Your Clinical SOPs Are Too Long! Reduce Wordy SOPs to Improve Compliance

Held Sept. 13, 2012
Sponsors, CROs and site personnel are buried under the weight of long, overly bloated and wordy SOPs.

A typical clinical SOP starts out being written by the clinical manager as a 4-page document, but by the time it is sent through pharmacovigilance, legal and the medical monitor, everyone adds their two cents and the document balloons to 12-15 pages.

Has this ever happened to you? If so, read on…

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Too many organizations believe that filing cabinets full of 4-inch SOP binders and reams of paper make an effective program. This is just not the case.

FDAnews has the answers. In 90-minutes, two of the industry’s best clinical SOP experts will teach you how to regain control of your SOP writing process, cut costs from duplicative writing activities and, most importantly, increase compliance.

Listeners will be treated to the following time-tested strategies:

  • Tips and tricks for turning 12-15 page “monsters” no one will ever read and comprehend into 4-page winners that boost learning and compliance
  • The good, the bad and the ugly. Speakers will highlight examples of what makes for good, bad and downright ugly SOP writing
  • How to break the cycle of manufacturing SOPs being used as the template for clinical SOPs
  • Best practices for how to title an SOP and create a well-defined scope — two of the most important elements to a good SOP
  • How to avoid the “everything and the kitchen sink” approach to SOP writing. Speakers will explain that good SOPs only include who does what and how to do it IF it involves a regulatory requirement
  • What 2 questions FDA investigators typically ask you regarding your clinical SOPs

You and your colleagues can listen from the comfort of your own office, conference room or auditorium. No planes, no hotels, no precious time away from work and family — just 90 minutes of solid learning.

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Meet Your Instructors

Steven Steinbrueck, MPH, CCRA, is President of Stonebridge GCP Consulting, where he focuses on good clinical practices and bioethics. His background combines research, healthcare and academic experience. Mr. Steinbrueck started his career as an Army corpsman and a physician assistant in family practice. Prior to founding Stonebridge, he led training in both large pharmaceutical and CRO settings. He served as a CRA and was the clinical director of a physician assistant training program. Currently, he serves on the graduate faculty of The George Washington University.

Elizabeth Bodi is a clinical research Senior Consultant, Halloran Consulting Group, where her focus is training in project management, infrastructure development and delivery of clinical training programs for biopharmaceutical companies. She has vast experience in developing SOPs at Antigenics, INC, MTRA/AAI, PAREXEL and Covance, where she also developed both basic and specialized CRA and GCP training courses.

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Here’s a suggested list of potential participants from your organization:

  • Compliance officials
  • QA/QC personnel
  • Regulatory affairs professionals
  • Training personnel
  • Procedural document writers
  • Clinical operations personnel
  • Clinical investigators
  • Clinical research coordinators

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600