Case Report Form Design, Strategy, and Standards

Course Description

The phrase “garbage in, garbage out” can be applied to the data collection efforts in clinical trials. To avoid this pitfall, it’s important to be thorough in the evaluation of the data collection items that will validate the protocol hypothesis endpoints and statistical analysis. It’s also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that the data are in compatible format. With this goal in mind, it’s essential for data collection to be consistent, concise and compatible – hence the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.

This web seminar will discuss the timing of case report form (CRF) design in relation to clinical trial startup and the team that will contribute to the data collection recommendations. We will review the resources utilized in determining what data collection is required and the current standards – CDISC and CDASH – for CRF data content. Best practices for CRF design as documented by the Society for Clinical Data Management Good Clinical Data Management Practices (SCDM GCDMP) will also be presented.

Learning Objectives

• Outline the clinical data management (CDM) focus on protocol review to identify data requirements
• Implement “best practices” for eCRF design
• Discuss the need for “customization” of CRFs
• Discuss CDASH standards for data collection in CRFs
• Identify data compatibility issues and solutions to ensure appropriate data integration

Who Should Attend

• Clinical Data Managers
• Clinical Database Developers
• Clinical Research Associates
• Statisticians
• Project Managers

Instructor

Denise G. Redkar-Brown, MT

Click here for complete trainer biographies

Registration Fees

$735

Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.  Participants will receive 2 hours (0.2 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation.  Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion.  ACPE#: 0778-0000-24-013-L99-P. Released: 2/24. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.