Start-up kit for clinical research

The purpose of this toolkit is to collate resources and templates that may be required in order to prepare a clinical trial site that is conducting regulated research, i.e. a trial requiring prior approval by Health Canada before the study can be permitted to begin in FHA, for start-up.

All studies require a certificate of approval from the Fraser Health Research Ethics Board (FHREB) and the Letter of Authorization to Conduct Research from the Department of Evaluation and Research Services for FHA before research is permitted to begin in FHA.

The toolkit is organized into 10 sections. Each section includes several sub-sections that provide specific resources and other tools that are available as separate attachments. Specific references used for the toolkit components are cited on each document.

For any questions, problems accessing the resources or suggestions for revisions, please contact Susan Chunick, Director, Department of Evaluation and Research Services.

Glossary

Alternate Word Glossary
A glossary for lay terms to medical terminology. The glossary can be used to improve the readability of your informed consent form by following the principles of plain language, including replacing difficult words with easier ones. This document adopted from the University of Western Ontario's Health Sciences Research Ethics Board.
Key Definitions
Definitions of words/phrases commonly used in Research Ethics
Acronyms
A compilation of acronyms commonly used in Research Ethics

Getting Research Started in Fraser Health

Information Management Guidelines
Explains how to obtain information management support (for FHA employees/physicians only)
Parking Pass
Explains how the parking pass can be requested through Protection Services (for FHA employees/physicians only)
Orientation For FHA Employees/Physicians
Explains how to access the on-line orientation program required for all new employees
Professional Development for FHA Employees/Physicians
Link to professional development opportunities and networks

Employee Resources

Department of Evaluation and Research Services
The link to the FH Department of Evaluation and Research Services website.

Office of Health Sciences and Innovation (HS&I)
The Office HS&I at Surrey Campus works with Surrey-based Investigators to initiate research and build research capacity.

  • Telephone #: 604-585-5666 ext. 773251

Finance

Study Budget Template
Template to construct a new study budget or as a guide to format existing study budget spreadsheets.
Clinical Trials Agreement (CTA)
FHA DERS process for initiating and completing a CTA.
Site Administration Form
Site Administration Form’ that must accompany all CTA submissions from the site to DERS.
Lab Services
(FHA employees/physicians only) For ‘Request for Clinical Research Laboratory Support Form’ and fee schedule Research fee schedule for FHA Lab Services.
Contact Caroline Arnold, Lab Research Coordinator, for further information: caroline.arnold@fraserhealth.ca

Pharmacy

Health Records

  • Research fee schedule for accessing Health Records services for research purposes. Contact Patty Chaster, Research Lead: patty.chaster@fraserhealth.ca

Protocol Templates for Investigator-initiated Research Studies

Clinical Trial Protocol Template
Template for Writing a Research Protocol for Research Involving Human Subjects/Participants. This describes how the study will be conducted.
Research Proposal Outline
Note that a proposal format is usually used when seeking funding.
Research Proposal Check List
Self-Evaluation Checklist

Research Ethics and Informed Consent

Required items

For guidance on the submission process to the review board, visit our approvals and ethics resources.

Subject Participant and Information Consent Requirements Forms and Guidance Notes
BC Common Clinical Subject and Information Consent Requirements - Consent Form Guide and Template.Use for all clinical research studies.
Assent Form Template
This consent form template is intended to assist investigators in producing consent forms which meet the FHREB’s requirements. This form is for children aged 7-13 years.
Consent Form Template – Non-Clinical Studies
This consent form template is intended to assist investigators in producing consent forms that meet the FHREB’s requirements.
Version Control Guidelines
Provides instruction on how to number draft and final documents. Version control should be used for clinical research documents, including the protocol, consent document, and case report forms.

