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 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.
Set up the study database or case report form
This activity takes time and care to ensure the data collected for the trial is complete, see Data Management.
Write Standard Operating Procedures
In accordance with GCP, the sponsor is responsible for implementing and maintaining quality assurance and quality control systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s).
Some of these SOPs may be generated by the sponsoring institution but others will be the responsibility of the Sponsor-Investigator.
The Sponsor-Investigator is responsible for developing any SOPs that are required to ensure compliance with the trial protocol. Examples of tasks that may require an SOP include:
- Clinical trial team roles and responsibilities
- Data management plan
- Safety monitoring and reporting
- Labelling of investigational product
Institutions should have an SOP template that researchers can use that will assist them to include all the necessary elements.
Depending on a person’s role in the trial, there will be different training requirements specific for the trial. 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 sponsoring institution should have a policy regarding who should undertake GCP training and what level of GCP is appropriate for a particular role.
For example Principal Investigators and Study Coordinators should all complete a course that meets the TransCelerate Biopharma Minimum Criteria for ICH E6 CP Investigator Site Personnel Training.
For further guidance, refer to the National Clinical Trials Governance Framework and User Guide.
For other staff, it may be appropriate to receive GCP training that is tailored to their role and responsibility in the trial. For example emergency department doctors or nurses who are only responsible for obtaining informed consent from participants may not require full GCP training.
The Sponsor-Investigator and Site Principal Investigator have responsibilities for ensuring their staff receive any training required by their institution relevant to their role, in addition to any trial-specific training, such as administration of investigational product or complex trial assessments.
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).
Set up 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.