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

by TLM

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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.