Bioequivalence and Bioavailability Forum

Dear Ms.Varsha,

It varies with the different activities captured in the CRF of BE study.

For Eg., Water measurement record, Food preparation and distribution record (in case of Fed study), Pre-dose compliance record, Dosing Record, Vital measurement record need to be checked immediately. Other activities such as custodian form, volunteer movement record etc., need not be checked immediately but in routine practice during the conduction of BE studies, it will be checked on the same day.

No guidelines states that the Principal Invesigator need to be present during the time of dosing. But, most of the sponsors are asking that the dosing should always be done in the presence of Principal Investigator and the same need to be captured in the protocol as well as the dosing record need to be signed by Principal Investigator as Supervising Investigator.

Regards,

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Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post. [Helmut]

Dear Varsha,

Whatever activity is being performed needs to be documented immediately, either directly in the CRF or in any other source document (depending on the protocol requirements and on your SOPs).

If data are transcribed from a source document into the CRF, this needs to be checked for transcription errors. This check can be done at a later stage.

Some critical activities need to be checked by a second person at the time when they are done. Dispensing and dosing for instance.

Regarding the PI: no requirement in GCP for the PI to be there personally at the time of dosing. He can delegate this task to another trained and qualified physician.

Regards
Ohlbe