Standard Operating Procedures

Standard Operating Procedures are sets of instructions having the force of a directive, covering those features of operations which lend themselves to a definite or standardized procedure without loss of effectiveness.

Every good quality system is based on its Standard Operating Procedures (SOPs). In clinical research, SOPs are defined by the International Conference on Harmonisation, or ICH, as “detailed, written instructions to achieve uniformity of the performance of a specific function.” SOPs are necessary for a clinical research organization – whether it concerns a pharmaceutical company, a sponsor, a contract research organization, an investigator site, an Ethics Committee or any other party involved in clinical research – to achieve maximum safety and efficiency of the performed clinical research operations.

It is therefore a must that all people and sites involved in Clinical Studies (both at the sponsor and at the investigative sites) have appropriate SOPs in place in order to conduct clinical research and to assure compliance with the current regulations. The ICH GCP (Good clinical practice) Step 5 Guideline (Section 3.2.2) also suggests that an Institutional Review Board have their own SOPs or written standard procedures. This itself proves that presence of SOPs are an integral part of the Clinical trial at all levels.

The presence of these quality documents is essential when inspections take place since the most frequent reported deficiencies during inspections are the lack of written SOPs and/or the failure to adhere to them. The risk of GCP non-compliance is high at organizations with a poor availability of clinical research specific SOPs and also if at all they are available the staff or the people for whom they were written are not either aware of them or their need.

It therefore becomes very important for the staff to train them on these SOPs so that they are actually aware of why and how SOPs can play important role in fulfilling the ICH and other regulatory requirements. This article will cover the importance and value of SOPs, as well as present an approach for the development and training of SOPs at staff levels.

Reference

 * ICH1 Guidance E6: Good Clinical Practice: Consolidated guideline
 * SOP Writing for Clinical Trials: Staff Training Aspects by Akanksha Saxena, International Biopharmaceutical Association Publication, 2005.