Regulatory authority(ies) To document compliance When related approvals are obtained from FDA or another authorizations/ with applicable regulatory regulatory agency for the trial, IND, or IDE: approvals/notifications requirements Provide a copy to the IRB Staff to be uploaded with your where required for: protocol file in the IRB Electronic System, and - Protocol amendment(s) Maintain a copy in hard or electronic format, or access at and other documents any time on the IRB Electronic Submission System. Curriculum vitae for new To document qualifications Maintain a copy of each protocol personnel’s cv investigator(s) and/or and eligibility to conduct OR subinvestigators trial and/or provide Ensure that each person maintains their cv as up-to-date on the medical supervision of UTA Profiles System, and maintain links to each electronic cv subjects Updates to normal To document normal Maintain any updated/changed values with a copy of the value(s)/range(s) for values and ranges that protocol or elsewhere. medical laboratory/ are revised during the technical trial procedure(s)/test(s) included in the protocol Updates of medical/ To document that tests Maintain copies of validation/quality control/certification laboratory/ technical remain adequate records for related tests, laboratory facilities, instrumentation, procedures/tests throughout the trial etc. Certification or period Accreditation or Established quality control and/or external quality assessment or Other validation (where required) Maintain log in hard-copy or electronic format. Documentation of To document shipment investigational product(s) Sample SOPs: dates, batch numbers, and trial-related materials and method of shipment [1MB ] shipment of investigational [1MB ] product(s) and trial- related materials. Allows [37KB ] tracking of product batch, review of shipping conditions, and accountability Certificate(s) of analysis To document identity, Obtain a certificate of analysis from the manufacturer and/or for new batches of purity, and strength of dispensing pharmacy. investigational products investigational products Guidance – description of certificate of analysis: to be used in the trial FDA Guidance – GMP of phase I investigational products:
Regulatory authority(ies) authorizations/ approvals/notifications where required for: - Protocol amendment(s) and other documents To document compliance with applicable regulatory requirements When related approvals are obtained from FDA or another regulatory agency for the trial, IND, or IDE: Provide a copy to the IRB Staff to be uploaded with your protocol file in the IRB Electronic System, and Maintain a copy in hard or electronic format, or access at any time on the IRB Electronic Submission System. Curriculum vitae for new investigator(s) and/or subinvestigators To document qualifications and eligibility to conduct trial and/or provide medical supervision of subjects Maintain a copy of each protocol personnel’s cv OR Ensure that each person maintains their cv as up-to-date on the UTA Profiles System, and maintain links to each electronic cv Updates to normal value(s)/range(s) for medical laboratory/ technical procedure(s)/test(s) included in the protocol To document normal values and ranges that are revised during the trial Maintain any updated/changed values with a copy of the protocol or elsewhere. Updates of medical/ laboratory/ technical procedures/tests Certification or Accreditation or Established quality control and/or external quality assessment or Other validation (where required) To document that tests remain adequate throughout the trial period Maintain copies of validation/quality control/certification records for related tests, laboratory facilities, instrumentation, etc. Documentation of investigational product(s) and trial-related materials shipment To document shipment dates, batch numbers, and method of shipment of investigational product(s) and trial- related materials. Allows tracking of product batch, review of shipping conditions, and accountability Maintain log in hard-copy or electronic format. Sample SOPs: [1MB ] [1MB ] [37KB ] Certificate(s) of analysis for new batches of investigational products To document identity, purity, and strength of investigational products to be used in the trial Obtain a certificate of analysis from the manufacturer and/or dispensing pharmacy. Guidance – description of certificate of analysis: FDA Guidance – GMP of phase I investigational products:
GCP%20Toolkit%20-%20Essential%20Documents%20and%20the%20Regulatory%20Binder.docx