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Changing the principal investigator without losing study oversight

Prepare a documented investigator handover covering participants, safety actions, delegation, access and regulatory records.

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An investigator change transfers active responsibilities, not merely a name on a cover letter. Open safety follow-up, eligibility decisions and product oversight need a clear owner throughout the transition.

Establish the transfer scope

TİTCK's clinical research resources include a responsibility transfer/acceptance document for applicable investigator changes. Check the current application route and ethics requirements alongside that document. An agreed employment start date does not by itself establish the date on which study responsibilities can change.

Prepare a responsibility handover

We recommend a participant-focused handover, signed or otherwise formally accepted by the responsible parties. It should identify ongoing treatment, unresolved adverse events, pending laboratory findings and delegated medical decisions. Include the location of source records and a route for clarifying historical decisions after the outgoing investigator leaves.

Reconcile the effective change

  • List open participant care and safety actions with named receiving owners.
  • Review delegation, qualifications, training and access against the incoming role.
  • Check consent contacts, insurance references and other documents naming the investigator.
  • Record applicable decisions, transfer acceptance and the controlled effective date.

Check the remaining blind spots

After transfer, sample a current participant record and a pharmacy reconciliation to confirm that responsibility works in practice. Remove obsolete access only after authorized continuity is established. Keep historical signatures and delegation periods intact rather than rewriting the record.

Frequently asked questions

Can the delegation log alone document the transfer?
It supports task assignment but does not replace the required regulatory and responsibility handover records.
Should old records be re-signed by the new investigator?
Preserve historical attribution. Document review or follow-up separately where needed.

Sources

  1. TİTCK — Clinical research application guidance and module notes
  2. TİTCK — Good Clinical Practice guidance