (for example, IRB approval periods), and perform searches in order to produce reports.
  • 3.4.2. The database is available in “view” mode to selected groups outside of the ORA (for example, Sponsored Programs Administration and the P&T Committee) to assist those groups in their roles in the HRPP.
  Records).
• 3.5. IRB Agendas, Meeting Minutes, and Membership Rosters:
  Copies of all IRB agendas, minutes, IRB member Curriculum Vitae, and IRB membership rosters are maintained electronicallywithin RSS or as electronic or paper documents within the ORA.
• 3.6. IRB Educational Items:
  Copies of all educational items given to the IRB members and ORA Staff are maintained inwithin RSS, or as electronic or paper documents within the ORA, either in paper or electronic format.ORA.
• 3.7. HRPP Policies and Procedures:
  Copies of HRPP policies and procedures as required by 45 CFR 46.115 and 21 CFR 56.115 are maintained on the IRBUNMC website, inaccessible RSSdirectly andor thru a link in hardcopy.RSS.
• 3.8.4.0. Availability of IRB and ORA records:
  All IRB records are accessible for inspection and copying at reasonable times and in a reasonable manner in accordance with 45 CFR 46.115 and 21 CFR 56.115.

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DOCUMENT HISTORY:

 Written: 4/7/2016 (Approved: 4/7/2016) - original author not recorded

 Revised: 2/2/2018 - revision not documented

 Revised: 10/11/2022 - typo corrected in 3.2.27.2/3.2.27.3 - rational to rationale {by Robert Lewis, IRB Assoc}

 Revised: 7/22/2022 - Extensive revisions; removed list of items to be retained, and substituted appropriate regulatory language; specified location of retained records; clarified duration of retention of paper records (per HRPP 1.17). {Bruce Gordon (Assistant Vice Chancellor for Regulatory Affairs, Executive Chair)}