According to the Society for Clinical Data Management (SCDM) Good Clinical Data Management Practices (GCDMP): “…no document in a clinical trial (other than the study protocol) is more important than the instrument designed and used to acquire data. The quality of the data collected relies first and foremost on the quality of this instrument. Regardless of the time and effort spent conducting the trial, the correct data points must be collected; otherwise, a meaningful analysis of the study’s outcome may not be possible. Therefore, it follows that the design, development, and quality assurance of such an instrument must receive the utmost attention.”
Other regulations, such as the ICH E6 Good Clinical Practice guidelines, identify the Case Report Form (CRF) as one of the essential documents for a clinical trial. Therefore, it is imperative to understand and implement the best practices of the CRF design process. That includes making sure all the protocol-required data are collected, ensuring the design of the CRF minimizes errors, and keeping the study coordinator in their normal workflow.
It is also important to consider the future compilation of data from multiple clinical trials for agency submission and the assurance that data collection is consistent, concise, and compatible, hence, the need for standards. CDISC and CDASH are instrumental in the establishment of these standards.
This workshop will discuss the principles of good CRF design, the timing of CRF design in relation to clinical trial start-up, and the team that will contribute to the data collection recommendations. Participants will review a sample protocol and determine which CRFs will be required to collect the appropriate data. We will discuss design philosophies and rationales and apply these principles in reviewing CRFs to critique design. We will also discuss the resources that are utilized in determining what data collection is required and the current standards for CRF data content.
The module based on best practices for CRF design as documented in the SCDM GCDMP will provide the understanding of the expectations for purposeful CRF design.
Note: This workshop will deal with the principles and fundamentals relating to data elements for good CRF design. It is not intended as a training in a software application to create the CRF.
Take advantage of our $800.00 price by registering early! * After November 4, costs are $1,000.00.