Standard Operating Procedures (SOPs)

As defined by the International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), standard operating procedures (SOPs) are “detailed, written instructions to achieve uniformity of the performance of a specific function.” SOPs document what the clinical research site does in its daily practice and are uniformly formatted to contain the purpose, policy, scope, and definitions associated with this practice. The goal of SOPs is to provide a method of clinical trials performance and documentation that embodies the high standards of good clinical practice. SOPs clarify and simplify the organization and documentation of clinical trials. In addition to the medical/clinical components of a trial, sponsors, monitors, and investigators (study team) must be well versed in their respective responsibilities as well as in those of the others. Everyone involved in clinical trials research must maintain up-to-date knowledge regarding the protection of trial subjects and informed consent as detailed in the Declaration of Helsinki. These individuals are obligated to conduct the research in the most ethical manner.

SOPs delineate the responsibilities of sponsors, monitors, and investigators. For example, a SOP defining the responsibilities of the study team would include the following: Sponsors choose the investigator and provide the study medication and all pertinent information for documentation of adverse event reporting; monitors provide the communication link between sponsors and investigators, conduct site visits with the investigator to determine if the trial is being performed correctly, and determine that information on source documents and case report forms (CRFs) are compatible; and investigators provide a subject pool and maintain familiarity with properties of the study medication, drug accountability, and procedures a study coordinator will follow.