Quality Assurance

Clinical Research conducted at Women’s College Hospital (WCH) should be carried out using sound research design; according to approved protocol; the terms of the grant(s) (if applicable); contract(s) and/or other pertinent written agreement(s); standard operating procedures (SOPs); applicable laws and regulations and protecting the rights, safety, and welfare of research participants.

Role of Quality Assurance Office

The Women’s College Hospital Research and Innovation Institute Quality Assurance office ensures that clinical research is conducted at the institution following the applicable policies, international standards, and applicable regulations. This is done by providing education and training for research staff, creating Standard Operating Procedures (SOPs) and templates, overseeing clinical trial monitoring, and conducting routine audits. Below is the list of activities that the quality assurance office supports (this is not an exhaustive list).

Drafting and Renewing Monitoring Plans for investigator-initiated trials
Conducting budget review for externally sponsored trials
Managing the Freezer room for research freezers
Assisting with Health Canada regulated trial applications (CTAs/ITAs)
Answering regulatory queries
Activating clinical trials at WCH
Conducting Internal audits
Providing support during Health Canada inspections
Providing support during external sponsors’ audits
Managing institutional SOPs
Creating standard research activity templates
Managing ClinicalTrials.gov registry
Organizing Research Best Practice sessions (CoRP)

Training Requirements

All staff, trainees, and investigators who wish to conduct research involving human participants at Women’s College Hospital must complete the following web-based courses:
• Good Clinical Practice (GCP)
• Responsible Conduct of Research (RCR)
• Basic Biomedical Research Ethics
• Health Canada Division 5 (Only mandatory for those conducting Health Canada Regulated clinical trials)
Please note these courses are not available on the Women’s College Hospital eLearning system. They must be completed through the CITI PROGRAM New users will be required to create an account with the CITI Program and will be prompted to select their Organization Affiliation –Women’s College Hospital (N2), and add the required courses to their account from the Learner Tools for Women’s College Hospital.

Research SOPs

Effective May 19, 2021, The Women’s College Hospital Research and Innovation Institute adopted the entire Network of Networks (N2) Standard Operating Procedures (SOPs) set. The N2 SOPs have been developed to reflect a national standardized set of operating procedures that are applicable to any therapeutic area.

Numerous Health Canada Inspections attest to the fact that sites using the N2 SOPs are deemed to be compliant with the regulations. These SOPs are externally reviewed by an independent expert every two years or sooner. This independent expert has attested in writing that the SOPs are compliant with Health Canada and US Food and Drug (FDA) regulations, the ICH-GCP Guidelines, including the current changes to ICH-E6 (R2) guidelines, and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects.

These SOPs should be used for all regulated clinical trials at WCH and by all research staff as applicable. In addition to N2 SOPs, the institution also publishes additional institute specific SOPs.

Institutional SOPs can be found here.

Research Operations Freezer

The research freezer room is located at 76 Grenville St on 7th floor room 7303. The room remains locked at all the time and access is controlled by an electronic lock system. Access to the freezer room is managed by the Clinical Research and Quality Assurance Specialist and access request is approved by the Manager, Academic Operations and Solutions.

The guideline for management of the freezer room and Research Operations freezer is outlined in the SOP “Ultra-Low Temperature Freezer Management in the Research Freezer Room”.

Community of Research Practice (CoRP)

CoRP events are organized monthly for the WCH Research community. This group event is usually hosted every third Thursday of the month. CoRP sessions create a common platform and provide opportunities for research staff to learn from fellow research staff and share their knowledge and experience.

Some of the recent topics discussed in CoRP are:

How to document and verify research staff qualification and training in clinical research? What are the PI’s responsibilities while delegating task to a research staff?

What are the best practices in writing Informed Consents? How is this done at WCH?

What is Good Documentation Practice? How to properly document research activities done at WCH?

How to identify and document protocol deviations? When and how to use CAPAs and Note to Files?

What are the Essential Documents in Research? How to maintain a Trail Master File?

The Clinical Research and Quality Assurance Specialist, Sarker Faisal, circulates invitations each month with the chosen topic. Research staff are also encouraged to contact Sarker Faisal with any concerns in research practice and with their interest in clinical research-related topics.

FAQs

Research teams are encouraged to use the institution specific research tools and templates when conducting research initiated by the WCH investigators. Research team can use the sponsor provided tools when research is sponsored by an external institution. Network of Networks (N2) online tools are also a good resource for research tools and templates.

Please see the clinical research tools and templates at this link.

A data management plan (DMP) is a formal document that outlines a researcher’s strategy for managing their research data during and after a project.

Creating a DMP can help with

Making decisions about managing data and understanding the implications of those decisions.
Identifying resources and tools needed for research.
Estimating costs for resources and tools and budget accordingly
Anticipating and mitigating potential issues such as, data loss, duplication of effort, and security breaches.
Ensuring clear understanding among all members of the research team regarding data management procedures

It is recommended that all researchers at WCH planning to generate scientific data should prepare a Data management Plan that describes how the scientific data will be managed and if applicable, shared.

