1. Updates and Announcements
  2. Sponsor-level Standard Operating Procedures for clinical trials

Sponsor-level Standard Operating Procedures for clinical trials

Sep 14, 2026

The Network of Networks (N2) organization has released the final five remaining updated English versions of the Sponsor-level Standard Operating Procedures (SOPs). The updated versions are dated July 8, 2026:

  • N2 SOP 112_01: Informed Consent Form and Assent Form Development
  • N2 SOP 119_01: Sponsor Essential Records
  • N2 SOP 120_01: Sponsor Oversight, Monitoring, and Audits
  • N2 SOP 121_01: Safety Assessment and Reporting
  • N2 SOP 124_01: Investigational Medical Device Management

Also available are an updated Glossary and the SOP Table of Contents.

The updated N2 SOPs have been approved for use at Queen's by Deputy Vice-Principal Research Steven Smith, effective October 1, 2026.

All other N2 SOPs had been previously released and authorized for use at Queen's as of April 1, 2026. The release of these new Sponsor SOPs completes the current suite of N2 Clinical Research SOPs.

To access the complete set of N2 SOPs, visit "Resources for Clinical Research" on the Compliance and Training for Human Participants Research webpage. Please note, Queen's NetID is required to access the files.

N2 SOPs are optional to use if clinical researchers have their own SOPs, however, use of N2 SOPs is strongly recommended.

Clinical researchers and clinical research personnel must complete and document adequate and timely training on the N2 SOPs or their own unit SOPs:

  • If you have not yet completed N2 SOP training: Please use the most recent training log (v.08Jul2026) with the complete set of clinical research SOPs listed.
  • If you previously completed training on the clinical research SOPs released on April, 1, 2026 and sponsor-level SOPs are relevant to your research: An additional training log listing only the five newly released sponsor-level SOPs along with the updated Glossary and the SOP Table of Contents has been created for your use.

If you have questions regarding N2 SOPs, please contact your local research administration:

Article Category
Compliance