Conducting clinical trials requires specialized knowledge in order to write study protocols, conduct drug safety activities, and monitor the trials. Clinical research professionals are required to demonstrate that clinical work has been performed in compliance with regulations and operational practices. Standard operating procedures (SOPs) are designed for that purpose. SOPs are a set of instructions that define and standardize procedures in clinical trials. They clearly document the rules of procedure to maintain consistency and accuracy.
Students in clinical research training explore the global and national healthcare systems, including health care legislation, guidelines, and standard operating procedures (SOPs). With an understanding of the rules and regulations that govern clinical research, students can pursue careers in pharmaceuticals, biotechnology, cosmetics, and natural health production.
Read on to discover more about SOPs and what makes them a crucial feature of clinical research.
Why SOPs are Important in Clinical Research Careers
When working in clinical research, the main purpose of SOPs is to guide your team’s clinical practices and to ensure they comply with quality standards. SOPs offer a clear-cut way of formulating a good clinical development plan, ensuring trial data is accurate, and maintaining the ethical standard of the trial.
SOPs provide a detailed plan to ensure clinical research complies with industry regulations
At minimum, SOPs facilitate the work of clinical professionals by encouraging:
- Consistency – Consistency across clinical processes ensures consistency of quality
- Communication – SOPs can be updated to communicate the changes to employees
- Elimination of errors: By following a clear set of written guidelines at work, employees are less likely to make mistakes
For a clinical research professional, SOPs are also useful for increasing efficiency in the workplace and ensuring uniformity of practices across a team. Professionals can thereby improve the overall quality of the trial and results.
SOPs encourage consistency across procedures and reduce the chance of errors
Guidelines for Developing SOPs
For students of clinical research training, it can be useful to see SOPs as protocols. They provide a written outline of the entire research plan, including the objectives, methodology, statistical analysis, and organization of the clinical trial.
SOPs ensure procedures are carried out efficiently. The process of developing SOPs includes:
- Task analysis – the necessary steps to carry out the work
- Consulting regulations to ensure compliance
- Drawing up a detailed guide for the practice
- Testing the SOP and assessing actions for effectiveness
When developing an SOP, it’s important to review them regularly to ensure they stay applicable to the work that’s being done. The best way to do this is to include effective start and end dates for the research study. That way, work can be tracked and SOPs can be updated if necessary.
SOPs should be updated regularly to ensure their relevance to the work
The Features of a Good SOP
An SOP should include the objective of the SOP, the list of accountable workers, and a detailed outline of the procedure steps. Any specialized terms should be included and clearly defined.
The document should include the following features:
- Who is responsible for the procedure
- The goal or intent of the procedure
- The timeframe of the procedure
- The required steps of the procedure
The purpose of the SOP should be clear to any employees who use it to guide their work. A uniform style and format should be used that includes effective dates. After consulting the SOP, it should be clear to employees who is responsible for which tasks and within which timeframe. By laying out different processes, an SOP should streamline the process of clinical research and reduce the likelihood of procedural deviations.
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