Delegation of Duties by PI in BA/BE studies [Regulatives / Guidelines]
Dear Dr Dan,
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:
❝ 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:
- have the PI sign the job description of each individual, to show that he agrees with its contents and considers the person as appropriately qualified for that job. In my experience, job descriptions are usually signed by management and/or HR, but not necessarily by the PI;
- maintain a list of individuals with a specific job title (e.g. study nurse). A copy should be put in the TMF;
- ensure (and document) that each protocol does not require any specific skills not covered by the "normal" job description.
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- Delegation of Duties by PI in BA/BE studies ratnakar1811 2015-09-22 09:14 [Regulatives / Guidelines]
- Delegation of Duties by PI in BA/BE studies ElMaestro 2015-09-22 10:32
- Delegation of Duties by PI in BA/BE studies Dr_Dan 2015-09-22 10:39
- Delegation of Duties by PI in BA/BE studiesOhlbe 2015-09-22 12:25
- Delegation of Duties by PI in BA/BE studies Dr_Dan 2015-09-23 08:59