Trial initiation monitoring To document that trial If working with a sponsor, maintain documentation of site report procedures were reviewed and monitoring reports conducted by sponsor. If with the investigator and investigator-initiated, maintain records of personnel training. investigator’s trial staff (may be combined with pretrial monitoring report) 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 Purpose Guidance, Templates, Tools Document Investigator’s brochure To document that If investigator’s brochure is available, maintain copies and any updates investigator is informed in subsequent versions/updates. a timely manner of relevant information as it becomes available Any revisions to: To document revisions of Maintain copies (and copies of each amended version) of your Protocol/amendment(s) these trial-related IRB protocol, any amendments, and any related IRB protocol and CRF documents that take documentation. Copies may be maintained in hard or Informed consent form effect during trial electronic format, or accessed at any time on the IRB Any other written Electronic Submission System. information provided to subjects Advertisement for subject recruitment Maintain a copy of the IRB approval letter for the original Dated, documented To document that the protocol, plus any subsequent modification approvals or approval/favorable amendment(s) and/or continuing review approvals. opinion of IRB of the revision(s) have been following: subject to IRB review and Protocol amendment(s) Copies may be maintained in hard or electronic format, or were given Revision(s) of: accessed at any time on the IRB Electronic Submission System. approval/favorable Informed consent form; opinion. To identify the Any other written version number and date information to be of the document(s) provided to the subject; Advertisement for subject recruitment (if used); Any other documents given approval/favorable opinion; Continuing review of trial
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.
GCP%20Toolkit%20-%20Essential%20Documents%20and%20the%20Regulatory%20Binder.docx