The Principal Investigator (PI) is the person delegated responsible for the leadership and conduct of a research study at their site. They must ensure that the study is conducted in accordance with the protocol, sponsor instructions, GCP and the relevant legislation; ensuring the dignity, rights, safety and well-being of subjects are given priority at all times.
The suitability of a Principal Investigator will be assessed and documented by the Chief Investigator during site selection (as part of a viability assessment). For Clinical Trials of Investigational Medicinal Products (CTIMPs), the Principal Investigator must be an authorised healthcare professional (if the PI is not a medically qualified doctor then s/he must delegate those duties required to be performed by a medically qualified doctor out appropriately). The responsibilities of the Principal Investigator will be clearly delegated in signed agreements between the host site and the sponsor (for NHS investigator’s /sites this will be through the mNCA) prior to host site approval.
The Principal Investigator can delegate responsibilities to other members of the study team (as appropriate) but must be involved in the active management of the study and should be able to demonstrate complete oversight at their site. It is not acceptable for a Principal Investigator to be a PI in name only, evidence of PI oversight should be demonstrable from audit/inspection of the Investigator Site File (ISF). Examples of evidenced PI oversight would be: up to date signed authorised delegation logs; sign off on the assessment of participant eligibility, sign off on SAEs, sign off on the review of new safety information, regular minuted team meetings and/or 1:1 training/supervision (stating who was in attendance), emails correspondence etc).
Any changes to the Principal Investigator’s circumstances that are likely to significantly impact on the management of the research study at site whilst it is active (for example planned change of Principal Investigator employer or absence due to ill health/sabbatical etc) should be notified by the site to the Chief Investigator /Sponsor Representative immediately so that the appropriate action can be taken (for example: a change of PI for a CTIMP would require substantial amendment to REC).
If you are a Principal Investigator working on a study that is sponsored by a Noclor partner the most relevant sections of the sponsored research life-cycle for you to refer to are from clockwise, study set-up right through to research outcomes.