IRB Submissions, Approval and Continuing Oversight

1. Purpose

This SOP describes how [SITE NAME] obtains IRB approval before a study starts, keeps approval current without a lapse, submits changes and reports, uses only IRB-approved materials, and closes the study with the IRB. FDA regulations prohibit starting a clinical investigation subject to 21 CFR 56 until an IRB has approved it and the study remains subject to continuing review. ICH E6(R3) expects documented, dated IRB approval of the protocol, consent materials, recruitment procedures and other participant information before the trial begins.

2. Scope

This SOP applies to all human-subjects research conducted at or by [SITE NAME], at all locations, from the first IRB submission through study closure. It covers central (commercial) IRBs, which are the default for the site, and local or institutional IRBs and reliance arrangements where a sponsor, funder or affiliated institution requires them.

Reportable events (unanticipated problems, protocol deviations requiring IRB reporting, new safety information) are reported to the IRB under SOP-502 and SOP-308; this SOP covers only how the submission is made and recorded. Consent form content and process are in SOP-301; recruitment materials are in SOP-300. Where a sponsor, CRO or IRB requirement is stricter than this SOP, the site follows the stricter requirement. Each IRB's written policies (investigator manual, reporting policy) are part of the requirements the site follows.

3. Responsibilities

4. Definitions

5. Procedure

5.1 Identify the IRB of record

• the study is federally funded cooperative research under the Common Rule, which requires a single IRB (45 CFR 46.114); the site may need a Federalwide Assurance (FWA) and must sign the reliance agreement the single IRB requires
• the investigator or a location is part of a hospital or health system that requires its own IRB review or acknowledgment before its patients, facilities or staff are used
• a state law or sponsor requires local review

5.2 Initial submission

• IRB investigator or site application form
• PI CV and medical license; Sub-I information if the IRB requires it
• Form FDA 1572 or investigator agreement, if the IRB requests it
• site-specific consent form and HIPAA authorization (combined or separate) with site contact details and costs and injury language consistent with the CTA (SOP-201) and coverage analysis (SOP-202)
• site recruitment materials and scripts (SOP-300)
• participant-facing materials, translations and translation certificates
• training documentation (human subjects protection, GCP) if requested
• conflict of interest disclosures (SOP-104)
• any local context information (state law on LAR, minors, age of majority from Appendix A)

5.3 IRB response and approval

• correct protocol number, version and date
• correct PI and site address(es); every location where study procedures will occur is listed
• approved consent form version(s) and languages, with IRB approval stamp or approval footer
• approved recruitment materials
• approval date and, where applicable, expiration date or next continuing review or check-in date
• any conditions or restrictions

5.4 Using IRB-approved materials only

5.5 Amendments and other changes

5.6 Continuing review, check-ins and avoiding a lapse

• FDA-regulated studies (21 CFR 56): continuing review at intervals appropriate to the degree of risk, not less than once per year. This applies even when the study is closed to enrollment or only in follow-up, until the study is closed with the IRB.
• Studies subject only to the 2018 Common Rule: continuing review is not required for minimal-risk research approved by expedited review, or for research that has progressed to data analysis or to accessing follow-up clinical data from procedures that are part of clinical care, unless the IRB decides otherwise and documents why (45 CFR 46.109(f)). The IRB may require a periodic check-in instead.
• Studies subject to both: the stricter FDA requirement applies.

• the Regulatory Coordinator tells the PI, Lead CRC, Site Director and sponsor the same day
• enrollment and all research activities stop, including screening and consent of new participants
• research interventions for enrolled participants continue only if the IRB determines it is in their best interests (for example to avoid harm from stopping treatment), and only as the IRB allows; the PI contacts the IRB immediately to request this determination
• the Regulatory Coordinator submits for renewal at once
• the Quality Lead records the lapse as a deviation (SOP-308) and opens a CAPA (SOP-703)
• activities resume only after renewed approval is received and filed

5.7 Reporting to the IRB during the study

• unanticipated problems involving risks to participants or others (SOP-502)
• deviations made to eliminate an immediate hazard, and other deviations the IRB requires to be reported (SOP-308)
• changes significantly affecting the conduct of the trial or increasing risk
• new information that may adversely affect participant safety or the conduct of the trial
• suspension or termination by the sponsor, or by the PI without sponsor agreement, with an explanation
• for device studies, IRB-required reports under 21 CFR 812.150(a)

5.8 Communications and correspondence

5.9 Study closure with the IRB

5.10 Records

6. Related Forms and SOPs

• F-205-01 Study Activation Checklist
• F-300-01 Pre-Screening Log
• F-301-02 Consent Form Version Control Log
• F-306-01 Note to File
• F-601-01 Study Closeout Checklist
• Appendix A State Law Worksheet
• Appendix B Central and Site Responsibility Matrix (Model N only)
• SOP-103 Staff Qualification, Training and Training Records
• SOP-104 Conflict of Interest and Financial Disclosure
• SOP-201 Confidentiality Agreements, Clinical Trial Agreements and Budgets
• SOP-202 Medicare Coverage Analysis and Research Billing Compliance
• SOP-204 Essential Documents and the Investigator Site File
• SOP-205 Site Qualification, Initiation and Study Activation
• SOP-300 Participant Recruitment, Pre-Screening and Advertising
• SOP-301 Informed Consent Process and Documentation
• SOP-308 Protocol Deviations and Noncompliance
• SOP-401 Computerized Systems and Electronic Records
• SOP-402 Record Retention, Archiving and Destruction
• SOP-502 Unanticipated Problems and Reportable New Information
• SOP-601 Study Closeout
• SOP-700 Internal Quality Control and Quality Assurance Audits
• SOP-703 Corrective and Preventive Action (CAPA)
• SOP-903 Network Oversight of Member Sites (Metrics, Central QA, Escalation) (Model N only)

7. References