Clinical Trials
Health Canada Regulated Clinical Trial Tools and Templates:
- Clinical Trial Glossary
- Clinical Trial Abbreviations
- Clinical Trial Document Management tool
- Template – Qualified Investigator Undertaking Form (QIU)
- Template – Delegation and Signature Log
- Template – Temperature Monitoring Log
- Template – Concomitant Medication Log
- Template – Note to File
- Template – Letter to GP (Patient is enrolled in a clinical trial)
New Investigators conducting a Health Canada regulated Clinical Trial
Supports for Investigator-Sponsored Clinical Trials
Health Canada Regulated Clinical Trial Required Training:
Good Clinical Practice (GCP)
Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Health Canada requires this training for investigational drug trials phases I-IV, Natural Health Product studies and Investigational Medical Device studies.
Health Canada Division 5 – Drugs for Clinical Trials Involving Human Subjects
Training in Part C, Division 5 of the Food and Drug Regulations is a Health Canada required expectation for investigational drug trials phases I-IV.
Two training options:
- Live (online) via Research Education Program Manager, contact Andrea.dean@nshealth.ca to book a TransCelerate GCP session with Division 5
- Online on your own time: As a member of N2, Nova Scotia Health is pleased to announce the following CITI-Canada courses that are available:
- ICH-GCP
- ICH-GCP Refresher
- Health Canada Division 5
When registering for a CITI account (https://www.citiprogram.org), please ensure that you choose “Nova Scotia Health Authority” for your institution.
Privacy and Research Supports
- Guidance Document: Circle of Care (July 10, 2013)
- Guidance Document: Impracticability (June 26, 2013)
PHIA came into force on June 1, 2013. This legislation, similar to that in existence in other provinces, deals with the collection, use, disclosure, retention, disposal and destruction of personal health information.
PIIDPA came into effect in 2006. It protects privacy by restricting the disclosure of personal information outside Canada, as other countries may not have equivalent data protection laws. Personal information (including participants’ personal health information and researchers’ CVs) may only be stored or accessed outside Canada with the consent of the individual.
Institutional Accreditation Certificates (for Regulated Clinical Trials)
- CH Accreditation Certificate 2010-2013
- CH Accreditation Certificate 2013-2017
- CH Accreditation Certificate Exemplary Standing 2013-2017
- NOVHA Accreditation Status 2015 Letter
- NSHA Accreditation Certificate 2017-2021
- Delegation and Signature Log Template
- Aneroid Sphygmomanometer Maintenance
- BME Requirements for Implementing Technology in the Clinical Research Setting
- ***HPF Compliance with FDA Title 21 Part 11 2014-02-24***
- Letter to FDA regarding Electronic Signature
Health Canada Government Resources
- Biologics, Radiopharmaceuticals and Genetic Therapies
- Compliance and Enforcement
- Drugs and Health Products: Legislation and Guidelines
- Regulations Amending the Food and Drug Regulations Division 5
- Medical Devices
- Natural Health Products
- Clinical Trials: Frequently Asked Questions
- Guide-100
SOP for Sponsors