Provincial Reference Tools: CATALIS Contributed to the Update
To fulfill its government mandate of optimizing Quebec’s clinical research environment and accelerating the development of innovative treatments for patients, CATALIS participated in the update of five provincial reference tools: the Standard Operating Procedures (SOPs) for Research Ethics Boards (REBs), the Statement on Optimizing the Research Contract Negotiation Process, a provincial model Confidentiality Disclosure Agreement (mCDA), a pan-Canadian model Clinical Trial Agreement (mCTA), and the participants’ home activities memo.
The REBs’ SOPs (v2) are intended to serve as a reference guide for managing and standardizing the administrative practices of REBs within Quebec’s health and social services network (HSSN) institutions. This latest review was made possible through the collaboration of CATALIS’ Ethics Advisory Committee, which comprises more than a dozen representatives of HSSN institutions’ REBs. These SOPs have also been reviewed by the Quebec Ministry of Health and Social Services to ensure that they meet government requirements. The English version of the SOPs will be available shortly.
CATALIS also coordinated the development of the Statement on Optimizing the Contract Negotiation Process by representatives from the Health and Social Services Network and the Ministry of Health and Social Services’ Direction de la recherche (research branch). This Statement targets pharmaceutical companies seeking to conduct clinical trials in Quebec and outlines the regulatory requirements which apply in HSSN institutions. It also incorporates the Charter of the French Language’s new provisions. The Statement also proposes using a provincial model Confidentiality Disclosure Agreement (mCDA) and a pan-Canadian model Clinical Trial Agreement (mCTA) which are accepted as is if used without modification by private companies.
The CATALIS network also produced a memo which aims to clarify stakeholders’ responsibilities in the context of activities carried out in participants’ homes.
Download the free SOPs in French (The English version of the SOPs will be available shortly)
