Resource Library

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

Documents

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.

Adopting 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.

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.

Providing feedback on controlled documents

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.

Document types explained

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.

Change log

Effective Date	Change	Release Note
01-Apr-2026	Release of Set 1: PHSA Clinical Research Controlled Documents	05-Mar-2026
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

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.

Policies & Memos

Policies:

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

Memorandum:

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 (under development)
FRM-QMS-001 PHSA Clinical Research Glossary of Terms
FRM-QMS-002 Controlled Document Internal Update Notification Form (QA use only)
FRM-QMS-003 SOP Adoption Record and Index Form
FRM-QMS-004 PHSA Clinical Research 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

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

FRM-QMS-008 CAPA Plan
FRM-QMS-009 CAPA Implementation and Verification

SOP-QMS-005 Trial Assessment Program (under development)

SOP-QMS-006 Audit Program

FRM-QMS-010 Audit Confirmation Letter (QA use only)
FRM-QMS-011 Audit Agenda (QA use only)
FRM-QMS-012 Audit Report (QA use only)
FRM-QMS-013 Audit Certificate (QA use only)

SOP-QMS-007 Service Provider Qualification and Surveillance (under development)

Investigative site: clinical trial conduct

SOP-CLN-001 Escalation (under development)

SOP-CLN-002 Transfer of Records to Secondary Medium (under development)

SOP-CLN-003 Satellite Site Qualification and Initiation (under development)

N2 Guideline: Provision of N2 SOPs for Sponsors

N2-SOP-001 Standard Operating Procedure (SOP) Administrative Management by Network of Networks

N2-SOP-002 Research Team Roles and Responsibilities

GUI-CLN-001 Site Personnel 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 Air and Ground Certificate
FRM-CLN-005 TDG Recertification Checklist

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

FDA 1572: Guidance and Support Tools (zip folder)

N2-SOP-005 Site Preparation for Study Initiation

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 Products

FRM-CLN-006 CW Site Cannabis IP Collection Log (under development)
Device Accountability 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

N2-SOP-014 Essential Records and Source Records Management

FRM-CLN-002 Note-to-File (NTF)
FRM-CLN-008 Protocol Deviation Log

N2-SOP-016 Study Close-Out and Archiving

GUI-CLN-003 Data Storage and Archiving Guide
FRM-CLN-007 Study Archive Form

N2-SOP-017 Audits and Inspections

N2-SOP-019 Confidentiality and Privacy

N2-SOP-025 Equipment and Device Fitness for Purpose

Investigator-initiated study: sponsor conduct

N2-SOP-110 Sponsor Roles and Responsibilites

FRM-IIT-001 Investigator-Initiated Clinical Trial Acknowledgement and Agreement

N2-SOP-111 Study Design

N2-SOP-112 Informed Consent Form and Assent Form Development (under development)

N2-SOP-113 Quality Risk Management

N2 Risk Management Tool - Study Level

N2-SOP-114 Regulatory Applications

FRM-IIT-002 Health Canada CTA Review Checklist
FRM-IIT-003 Health Canada ITA Review Checklist

N2-SOP-115 Study Contracts and Budgets

N2-SOP-116 Investigational Product

N2-SOP-117 Sponsor Electronic Systems

N2-SOP-118 Study Database

N2-SOP-119 Essential Records (under development)

N2-SOP-120 Sponsor Oversight, Monitoring, and Audits (under development)

N2-SOP-121 Safety Assessment and Reporting (under development)

N2-SOP-122 Study Analysis and Reporting

N2-SOP-123 Study Close-Out and Archiving

N2-SOP-124 Investigational Medical Devices (under development)

PHSA monitoring program

The following monitoring program SOP, forms, and templates are available to sponsors who have contracted monitoring services with PHSA Clinical Trial Support Services. Support in developing the study monitoring document package is available.

