As per the Good Clinical Practice Guidelines by CDSCO (section 3.1.3), the sponsor should develop a set of Standard Operating Procedures (SOPs), pertaining to each aspect of the trial. This is a key part of quality assurance. SOPs are standard elaborate written instructions to achieve uniformity of performance in the management of clinical trials. They provide a general framework for the efficient implementation and performance of all functions and activities related to a particular trial.
The list of SOPs that should be developed, to ensure quality and compliance in a trial include:
SOPs for essential documents:
- Protocol Development: Prepare, Review, Approval and Amendments
- Informed Consent Document: Prepare, Review, Approval and Amendments
- Investigator Brochure: Preparation, Review and Update
- Statistical Analysis Plan
- Randomization, Blinding and Code Break Procedures
SOPs pertaining to oversight committees:
- Ethics Committee Submission and Communication
- Data Safety Monitoring Board
SOPs for operation or project management:
- Investigator selection and Site Qualification
- Site Preparedness and Initiation
- Site Monitoring
- Management of Protocol Deviation
- Clinical Monitoring Plan
- Study Site Close Out
Process related SOPs:
- Data Management
- Statistical Data Analysis
This above list is not exhaustive, and is only meant as an example. There are a number of other SOPs that are often developed in the course of a trial. It is important to customise the SOP list as per the requirements of the trial, and the institution.
Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).