Regulatory authority(ies) authorization/approval/ notification of protocol (where required) To document appropriate authorization/approval/ notification by the regulatory authority(ies) has been obtained prior to initiation of the trial in compliance with the applicable regulatory requirement(s) 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 Maintain a copy in hard or electronic format, or access at any time on the IRB Electronic Submission System. Curriculum vitae and/or other relevant documents evidencing qualifications of investigator(s) and 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 Sample Training Log: Normal value(s)/range(s) for medical/laboratory/ technical procedure(s) and/or test(s) included in the protocol To document normal values and/or ranges of the tests Maintain values with a copy of the protocol or elsewhere. Medical/ laboratory/ technical procedures/ tests Certification or Accreditation or Established quality control and/or external quality assessment or Other validation (where required) To document competence of facility to perform required test(s), and support reliability of results Maintain copies of validation/quality control/certification records for related tests, laboratory facilities, instrumentation, etc. Sample of label(s) attached to investigational product container(s) To document compliance with applicable labeling regulations and appropriateness of instructions provided to the subjects Maintain copy of investigational product label.
Trial initiation monitoring report To document that trial procedures were reviewed with the investigator and investigator’s trial staff (may be combined with pretrial monitoring report) If working with a sponsor, maintain documentation of site and monitoring reports conducted by sponsor. If investigator-initiated, maintain records of personnel training. During the Clinical Conduct of the Trial In addition to having on file the above documents, the following should be added to the files during the trial as evidence that all new relevant information is documented as it becomes available. Guidance: Title of Essential Document Purpose Guidance, Templates, Tools Investigator’s brochure updates To document that investigator is informed in a timely manner of relevant information as it becomes available If investigator’s brochure is available, maintain copies and any subsequent versions/updates. Any revisions to: Protocol/amendment(s) and CRF Informed consent form Any other written information provided to subjects Advertisement for subject recruitment To document revisions of these trial-related documents that take effect during trial Maintain copies (and copies of each amended version) of your IRB protocol, any amendments, and any related IRB protocol documentation. Copies may be maintained in hard or electronic format, or accessed at any time on the IRB Electronic Submission System. Dated, documented approval/favorable opinion of IRB of the following: Protocol amendment(s) Revision(s) of: Informed consent form; Any other written information to be provided to the subject; Advertisement for subject recruitment (if used); Any other documents given approval/favorable opinion; Continuing review of trial To document that the amendment(s) and/or revision(s) have been subject to IRB review and were given approval/favorable opinion. To identify the version number and date of the document(s) Maintain a copy of the IRB approval letter for the original protocol, plus any subsequent modification approvals or continuing review approvals. Copies may be maintained in hard or electronic format, or accessed at any time on the IRB Electronic Submission System.
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: