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RegisterResponsibility of PI in BA/BE Study [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2006-11-27 14:16 (7137 d 01:42 ago) – Posting: # 375
Views: 12,061
Dear Dr. Pravin!
CDSCO's Guideline states at
6.3 Organisation and management:
The study site organization must include the following:
a. An Investigator who has the overall responsibility to provide of the human subjects. The Investigator(s) should possess appropriate medical qualifications and relevant experience for conducting pharmacokinetic studies.
I don't feel competent enough to explain what 'appropriate medical qualifications and relevant experience' are; but since according to my server-logs our colleagues from India represent the largest group of participants of the BE/BE-Forum within the last month (19% of all accesses), someone else should fill in this gap!
❝ give me detail idea about the Responsibility for PI in India. like conduct of BA/Be trials,
CDSCO's Guideline states at
6.3 Organisation and management:
The study site organization must include the following:
a. An Investigator who has the overall responsibility to provide of the human subjects. The Investigator(s) should possess appropriate medical qualifications and relevant experience for conducting pharmacokinetic studies.
I don't feel competent enough to explain what 'appropriate medical qualifications and relevant experience' are; but since according to my server-logs our colleagues from India represent the largest group of participants of the BE/BE-Forum within the last month (19% of all accesses), someone else should fill in this gap!
—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- qualification of Principal Investigator isra_amm 2006-04-29 14:38 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Qualification of Principal Investigator (Germany, Austria) Helmut 2006-05-02 17:21
- qualification of PI (USA) Helmut 2006-07-21 20:34
- Responsibility of Principal Investigator in BA/BE Study Dr.Pravin 2006-11-23 12:45
- Responsibility of PI in BA/BE Study Helmut 2006-11-23 13:07
- Responsibility of PI in BA/BE Study Dr.Pravin 2006-11-27 11:28
- Responsibility of PI in BA/BE StudyHelmut 2006-11-27 13:16
- PI in India Helmut 2006-12-08 22:05
- Responsibility of PI in BA/BE StudyHelmut 2006-11-27 13:16
- Responsibility of PI in BA/BE Study Dr.Pravin 2006-11-27 11:28
- Responsibility of PI in BA/BE Study Helmut 2006-11-23 13:07
Ing. Helmut Schütz