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.