The Site Principal Investigator is the person responsible, individually or as a leader of the clinical trial team at a site, for the conduct of a clinical trial at that site. As such, the Principal Investigator supports a culture of responsible clinical trial conduct in their health service organisation in their field of practice and is responsible for adequately supervising his or her clinical trial team.
Trial protocol and accountability
The Principal Investigator must conduct the clinical trial in accordance with the approved clinical trial protocol. Principal Investigators are accountable to their employer who may or may not be the health service organisation hosting the clinical trial research and the clinical trial sponsor.
The Principal Investigator provides guidance and mentorship on responsible clinical trial conduct to other researchers or research trainees under their supervision, promotes education and training in responsible clinical trial conduct and complies with the relevant laws, regulations, disciplinary standards, ethics guidelines and institutional policies related to responsible clinical trial conduct.
Additionally, the functions of the principal investigator, for clinical trials in general, include:
- Ensuring that appropriate approvals are obtained prior to the commencement of the trial, and that conditions of any approvals are adhered to during the course of the trial
- Ensuring any contractual requirements such as those under a clinical trial agreement are met
- Engaging with Aboriginal and Torres Strait Islander peoples and respecting their legal rights and local laws, customs and protocols as they relate to clinical trials (requirements regarding this are provided in the National Clinical Trials Governance Framework and User Guide
- Complying with the requirements for consent as approved in the trial protocol
- Ensuring participants’ welfare during the clinical trial
- Provide the necessary clinical care to study participants required as a result of any adverse events experienced during or following the study that are related to the study
- Informing the participant's primary physician about the participant's involvement in the project. That is, if the participant has a primary physician and if the participant agrees to the primary physician being informed
- Providing reports to the local Research Governance Office (RGO) and site on:
- all significant safety issues (SSIs)
- suspected unexpected serious adverse reactions (SUSARs) and unanticipated serious
adverse device effects (USADEs)
- proposed amendments to the protocol
- information that might affect the continued ethical and scientific acceptability of the project
- Providing site information to the Sponsor or CPI for annual progress reports and the final report to the HREC and the site
- Disclosing and managing actual, potential or perceived conflicts of interest
- Responsible for ongoing consent
- Retaining the participant on a clinical trial. Although a participant is not obliged to give his/her reason(s) for withdrawing prematurely from a study, the principal investigator should make a reasonable effort to ascertain the reason(s), whilst fully respecting the participant's rights
- Retaining clear, accurate, secure and complete records of all clinical trial documentation including clinical trial data and primary materials. Where possible and appropriate, allow access and reference to these by interested parties
- Complying with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority and the Sponsor or CPI as required by the approved clinical trial protocol
- Reporting suspected breaches of the code to the relevant institution and/or authority
- Taking responsibility for site Associate Investigator
- Supervising and working with site Study Coordinator/Research Nurse
