Standard Operating Procedures

Standard Operating Procedures (SOPs) are written documentation of processes that require a standard of quality and consistency. SOPs are an essential element for the control of clinical research from planning through to study closure, and for all the activities which support the clinical research process.

The Primary Care Research Network have developed a range of SOPs which are available for researchers to use for their research studies should they find them helpful. This site should be checked each time you embark upon a study as new SOPs may be added or updated versions may be available.

Current SOPs

1. Audit and Inspection
2. Preparation, Approval, Review
3. Obtaining written informed consent for competent adults and Issue of SOPs
4. Definition of responsibilities of staff at local sites
5. Study files and filing (paper)
6. Adverse Events and Serious Adverse Event Reporting
7. Archiving and destroying documents (paper)
8. Initiation Visit
9. Monitoring Visit
10. Study Close-down (paper)
11. Obtaining informed consent for adults who lack capacity for trials other than Clinical Trials of Investigational Medicinal Products (CTIMPs)
12. Obtaining informed consent for minors
13. Obtaining informed consent for adults with communication problems or comprehension difficulties
14. Data Protection
15. Good Clinical Practice and Training Records