Updated: Jul 2
This post and additional posts over the coming week will focus on the Sponsor responsibilities for sites conducting their own Investigator Initiated Trials. This is an area where it can often be difficult to know where to go for guidance or what the new updates to GCP mean for sites sponsoring their own studies.
GCP 5.0 The sponsor should implement a system to manage quality throughout the design, conduct, recording, evaluation, reporting and archiving of clinical trials"
How can we best manage this at a site level? Start with your SOPs and ensure they cover off all aspects of the trial process, from protocol design through to archiving. This can be a significant piece of work but it will form the basis of your site Quality Management System (QMS). An excellent recommendation is to purchase Sponsor SOPs and modify for use at your own site - I recommend Centrewatch. Their SOPs and associated templates are easily able to be customised to site requirements and are FDA compliant as well as covering the entire study life cycle
Once you have a set of SOPs, build your QMS from here. Ensure you have templates for protocol and PICF design - review the work being done by the National PICF project https://www.nationalpicf.com.au/research.html
and for protocol templates, review the work being done by TransCelerate https://transceleratebiopharmainc.com/initiatives/common-protocol-template/
Check you have quality review checks in place at all stages of protocol design, study start up, patient recruitment, study close out, data management and reporting and archiving. Consider how you will train your teams and ensure they are complying