Delegation of Duties by PI in BA/BE studies [Regulatives / Guidelines]

posted by Ohlbe – France, 2015-09-22 14:25 (3430 d 16:40 ago) – Posting: # 15440
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Dear Dr Dan,

❝ You have to differentiate between functions and names (of individual staff members). For example if the PI delegates blood drawing to study nurses he/she does not have to name the individual person as long as there is a detailed job description explaining the study nurse´s tasks and responsibilities.


We'll, I'm afraid I have to slightly disagree here. ICH 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.

Your system would require to:

Regards
Ohlbe

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