Originally Posted by
a123456
The EU PROPOSED regulation to replace Directive 2001/320/EC defines ‘Start of the clinical trial’: the first act of recruitment of a potential subject, unless
defined differently in the protocol. Many sponsor define this as the date of the first subject signing the first consent form. I hasten to emphasize that this is PROPOSED regulation and may not be passed into law intact. I realize that you may say that this definition is the same as start of the clinical phase but this is what the regulators have given us! The new MHRA GCP Guide does not seem to define start of study but it does say this:- It is a legislative requirement7 that a trial does not start until an authorisation has been granted and favourable REC opinion has been received – ‘regulatory release’ and that IMP must27 not be sold or supplied until an authorisation has been granted and it has been certified by a Qualified Person (QP) where required -‘technical release.’ (7 = regulation 12 of SI 2004/1031) (27= regulation 13 of SI 2044/1031). The sponsor’s authorisation to start the trial is usually marked by the shipment of IMP to the investigator sites. However, there are occasions where this may vary". Good idea to buy a copy