Regulatory authority(ies) To document appropriate When related approvals are obtained from FDA or another authorization/approval/ authorization/approval/ regulatory agency for the trial, IND, or IDE: notification of protocol notification by the Provide a copy to the IRB Staff to be uploaded with your (where required) regulatory authority(ies) protocol file in the IRB Electronic System has been obtained prior to Maintain a copy in hard or electronic format, or access at initiation of the trial in any time on the IRB Electronic Submission System. compliance with the applicable regulatory requirement(s) Curriculum vitae and/or To document qualifications Maintain a copy of each protocol personnel’s cv other relevant documents and eligibility to conduct OR evidencing qualifications trial and/or provide of investigator(s) and Ensure that each person maintains their cv as up-to-date on the medical supervision of subinvestigators UTA Profiles System, and maintain links to each electronic cv subjects Sample Training Log: Normal value(s)/range(s) To document normal Maintain values with a copy of the protocol or elsewhere. for medical/laboratory/ values and/or ranges of the technical procedure(s) tests and/or test(s) included in the protocol Medical/ laboratory/ To document competence Maintain copies of validation/quality control/certification technical procedures/ of facility to perform records for related tests, laboratory facilities, instrumentation, tests required test(s), and etc. Certification or support reliability of results Accreditation or Established quality control and/or external quality assessment or Other validation (where required) Sample of label(s) To document compliance Maintain copy of investigational product label. attached to with applicable labeling investigational product regulations and container(s) appropriateness of instructions provided to the subjects
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.
GCP%20Toolkit%20-%20Essential%20Documents%20and%20the%20Regulatory%20Binder.docx