SOPs provide a description of procedure(s) to be followed to achieve performance uniformity for specific activities. SOPs are intended to be specific to the organization or facility whose activities are described and assist that organization in maintaining quality control and quality assurance processes and ensure compliance with governmental regulations. Each site should develop its own Standard Operating Procedures (SOP´s and should be customized as per the infrastructure the site has.
SOPs need to provide enough detail to:
- Clearly define staff roles and responsibilities
- Identify the critical steps and activities of the process including the key approvals and interactions that must occur at critical points, such as interfaces with other functions
- Enable a trained user to carry out the activities
- It provides the governance process on the development, update and management of the institution’s SOPs. SOPs cannot exist without a governing SOP which describes how the SOPs are developed, updated and managed.
What You and Your Staff Need to Know about SOPS:
- Standard Operating Procedures (SOPs) are developed/updated, published, and maintained by the Strategic Coordinator of the Institution, Principal Investigator or designee.
- SOPs provide a general concept of a specific procedure which outlines what needs to be done, when, where, and by whom and how procedures are documented.
- All SOPs should be read by site staff and documented on a training form to acknowledge completion and confirm the effort to comply with the SOP.
- New and revised SOPs will be published [at actual or specified time] unless there are exceptional circumstances.
- Site staff will be notified 30 days prior to a new or revised SOP becomes effective to ensure completion of training on the new or revised SOP.
- It is the responsibility of each site staff member to complete the SOP training in a timely manner.
- SOPs are written to comply with international and local regulations and guidelines.
- Adherence to SOPs is a requirement for all site staff.
- All SOPs will be reviewed [at specified time, suggested bi-annually] for any required changes to comply with ICH, GCP, other applicable regulations, and current practices of the site.
- SOPS should be reviewed every two to three years to make sure they are still applicable and no changes are necessary.
Your Checklist for Creating SOPs:
When you are developing a new SOP, or updating an existing one, use this checklist to make sure each of these items is clearly covered:
- Purpose: It establishes what the procedure is intended to do
- Scope: What areas are affected by the procedure in the institution/company
- Rationale and Principles: Why the process is necessary. Provide background information in brief and state any principles involved.
- Personnel Responsible: It explains who in the organization is responsible for conducting the procedures.
- Procedures. This is the description of the activities and steps to be followed by the applicable staff
- Resources: It mentions external documents that support the procedure, such as regulations etc.
- Tools: The tools are additional documents such as manuals or guidance notes etc., sometimes detailed explanations that help explain the procedure, or specific documents that the site has developed.
- Revision History: The revision history of the document which states all the versions and dates changes were made to ensure good audit trail.
- Approval History: SOPs should be signed off for authorization before they are followed or implemented.
- Naming Conventions: Each SOP should have a unique identifier or document number as well as a version number.
The Importance of Training Employees on SOPs
All employees that are affected by a process, must be trained on the respective SOPs for that process. When there is a change to the process, the SOP will need to be modified and all relevant employees will need to be retrained on the updated SOP.
A training period should be determined which allows time for those who are affected by and actively performing the process to train on the SOP prior to the effective date if required. The expectation is that employees train on a SOP prior to performing the process defined in it, which may be after the effective date in some cases and would be considered as “Just in Time” training. All SOP training must be documented and employees are responsible to ensure they are compliant to defined training periods.
Recommended SOPs for Sites
Below you can find a recommended list of SOPs that may be applicable to your site. Click on the link to see some considerations to keep in mind while developing that SOP:
- Site Job descriptions (JD) and Curriculum Vitae (CV)
- Informed consent process and documentation
- Staff Training
- Feasibility and selection of the protocol
- Management and archiving Study files
- Computer System Accounts and security
- Regulatory procedures and Institutional Review Board (IRB) approval
- Investigational Product Management
- Patient recruitment strategies and tools
- Initiation and Monitoring
- Study close out visit
- Calibration and Maintenance of study equipment
- Case report forms
- Handling of study emergencies
- Hosting study audits and inspections
- Preparation and Handling of laboratory samples