Resource Library

Explore essential documents and educational resources to help you conduct high-quality research.

Overview

Controlled documents are official, regularly updated records such as Standard Operating Procedures (SOPs) and guidelines that ensure clinical trial activities are conducted consistently and in compliance with regulations.

How to adopt controlled documents

All regulated studies must follow Standard Operating Procedures (SOPs) to ensure quality and consistency. SOPs are adopted by sponsors and sites to control their conduct, supported by detailed work instructions and study manuals that guide day-to-day tasks.

How to adopt SOPs for your study:

Electronically: Use a system like RealTime CTMS to sign and track all applicable SOPs with one click. The system automatically logs signatures, dates, and any changes.
Paper-based: SOPs can be adopted at the study, Qualified Investigator (QI), or research group level. Print and file relevant SOPs in your binder. Sign an index in the site binder to track adopted SOPs and any version changes during the study.

Examples of required SOPs:

Informed consent process
Adverse event reporting
Drug storage and accountability
Handling biological samples
Equipment maintenance
Staff training
Study monitoring
Record retention

Only adopt SOPs relevant to your study, and keep documentation up to date for regulatory review. Work instructions and study manuals can help your team follow SOPs in daily practice.

How to provide feedback

BC Cancer maintains its own institution-specific SOPs, while all other PHSA sites adopt a hybrid set consisting of national N2 and institution-specific SOPs. All SOPs are reviewed and updated every two years and are regularly monitored for suitability.

Keeping our SOPs effective and relevant is a team effort. Please let us know about any planned deviations or addendums when implementing these SOPs. Your feedback helps us identify trends, assess where SOPs are not working, and determine if custom SOPs are needed for specialized departments.

Please submit SOP deviations, addendums, feedback, or requests for new documents via the Controlled Document Feedback Form.

For questions or suggestions, contact the PHSA Quality Team.

Change log

Effective Date	Change	Release Note
15-Sep-2025	RealTime CTMS new document set released, migrated to eQMS (SOP-SYS-001; WIN-SYS-001 to -007; FRM-SYS-001 to -008)	15-Aug-2025

Other important information

There are three levels of documents that guide study conduct:

Standard Operating Procedures (SOPs): Broad, high-level procedures that provide the guardrails on what to do, rigorously reviewed to ensure compliance with regulations.
Work Instructions: Detailed, step-by-step instructions created by teams to direct personnel on how to complete daily tasks within SOP guardrails.
Study Manuals: Study-specific instructions covering protocol details from recruitment to completion, often referencing work instructions.

After SOP training, research staff should be able to follow the study manual and work instructions for day-to-day activities, using forms and other tools as needed.

Documents

Browse key clinical research documents, with links that will take you to PHSA on Demand (POD) where you can log in with your institutional credentials.

Can't find what you're looking for? Contact the PHSA Quality Team

Policies & memos

Policy:

LR2 UBC Research Policy
LR9 UBC Research Involving Human Participants
C-99-11-20355 PHSA Privacy Management & Accountability

Memorandum:

Monitor/Auditor Access to Electronic Medical Records

Clinical Trial Management System (CTMS)

SOP-SYS-001 Use of RealTime Clinical Trial Management System

WIN-SYS-001 RealTime CTMS New Site Activation
WIN-SYS-002 RealTime CTMS User Account Management

FRM-SYS-001 User Onboarding Form
FRM-SYS-002 User Training Form
RealTime CTMS Introductory Training for Coordinators
RealTime CTMS Introductory Training for Investigators

WIN-SYS-003 RealTime CTMS Study Activation and Maintenance

FRM-SYS-003 New Study Request Form
FRM-SYS-004 Template and eSOURCE Request Form

WIN-SYS-004 RealTime CTMS Support and Maintenance

FRM-SYS-005 System and User Audit Form
FRM-SYS-006 Site Contacts Form

WIN-SYS-005 RealTime CTMS Downtime Procedures

FRM-SYS-008 Downtime Procedures Form

WIN-SYS-006 RealTime CTMS Privacy Breach Management
WIN-SYS-007 RealTime CTMS Monitor Access

FRM-SYS-007 Monitor Access Form

Quality management

SOP-QMS-001* Controlled Document Management

GUI-QMS-001 Controlled Document Management Guide
FRM-QMS-001 PHSA Clinical Research Glossary of Terms
FRM-QMS-002 Controlled Document Internal Update Notification Form
FRM-QMS-003 SOP Adoption Record and Index Form
FRM-QMS-004 Controlled Document Feedback Form
TEM-QMS-001 Work Instruction Template
TEM-QMS-002 Controlled Document Form Template

SOP-QMS-002* Clinical Research Training Program

GUI-QMS-002 Clinical Research Training Guide
FRM-QMS-005 Clinical Research Individual Training Log
FRM-QMS-006 Clinical Research Group Training Log
TEM-QMS-003 Onboard Training Checklist Template
TEM-QMS-004 Clinical Research Training Tracker Template

SOP-QMS-003 Deviation Reporting and Internal Investigation

FRM-QMS-007 Deviation and Investigation Report Form

SOP-QMS-004 Corrective and Preventative Action (CAPA)

FRM-QMS-008 CAPA Report Form

SOP-QMS-005 Clinical Trial Assessment Program (CTAP)

FRM-QMS-### CTAP Confirmation Letter
FRM-QMS-### CTAP Agenda
FRM-QMS-### CTAP Report
FRM-QMS-### PHSA CTAP Certificate

