Resources
Clinical Trials Listings
Granting Agencies
Clinical Trials Regulations
- Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice
- Recording and presentations from the stakeholder engagement sessions held by the Clinical Trials Transformation Initiative (CTTI) on June 4-5, 2020.
Canadian Regulations
- Food and Drugs Act and Regulations
- The Personal Information Protection and Electronic Documents Act (PIPEDA)
- Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans
International Regulations
- ICH Good Clinical Practice (GCP) Guidelines
- USA Food and Drug Administration (FDA) Code of Federal Regulations, Title 21
- Office for Human Research Protection (OHRP), US Department of Health and Human Services
Clinical Research Professionals
Professional Education
- Drug Information Association (DIA)
- Collaborative Institutional Training Initiative (CITI) Program
- NIH Human Research Protections Training
- TCPS2 – CORE (Course in Research Ethics) Tutorial
- Health Canada Division 5, Part C Training
- N2 Health Canada Inspection Survey Results
- ACRP Introduction to Clinical Trials
- NIH Clinical Research Training
- PRIM&R Public Responsibility in Medicine and Research
Standard Operating Procedures
Tools
- Canadian Remote Access Framework for Clinical Trials
- How to write good lay documents and lay summaries:
- Canadian Tissue Repository Network (CTRNet)
- Cancer Care Ontario – Symptom Management Tool
- Common Terminology Criteria for Adverse Events (CTEP CTC/CTCAE) Mapping Document
- NCI Guidelines for Investigators: Adverse Event Reporting Requirements
- CTMS – Edge
- Clinical Research Resources – Purchase Research Reference Guidebook
Informed Consent Form Templates
Protocol Development
- NCI Cancer Therapy Evaluation Program Protocol Templates and Guidelines
- Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)
Professional Associations