BEBAC   Ing. Helmut Schütz

Records Related to Clinical Trials

Canada – HPFB

On 23 May 2006 Canada’s HPFB published a ‘Guidance for Records Related to Clinical Trials’ (HTML-version)

The guidance applies to all records created during the conduct of clinical trials and includes the records of Sponsors, Qualified Investigators, Research Ethics Boards which approved clinical trials.

The guidance is in effect as of 15 June 2006.