SOP	Description	REDOXS© Specific Procedures
General Topics (000 Series)
SOP-001 Standard Operating Procedures SOP Development Worksheet  SOP Revisions Log	A guide for development, approval and review of standard operating procedures.	N/A
SOP-002 Work Instructions SOP Work Instruction Template	A guide for development and review of project specific operating procedures.	N/A
SOP-003 Vision Statement and Organizational Structure SOP Organizational Structure	Describes the research objectives and the organizational structure of the Methods Center.	N/A
Study Setup (200 Series)
SOP-201 Delegation of Authority SOP Delegation of Authority Log (QI) Delegation of Authority Log (Sponsor)	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)	Delegation of Authority Logs
SOP-202 Study Operations SOP	General overview of the procedures that ensure proper organization and conduct of a clinical study site.	N/A
SOP-204 Development and Administration of Informed Consent SOP ICF Development Checklist Site ICF Review and Approval Form	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.	Review of Informed Consent Forms
SOP-205 Site Selection and Qualifications SOP Site Screening Questionnaire Site Screening Waiver Form	Defines the investigative site selection process. Outlining the suitability and qualifications required for site participation in research.	N/A
SOP-206 Generation and Distribution of Agreements SOP	Outlines the creation, review and distribution of Agreements between the Methods Center and research sites.	Generation and Distribution of Agreements
SOP-208 Study Files and Regulatory Documents SOP	Describes procedures for maintenance, storage and retention of study related documents and records.	N/A
Study Implementation and Conduct (300 Series)
SOP-301 Investigational Product Storage and Accountability SOP	Outlines the management and tracking and investigational product inventory.	N/A
SOP-302 Serious Adverse Event Recognition and Reporting SOP	Outlines the process for identifying and processing serious adverse event (SAE) information reported during the conduct of a research study.	302-R01 SAE Reporting: Methods Centre 302-R02 SAE Reporting: Research Sites
SOP-303 Protocol Deviations and Violations SOP	Defines protocol deviations and violations. Describes procedures for identification, documentation and follow-up or protocol deviations and violations.	N/A
SOP-304 Study Treatment Code Unblinding SOP	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.	Study Treatment Code Unblinding
SOP-305 Monitoring Clinical Trials SOP Site Monitoring Report	Describes the process and documentation of on site monitoring visits. Ensures optimal communication between the Methods Center and the research site(s).	N/A
SOP-306 Event Adjudication SOP	Outlines the process for assessment of the validity of outcomes for a particular study.	N/A
Data Management(400 Series)
SOP-407 Data Monitoring Committees SOP Sample DMC Operating Procedures	Outlines the role and composition of the independent Data Monitoring Committee (DMC) during the conduct of a clinical trial.	N/A
Study Closeout(500 Series)
SOP-501 Study Closeout SOP Closeout Checklist	Describes the process followed when a research study enters the closeout phase.	N/A
SOP-502 Premature Termination or Suspension of the Study SOP	Describes the process followed in the event that there is an unforeseen termination or suspension of the study.	N/A
SOP-503 Research Site Closeout SOP Closure Checklist	Guide for facilitating study closeout for participating research sites.	N/A