Activate Helps Stakeholders Adhere to SOPs and Streamline Study Startup
Standard Operating Procedures (SOPs) have long been fundamental to many industries, and the clinical trials sector is no exception. With the advent of the Good Clinical Practice Guideline in 1996 from the International Conference on Harmonisation (ICH-GCP), stakeholders have been motivated to develop SOPs, not only for regulatory compliance, but also as a routine business practice. SOPs are defined in the GCP Guideline as detailed, written instructions needed to achieve consistent performance for a specific function,1 with a goal of instilling quality into clinical trial operations. Yet, too often, after companies devote significant time and resources into creating SOPs, they may not be followed. They may be ignored or even avoided.