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Public Comments on the Proposed Changes to TCPS 2 ( 2014)

Public Comments on the Proposed Changes to TCPS 2 ( 2014)

In October 2016, the Panel on Research Ethics released proposed changes to TCPS 2 (2014) to the public for comment. Written comments were accepted until January 31, 2017. All comments received have been posted to the Panel’s website unless the contributor requested that they remain confidential.

This valuable feedback will now be taken into consideration as the Panel and Secretariat prepare recommendations to the federal research Agencies (CIHR, NSERC and SSHRC) that are responsible for approving revisions to TCPS 2 (2014).

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Release of CCTCC REB Accreditation WG Final Recommendations & Joint Response by CCTCC & Health Canada

The purpose of this message is to introduce the CCTCC REB Accreditation WG’s Final Recommendations (FRs), and the joint response by the CCTCC and Health Canada (HC) to the FRs.
The full package is available HERE.

CCTCC REB WG FRs:

There are seven FRs in total, aimed at ensuring Canada’s REB competitiveness on a global scale. FR#7, which calls for the establishment of a National Strategic Leadership Forum, is seen as the foundation of the other FRs. The FRs are based on data collected through interviews with key stakeholders in the Canadian and US REB fields as well as consultations and feedback provided by key REB stakeholders in Canada.

Background:

The CCTCC REB Accreditation WG was established in 2015, in collaboration with Health Canada, to identify strategies to improve efficiencies of ethics reviews and advance strategic issues like accreditation in regards to clinical trials. The establishment of the WG is consistent with Recommendation #4 of the Action Plant to Help Attract More Clinical Trials to Canada as well as Recommendation #3 of the Senate Report entitled “Canada’s Clinical Trials Infrastructure: A prescription for Improved Access to New Medicines”.

Given the REB centralization and harmonization initiatives that have been taking place across Canada, the WG, as stated in their Interim Report (IR), did not see formal accreditation scheme as a given. The IR’s key recommendations called for investigating the:

  • impact of these provincial initiatives
  • models of review being adopted by these initiatives,
  • standards and metrics currently being applied to REB operations (in Canada and USA)

The WG proceed with addressing the IR’s recommendations which resulted in the presented/attached FRs.

The contents of the full package include:

  1. Summary of the FRs and joint response by CCTCC and HC
  2. Full text of the FRs
  3. SPOR SHRER Report Committee recommendations – in fulfillment of FR I

CCTCC and Health Canada wish to express their profound gratitude to the members of the REB Accreditation Working Group (WG) and specifically the chair of the WG – Laurel Evans and the co-chair Karine Morine for their continued dedication and invaluable efforts in making the attached report a reality.

Please direct any questions to Elena Aminkova, Interim Director of Project Facilitation, CCTCC by emailing eaminkova@cctcc.ca

Results of “Good Clinical Practices” Health Canada inspections now posted on public database

As part of Health Canada’s (HC) commitment to regulatory transparency, information on all clinical trial inspections performed in Canada will be published by December 11, 2015 in Health Canada’s existing Drug and Health Product Inspections Database.

The database will include three main elements:

Lists of Inspections

  • A list of all Good Clinical Practices inspections conducted since January 1, 2012 to present will be included within the database.  The list includes general information such as sponsor name, date of inspection and rating.

Initial Inspection Deficiencies

  • The Initial Inspection Deficiencies provide a preliminary overview of the inspection findings and are published within 3 days of the inspection.  Initial Inspection Deficiencies will be published for all inspections which occur after the launch of Good Clinical Practice inspections in the database.

Inspection Report Cards: The Inspection Report Cards offer plain language summaries of inspections.  They are published within 30 days of the inspection and will include the following:

  • information identifying the sponsor and drug name
  • date of the inspection
  • trial phase
  • region of the site inspected
  • inspection type
  • inspection rating
  • observations made by the inspector
  • measures taken by Health Canada.

Inspection Report Cards will be published for all inspections conducted on or after September 15, 2015.

Inspection Report Cards will be published for any inspection conducted between January 1, 2012 and September 15, 2015 that received a non-compliant rating.
If you have inquiries about this initiative, please contact Health Canada at the following e-mail address: gcp_bpc@hc-sc.gc.ca

Further information about Health Canada’s Regulatory Transparency and Openness Framework can be found here.

Health Canada Consultation Survey for Bill C-17 Transparency Measures: open to May 25, 2015

Health Canada is requesting feedback from healthcare professionals, patients/family, researchers, pharmacists, data managers, and the general public regarding how therapeutic product information is disseminated as part of Bill C-17.

To participate in this survey click here, or go to the following Health Canada website and select “Consultation Document” under “How to Get Involved”. This consultation process is open until May 25, 2015 and will take only 5 minutes of your time.

Bill C-17 introduced new transparency measures for therapeutic products, including:

  • an obligation on therapeutic product authorization holders to make required information about their clinical trials publicly available on a website;
  • an obligation on the Minister of Health to make publicly available all orders issued with respect to therapeutic products and positive and negative regulatory decisions; and,
  • an authority for the Minister of Health to disclose confidential business information in certain circumstances.