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Do you know what you need in your Regulatory Binder??



Creating Your Regulatory Binder

  1. Monitoring Log Monitors should sign & date this log during each visit.

  2. Delegation Log - Personnel involved in the study identifying their responsibilities

  3. Curriculum Vitaes – Curriculum Vitae signed/dated within the past two years and Medical Licensures.

  4. Screening Enrollment Log List of subjects screened, screen failures, withdrew

  5. Informed Consent – All IRB approved Informed Consents

  6. Protocol - All IRB protocols and amendments (All IRB approved versions)

  7. Registration of Trial - Trials must be registered at www.clinicaltrials.gov

  8. Investigator’s Brochure - For Investigational drug studies, this section should include the Investigator’s brochure(s)

  9. Advertisements – Any advertisement announcing the clinical study, must have IRB approval

  10. IRB Correspondence - IRB application/submission, approval letters correspondence, progress reports, continuing review.

  11. Sponsor Correspondence – All communication with sponsor via e-mail, telephone logs.

  12. Laboratory Certification/ Reference Ranges - Laboratory Certificate & Lab Director’s CV

  13. IRB Federal Wide Assurance Letter – The IRB assurance letter

  14. 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.


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