| SOP | Description | Documentation |
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| 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) |
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| 202-00 Study Operations |
General overview of the procedures that ensure proper organization and conduct of a clinical study site. |
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| 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. |
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| 205-00 Site Selection and Qualifications |
Defines the investigative site selection process. Outlining the suitability and qualifications required for site participation in research. |
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| 206-01 Generation and Distribution of Agreements |
Outlines the creation, review and distribution of Agreements between the Methods Center and research sites. |
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| 207-00 Methods Centre Staff Qualifications and Training |
Ensures the Methods Centre research team is appropriately trained to perform their responsibilities. |
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| 208-00 Study Files and Regulatory Documentation |
Describes procedures for maintenance, storage and retention of study related documents and records. |
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| 209-00 Study Protocol Development |
The purpose of this SOP is to guide authors on the content requirements when developing clinical trial protocols. |
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| 211-00 Research Site Qualifications & Training |
Ensures Research Site staff participating in CERU clinical trials are appropriately trained to perform their protocol related responsibilities. |
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| SOP | Description | Documentation |
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| 301-01 Investigational Product Storage and Accountability |
Outlines the management and tracking and investigational product inventory |
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| 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. |
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| 303-01 Protocol Deviations and Violations |
Defines protocol deviations and violations. Describes procedures for identification, documentation and follow-up or protocol deviations and violations. |
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| 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. |
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| 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). |
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| 306-01 Event Adjudication |
Outlines the process for assessment of the validity of outcomes for a particular study. |
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| 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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| SOP | Description | Documentation |
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| 310-01 Data Management Plans |
Defines the most important aspects of the data management process for research studies |
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| 311-01 Randomization System Setup, Maintenance & Backup |
Outlines the development, implementation, maintenance and backup of the randomization system for a research study. |
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| 312-01 Case Report Form Development |
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| 313-01 Data Monitoring Committees |
Outlines the role and composition of the independent Data Monitoring Committee (DMC) during the conduct of a clinical trial. |
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