SOPs for Clinical Trials: Regulatory Requirements

Since the year 2000 there has been an increasing trend of registered clinical studies from approximately 4,000 in 2000 to 160,000 in 2014. In 2014 Forbes Magazine reported that the FDA had approved 44 drugs the highest in 18 years.

As innovation and new technological approaches are applied to the discovery of novel molecules, the number of studies will continue to increase to meet the areas of unmet medical needs and especially rare diseases. Clinical Trial.gov currently list 193,510 studies in 50 states and in 190 countries. Given the enormity of studies, the many clinical sites and the number of clinical professionals involved in these studies, guidelines and regulations have to be in place to direct the daily monitoring of the studies, training of staff and data management. Therefore it is important to have Standard Operating Procedures (SOPs) in place to outline the administrative duties, principal responsibilities, regulatory requirements and data management.

The SOPs, although not specifically required by the FDA, are mentioned in the ICH GCP and HSP Guidelines, “Ensures that all research conducted within the clinical site follows federal regulations, ICH GCP and institutional policies to protect the rights and welfare of human study participants.” SOPs benefit by providing autonomy within the clinical site, improves the quality of the data collected, thereby improving the science of the study. They can be utilized as a reference and guideline as to how the research will be conducted within the clinical site as well as an excellent training resource for administrative and clinical staff.

This session will expand on the key SOP topics, such as submitting Institutional Review Board documents, establishing and training the clinical study team and delegating duties. Study participant recruitment plans, obtaining informed consent from potential study subjects, identifying and reporting adverse events and reporting protocol deviations. In addition to the benefits of SOPs in clinical development, this webinar will provide a complete blueprint to a successful clinical trial that will result in an FDA approval on a preclinical candidate.

Why should you Attend: In clinical research, Standard Operating Procedures (SOPs) assist in defining the clinical groups standard practices and daily processes conducted to assure execution of research task in accordance with institutional, state and federal guidelines.

Since the 1970s the regulations for conducting clinical trials has been under the directions of the Food and Drug Administration’s Good Clinical Practice (GCPs) and human subject protection (HSP) Guidelines. The International Conference on Harmonization (ICH) defines a SOP as “Detailed, written instructions to achieve uniformity of the performance of a specific function”. In simple terms a SOP is a written process and a way for the clinical site(s) to perform a task the same way each time it is completed.

Areas Covered in the Session:

• ICH guidelines and Good Clinical Practice (GCP)
• Standard Operating Procedures (SOPs)
• Benefits of SOPs
• Writing SOPs
• Highlight Different SOP Topics
• Regulatory Requirement of SOPs
• Importance of SOPs in Data Management
• Study Participant Recruitment Plans

• Healthcare Providers in Clinical Research
• New Clinical Research Coordinators (1-2 years)
• New Principal Investigators
• Administrative Managers in charge of Clinical Research
• Regulatory Compliance Associates and Managers
• Medical Writers
• Nursing and/or Clinical Monitoring Staff
• Marketing Team Members