With the aim of protecting participants and achieving high quality standards in clinical research, we are setting up an audit and quality assurance support service.
This service is part of an ongoing training process on Good Clinical Practice (GCP) as developed by the International Conference on Harmonisation (ICH) and the Standard Operating Procedures (SOP) of the CHU de Québec-Université Laval.
In addition to the assistance and training offered, educational audits are proposed to validate whether the GCP and SOPs are being applied and respected by clinical research staff. If necessary, and with the team’s help, a corrective and preventive action plan (CAPA) will be put in place to comply with clinical research requirements.
Services Offered
- Support and assistance during an external audit.
- Support during a regulatory inspection.
- Contact person to help you obtain specific information on a research question.
- Checking documentation for compliance with regulatory requirements.
- Training on standard operating procedures.
- Standard operating procedures.
- Revision of work instructions.
- Sponsor-researcher support.
Price List
An hourly rate may apply in certain situations; please contact us for more information.