For Researchers

Resources

COVID-19 Resources for Clinical Trial Centres

3CTN has compiled a list of COVID-19 clinical research resources to assist sites in managing and navigating clinical trials during this challenging time: 

• General
  • Network of Networks provides central links to Canadian/US regulatory COVID-19 guidelines, links to information and materials provided by provincial clinical research organizations.
  • ASCO Survey on Early Impact of COVID-19 on the Performance of Oncology Clinical Trials
  • Interim Order Respecting Clinical Trials for Medical Devices and Drugs Relating to COVID-19
  • Rethinking cancer clinical trials for COVID-19 and beyond
• Research Ethics Board Guidance
  • Canadian Association of Research Ethics Board provides a collective resources for institutional research ethics boards
  • Central Institutional Review Board for the National Cancer Institute
• Funding Opportunities
  • Launch of Operating Grant: COVID-19 Rapid Research Funding Opportunity 
  • Canada Research Continuity Emergency Fund

Clinical Trials Listings

• CanadianCancerTrials.ca
• 3CTN Portfolio 
• ClinicalTrials.gov
• International Cancer Genome Consortium

Granting Agencies

• Canadian Institutes of Health Research

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

• Network of Networks – Clinical Research
• SOP Impact Assessment Procedure
• SOP Start Up Procedures

Tools

• Canadian Remote Access Framework for Clinical Trials
• How to write good lay documents and lay summaries:
  • NIHR Involve Resources 
  • NIHR Involve Plain English Summaries 
  • Clinical and Translational Radiotherapy: How to write a good lay summary
  • CIHR Jargon Buster glossary 
• 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

• NIH National Cancer Institute Informed Consent 
• Clinical Trials Ontario Tools and Resources

Protocol Development

• NCI Cancer Therapy Evaluation Program Protocol Templates and Guidelines
• Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 

Professional Associations

• ACRP: Association of Clinical Research Professionals
• SoCRA: The Society of Clinical Research Associates
• CANO: Canadian Association of Nurses in Oncology