A view point: Site standard operative procedures and training: Pillars for sustenance at clinical trial site

Abstract

Abstract According to Schedule Y and ICH-GCP, Standard Operating Procedures (SOP) is a set of standard written instructions generated by research staff and signed off by Investigator or director of unit, to achieve uniformity and consistency of performance in the management of clinical studies. In clinical research, SOPs help define daily processes conducted to assure execution of research tasks in accordance with institutional, GCP and regulations. The article aims to submit author’s view point on the need, awareness, challenges and solutions that revolve around this important regulatory document. This view point is based on data points collected from clinical trial sites pan India. Keeping in view 2013 and 2014 Schedule Y updates pertaining to trial regulations, author has listed some of the mandatory SOPs sites required to be generated in order to complete the spectrum of clinical trial conduct at site. Emphasis has also been laid on need of consistency in distribution, education and training on new and revised SOPs in order to ensure compliance to the same.