Standard Operating Procedure List

Research Tools


  • Pre-Study Activities



  • Financial

    • Inter Institutional Agreement Template (pdf)
    • Site Budget Template
    • Site Payment Cover letters


  • Operational Activities (Start-up, maintenance, closeout)

    • Site Screening Questionnaire (doc)
    • Site Review Waiver Form (doc)
    • Delegation of Authority Log (Qualified Investigator) (doc)
    • Delegation of Authority Log (Sponsor) (doc)
    • Monitoring Report (doc)
    • Training Record template (doc)
    • Screening and Enrolment Log (xls)
    • Patient Identification List template
    • Trackers


  • Data Management

    • Case Report Form templates (pdf)
      • Case Report Form (Landscape Template) (pdf)
      • APACHE Template (pdf)
    • Data Management Plan template (doc)
    • Data Monitoring Committee Procedures (doc)
    • Data Query Form template
    • Report templates


  • Statistics

    • Analysis Plan
    • Centralized randomization system requirements



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General Topics



SOP DescriptionDocumentation
001-02 Standard Operating Procedures A guide for development, approval and review of standard operating procedures.
SOP
002-02 Work Instructions A guide for development and review of project specific operating procedures.
SOP
003-02 Mission Statement and Organizational Structure Describes the research objectives and the organizational structure of the Methods Center.
SOP

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Study Setup



SOP DescriptionDocumentation
201-01 Delegation of Authority Describes the process of delegating and documenting responsibilities of both the sponsor-investigator at the methods center and the qualified investigator(s) at (a) study site(s)
SOP
202-00 Study Operations General overview of the procedures that ensure proper organization and conduct of a clinical study site.
SOP
204-00 Development and Administration of Informed Consent Outline the process for development, review and approval of written informed consent forms; Define the content requirements for written informed consent forms; Outline procedures for research sites to administer informed consent to potential study participants in compliance with governing regulations.
SOP
205-01 Site Selection and Qualifications Defines the investigative site selection process. Outlining the suitability and qualifications required for site participation in research.
SOP
206-01 Generation and Distribution of Agreements Outlines the creation, review and distribution of Agreements between the Methods Center and research sites.
SOP
207-00 Methods Centre Staff Qualifications and Training Ensures the Methods Centre research team is appropriately trained to perform their responsibilities.
SOP
208-01 Study Files and Regulatory Documentation Describes procedures for maintenance, storage and retention of study related documents and records.
SOP
209-00 Study Protocol Development The purpose of this SOP is to guide authors on the content requirements when developing clinical trial protocols.
SOP
210-01 Filing Health Canada Clinical Trials Applications The purpose of this SOP is to outline the process for filing a Clinical Trial Application with health Canada.
SOP
211-00 Research Site Qualifications & Training Ensures Research Site staff participating in CERU clinical trials are appropriately trained to perform their protocol related responsibilities.
SOP
212-01 Collection and storage of biological samples Describes the management of biological samples used in the context of a clinical trial.
SOP
214-00 Research Site Activation The purpose of this SOP is to outline the tasks and activities associated with the activation of research sites in trials managed by CERU.
SOP
215-00 External sponsors The purpose of this SOP is to outline the procedures CERU should follow when engaging in operational activities for an external sponsor.
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Study Implementation & Conduct



SOP DescriptionDocumentation
301-02 Investigational Product Storage and Accountability Outlines the management and tracking and investigational product inventory
SOP
302-01 Serious Adverse Event Recognition and Reporting Outlines the process for identifying and processing serious adverse event (SAE) information reported during the conduct of a research study.
SOP
303-00 Protocol Deviations and Violations Defines protocol deviations and violations. Describes procedures for identification, documentation and follow-up or protocol deviations and violations.
SOP
304-01 Study Treatment Code Unblinding To ensure the safety of study participants and integrity of the study treatment code, this procedure outlines the algorithm to be followed to determine if study treatment code unblinding is necessary and appropriate, as well as documentation and follow-up.
SOP
305-01 Monitoring Clinical Trialss Describes the process and documentation of on site monitoring visits. Ensures optimal communication between the Methods Center and the research site(s).
SOP
306-00 Event Adjudication Outlines the process for assessment of the validity of outcomes for a particular study.
SOP
307-01 Administration of Health Related Quality of Life Assessments Outlines the policy related to the administration of Health Related Quality of Life (HRQOL) assessments.
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Data Management



SOP DescriptionDocumentation
402-00 Data Management Plans Defines the most important aspects of the data management process for research studies
SOP
403-00 Randomization System Setup, Maintenance & Backup Outlines the development, implementation, maintenance and backup of the randomization system for a research study.
SOP
405-00 Case Report Form Development Outlines how to design protocol specific paper Case Report Forms (CRFs).
SOP
407-00 Data Monitoring Committees Outlines the role and composition of the independent Data Monitoring Committee (DMC) during the conduct of a clinical trial.
SOP

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Study Closeout



SOP DescriptionDocumentation
501-01 Study Closeout Describes the process followed when a research study enters the closeout phase.
SOP
502-02 Premature Termination or Suspension of the Study Describes the process followed in the event that there is an unforeseen termination or suspension of the study.
SOP
503-01 Research Site Closeout Guide for facilitating study closeout for participating research sites.
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Regulatory Inspections/Audits



SOP DescriptionDocumentation
601-01 Regulatory Inspections/Audits The objective of this operating procedure is to delineate the steps to be followed when clinical trial audits and inspections are performed by governing regulatory bodies at either the Methods Centre or participating Research Sites.
SOP

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