Version 6.0 - effective May 15, 2015
Standard Operating Procedures (SOPs) for Clinical Research conducted by investigators affiliated with McMaster University's Faculty of Health Sciences teaching hospitals are located here for users with Mac IDs. 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.
The SOPs are provided in PDF format, are copyrighted and may not be modified, reproduced or used in other contexts. However, the templates which accompany the SOPs are provided in Microsoft Word so researchers may customized them for use in their clinical studies.
If you experience difficulty accessing the SOPs, or have questions or wish to provide feedback, please contact Health Research Services at firstname.lastname@example.org.