CLINICAL RESEARCH SOP COMMITTEE
The N2 Clinical Research SOP Committee is responsible for developing and maintaining all current N2 SOPs and ensuring they meet all applicable regulatory requirements and guidelines. The SOPs are written to ensure a site will be deemed compliant during Health Canada inspections. The committee also makes available associated tools and a package to help an organization roll the SOPs and tools out to its N2 community members.
Currently N2 has several sets of SOPs:
- Clinical site SOPs for conducting clinical research (including for example how to properly consent a study participant, and how to manage Investigational Products etc)
- Site SOPs specifically developed for conducting investigator initiated research (including for example how to set up a study protocol, or write a data management plan)
The SOPs provide a mechanism to assist sites to be compliant without each site having to develop their own. All SOPs are reviewed regularly, and re-issued every two years by the N2 SOP committee and independently audited to ensure compliance, and to enable efficient, effective research conduct.