Trial Maste File Checklist V1.0 Protocol ID:
PI Name:
Study ID Number: File Heading
Gen Correspondence
Protocol
Informed consent
Case Report Forms Investigator's Brochure Study Procedures Manual
FDA Form 1572
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Site Number : Documents Letter, faxes, memos and emails from the sponsor Letter, faxes, memos and emails to the sponsor Forms and procedural documents Newsletters Monitoring Visit Follow-Up Letters Current IRB approved version of protocol All previous IRB approved versions of protocol All IRB approved protocol amendments Protocol Signature Page(S) Current IRB approved informed consent form All prior IRB approved versions of the informed consent form Human subjects bill of rights Parental Permission for Participation of a Minor (if applicable) Final CRF package Current Investigator's Brochure or package insert for all study drugs Study Operations Manual (if any) signed FDA Form 1572 (all versions)
FDQs For Invesitgator/Sub-I(s) CV of principal investigator CVs of subinvestigators Laboratory certification(s) Laboratory Laboratory normal ranges CV of laboratory director Membership roster Approval letter for protocol and all amendments Approval letter for consent form and all amendments IRB/IEC Annual approval letters Advertising material approvals Submission of adverse event reports to IRB/IEC Other IRB/IEC correspondence Serious adverse event reports sent to sponsor Adverse Events Serious adverse event reports received from sponsor Documentation and sponsor approval Protocol Exceptions/Violations of all protocol exceptions and violoations Records of drug reciept Records of drug dispensing(Logs) Records of drug disposition or return Drug storage, preparation and Drug Accountability administration instructions Drug unblinding instructions (if applicable) Documentation of subject unblinding (if applicable) All approved advertising and Advertising/recruitment recruitment materials Recruiting/enrollment logs Interim report(s) Reports Final report
Date
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