Action Plan of The Initiative CATALIS

CATALIS: An Initiative in Action!

Last update: 2018-19-11

Operational Excellence

Summary

Activity

Progress

Performance indicators: automated performance report

Implement a standardized automated performance report for Quebec institutions.

This new report will let institutions obtain real-time data on their activities and performance in clinical research (clinical trials) and compare them to their established targets.

The automated report is in the pilot phase in the CATALIS initiative’s partner institutions.

Ethical assessment: continuous improvement of the multicenter evaluation process

Organize and manage discussion workshops with our public and private partners to oversee the excellence of the provincial multicenter assessment process.

An initial discussion workshop was held on October 18.

 

This workshop allowed us to establish an action plan which mainly prioritizes these activities:

  • Providing new Nagano data processing system functionalities to facilitate provincial multicenter assessments.
  • Providing an update of standard clauses in the consent forms (FR/EN).
  • Providing Network of networks (N2) standard operating procedures (SOPs) for ethics committees which are revised for Quebec (FR/EN).
  • Providing the industry with access to the Nagano data processing system.

Ethical assessment: provincial information system (Nagano)

Develop new functionalities for the provincial data processing system to facilitate multicenter clinical project assessments.

For more than a year, CATALIS has been supporting the development of new functionalities which will allow Quebec institutions to be interconnected in the Nagano data processing system.

Synchronization tests are currently being done and we are confident that these new functionalities will be available for the new studies which will be submitted in early 2019.

Ethical assessment: consent forms

Update the standard clauses in the consent forms (FR/EN).

New proposals for the standard clauses will be presented to the industry during a discussion workshop with our public and private partners. Once approved, the clauses will be translated (FR/EN).

A preliminary workshop took place in November 2018 with our five participating ethics committees, the FRQS, and the MSSS. The new clauses will be presented to the industry in February-March 2019.

Ethical assessment: SOPs for ethics committees

Review the N2 SOPs for ethics committees to ensure they comply with Quebec policies.

The N2 SOPs have been revised to adapt them to Quebec policies.

A discussion workshop took place in November with the FRQS and the MSSS to create, in early 2019, a distribution strategy for Quebec. (FR/EN).

Ethical assessment: 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 for early 2019.

Contract assessment (legal)  

Optimize the contract assessment period.

Several strategies were tested in 2017-2018 and a discussion workshop with our public and private partners is scheduled for early 2019.

Contract assessment (budget)

Establish a reference price list for common clinical research procedures and integrate it into the Nagano system (PLUS module) to facilitate budget negotiations and management of institution-based studies.

After several of our partners anonymously shared their price lists, our public and private partners’ budget experts are now completing a proposed basic reference price list.

Feasibility study

Optimize a study’s feasibility processes.

Pending

Quality assurance support

Conduct inspection simulations in participating institutions.

Pending

Operational Excellence

Summary

Activity

Progress

Network of researchers

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

A discussion workshop is scheduled for December 2018.

Promotion and business development

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

A discussion workshop is scheduled for December 2018.

Collaboration

Summary

Activity

Progress

Canadian

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

Pending