Identify a knowledge gap, formulate a research question to address a clinical problem, review the literature, and outline your project's goals and methods.
Resources:
Build your project team by securing support, recruiting multidisciplinary members, defining roles, and identifying resource or personnel needs.
Develop a detailed clinical protocol by following established guidelines, ensuring feasibility, quality, risk management, statistical analysis planning, and peer review.
For clinical trials, develop a risk assessment and management plan, along with a monitoring plan, to support quality oversight, regulatory alignment, and informed budgeting for trial conduct.
Secure funding by developing a budget, identifying potential funding sources, and preparing and submitting grant applications.
Secure funding by developing a budget, identifying potential funding sources, and preparing and submitting grant applications.
Contacts:
Content
Develop all essential supporting documents, service provider contracts, training materials, and oversight plans needed for study execution and compliance.
PHSA Quality Team or BC Cancer Quality Lead for support and access to required templates
Obtain all necessary regulatory, ethics, privacy, and institutional approvals to ensure your study is safe, feasible, and compliant with policies.
PHSA Approvals at a Glance
BC Cancer Research Ethics
BC Children's and Women's (C&W) Research Ethics, includes BCMHSUS
UBC Clinical Research Ethics reviews studies which do not fall under site-specific BC Cancer or C&W Research Ethics Boards (REBs)
Navigating UBC Researcher Information System (RISe) web-based platform for ethical review of research involving human participants
PHSA Research Privacy reviews studies involving personal identifiers, data sharing, or significant privacy risks
Health Canada:
Clinical Trial Application (CTA) for drugs (pharmaceuticals, biologics, gene/cell therapies, blood products, vaccines, and radiopharmaceuticals)
CTA for Natural Health Products
Investigational Testing Authorization (ITA) for medical devices (including software as a medical device, and diagnostic devices)
Operational review and institutional approvals may be required for access to clinical data, laboratory, pathology, imaging, pharmacy, or other services:
PHSA
Interior Health
Island Health
Fraser Health
Northern Health
Vancouver Coastal Health
PHSA Quality Team for support with CTA or ITA process
BC Cancer Research Ethics Office
C&W Research Ethics Office
PHSA Director Research Integration and Innovation
Prepare for study initiation by setting up data systems, organizing documentation, training the team, and completing site activation.
CANTRAIN clinical trial training modules available at no cost to PHSA-affiliated researchers with dedicated learning pathways based on research role
N2 supported CITI platform offers fundamental clinical trial training courses
RealTime CTMS supports participant tracking, delegation and document management, electronic source data collection, study progress monitoring, and financial management for comprehensive clinical research portfolio oversight
BCCHR REDCap is a validated platform for electronic data collection with randomization module, supporting everything from simple questionnaire studies to complex multi-site investigator-initiated trials
Clinical Trials Registration provides the information and contacts you need to register your clinical study on ClinicalTrials.gov, including help setting up an account
PHSA Clinical Trial Support Team for training, trial management set-up, and study activation support including Site Initiation Visit (SIV) readiness
BCCHR Data Management Team for REDCap support
To receive funding or pay expenses for your project, you'll need an account with either PHSA or your affiliated university, depending on the designated payee in your negotiated clinical trial or research agreement. PHSA utilizes the PeopleSoft system, which requires you to select the appropriate fund type (Fund 01, 06, 07, or 08) based on the specific needs of your project.
PHSA Restricted Fund Policy provides guidance on setting up and administering project accounts for restricted purposes including research and clinical trials
Screen, recruit, and consent eligible participants, then complete medical review and randomization if applicable.
Collect data and biological samples according to the protocol and SOPs, ensuring accuracy, confidentiality, and proper documentation throughout the study.
Monitor study conduct to ensure regulatory and ethical compliance by addressing safety and quality issues, maintaing REB application status through amendments and renewals, auditing as needed, and maintaining site readiness.
Manage study finances by tracking expenditures, invoicing, processing payments, managing participant stipends, and reconciling all financial activities.
Close the study by completing final monitoring, resolving queries, verifying data, submitting REB study closure notice, and notifying regulatory authorities.
Analyze the data according to the statistical analysis plan, and interpret results in the context of research objectives, existing literature, and clinical practice.
Archive the study according to the data management plan, regulations, and institutional policy.
Prepare, submit, and publish your research, and communicate findings through presentations, reports or peer-reviewed manuscripts.
Translate findings into practice, assess their impact on care and policy, and monitor dissemination efforts.
Identify opportunities for further investigation or quality improvement based on your results. When you're ready to address new challenges, return to the first step of this research process to begin the journey of discovery once again.