Database Validation and Surviving an Audit

 

2 part webinar
60-minute presentation followed by 30-minute Q&A

Presenters

Tim Peters, CCDM

With more than a dozen years experience in clinical research, Tim has been involved in many validation projects, including commercial software packages (SAS, Oracle Clinical, etc.), in-house developed software applications and myriad study databases. He has held data management and clinical information technology positions with a CRO, a large biotech company and is currently with the largest pediatric oncology research organization in the world – the Children’s Oncology Group, an NCI designated Cooperative Cancer Group.

Olivia Montano, CCDM
Olivia is the director, Clinical Data Management at Synteract, Inc., and has more than 15 years of clinical research experience. Olivia started in academia and then went on to work in biotech before entering the Clinical Research Organization world.

Overview

Points to be addressed include:

  • SOP's - doing what you say you are doing and surviving the audit
  • Client/Internal audits versus FAD audits: what's the difference and how to prepare for each
  • Requirements tracing - Minding the gap between the DB spec and validation tests
  • Conducting vendor audits - what to look for and what is required</li>
  • How technology is changing the face of audits and how you need to prepare

Level

Intermediate to Advanced

Target Audience

CEOs, chief learning officers and trainers, clinical data managers, managers of data groups, quality control and quality assurance statisticians, biostatisticians, and project managers working within the clinical trials industry.

Continuing Education Credit Opportunity

Attendees are eligible for CEUs upon attendance and successful completion of assessment questions. Each part of this 2 part webinar carries 0.2 CEUs.
SCDM is authorized by IACET to offer .2 CEUs for this program.

 

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