A guide to standard operating procedures (SOPs) in clinical trials
Standard Operating Procedures (SOPs) are the backbone of any well-run clinical trial. These detailed, written instructions outline every step of the trial process – from participant recruitment and informed consent to data collection, analysis, and reporting.
This guide will explain clinical trial SOPs—what they are, why they matter, essential elements, and best practices for implementing them correctly from the start.
What is a standard operating procedure (SOP)?
A Clinical Trial SOP is a written formal document that outlines step-by-step procedures for various aspects of a clinical trial. They provide details on what to do, when to do it and how to do it. SOPs are designed to ensure uniformity in the performance of specific functions within clinical research, maintain consistency across different sites and throughout the trial duration, facilitate training of personnel involved, and enhance quality control.
An SOP is required when an SOP doesn’t already exist for any repetitive technical activity, as well as for any administrative or functional procedure, that is being followed within an organisation.
When conducting a clinical trial, utilise both Sponsor and Local Site SOPs where they already exist. Additional SOPs might need to be developed to meet the specific requirements of the trial. Ultimately, SOPs help ensure that clinical trials comply with regulatory requirements, Good Clinical Practice (GCP) guidelines, and the established protocol while reducing the risk of errors or discrepancies in data collection and analysis.
What is included in a Standard Operating Procedure?
The following are elements required in a clinical trial SOP:
- Identification, versioning, and control: Procedure title and number, version number, effective date, review date, author's name, job title, signature and date, SOP approver's name, job title, signature and date.
- Background to the SOP: Introduction providing context and purpose, objective outlining the specific goals of the SOP, scope defining the areas or processes covered, glossary or definitions of key terms used.
- The SOP details the procedures and activities it covers and the responsible roles: It provides step-by-step instructions for the procedures and activities covered by the SOP and clearly defines the roles and responsibilities for each task.
- Review and updating information: Guidelines for periodic review and revision of the SOP processes for updating and approving changes to the SOP.
- References: Relevant regulations, guidelines, or other documents referenced within the SOP.
- Amendment history: A record of changes made to the SOP over time, including version numbers, effective dates, and brief descriptions of the amendments.
How to utilise SOPs throughout your trial
Using SOPs throughout your trial ensures uniformity, compliance, and quality in all processes. The following describes how to utilise SOPs effectively during your trial:
- Training and onboarding: Start by providing comprehensive training to all personnel involved in the trial, ensuring they understand the SOPs relevant to their roles. This training should cover the purpose of each SOP, how to follow its procedures and the importance of adherence to SOPs for maintaining data integrity and participant safety.
- Document control: Establish a robust document management system to centralise and control access to SOPs. Ensure that all SOPs are current, easily accessible, and clearly labelled to facilitate quick reference by trial personnel. Implement version control procedures to track revisions and updates to SOPs.
- Implementation: Integrate SOPs into the trial's day-to-day operations by incorporating them into routine workflows and procedures. Emphasise the importance of following SOPs consistently and accurately to ensure uniformity and standardisation across study sites and personnel.
- Monitoring and compliance: Monitor adherence to SOPs regularly through internal audits, quality control checks, and oversight mechanisms. Identify any deviations from SOPs promptly and take corrective action to address deficiencies or non-compliance issues. Document all deviations and corrective actions taken for transparency and accountability.
- Continuous improvement: Obtain feedback from trial personnel regarding the usability and effectiveness of SOPs during the trial. Use this feedback to identify areas for improvement and update SOPs as needed to reflect lessons learned, best practices, and changes in regulations or guidelines.
- Communication and training updates: Regular communication channels should be used to inform trial personnel of any changes or updates to SOPs. Ongoing training and refresher courses should also be provided to ensure all personnel remain up-to-date on the latest SOPs and understand their responsibilities.
- Collaboration and consultation: Foster a culture of collaboration and consultation among trial personnel when implementing SOPs. Encourage open communication and sharing insights and best practices to enhance compliance and efficiency in SOP implementation.
FAQs about clinical trials SOPs
Common SOPs for clinical trials include:
- GCP training
- authority and delegation of responsibilities of research staff
- participant screening and recruitment
- informed consent process and documentation
- eligibility confirmation
- source documentation
- data management
- protocol deviations
- Adverse Events (AE) and Serious Adverse Events (SAE) 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 and internal audits
- regulatory audits
- writing SOPs
- record organisation and retention
- sub-site management.
Existing templates and resources can be used as a starting point. However, the templates may need to be customised or adapted to fit the specific requirements of a trial. Additionally, depending on needs, more detailed working instructions may need to be created.
SOPs play a critical role in clinical trials by guaranteeing adherence to Good Clinical Practice guidelines, thereby safeguarding the interests of human participants and researchers. SOPs ensure the maintenance of data integrity, correction of errors, and prevention of protocol deviations through the provision of explicit instructions, delineation of responsibilities, and management of risks. SOPs are ultimately instrumental in guaranteeing the safety, quality, and regulatory adherence of clinical research.
Typically, the Sponsor or Principal Investigator works in conjunction with the clinical research team to develop SOPs. In addition, their development may incorporate the perspectives of regulatory affairs and quality assurance specialists.
For clinical trials, numerous organisations, regulatory agencies and professional associations offer templates or examples.
Example templates can be found at National Standard Operating Procedures for Clinical Trials, including Teletrials, in Australia.
When initiating or amending an SOP, it is crucial to establish a formal review process that involves relevant users reviewing the draft. The Sponsor or Principal Investigator should ensure effective implementation and central access to the approved SOP.
Routine reviews and updates of SOPs are imperative in order to incorporate modifications in regulations, guidelines, optimal methodologies, and insights gained from prior trials. SOPs are typically reviewed annually at minimum; however, more frequent revisions may be necessary in the event of substantial changes.
It is mandatory that personnel conducting clinical trials be properly instructed on the SOPs that pertain to their respective roles and responsibilities. Initial orientation and continuous education are all components of training that guarantee adherence to SOPs and regulatory obligations.
Should a situation arise that is not covered in the SOPs, it is advisable to seek guidance from the relevant personnel, including the PI and study coordinator, to ascertain the most suitable course of action. Deviations from SOPs may require documentation and sanction from the appropriate authorities.
Quality assurance functions, including audits and inspections, are of the utmost importance in detecting any noncompliance or deviation from SOPs. Consistent evaluation and monitoring of SOP implementation contribute to the preservation of the quality and integrity of clinical trial conduct.
While sponsor organisations provide overarching SOPs, individual clinical trial sites may also have their own site-specific SOPs that align with the sponsor's SOPs and local regulations.
SOPs are often distributed electronically through document management systems or internal websites, ensuring controlled access and version control. Paper copies may also be available at study sites.
Any deviations from SOPs must be documented, investigated, and addressed through corrective and preventive actions (CAPAs) to mitigate risks and prevent recurrence.
Yes, SOPs are required for all clinical trials involving human participants, regardless of the phase or type of study, to ensure participant safety, data integrity, and regulatory compliance.
In addition to general SOPs, sponsors and sites may develop study-specific or protocol-specific SOPs to address unique aspects of a particular clinical trial.
SOPs are a key component of GCP, as they provide detailed instructions for implementing GCP principles and regulations in the conduct of clinical trials.
While SOPs themselves are not legally binding, adherence to SOPs is often required by regulatory authorities and considered part of GCP compliance.