Use as applicable or as needed:

Consent to Contact Template and Guidance
Consent to Contact for future participation in research Template and Guidance
Consent Form Template - Case Report
This consent form template is intended to assist investigators in producing a consent form for a ‘case report’ that meets the FHREB’s requirements.
Consent to Review Records & Contact for Participating in Research
Consent to Review Records & Contact for Participating in Research (Note: this document is different from the template noted below)
Consent Form Template for Optional Research
This consent form template is intended to assist investigators in producing a consent form for optional research that meets the FHREB’s requirements.
Consent to Screen Template
This consent form template is intended to assist investigators in producing a consent form that is strictly for obtaining consent to review a patient’s medical record to determine their eligibility for research and that meets the FHREB’s requirements.

Regulatory Binder

Extramural Essential Documents Binder Tabs
Provides a list of tabs for organizing essential documents for clinical research in an Essential Documents Binder. Sometimes called an Investigator Binder or Regulatory Binder, this must be retained at the investigator’s clinical site or office.
Regulatory Document History Log
Used to organize date and topic of correspondence between the investigator and Health Canada (HC).
Delegation of Responsibilities
Used to list all study personnel and their specific responsibilities, signatures, and dates of obligation during the conduct of a clinical research study.
Training Log
Documents study-specific training completed by staff exhibiting their qualifications to perform tasks involved in the clinical research study. Other training may also be listed on this log.
Site Screening and Enrolment Log
Used to list research subjects/participants screened; includes those who fail screening and those who are enrolled.
Investigational Product Accountability Log: Stock Record
Used to document all study product disposition and accountability on the site level.
Investigational Product Accountability Log: Subject Record
To be completed by investigators for studies using an investigational product; provides a comprehensive list of product disposition on a subject/participant level. Assists in compliance with the protocol and Good Clinical Practice.
Specimen Tracking Log
Used to track the type of clinical specimen, purpose of storage, and location of storage. Also helpful to document if the subject/participant consented for the sample to be retained for future research.
Monitoring Visit Log
Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.
Subject/Participant Code List
Used to document the subject/participant study identification number, name, and other identifying information. Must be stored securely and separately from research records since it is the link between a study ID and the subject’s/participant’s name.
Telephone Contact Form
Used to document pertinent study-related telephone conversations with regulatory bodies (HC, REB) and others. Not intended to document conversations with study subjects/participants.
Telephone Log
Used to document study-specific conversations with a study subject/participant.
Protocol Deviation Tracking Log
Used to record all protocol deviations that occur at a study site.
Electronic Record System Validation
Validation requirements for use of Meditech to obtain electronic health record data.

Clinical Site and Study Start-up

Standard Operating Procedures
N2 Standard Operating Procedures (SOPs) for Regulated Clinical Trial Research. FHA is a member of N2, a Canadian network that has developed Health Canada compliant SOPs which are available to all FHA investigators. Contact Susan Chunick for copies susan.chunick@fraserhealth.ca.
Site Qualification Visit Checklist
This checklist should be used as a tool to assist the study site with a Pre-study/Site Qualification Visit.
Site Initiation Visit Agenda Template
Describes topics, tasks, and operations that are discussed during a site initiation meeting to ensure all staff, facilities, and procedures are in place to conduct the clinical research study.
Site Initiation Visit Checklist
Documents the site initiation visit.
Monitor Visit Request Form
Each monitoring visit should have this form completed ensuring that both the site and sponsor are aware of mutual responsibilities.
Subject/Participant Visit Log
This template provides a timeframe for projected visits and the dates of the actual study visits.

Documents to be Used During the Conduct of Clinical Research

Serious Adverse Event (SAE) Report Template
Use to report Serious Adverse and Unexpected Events (SAEs) which have occurred at the FHA site to the FHREB.
Notes to File template
Used by clinical site staff to document a discrepancy or problem with the conduct of the clinical research study, and plans to resolve and prevent the problem from recurring. May be used to document a Corrective and Preventive Action Plan (CAPA).
Documenting the Consent Process
Provides a framework for documenting the consent process. May be modified to suit the needs of the clinical research study.
Consent Log
Documents all the consent versions signed by all study patients.

Clinical Research Study Completion & Close-out Documents

Study Close-out Checklist
Helps the investigator plan the orderly closure of study documents, data, and publication.