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If someone is performing a Standard of Care procedure for a trial patient, do they need to be on the delegation log?  If the “Standard of Care” procedure does not form part of the trial, the answer is “no” and the procedure becomes part of the patient’s medical records with adverse events, con meds and procedures recorded in the CRF as appropriate.  However, if the Standard of Care procedure is also a trial related procedure (eg vital signs on admission to the ward), the answer is not so straight forward.

GCP 4.1.5 states that “the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties”.  The key word here is significant.  Identifying adverse events as part of a routine nursing assessment is very different from administering the comparator drug in a multi-arm study.  The impact of the procedure on the study endpoints and subject safety as well as overall involvement of the person in the study will guide your judgment.

If in doubt, it is better to add the person to the delegation log to cover yourself in case of an audit.  It is much easier to remove someone from the log than it is to add them months down the track.

 

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