This is a two-part webinar
As we all know, this industry started with sites capturing data on paper Case Report Forms (CRFs) and data management subsequently entering these paper CRFs into an internal database which had batch or real time validations. All queries were printed on paper and faxed, shipped or sent electronically to the site for clarification. This process was very manual and time consuming.
When designing a paper CRF, the primary focus of the design was to minimize the amount of paper needing to be printed for each CRF book and collect data in a sensible and logical order. The only way to try and control data that was being entered by the site was to visually nest fields and organize the modules and fields in a logical and organized fashion.
As a result of technology and industry trends in the mid-1990s, the industry started paving a new approach for collecting and managing data. The Electronic Data Capture system was created which allowed remote data by the entry users (sites and/or stakeholders). Many new considerations came into play with how we design eCRFs for EDC systems.
EDC baseline functionality (field attributes, field masks, derived fields, edit check validations, dynamic real-time branching and dynamic form/ visit flows) will dictate how one approaches an eCRF design. When we used paper CRFs as data collection methods, they were designed at minimum, for ease of copying information, presentation of a simply designed form, and a logically presented casebook. We did not have to worry about any of the data validation, as this was always done in the back end. Yet, one of the most important features of EDC is the ability to validate and control data during the entry process by a site user and/or stakeholder.
The validation of the data is going to be dependent on the specific EDC system that is used. There are few commonalities between EDC systems, and knowing which data requires the validation before designing the eCRF layout is an important consideration. For example, systems that don’t have real-time dynamic branching should have edit check validations built into the design to ensure data being entered has the correct data relationships and flow.
There are many basic fundamentals one should consider when designing CRFs such as understanding the purpose of lead-in questions, visit-level and ongoing/log records or knowing when to use free text, unknown or unavailable tick boxes. One should understand the reason for a modular approach and how it directly affects development programming.
How one designs an eCRF for interventional, observational (non-interventional) prospective study or retrospective study will be completely different. We will discuss the differences in approach in detail and ensure you have a clear understanding.
Join us in this fast-paced webinar where we review best practice for eCRF design, allowing for a robust eCRF study build leading to cleaner data faster.
• Understanding the difference between paper CRFs and eCRF designs.
• Understanding how different EDC system features and functionalities influence eCRF designs as well as validations.
• Guiding the study team, upfront, to best represent the data for the EDC system in use.
• Understanding the basic fundamental rules in designs
• Understanding the different types of studies (Interventional, Observational, Retrospective) and phases of studies and how they impact data collection.
Who Should Attend
Beginners and Intermediate CDMs – This webinar is designed to help those preparing to create their first eCRFs or wanting to expand their current knowledge and understanding of eCRF designs. It will give them a better understanding of different EDC platforms used within the industry, phases and types of trials and the basic concepts of solid eCRF design approaches for each given circumstance
Meet the Instructor
David Eade, BAS, CTRA, AGE - David is a Sr. Manager, of Clinical Data Management at United BioSource Corporation (UBC) and has been in actively participating in the Clinical Trial industry since 1999. He has 12 years of Clinical Data Management experience and 5 years in ClinOps/Phase I Operations in both the Contract Research Organization (CRO) as well as a Pharmaceutical and Biotechnology settings. He has experience in all phases of studies (Phase I, II, III and IV) including Registries, REMS/KAB/RiskMap studies.
He continues to be an active member of a standards committee and has an array of experience in multiple EDC platforms, eCRF designs, and standard data libraries. David has been a part of the SCDM educational committee since 2013 and has guest lectured for the Clinical Trials Research Degree program at Durham Technical Community College in Durham, North Carolina.
Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assesment deadline.
SCDM is authorized by IACET to offer 0.4 CEUs for this program.
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