SOP-QMS-006 Vendor Qualification and Surveillance

*preview for comment

Investigative site: clinical trial conduct

SOP-CLN-001 Escalation

SOP-CLN-002 Certified True Copy

N2 Guideline: Provision of N2 SOPs for Sponsors

N2-SOP-001 Administrative Management by Network of Networks

N2-SOP-002 Research Team Roles and Responsibilities

GUI-CLN-001 Site Staff Offboarding Guide
FRM-CLN-001 Clinical Research Delegation Log

N2-SOP-003 Research Team Training

GUI-CLN-002 Transportation of Dangerous Goods (TDG) Training and Certification Guide
FRM-CLN-003 TDG Competency Assessment Checklist
FRM-CLN-004 TDG Ground and Air Certificate
FRM-CLN-005 TDG Recertification Checklist

N2-SOP-004 Clinical Research Protocol Feasibility and Site Selection

N2-SOP-005 Site Preparation for Study Initiation

N2-SOP-006 Informed Consent Form & Assent Form Management

N2-SOP-007 Research Ethics Board: Submissions and Ongoing Communications

N2-SOP-008 Informed Consent Process

N2-SOP-009 Participant Recruitment and Screening

N2-SOP-010 Management of Investigational Product

FRM-CLN-006 CW Site Cannabis IP Collection Log

N2-SOP-011 Management of Biological Specimens

N2-SOP-012 Adverse Event / Drug Reaction Documentation, Assessment and Reporting

N2-SOP-013 Study Monitoring and Communication

FRM-CLIN-008 Monitoring Visit Log

N2-SOP-014 Clinical Data Management

N2-SOP-015 Investigator Study Files and Essential Documents

GUI-CLN-003 Data Storage and Archiving Guide
FRM-CLN-002 Note-to-File (NTF)
FRM-CLN-007 Study Archive Form
FRM-CLN-009 Protocol Deviation Log

N2-SOP-016 Study Close-Out

N2-SOP-017 Audits and Inspections

N2-SOP-018 Clinical Trial Application (Drugs)

N2-SOP-019 Confidentiality and Privacy

N2-SOP-023 Clinical Trial Application (Natural Health Products)

N2-SOP-024 Investigational Testing Authorization (ITA) for Medical Devices (non-IVDD) and Clinical Site Obligations

N2-SOP-025 Equipment Calibration and Maintenance

Investigator-initiated study: sponsor conduct

N2-SOP-100 Case Report Form Design

N2-SOP-101 Study Analysis and Reporting

N2-SOP-102 Protocol Development

N2-SOP-103 Data Management Plan

N2-SOP-104 Database Set-up

N2-SOP-105 Database Maintenance and Management

N2-SOP-106 File Transfer

N2-SOP-107 Database Lock and Archiving

N2-SOP-108 System Setup, Maintenance, and Security

N2-SOP-109 System Backup and Recovery Planning

FRM-IIT-001 Investigator-Initiated Trial (IIT) Acknowledgement and Agreement

FRM-IIT-002 Health Canada CTA Sign-off Checklist

FRM-IIT-003 Health Canada ITA Sign-off Checklist

Health Canada guidance

GUI-100 Guidance Document: Part C, Div 5 of the Food and Drug Regulations "Drugs for Clinical Trials Involving Human Subjects"

GUI-0043 Health Canada Risk classification guide for observations related to inspections of clinical trials of human drugs

FRM-0234-01 Health Canada Notice of clinical trial inspection letter - Qualified Investigator
FRM-0450 Health Canada Clinical trial inspection checklists

CIOMS Adverse Reaction Reporting Form

Health Canada CIOMS Form Guidance

HC Form 01-03 Health Canada Adverse Drug Reactions (ADRs) for Clinical Trials Expedited Reporting Summary Form

Health Canada Safety Reporting Guidance

Education

PHSA's vibrant clinical research community shares knowledge, supports each other, and inspires excellence in patient-focused healthcare.

Educational videos

Understanding Clinical Trials:

Content Editor ‭[2]‬

Best Practices in Data Management:

Content Editor ‭[3]‬

Community of practice

PHSA RealTime Clinical Trial Management System (CTMS) Working Group meets monthly to discuss the latest system updates and to share best practices for CTMS use. Contact Mary to join.

BC Children's & Women's Hospitals Clinical Trials Community of Practice peer-led group meets monthly to support knowledge-sharing across clinical trial teams. Contact Alecia or Grace to join.

BC Cancer quarterly ASK QA sessions help clinical researchers navigate regulated clinical trials. Contact Mary to join.

Cultural competence

N2 Cultural Competency Self-Assessment Checklist

N2 Cultural Competency Skills in Clinical Research course available at no cost to PHSA-affiliated researchers, accessible via Dual Code.

Indigenous Data Governance Frameworks:

CIHI Respectful Governance of Indigenous Data
First Nations Principles of OCAP
Metis OCAS Governance Practices
Inuit Principles of Qaujimajatuqangit

Quality office hours

Clinical Trial Quality Team Office Hours (virtual) are held every Friday from 2-3pm. Drop in with your questions - no appointment required! The first Friday of each month features a special theme. Contact clinicaltrials@phsa.ca for the Zoom link.

2025 Themes and Presentations:

Collecting Clinical Trial Metrics (September)
Serious Adverse Event (AE/SAE) Reporting (August)
Quality Management Overview - Deviations/CAPA (July)
Gender Inclusive Language in Research (June)
Equipment Calibration and Maintenance (May)
Investigator Site File (April)
Training Requirements for Research (March)

Regulatory compliance

Did you know monitoring is a Health Canada requirement for regulated clinical trials?

Learn more about PHSA Clinical Trial Monitoring

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