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

Who Will Benefit:

• 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