Course Description

The phrase EEgarbage in, garbage outEE can be applied to the data collection efforts in clinical trials. To avoid this pitfall, itEEs important to be thorough in the evaluation of the data collection items that will valida"protocol hypothesis endpoints and statistical analysis. ItEEs 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, itEEs essential for data collection to be consistent, concise and compatible EE 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 EE CDISC and CDASH EE 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.

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Learning Objectives

• Outline the clinical data management (CDM) focus on protocol review to identify data requirements
• Implement EEbest practicesEE for eCRF design
• Disc