Bioequivalence and Bioavailability Forum • record retention period

record retention period - European submission [Regulatives / Guidelines]

posted by Ohlbe – France, 2010-12-30 13:28 (5647 d 02:26 ago) – Posting: # 6357
Views: 3,294

Dear Patilatu,

Directive 2005/28/EC, article 17:

The sponsor and the investigator shall retain the essential documents relating to a clinical trial for at least five years after its completion.

Directive 2001/83/EC (which applies to trials submitted as part of marketing authorisation applications), Annex 1, § 5.2.c:

Marketing authorisation holders must arrange for essential clinical trial documents (including case report forms) other than subject's medical files, to be kept by the owners of the data:

for at least 15 years after completion or discontinuation of the trial,
or for at least two years after the granting of the last marketing authorisation in the European Community and when there are no pending or contemplated marketing applications in the European Community,
or for at least two years after formal discontinuation of clinical development of the investigational product.

Subject's medical files should be retained in accordance with applicable legislation and in accordance with the maximum period of time permitted by the hospital, institution or private practice.

The documents can be retained for a longer period, however, if required by the applicable regulatory requirements or by agreement with the sponsor. It is the responsibility of the sponsor to inform the hospital, institution or practice as to when these documents no longer need to be retained.

The sponsor or other owner of the data shall retain all other documentation pertaining to the trial as long as the product is authorised.
This documentation shall include: the protocol including the rationale, objectives and statistical design and methodology of the trial, with conditions under which it is performed and managed, and details of the investigational product, the reference medicinal product and/or the placebo used; standard operating procedures; all written opinions on the protocol and procedures; the investigator's brochure; case report forms on each trial subject; final report; audit certificate(s), if available. The final report shall be retained by the sponsor or subsequent owner, for five years after the medicinal product is no longer authorised.

Regards
Ohlbe

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Regards
Ohlbe

Complete thread:

record retention period patilatu 2010-12-10 10:43 [Regulatives / Guidelines]
- record retention period pravin17 2010-12-30 06:21
  - record retention period patilatu 2010-12-30 06:58
    - record retention period - European submissionOhlbe 2010-12-30 12:28
      - record retention period - European submission patilatu 2010-12-31 05:05