Creating a Quality Assurance Program for (Clinical) Research Sites

Does your research site have a quality assurance program or SOPs that document how critical pieces of the research process are managed? Research site personnel must conduct research in compliance with Good Clinical Practices (GCP). To support high quality research, the research site should consider the development of a quality assurance program, SOPs, forms, and documented procedures and work instructions for their site.

This one-hour webinar training will provide practical guidance on a GCP quality system for clinical research sites. This session will review the GCP regulations, ICH guidelines, key roles and responsibilities, and provide an outline to get started on a quality system build. Tips on the development and roll-out of the quality assurance program across the site will also be discussed.

Why Should You Attend:

• Does your site lack any documented quality assurance processes? Or, do you have a quality system and SOPs that are hard to use and not reflective of your processes?
• Have you received some recent 483's after an FDA inspection?
• Are you a new CRC, research director, or PI that is building the research practice and would like to learn more about the role of a quality assurance system for your site?
• Are you looking for some additional training for your staff?
• Are you a sponsor or CRO who has responsibility for oversight and training of site personnel?
• Do you conduct site assessment and audits? Do you conduct study monitoring?

If yes, you should consider attending this one-hour webinar.

Learning Objective:

At the end of this webinar, participants will better understand the GCP regulations, the need for a quality assurance program for a research site, and how they can get started building the system that day.

Areas Covered in this Webinar:

• What are the key elements of a site quality system?
• How to prioritize the priorities for your quality system?
• How do document in SOPs what your site does on a daily basis
• FDA GCP regulations
• The History of GCP and human subject projection
• The International Conference on Harmonisation (ICH-GCP)
• The roles and responsibilities of the PI
• IRB human subject protection regulations

Who will Benefit:

This webinar will provide valuable assistance to the following personnel:

• Research site Principal Investigators
• Research site Clinical Research Coordinators
• Research Directors at a site, regional hospital or academic center
• GCP auditors
• Study monitors
• Sponsor staff who oversee site conduct and provide training to their sites

Instructor Profile:

Amanda Shepler, is an experienced clinical research talent with experience at a CRO (Covance) and research sites. She has served in roles including project manager at a CRO, research coordinator and research director. She has overseen all aspects of research from study execution to contracts and budget negotiation to quality system oversight. She grew a regional hospital research program from one enrolling pharmaceutical trial to over 30 ongoing studies covering Phase II through IV for the pharmaceutical and device industry. Her specific area of expertise is in Cardiovascular and Cardio-thoracic research.

Amanda began her career as a Clinical Microbiologist at St. Francis Hospital, where she later became an Instructor in the School of Medical Technology teaching Microbiology, Parasitology, Mycology and Hematology.

Amanda is a Certified Clinical Research Professional with the Society of Clinical Research Associates (SoCRA) as well as an active member of the Association for Clinical Research Professionals (ACRP). She is certified in Good Clinical Practice (GCP), ICH and has been directly involved with the development and implementation of research site SOP's and Quality Assurance Programs. Amanda enjoys sharing her practical experiences in all levels of Clinical Research.

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