Bioequivalence and Bioavailability Forum • qualification of PI (USA)

qualification of PI (USA) [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2006-07-21 22:34 (6873 d 00:56 ago) – Posting: # 186
Views: 10,145

Hello Isra',

here you may find US-FDA's form #1572 'Statement of Investigator' in PDF-format.

You have two options...

2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFIES THE INVESTIGATOR

   AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE DRUG FOR THE USE

   UNDER INVESTIGATION. ONE OF THE FOLLOWING IS ATTACHED.



       ☐ Curriculum vitae   ☐ Other Statement of Qualifications

FDA's Help Page does not give examples what 'qualification' actually means... ;-)

Concerning your question (MD, PhD,... and responsibilities) have a look at this message at FDA's GCP board.

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Helmut Schütz

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Complete thread:

qualification of Principal Investigator isra_amm 2006-04-29 14:38 [Regulatives / Guidelines]
- 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 Study Helmut 2006-11-27 13:16
        
        PI in India Helmut 2006-12-08 22:05