Bioequivalence and Bioavailability Forum • record retention period

record retention period [Regulatives / Guidelines]

posted by pravin17 – India, 2010-12-30 07:21 (5647 d 07:46 ago) – Posting: # 6352
Views: 3,302

❝ Could you please help me to know the record retention period for pilot/pivotal passed or failed studies for different regulatory guidelines?

Dear Sir,

The record should be retained until at least 2 years after the last approval of a marketing application in an ICH region.

The record should be retained for a longer period if needed by the sponsor. In such cases the sponsor should inform the institution(s) in writing of the need for record retention and should notify the investigator(s)/institution(s) in writing when the trial related records are no longer needed.

Hope this will help you.

Pravin Borde

Complete thread:

record retention period patilatu 2010-12-10 10:43 [Regulatives / Guidelines]
- record retention periodpravin17 2010-12-30 06:21
  - record retention period patilatu 2010-12-30 06:58
    - record retention period - European submission Ohlbe 2010-12-30 12:28
      - record retention period - European submission patilatu 2010-12-31 05:05