11th Mar 2013, 03:58 PM
Initiation Visit before IMP relaesed to Investigator Site
Not an ideal situation but due to resource issues would it be possible to carry out the Initiation Visit prior to IMP being sent to the Investigator Site (for example, using mock up of packs as examples)? I realise that approvals from the CA and REC would need to be in place first.
27th Mar 2013, 08:53 PM
GCP does not require to have IMP at a trial site before initiation visit.
27th Mar 2013, 08:57 PM
ICH GCP also does not require to have approvals by CA/IEC/IRB before initiation visit is conducted. It just does not have sense to review trial procedures with the investigator before the trial is not approved.
2nd Apr 2013, 08:08 PM
Initiating a site without CA & IEC/IRB approvals is a risky business. Initiation of a site ready for a study, says that the site is "ready to start" or "good to go". A site that does not have approvals is not ready to go. They cannot begin screening subjects and other study related processes. The danger with initiating a site before approvals, is that the site may begin study related activities before those activities have been explicitly approved and documented for this investigator at this site.
The MHRA have commented in their GCP Guide 2012 that initiation visits are not always required:-
"there is usually an initiation visit where the monitor will schedule a meeting with the site to ensure the site staff are adequately trained and ready to start the trial. There may be occasions where either an investigators’ meeting and/or the initiation visit can be more limited in scope - for example, conducted via telephone between the monitor and the site, and/or an initiation pack sent to site containing information and instructions with forms/checklist to complete and return. ... the meetings may not conducted at all - for example, where there is familiarity with the site, the site has previously received training in similar trials, or the simplicity of the trial is such that training is considered unnecessary. However, any such decisions should be clearly documented and justified in the risk assessment and/or monitoring plan".