During Ethics and Governance Review
There are many activities that the Sponsor-Investigator and central coordinating trial team should undertake while the project is undergoing ethics or governance review. Time spent on these activities now will save time later and shorten the time from ethics or governance approval to site activation and recruiting the first participant.
Respond to HREC questions promptly
Promptly respond to queries from the ethics committee during the review period. A quick response will be appreciated by the committee and facilitate a shorter turnaround from ethics submission to ethics approval.
Training and Delegation of clinical trial staff
According to ICH GCP, all staff that work on a study need to be appropriately qualified. Staff directly involved with a clinical trial are required to complete a course that meets the TransCelerate Biopharma Minimum Criteria for ICH E6 CP Investigator Site Personnel Training.
Both the sponsoring institution and the Sponsor-Investigator should establish the appropriate training requirements for each role in the central coordinating trial team and participating sites clinical trial team(s).
The Sponsor-Investigator and Site Principal Investigator have responsibilities for ensuring the study staff receive any training required by their institution relevant to their role on the study, in addition to any trial-specific training, such as complex trial assessments. These staff will be listed on the Delegation of duties log. While waiting for Ethics and Governance review, members of the Clinical Trials Team can prepare the Delegation of duties log.
Training documentation, including GCP certification, attendance at courses, reading SOPs, must be maintained and retained for all members of the clinical trial team. Records are maintained in the Trial Master File (for Sponsor-Investigators and the central coordinating trial team) or Investigator Site File (for the Site Principal Investigator and site staff).
For further guidance, refer to the National Clinical Trials Governance Framework and User Guide.
The Trial Master File and Investigator Site File
Set up the Trial Master File and guidance for sites for managing the Investigator Site File in accordance with the sponsoring institution’s SOP for managing essential documents.
Draft the Clinical Trial Notification or Clinical Trial Exemption
Draft the Clinical Trial Notification (CTN) (if applicable), see TGA: Australian clinical trial handbook, CTN and CTX schemes.
The CTN form is accessed and submitted via the TGA Business Services website.
Institutions will have their own account for drafting and submitting CTNs. The account will be administered by a person(s) who has been delegated this task by the Institution.
Contact the Research Office of the sponsoring institution to find out who this is and the local procedure for submitting the CTN.
Register the trial
Begin the trial registration process using either the Australian New Zealand Clinical Trials Registry (ANZCTR) or ClinicalTrials.gov.
Registration in these registries is acceptable to the International Committee of Medical Journal Editors (ICMJE) and will meet the requirement that clinical trials are registered at or before the time of first patient enrolment as a condition for publication.