Historical resource — published January 12, 2018. This checklist is not comprehensive. Required study records depend on the study, applicable regulations, and sponsor and IRB requirements. Confirm current requirements before using it.
Creating Your Regulatory Binder
- Monitoring Log – Monitors should sign & date this log during each visit.
- Delegation Log – Personnel involved in the study identifying their responsibilities
- Curriculum Vitaes – Curriculum Vitae signed/dated within the past two years and Medical Licensures.
- Screening Enrollment Log – List of subjects screened, screen failures, withdrew
- Informed Consent – All IRB approved Informed Consents
- Protocol – All IRB protocols and amendments (All IRB approved versions)
- Registration of Trial – Trials must be registered at www.clinicaltrials.gov
- Investigator’s Brochure – For Investigational drug studies, this section should include the Investigator’s brochure(s)
- Advertisements – Any advertisement announcing the clinical study, must have IRB approval
- IRB Correspondence – IRB application/submission, approval letters correspondence, progress reports, continuing review.
- Sponsor Correspondence – All communication with sponsor via e-mail, telephone logs.
- Laboratory Certification/ Reference Ranges – Laboratory Certificate & Lab Director’s CV
- IRB Federal Wide Assurance Letter – The IRB assurance letter
- Study Termination – If study is not to continue due to Principal Investigator unable to complete the study, a report needs to be submitted to the IRB stating study closure.