Transcription of ICH GCP Essential Document Checklist
1 ICH GCP Essential Document Checklist _____ _____ Regulatory contact signature Initial review date Pre-activation requirements, Active study requirements, Study closure requirements, Other required documents. Study Number: _____ Status: Pre-Activation; Active Study; Closing Study Type: Clinical Drug Trial; Non-Drug Subject Research (ICF); Non-Drug Research (No ICF) Usual Regulatory Binder Items: Location of Document (if/when applicable) date: Regulation Section Number Document Not Applicable Regulatory Binder Coordinator Manual Other Location Subject Screening log , & Subject ID code list Subject enrollment Log Signed ICFs & (Signed) Protocol & Amendments Data Safety Monitoring Plan (if applicable) , & IRB approval IRB Membership Roster & & Ongoing approved ICF & subject materials & ^IND (1571, 3674, FDA correspondence) Interim/annual IRB reports Audit certificate (if performed) ^Sponsor only Final close-out monitor & DSMB reports ^Sponsor only IRB/FDA closure report(s) PI to IRB/FDA.
2 SAE reports Pre-Trial Monitor report ^Sponsor only Trial Initiation (SIV) Monitoring Report Monitoring visit reports ^Sponsor only Relevant correspondence Clinical study report (if applicable) & Lab normal reference ranges (& updates) & Lab Certificate, CV, ML (& updates) & Investigator Brochure & Updates Sponsor to Site: safety & DSMB reports & CV, ML, FDF of PI & sub-Is Delegation Log or List signatures/initials for CRF entry/corrections Training (Documentation) Completed FDA form 1572 Place NTF in binder noting other location as necessary. ICH GCP Essential Document Checklist _____ _____ Regulatory contact signature Initial review date Pre-activation requirements, Active study requirements, Study closure requirements, Other required documents. Individual Subject Related Items (maintained by coordinator) Section Numbers Document Not Applicable Regulatory Binder Coordinator Manual Other Location Subject Screening log & Subject ID code list Subject enrollment Log Relevant correspondence Source documents Signed/dated completed CRFs Documentation of CRF corrections CRF signature & Initials sheet Record of sample storage PI to sponsor: SAE reports PI to IRB/FDA: SAE reports Contract items (when applicable) Section Numbers Document Not Applicable Regulatory Binder Coordinator Manual Other Location COI information (if applicable) Financial Agreement *Contracts Insurance Statement *Contracts Signed Agreement/Contract *Contracts *Budget & Contract stored in contracts office.
3 Place NTF in binder with contact information. Pharmacy Specific Items (when applicable) Section Numbers Document Not Applicable Regulatory Binder Coordinator Manual Other Location Master randomization list (if applicable) ^Sponsor only *Pharmacy Sample of IP label ^Sponsor only *Pharmacy IP Manual/instructions *Pharmacy & IP shipping records *Pharmacy & IP certification of purity ^Sponsor only *Pharmacy & Subject allocation/decoding procedures & documents ^Sponsor only *Pharmacy & & IP accountability log, temp logs *Pharmacy IP destruction records *Pharmacy *IP & documents (if applicable) maintained by pharmacists/in pharmacy during the study; place NTF in binder.
