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Regulatory Procedures and IRB Approval SOP Considerations

It is important to customize this SOP as per local regulations and add a process around translations if necessary.

  • The Principal Investigator or his/her designee will submit all proposed research for review to the site´s Institutional Review Board (IRB).
  • The Principal Investigator or his/her designee will obtain written approval before any potential subject is approached and asked to participate in the research: For US site´s there may be exceptions, such as provided in 21 CFR 56.104 (Exemptions from IRB requirement) and 56.105 (waiver of IRB requirement).
  • The Principal Investigator or his/her designee is responsible for submitting all documents to the reviewing IRB in a timely manner.  Documents requiring IRB review include:
    • Protocol and any amendments
    • Investigator’s brochure and any amendments
    • Consent form(s) and any revisions
    • Advertisements to be used for subject recruitment
    • Other materials that will be provided to subjects (such as diaries and questionnaires)
    • Safety reports, Data Safety Monitoring Board (DSMB) reports and other related information
    • Any site serious adverse events per IRB requirements
    • Report of any protocol deviations/violations per IRB requirements
    • Any other documents as required by the IRB.
  • The Principal Investigator will not implement any deviations or changes to the protocol without agreement by the sponsor and prior review and documented approval from the IRB, except where necessary to eliminate immediate hazard(s) to subjects, or when the change(s) involve only logistical or very minor administrative aspects of the research (such as, change in monitor(s), change in telephone(s)) [ICH GCP 4.5.2].
  • Continuing (usually annual unless IRB requires it to be more frequent) review reports will be submitted as required by the IRB. The annual review should be submitted on time to assure no lapse in approval. 
  • The Principal Investigator or his/her designee will submit IRB specific reports according to IRB requirements.
  • The Principal Investigator or his/her designee will maintain records of all submissions, correspondence and all actions by the IRB regarding the research in the study file.   
  • If directed by the IRB, the consent forms will be revised in the event of new safety information that may impact subject’s willingness to participate in the research. Only current, IRB-approved versions of consent forms will be utilized for obtaining informed consent. NOTE: If there is a sponsoring company involved, they will be informed of the IRB required revision and given a chance to review the consent before final approval.
  • The Principal Investigator or his/her designee will submit all protocol amendments (and related consent form revisions) to the IRB for approval prior to implementation, except whereas to eliminate immediate hazards to subjects. NOTE: All revisions will be submitted to the IRB as soon as possible after immediate danger to subjects has been resolved.  
  • At the end of the research, the Principal Investigator will complete and submit a final report to the IRB.