HealthTrials SOP

STANDARD OPERATING PROCEDURES MANUAL
FOR CLINICAL RESEARCH AT THE HEALTH SCIENCES CENTRE (HSC)

A template for Standard Operating Procedures (SOPs) for Clinical Research at Health Sciences Centre is available through the HealthTrials office.

The document Standard Operating Procedures (SOPs) for Good Clinical Practice at the Investigative Site (the SOP Template) (2001) has been licensed by the HSC Department of Research from the Center for Clinical Research Practice, Inc. The SOP template has undergone revisions specific to the needs of the HSC and the template is available for purchase by HSC Clinical Research Groups for a nominal fee ($125 as provided by the Multiple User Option). The template can be revised as required for your clinical trial site.

The SOP template, with HSC revisions, is based on Good Clinical Practice Guidelines and the Code of Federal Regulations, Health Canada Therapeutic Product Directorate Guidelines, and the ICH Harmonized Tripartitie Guideline (Good Clinical Practice: Consolidated Guideline).

The document includes SOP templates, forms, and checklists. Some examples of the Standard Operating Procedures in the template are as follows:

  • Responsibilities of the Research Team

  • Assessing Protocol Feasibility

  • Investigator and Site Initiation Meetings

  • Site-Sponsor/CRO Communications

  • Sponsor/CRO Monitoring Visits

  • Investigational Drug Accountability

  • Adverse Event Reporting

  • Specimen Collection and Handling

  • Data Management

  • Audits

For more information or to view a hard copy of the template, please contact Theresa Ronson at 787-2046 or email healthtrials@hsc.mb.ca.