Basics of Quality Management in CT

2. Standard Operating Procedures (SOPs)

Standard operating procedures (SOPs) are defined in the GCP-guideline as: ‘Detailed, written instructions to achieve uniformity of the performance of a specific function’. It is not a requirement to have SOPs when performing clinical trials, since one may also have detailed, written instructions in the trial protocol. However, most organisations and hospital departments working with many trials usually have SOPs that describe the critical procedures of a trial. Often the SOPs are more general and can be used for many trials. For example:
  • An SOP can describe the procedures used when informing patients about a new trial.
  • If measurement of blood pressure is the most important parameter in a certain trial, a specific SOP can be developed describing exactly how this must be done and by whom, as there are multiple methods available to measure blood pressure.
SOPs are characterised as being ‘controlled documents’. This is to ensure that old and new versions of the instructions are not mixed, and that one always has access to all pages and attachments of the SOP in force. It is also important to be able to document the version af an instruction that has been followed in a clinical trial in case of an inspection from the health authority years after the trial has been completed.

SOPs are always assigned a version number and it is stated from what date they should be used. Whenever a new version is made, all old versions must be replaced. It is however important that old versions are archived. The purpose of this is to ensure transparency if procedures are changed during the course of a clinical trial. There must be a named person who has the task of managing SOP replacements and archiving. In fact, one must also have a separate SOP that describes the procedures for writing, approving, distributing, replacing and archiving SOPs. This is normally the first SOP written!

It is the responsibility of the sponsor of the trial to establish a system of SOPs, if necessary. If an SOP system has been established, all personnel involved in a trial should be trained in the relevant SOPs. This training must of course be completed before undertaking any trial related duties and must be documented as well.