McMaster University

McMaster University

SOPs for Clinical Research

Version 8.0 - effective May 15, 2019

Standard Operating Procedures (SOPs) for Clinical Research conducted by investigators affiliated with McMaster University's Faculty of Health Sciences teaching hospitals are available by contacting Health Research Services at hsresadm@mcmaster.ca. The SOPs are also available for users located at St. Joseph's Healthcare Hamilton and Hamilton Health Sciences via their respective hospital intranet sites.  Investigators are welcome to make use of this valuable tool in their day to day research activities.  The SOPs are an especially important resource for both new and experienced research personnel conducting clinical drug, device or natural health products trials in accordance with Health Canada regulations.

SOPs describe specific procedures performed during the conduct of a clinical research study involving human subjects. The SOPs are based on ICH: Good Clinical Practice guidelines, Health Canada Food and Drug regulations, and Tri-Council Policy Statement guidelines for the ethical conduct of research involving humans.

In all studies, the Principal Investigator has full responsibility for all the activities performed during the conduct of the study and must personally sign all major documents and correspondence.  All activities detailed in these SOPs are to be completed under the supervision of the Principal Investigator.  The Investigator may delegate activities to members of the research team.  This delegation must be documented in writing.

These SOPs are for the sole use of investigators and their research team members affiliated with St. Joseph’s Healthcare Hamilton, McMaster University, and Hamilton Health Sciences.  Additional procedural responsibilities of the Investigator will be outlined in additional departmental manuals, institutional policy and procedural manuals and other institutional and external agency manuals as required.

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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