SOPs have recently been in the spotlight with some sites and CRAs reaching out to SACRA to look for guidance on the compilation of these documents.
In 2009, I assisted in the compilation of an SOP guidance document that was meant to assist sites with drawing up their own SOPs. This document is available at this link.
Many questions that have come through relate to the list of SOPs that sites are expected to have. Since 2009, we have been engaging periodically with MCC and now SAHPRA, and there is currently no specific minimum list of expected SOPs (despite the latest Capacity Building Document received from SAHPRA stating that “Uniform standards with appropriate standard operating procedures be implemented across all sites.”)
Apart from the frequently requested Informed Consent Discussion SOP, and the Emergency Trolley SOP, there are no specific SOPs that a site MUST have. However, in order to build a successful and professional trial site, it is imperative that the site produce its own Site-Specific SOPs.
I would suggest working with 3 broad categories:
Prior to commencement of a trial
During the trial
After the trial has ended
Think about all possible procedures that can be done during these phases and write up your SOP on each procedure. Use the link above for a template that you can use.
There will be an SOP workshop conducted at the SACRA Clinical Trial Conference in September, so make sure you book your place.
Dr Essack Mitha