The Quality Assurance Department managed by the RI-MUHC is responsible for implementing and providing the necessary training and support to sponsor investigator/investigators and their staff and to ensure compliance with standards dictated in clinical research.
The RI-MUHC offers the following support to its community:
- preparation and maintenance of Standard Operating Procedure (SOPs)
- Standard Operating Procedure (SOPs) in-class training (3 hours)
- Good Clinical Practice in-class training (3 hours)
- CITI Good Clinical Practice online training
- mentoring new investigators/sponsor-investigators
- orientation session for new clinical research staff
- internal audit and external audit assistance
- assistance with Health Canada and FDA submissions.
The RI-MUHC offers the following services:
- audit and monitoring services
- informed consent preparation and translation
- Data Safety Monitoring Board (DSMB) and adjudication committee services
- equipment maintenance and certification
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NEWS: Since January 2012, all MUHC staff must request certification to conduct clinical research at the MUHC. This new certification program is offered by the RI-MUHC and is linked to in-class training in Good Clinical Practice and Standard Operating Procedure (6 hours of training). For more information or to schedule services with us, please contact qaclinicalresearch@muhc.mcgill.ca |
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