Provincial Tools

Data Access for Research

As part of its government mandate, Terra Veris has been tasked by the research branch of governing bodies to support the operationalization of enacted bills on health and social services information.

This mandate, which also mobilizes the public/private experts of the Terra Veris Network, is intended to facilitate and regulate access to health information for research purposes in order to accelerate the development of innovative treatments for the well-being of patients in BC.

As part of this mandate, Terra Veris has been asked to work on the following:

1. Consult with 10 or so health and social services bodies (HSSBs) identified by the governing bodies to (1) assess the current state of access to health information (HI) for research purposes, (2) identify issues to be resolved, and (3) make recommendations prior to implementation. Following meetings, Terra Veris produced an initial consultation report which was submitted to the governing bodies for analysis.

Following submission of the report, a sequential action plan was developed with the governing bodies to (1) identify and plan the different steps required to orchestrate provincial implementation with harmonized processes for accessing HI for research purposes, and (2) provide for continuous improvement of provincial processes based on automated performance indicators.

2. Develop flow diagrams to map the path of an access request for attached researchers and other researchers (private and public) in accordance with the processes outlined in the Act respecting health and social services information. The following flow diagrams were produced:

• Process for requesting access to health information (HI) in accordance with the governing bodies:
  • Which HI process applies to me? To come
  • Access to HI for RESEARCHERS LINKED to an HSSB To come
  • Access to HI for OTHER (PUBLIC) RESEARCHERS To come
  • Access to HI for OTHER (PRIVATE) RESEARCHERS To come

3. Support the governing bodies in the development of common provincial tools to facilitate access to health information for research purposes. The following common provincial tools have been developed for access:

• Privacy Impact Assessment (PIA) form templates
  • Guide for completing the PIA Form and Report – being developed by members of the PIA working committee, made up of representatives and coordinated by the governing bodies

  4. Ensure ongoing consultation with professionals in support of access to HI for research purposes through a Data Advisory Committee comprising the 23 member healthcare institutions of the Terra Veris Network, in order to optimize provincial processes and tools to facilitate research.

  If you have any questions, please contact [email protected].

Regulatory Standards: FDA 1572

Terra Veris and its network of private and public partners have prepared a memo which serves to clarify the requirements for the signing of form FDA 1572 in both BC and the rest of Canada as applicable to clinical trials.

Although signing FDA 1572 is a regulatory obligation and thus a contractual requirement in agreements for sites in the United States that are participating in clinical trials regulated by the Food and Drug Administration (FDA), sites located within BC’s health and social services network must be exempt from this requirement and from the requirements relating to research ethics boards’ composition and operating methods.

Therefore, to maximize compliance requirements, sponsors must proceed in one of the two following ways:

1. 1. When BC sites are listed in the Investigational New Drug (IND) application:

Submit a waiver request pertaining to the signing of FDA 1572 and to the requirements relating to research ethics boards’ composition and operating methods for any such site. (21 CFR 312.

2. When BC sites aren’t listed in the IND application:

Since clinical trials performed in Canada must be conducted according to the principles outlined in ICH BPC E6 and that an inspection of Canadian sites by the FDA may occur, the requirements pertaining to signing FDA 1572 and the requirement relating to research ethics boards’ composition and operating methods would therefore no longer apply to any such site. (21 CFR 312.120)

In both cases, qualified researchers at sites located within the BC health and social services network no longer sign FDA 1572 forms.

Update – Standard Operating Procedures (SOPs) for the Ethical Review of Clinical Research Projects in BC

Terra Veris and its Network of public and private partners have implemented the second version of the REB SOPs. These SOPs are a BC adaptation of the N2 Canada SOPs. The new version, orchestrated by Terra Veris, was developed in collaboration with its Ethics Advisory Committee, composed of about fifteen representatives of Research Ethics Boards (REBs) in the BC Health and Social Services Network, in order to incorporate the latest changes in the regulatory framework. These new SOPs (v2) have been reviewed by the governing bodies to ensure that they meet ministerial requirements.

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If you have any questions, please contact [email protected].

Standards for Ethics Reviews: Informed Consent Forms (ICFs)

Terra Veris and its network of public and private partners have prepared standard wordings for the legal clauses that must be included in the consent forms for clinical trials.

The objective is to use these standard legal clauses in the relevant consent forms by default and thereby improve the efficiency of the process involved in drafting these forms and their approval by the governing bodies’ research ethics boards. Ultimately, the clauses are intended for those who are being asked to participate in clinical trials.

Standards for Evaluating Contracts

Coordinated by Terra Veris, new provincial best practices reference tools aimed at speeding up the evaluation process for clinical research contracts with private companies, have been developed by representatives of the Health and Social Services Network and the Research Department of the governing bodies.

Aimed at pharmaceutical companies wishing to conduct clinical trials in BC, the Statement on optimizing contract negotiation processes confirms the regulatory requirements applicable in the institutions. It now includes the new provisions of the French Language Charter.

The Statement also suggests the use of a provincial model confidentiality agreement (mCDA) and a pan-Canadian model clinical trial agreement (mCTA), which will be accepted as is if used without modification by the private company.

The Terra Veris Network also developed a memo to clarify the responsibilities of stakeholders in the context of activities carried out in participants’ homes.

For more information, please contact [email protected].

Clinical Research Training

CITI-Canada Training

Terra Veris is proud to partner with N2 Canada to offer Terra Veris network member health institutions free access to a shared training platform designed to ensure the conduct of high-quality research. Through N2 Canada, institutions have access to the CITI-Canada (Collaborative Institutional Training Initiative) training platform.

Terra Veris is now N2 Canada’s new provincial representative; we will actively participate in various panCanadian activities, including organizing regional events with N2 Canada.