SOPs for Clinical Trials: Regulatory Requirements
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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:
Who Will Benefit:
- 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
Harold Thibodeaux is a medical research scientist with in vivo pharmacological experiences in both academia and biopharmaceutical industry. During his prestigious career the focus of His research efforts has been on the efficacy of cardiovascular drugs most notably Hypertension, Myocardial Infarction, Focal Ischemia (Stroke), Beyond Advair Pulmonary Research and topical antibiotics. Optimal therapeutic benefits were the goal in all of these projects but cardiovascular safety to provide safer medicines to patients was a priority. Mr. Thibodeaux transitioned into the pharmaceutical industry when he joined the Cardiovascular Department of Genentech in 1990, as a technical lead with the Second Generation TPA Project Team. Mr. Thibodeaux is a graduate from the College of Charleston with a Bachelor of Science Degree in biology and is a member of The Safety Pharmacology Society.
During his prestigious career, Harold Thibodeaux’s ambition and innovation resulted in the successful clinical development of several novel drugs. As a young scientist with Genentech, his contributions to the Second Generation TPA Project were rewarded with the FDA approval of a thrombolytic drug (TNK-TPA or Tenectaplase) that was indicated for Acute Myocardial Infarction. Another notable achievement with the same project team was the approval of Activase Alterplase for Acute Ischemic Stroke Treatment.
As a scientist at Theravance, his innovative models of cardiovascular safety were instrumental in the formation of a Theravance/GlaxoSmithKline Partnership and the development of two clinical candidates for Chronic Obstructive Pulmonary Disease (COPD). Both drugs, BREO Ellipta and ANORO Ellipta, were approved by the FDA and are currently providing therapeutic benefits with patients with COPD.
In his role as an investigative scientist with Stiefel, a GlaxoSmithKline Company, Mr. Thibodeaux explored new medical research paths and using his many years of experience in the industry to support project efforts for the reformulations of topical antibiotics, development of models to study acne and writing protocols psoriasis.
During his years of academia and pharmaceutical industry provided an opportunity to authored 23 published articles and discussed his work with poster presentation at major scientific meetings. Harold is proud to have been a medical researcher in both academia and the biopharmaceutical industry and continues to support projects that lead to strategic partnerships that will develop novel drug pipelines for unmet medical needs and present webinars and seminars on drug development to assist pharmaceutical companies achieve their goals.