Writing Standard Operating Procedures (SOPS)

In clinical research, SOPs help define the group’s (e.g., unit, division, department, institution, etc...) standard practices and daily processes conducted to assure execution of research tasks in accordance with institutional, state and federal guidance. SOPs should contain enough detail to guide research staff through a particular procedure and thereby establish uniformity in the everyday functions of the department. The SOP should have a specific aim but be written in a general format to allow for easy implementation across a broad set of venues and circumstances. The SOP however, should contain specifically defined procedures that can be followed without deviation.

All SOPs for the department should be written in the same format with consistent font size, unit title, and section headers. It should include page numbers, date of initial approval, date it was effective within the department and date of revision if applicable. The body of the SOP at a minimum should include the objective of the SOP, definition of key terms and acronyms, defined list of responsible individuals and details outlining the procedures with attachments of examples if applicable. It is important to reference applicable guidance and regulations within the SOP, such as ICH E6 Good Clinical Practice and 21 CFR 50. The SOP should also include the signature of the Administrator or Director of the group with the date of approval. Existing SOPs should be reviewed at regular intervals to reassess applicability of the policy. Annual review is recommended and review prior to sponsor interactions is encouraged.

Distribution, education, and training on new departmental SOPs should be consistent. In-service training and Computer Based Learning modules (CBLs) are typical methods that can be used to educate and train staff on SOPs. It is important to document the date responsible research staff has been appropriately trained and agree to comply with new SOPs that are implemented by the department. Research staff should be monitored consistently to ensure compliance and receive refresher training at regular intervals.

Common SOPs

• GCP Training
• Authority and Delegations of Responsibilities of Research Staff
• Subject Screening and Recruitment
• Informed Consent Process and Documentation
• Eligibility Confirmation
• Source Documentation
• Data Management
• Protocol Deviations
• Adverse Events and Serious Adverse Events Reporting
• Confidentiality of Information
• Drug/Device Storage, Accountability, and Management
• Regulatory Document Submission Process (Initial Submissions, Amendments and Continuing Reviews)
• Sample Processing and Shipping Training
• Monitoring Visits
• Sponsor, CRO and Internal Audits
• FDA Audits
• Writing SOPs
• Record Organization and Retention
• Sub-Site Management

See also Standard Operating Procedure for Good Clinical Practice.