Drug Evaluation Committee 2023-65 Investigator's Signature on the List of Reference Values for In-Hospital Inspections

Related classification: Record keeping

Initial release date: October 2024

QUESTION

I would like to inquire about the method of storing the list of reference values for in-hospital inspections.

In the past, after obtaining the signature of the responsible physician on the list of in-hospital laboratory reference values, the original was kept at the site and a copy at the sponsor's side.
In recent clinical trials, we have experienced cases in which the signature of the responsible physician was not obtained, but is it correct to think that the signature of the responsible physician is not required as long as the list of in-hospital laboratory reference values is kept without problems?

Pharmaceutical Association's Opinion

If the head of the site is responsible for issuing and providing to the sponsor the in-house reference values for tests used in clinical trials in accordance with the internally prescribed process, the signature of the investigator is not necessarily required. However, if the list of reference values does not clearly indicate the name of the site or the start date of application of the reference values, or if some information has been added to the original list of reference values, or if each site or sponsor has its own regulations, it may be necessary for the investigator's signature to guarantee the document. Therefore, it is recommended to check the regulations of each institution and consult with the sponsor before taking any action.

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