From 22 March 2010, the period for which sponsors must keep basic documentation of a clinical trial will be extended from two to five years.
This change to the detailed requirements of Good Clinical Practice will only apply to existing trials where the two-year retention period has not already expired.
The retention period runs:
- throughout the time an application to obtain marketing authorisation is being considered in any country and for five years after final authorisation has been obtained in any EU/EEA country
- for five years from the beginning of the calendar year after the year in which the clinical trial was suspended by the sponsor
The scope of documentation required to be retained is set out in the Annex to the GCP Regulations.
Law: amendment to § 13 paragraph 1 point 3 of the GCP Regulations
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The original publication date for this article was 11/03/2010.