What are standard operating procedures?
Standard operating procedures (SOPs) are defined as: detailed, written instructions to achieve uniformity of the performance of a specific function.
They are controlled documents (version numbered and dated) and are revision-sensitive with a formal release date and periodic revision.
Does GCP require sites to have SOPs?
Yes. ICH GCP (R2) E6 contains two key statements:
- Systems with procedures that ensure the quality of every aspect of the trial should be implemented (Principle 2.13)
- The investigator/institution… should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated (4.2.6).
Do SOPs need to cover sponsor responsibilities?
The National Clinical Trials Governance Framework requires organisations sponsoring clinical trials to delineate sponsor and site activities (trial management versus trial conduct). SOPs for trial conduct are used for site activities.
Do SOPs need to work to ‘principles of GCP’?
Internationally, neither the FDA nor European regulatory authorities require trials to work to full GCP when they are not intended to support a marketing application.
SOPs should be written to facilitate all clinical trials by explicitly recognising that risk-proportionate procedures are appropriate for some trials. This does not mean that trial quality will be compromised as quality is often enhanced using Quality by Design principles that focus on activities that are ‘critical to quality’.
The SOPs should also be written to discourage over-interpretation of ICH GCP which can make trials more burdensome than they need to be.
What are controlled documents?
Controlled documents are essential for ensuring consistency and reliability in processes and operations. ISO9001:2015 Quality Management Systems states documented information shall be controlled to ensure it is available and suitable for use and is adequately protected to maintain accuracy and completeness.
This diagram explains the hierarchy of three types of controlled documents.
Visit the Australian Clinical Trials website to download the National Standard Operating Procedures, including an SOP template.