There are several tools available in the internet free to use while creating a DMP. University of Toronto online library has some great tools and so is National Institute of Health (NIH). NIH Website also has some sample plans. Below are the few tools most frequently used:

Data Management Plan (DMP) – Planning Checklist – this checklist can be used to ensure you’ve included all relevant information in a DMP or to help you gather information you will need to complete your DMP.
Data Management Plan (DMP) – Question Guide – this guide includes prompting questions and guidance to help you develop a DMP.
Data Management and Sharing Plan Format: DMP writing format recommended by the NIH.

If the clinical research study is not regulated, it is encouraged to follow the N2 SOPs as closely as feasible for best practice purposes.

Study teams may grant Sponsors/CROs access to view these SOPs during onsite monitoring visits. Copies of the SOPs are not distributed when onsite CRO/sponsor visits are feasible.
These SOPs are externally reviewed by an independent expert every two years or sooner. This independent expert has attested in writing that the SOPs are compliant with Health Canada and US Food and Drug (FDA) regulations, the ICH-GCP Guidelines, including the current changes to ICH-E6 (R2) guidelines, and the revised Canadian Tri-Council Policy Statement on Research Involving Human Subjects.

N2 SOP training can be completed using the REDCap Quiz. Rest of the institutional SOP training should be documented using a training documentation template available on the intranet.

To complete N2 SOP training and access REDCap Quiz, please go to the WCRI Intranet.

As per Tri-council Policy Statement: Ethical Conduct for Research Involving Humans – TCPS 2 (2022) Article 11.10 “All clinical trials shall be registered before recruitment of the first trial participant in a publicly accessible registry that is acceptable to the World Health Organization (WHO) or the International Committee of Medical Journal Editors (ICMJE).”

Clinical trial registries are intended to increase transparency and accountability by providing a record of clinical trials at the recruitment stage that can be used to locate publication of trial results. This helps prevent publication bias, that is, the selective publication of only those trials that yield results in support of an intervention.

Clinical trial means any investigation involving participants that evaluates the effects of one or more health-related interventions on health outcomes. Interventions include, but are not restricted to, drugs, radiopharmaceuticals, cells and other biological products, surgical procedures, radiologic procedures, devices, genetic therapies, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies. Clinical trials may also include questions that are not directly related to therapeutic goals (e.g., drug metabolism) in addition to those that directly evaluate the treatment of participants.

Women’s College Hospital uses ClinicalTrials.gov PRS to register trials publicly. It is the WCH investigator’s responsibility to ensure applicable trials are registered in this Registry. Research team must contact the Clinical Research and Quality Assurance Specialist, Sarker Faisal, to create an account with the ClinicalTrails.gov Protocol Registration and Result System.

Pharmaceutical Drugs / Biological Drugs / Radiopharmaceutical Drugs
Clinical Trial Applications (CTAs) must be filed with Health Canada in order to conduct clinical trials in Phases I through III of drug development and comparative bioavailability trials.
This includes trials involving marketed drugs, where the proposed use of the product is outside the parameters of the approved Notice of Compliance (NOC) or Drug Identification Number (DIN) application.
For example, one or more of the following is different:

indication(s) and clinical use
target patient populations(s)
route(s) of administration
dosage regimen(s).

It is not required to file a CTA for a clinical trial involving a marketed drug where the investigation is to be conducted within the parameters of the approved NOC or DIN application. This type of trial is referred to as a Phase IV clinical trial.

Natural Health Products (NHPs)

A CTA must be filed with Health Canada in order to conduct a Phase I, II, or III clinical trial for an NHP or a comparative bioavailability study to evaluate the pharmacokinetics of two NHP formulations in healthy volunteers.
This includes trials involving NHPs approved by Health Canada but used outside the parameters of their approved conditions of use.
“Within approved conditions of use” means that the product is being used as per the product label approved by Health Canada. The product is considered approved by Health Canada if has a Natural Product Number (NPN), Drug Identification Number (DIN), or Drug Identification Number for Homeopathic Medicine (DIN-HM).

Medical Devices

An Investigational Testing Authorization (ITA) application is required for all unlicensed class II, III, and IV medical devices that will be imported and/or sold in Canada for the purpose of investigational testing involving humans.
The study does NOT need to be a clinical trial for an ITA to be required.
For example: If an unlicensed Class II, III or IV medical device is used to analyze biological specimens within the context of an observational study an ITA would be required. The device would be likely be classified as an in vitro diagnostic device (IVDD)
Software can be considered a medical device.

Whether an ITA is required can be determined thorough this flowchart.

For any questions related to clinical trial application please contact Sarker Faisal, Clinical Trials & Quality Assurance Specialist – Sarker.Faisal@wchospital.ca.