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Medical Oversight

Principal Investigator’s are responsible for ensuring that the dignity, rights, safety and well-being of the study participants at their site.  The suitability of a Principal Investigator should be assessed and documented by the Chief Investigator during site selection (as part of a viability assessment).

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.

For clinical trials, the Principal Investigator is responsible for the medical care/decisions of the participants enrolled on the trial and should be closely involved in their management; s/he should also be able to demonstrate (evidence on file) complete oversight of the trial for the duration of the trial (even if responsibilities are delegated out).

The medical review of any participant assessments by qualified physicians (as delegated by the Principal Investigator and as they appear on the delegation log) should be clearly documented in medical records and CRFs (i.e evidence that they have been reviewed with a date and signature of medical reviewer).  Any clinically significant events should be recorded, reported and monitored as required for the medical event (and for the trial).

Where the protocol stipulates certain stopping rules these must be followed (for example stopping treatment if defined safety parameters/levels are breached).

GPs should be informed of participant involvement if this has been consented to at the outset (with GP letter approved by REC), evidence that this has been done should be retained on file for monitoring and audit purposes (i.e copy of signed /dated letter).