McMaster University

McMaster University

SOPs for Clinical Research

 

The latest version, Version 8.0 (effective May 15, 2019), of the Network of Network (N2) SOPs for Clinical Research are available by contacting Health Research Services at hsresadm@mcmaster.ca

City-wide adoption of the SOPs - McMaster University, Hamilton Health Sciences and St. Joseph's Healthcare Hamilton first adopted these SOPs in August 2010, along with our N2 partners (representing 200+ hospitals, universities and other research sites). The SOPs are available through the Hamilton Health Sciences and St. Joseph's Healthcare Hamilton intranets for those affiliated with the hospitals.

Why should I consider using the SOPs provided by HHS, McMaster and SJHH? These SOPs will ensure you have documented procedural guides for your clinical research activities which are expected by regulatory authorities when conducting random audits. When individual investigators or research groups are not able to refer to a full set of SOPs for their activities, a range of actions usually ensue including the extreme possibility that research activities will be halted. The best way to avoid this is to be familiar with current regulatory guidelines and to ensure you have a well developed set of SOPs.

What if I (or my group) already have a set of SOPs? It is important to note that these SOPs are not meant to replace existing SOPs of any research group, centre and/or institute. If you are satisfied that your SOPs meet current regulatory requirements, you can elect to continue using your documents.

Should I expect the SOPs to cover ALL of my needs? No, the SOPs were selected by the Institutions as a means of providing minimum standards to be compliant with Health Canada requirements and provide best practices to research areas where SOPs do not exist or are not readily available. It is very likely that after you review the resources available, you will want to add a few additional SOPs customized to your specific studies.

What are these SOPs compliant with? These SOPs are compliant with Health Canada, FDA, ICH-GCP Guidelines and the Canadian Tri-Council Policy Statement on Research Involving Humans. While changes to the formal set of SOPs provided are not recommended, you may find a need to develop further documents to 'bridge' any gaps identified between the SOPs and site-specific or local procedures.

You may copy, distribute and use the SOPs within your own clinical research areas; however, it is prohibited to sell, distribute, export, lease, loan or rent these SOPs to any third/external party; and when required, study sponsors, regulatory inspectors or auditors can be granted access to view, but not copy, the SOPs at the clinical research sites.

Any questions about the SOPs should be directed to Health Research Services at hsresadm@mcmaster.ca.

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