Action Plan of The Initiative CATALIS

CATALIS: An Initiative in Action!

Last update: 2019-22-01

Operational Excellence

Summary

Activity

Progress

Performance indicators

Implement a standardized automated performance report for Quebec institutions.

The new automated performance report developed by the CATALIS initiative was deployed on March 1, 2019 in all health care institutions in Quebec. This report allows network institutions to obtain real-time data on their activities and performance in clinical research (clinical trials).

Ethical assessment

Provincial Information System (Nagano)

Support the development of new functionalities to enable Quebec institutions to be interconnected in the Nagano computer system.

The CATALIS initiative made a first launch on March 1, 2019, so that studies submitted in Nagano after that date would be interconnected in the network.

A second launch is planned for the summer of 2019 to interconnect studies that were submitted in Nagano before March 1, 2019.

Consent forms

Update the normative clauses of the consent forms.

New proposals for the standard clauses will be presented to the industry during a discussion workshop scheduled in April 2019 with our five (5) participating ethics committees, the FRQS, and the MSSS. The new clauses are expected to be presented to the industry in April-May 2019.

SOP for ethics committees

Review the N2 Standard Operating Procedures (SOP) for ethics committees to ensure their compliance with Quebec policies.

The revised SOP will soon be available on the CATALIS Quebec website.

Industry access to the Nagano information system

Assess the feasibility of providing the industry with direct access to Nagano to facilitate communication.

A discussion workshop is scheduled in April 2019.

Contract assessment

Legal

Optimize contract evaluation time.

Centralize and update current reference documents to provide a single guide on best practices for reviewing clinical research contracts with private companies.

Pending.

Budget

Establish a reference price list for common clinical research procedures to facilitate budget negotiations and management of institution-based studies.

The budget specialists have agreed on a proposed reference price list. This list is currently being piloted by CATALIS members. A follow-up will be carried out on the summer of 2019 to finalize the terms of use.

Feasibility assesment

Optimize a study’s feasibility processes.

Pending

Quality

Coordinate SOCRA certification exams in Quebec.

An examination is scheduled for June 6, 2019 in Montreal. Information and registration here.

Operational Excellence

Summary

Activity

Progress

Network of researchers

Create a joint directory of researchers which showcases Quebec’s early stage clinical research expertise.

Pending.

Promotion and business development

Promote and provide visibility for Quebec clinical research institutions and researchers.

Pending.

Collaboration

Summary

Activity

Progress

Québec and Canada

Work with the other provincial and national initiatives to maximize benefits in Canada.

Continuous.