101 Writing, Training, and Maintenance of SOPs

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.  

This Standard Operating Procedure (SOP) describes the standard writing, training, and maintenance of SOPs for clinical research at the CTRU. Attachment templates include:

A: SOP Template, B: SOP Training and Compliance Form, C: SOP Revision History Log

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Changes to federal regulations, guidelines, institutional policies, or procedures determine whether an SOP should be created or revised. Departments and research teams conducting human subject research will have access to the applicable documents.

Definitions

Document Name: The wording should be descriptive but not too long.

Document Number: Numerical code assigned to the SOP.

Revision: Date the SOP was revised from a previous version.

Supersedes: Details the previously approved version of the document.

Target Group: List the individual group to which the SOP applies.

Approval Date: Date the approver approved the SOP.

Effective Date: Date the SOP becomes active.

Training Required: List any training modules, classes, certifications, etc. required to implement the SOP.

Purpose of SOP: The writer describes the rationale of the SOP.

Definitions: The writer defines terms in the SOP that may require further explanation.

Responsibilities: The writer lists here who is responsible for overseeing the SOP, performing the activities, or having other procedure responsibilities.

Procedures: The writer describes the tasks or step-by-step procedures for completing the activity. Include definitions as necessary.

Reference: The section notes why this activity is being performed. For example, it meets regulations or hospital requirements. It may be included as part of the objective.

Attachments: The writer attaches applicable forms here.

Appendix: The writer attaches other additional information here.

Procedures

1. Procedure for writing the SOP

• After delegating the writing of the SOP to an appropriate staff member, the writer decides on the level of detail for the SOP.
• The SOP will contain enough detail to guide clinical research team members through the procedure and create uniformity in the department's daily operations. The procedures should be written to be followed without deviation and easily implemented.
• The SOP format will, at minimum, contain the following elements: Document Name, Document Number, Revision Date, supersedes, Target Group, Approval Date, Effective Date, Purpose, Responsibilities, Procedures, Application Regulations, Guidelines and References to other SOPs, and Attachments.
• The procedures are evaluated for efficiency, effectiveness, and compliance with institutional, state, and FDA regulations and guidelines.
• The appropriate department administrator or CTRU Director will review and approve the final SOP, which will then be updated with its approved and effective date.

2. Procedure for Distribution and Training on SOPs

• Supervisors will ensure that each current research staff member reviews all applicable SOPs and will document the review date and training for each SOP.
• Supervisors will also ensure that each current research staff member has documented training on any new or revised SOP
• Documentation of training for SOPs should be kept on file for all research team members and available for review upon request.

3. Procedures for Maintaining SOPs

• The appropriate team members should review all SOPs to assess applicability and revise and/or edit the document a minimum of every 3 years.
• If revisions or additions are required, the procedures will be followed as outlined above.
• If no changes are required, the SOP Revision History Log will be updated to reflect the date of the last review.

References: None

Attachments: A: SOP Template, B: SOP Training and Compliance Form, C: SOP Revision History Log

Appendices: None

Approver: Director, CTRU and Clinical Partnerships

Click here to request attachments