Get resources and templates to support you in setting up a clinical trial.

We have created a toolkit of resources and templates to support you in setting up a clinical trial. The purpose of this toolkit is to collate resources and templates that may be required to prepare a clinical trial site conducting regulated research.

All studies require a certificate of approval from the Fraser Health Research Ethics Board and Letter of Authorization to Conduct Research before research is permitted to begin.

Budgeting and finance

  • Template to construct a new study budget or use as a guide for existing study budget spreadsheets.

    xls
    35 KB
    Updated 17/05/2018

Protocol templates for investigator-initiated research studies

Research ethics and informed consent

Required items

  • Fraser Health Research Ethics Board policy requires written consent in all cases, unless under special circumstances have been approved a waiver of consent. All of the following information must be included in the consent form and not fragmented into information sheets.

    doc
    124.5 KB
    Updated 17/05/2018
  • This consent form template is intended to assist investigators in producing consent forms that meet the Fraser Health Research Ethics Board requirements. This form is for children aged 7-13 years.

    doc
    263.5 KB
    Updated 17/05/2018
  • 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.

    doc
    149.5 KB
    Updated 17/05/2018
  • Used to list research subjects/participants screened; includes those who fail screening and those who are enrolled.

    doc
    100.5 KB
    Updated 17/05/2018

Use as applicable or as needed

  • Consent to contact for future participation in research template and guidance.

    doc
    242 KB
    Updated 17/05/2018
  • This consent form template is intended to assist investigators in producing a consent form for a ‘case report’ that meets the Fraser Health Research Ethics Board requirements.

    doc
    246.5 KB
    Updated 17/05/2018
  • Consent to Review Records and Contact for Participating in Research (Note: this document is different from the template noted below)

    doc
    244 KB
    Updated 17/05/2018
  • This consent form template is intended to assist investigators in producing a consent form for optional research that meets the Fraser Health Research Ethics Board's requirements.

    doc
    298 KB
    Updated 17/05/2018
  • Consent form to obtain consent to review a patient’s medical record to determine their eligibility for research and that meets the Fraser Health Research Ethics Board's requirements.

    doc
    247 KB
    Updated 17/05/2018

Regulatory binder

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    doc
    97 KB
    Updated 17/05/2018
  • 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.

    doc
    100.5 KB
    Updated 17/05/2018
  • Used to list research subjects/participants screened; includes those who fail screening and those who are enrolled.

    doc
    100.5 KB
    Updated 17/05/2018
  • Documents all study product disposition and accountability on the site level.

    doc
    136 KB
    Updated 17/05/2018
  • Track clinical specimen, purpose and location of storage. Also document if the subject/participant consented for the sample to be retained for future research.

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    106 KB
    Updated 17/05/2018
  • Completed by the clinical site monitor to document dates and purpose of clinical site monitoring visits.

    doc
    99.5 KB
    Updated 17/05/2018
  • 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.

    doc
    128.5 KB
    Updated 17/05/2018
  • Used to document pertinent study-related telephone conversations with regulatory bodies. Not intended to document conversations with study subjects/participants.

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    257.5 KB
    Updated 17/05/2018
  • Used to document study-specific conversations with a study subject/participant.

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    103 KB
    Updated 17/05/2018
  • Used to record all protocol deviations that occur at a study site.

    doc
    104.5 KB
    Updated 17/05/2018
  • Validation requirements for use of Meditech to obtain electronic health record data.

    doc
    115.5 KB
    Updated 17/05/2018

Clinical site and study start-up

  • To be used to assist with a pre-study/site qualification visit.

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    167 KB
    Updated 17/05/2018
  • 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.

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    113 KB
    Updated 17/05/2018
  • Documents the site initiation visit.

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    165 KB
    Updated 17/05/2018
  • Each monitoring visit should have this form completed ensuring that both the site and sponsor are aware of mutual responsibilities.

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    119 KB
    Updated 17/05/2018
  • Provides a timeframe for projected visits and the dates of the actual study visits.

    xls
    47 KB
    Updated 17/05/2018

Conduct of clinical research documents

  • Use to report serious adverse and unexpected events that have occurred at our sites.

    doc
    99.5 KB
    Updated 17/05/2018
  • 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.

    doc
    111 KB
    Updated 17/05/2018
  • Provides a framework for documenting the consent process. May be modified to suit the needs of the clinical research study.

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    80 KB
    Updated 17/05/2018
  • Documents all the consent versions signed by all study patients.

    xls
    103.5 KB
    Updated 17/05/2018

Clinical research study completion and close-out documents

  • Use this site feasibility questionnaire sample for your research.

    doc
    156.5 KB
    Updated 17/05/2018
  • Helps the investigator plan the orderly closure of study documents, data and publication.

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    119 KB
    Updated 17/05/2018