SOP-ISP-001 PHSA Monitoring Program

TEM-ISP-001 Monitoring SOW Template
TEM-ISP-002 Monitoring Plan Template
TEM-ISP-003 Site Initiation Visit Report Template
TEM-ISP-004 Interim Monitoring Visit Report Template
TEM-ISP-005 Close-Out Visit Report Template
FRM-ISP-001 Site Qualification Visit Confirmation Letter
FRM-ISP-002 Site Qualification Visit Checklist
FRM-ISP-003 Site Qualification Visit Report
FRM-ISP-004 Site Qualification Visit Follow-up Letter
FRM-ISP-005 Site Initiation Visit Confirmation Letter
FRM-ISP-006 Site Initiation Visit Follow-up Letter
FRM-ISP-007 Site Activation Letter
FRM-ISP-008 Interim Monitoring Visit Confirmation Letter
FRM-ISP-009 Interim Monitoring Visit Follow-up Letter
FRM-ISP-010 Close-Out Visit Confirmation Letter
FRM-ISP-011 Close-Out Visit Follow-up Letter
FRM-ISP-012 Site Close-out Letter
FRM-ISP-013 Site Warning Letter
FRM-ISP-014 Site Suspension or Termination Letter

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
FRM-0523 Clinical trial compliance readiness inspection checklist

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

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

For convenience, you may also download a zip folder containing all Set 1 PHSA Controlled Documents (effective 01Apr2026, last updated 05Mar2026).

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.

Education

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

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 and BC Women's clinical trials community of practice peer-led group meets monthly to support knowledge-sharing across clinical trial teams. Contact Alecia 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! First Friday of each month features a special theme. Contact clinicaltrials@phsa.ca for Zoom link.

2025 Themes and Presentations:

Cerner EMR for Research (November)
Archiving Clinical Trials (October)
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

Glossary of terms

There are a lot of acronyms in clinical research!

Please refer to our PHSA Clinical Research Glossary of Terms for a complete list of terms and definitions.

CANTRAIN also maintains a searchable Clinical Trial Glossary of key terms and concepts in clinical research. This resource offers clear, concise definitions of essential terminology, including regulatory, ethical, and procedural language commonly used in clinical trials. Regularly updated to reflect evolving industry standards.

Videos

Educational videos to support better research, quality improvement, and patient care practices. Need custom content? We can help create videos tailored to your needs.

Understanding Clinical Trials

An overview of clinical trials, why they matter, and how they're integrated into care at PHSA. Learn how patients benefit from the latest advances while contributing to global health, and see how you can be part of this important journey!

Best Practices in Data Management

Discover best practices in data management and why they matter for research, quality improvement, and patient outcomes. Learn how strong data practices - like accurate collection, secure storage, and clear governance - support better care and continuous improvement. Want a training certificate? Watch the video and pass the quiz in BCCHR's Best Practices in Data Management 101 Course.

Culturally Sensitive Demographic Data Collection

Explore respectful, inclusive approaches to collecting information on Indigenous identity, race, ethnicity, and preferred language - supporting equity and enhancing patient care.

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

Learn more about PHSA Clinical Trial Monitoring

Informed Consent

A series of videos from BC Children’s & Women’s Hospitals Research Institutes explaining the informed consent and assent process for research. Follow a real-world example using the C&W biobank to learn best practices and helpful tips to ensure participants fully understand and voluntarily agree to take part in studies.

In addition to watching these training videos, researchers are encouraged to complete TCPS2 CORE and the CANTRAIN Ethics & Informed Consent module.

Want a training certificate? Watch the videos and complete mock consent via BCCHR's Informed Consent Training Pathway (~3 hours).

Consent Gone Wrong (6 mins)

Consent Done Well  (14 mins)
Assent Gone Wrong  (3 mins)
Assent Done Well  (5 mins)
Informed Consent Tips  (7 mins)

Personalized Cancer Care

BC Cancer conducts leading-edge research using intensive genomic data collection and analysis to identify and better understand the genomic alternations that drive cancer growth, metastasis, and response to therapies.

Learn more about the Personalized OncoGenomics (POG) Program through a series of videos featuring impactful patient stories.

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Conducting Research at PHSA