Standard Operating Procedures (SOPs)

Quality assurance for clinical trials

Regulatory authorities require that clinical research sites utilize standard operating procedures (SOPs) to ensure that their research is conducted in manner that protects the rights and safety of study subjects and the integrity of the research data collected.

The University of Calgary is strongly recommending that all clinical research groups adopt the use of the SOPs created by the Network of Networks’ (N2). These SOPs are externally reviewed by an independent expert to ensure compliance with the regulations governing clinical research.

Changes to the formal set of SOPs at the site/institutional level are NOT recommended and may result in the SOPs no longer being compliant.

 

Due to our agreement with N2, the SOPs may not be shared with parties external to our institution. The Sponsor may review the SOPs while on site, but is unable to bring a copy with them. If a Sponsor requests to see your SOPs as part of your site activation, you may send them a copy of the Table of Contents.

Researchers and their teams are required to provide documented proof of training on SOPs.

For more information about SOP training, please contact Linda Longpre at linda.longpre@ucalgary.ca.