The eCRF Portal consists of ready-to-use, CDASH-compliant, annotated eCRFs, available in PDF, HTML, and XML, to use as is or import to an EDC system for customization. This "out-of-the-box" solution is designed to meet most users' basic needs while allowing for customization, facilitating data reuse, and reducing the time needed to develop eCRFs.
Since the eCRFs are based on CDASH, they are aligned with SDTM and SDTMIG, enabling the flow of data from collection to tabulation. The eCRFs also help promote data quality by encouraging users to implement similar questions/answers and apply the same data assumptions. These practices increase data comparability across studies, programs, companies, and even non-industry research, allowing for better poolability and interoperability. Ultimately, this can result in more meaningful research and more reliable results, benefiting all communities.
How Viedoc can help you leverage these benefits
Providing eCRFs through a portal is a great initiative. As Viedoc supports CDISC ODM (import and export), any Viedoc Designer application user can easily import the CDASH compliant forms for use in a study. However, the eCRFs still need some of the fundamentals to make them robust enough for efficient data collection, i.e., visibility conditions and data validation. These "extensions" need to be handled by the EDC system.
The solution — Viedoc templates
To support our clients who want to use the eCRFs from CDISC, we recently introduced Viedoc Templates. The purpose of this ready-to-use template catalog is to provide a list of best practice eCRFs that are based on CDASH. We've also included visibility conditions and edit checks, allowing for a significantly reduced setup time as well as for a more powerful end-user experience.
Viedoc supports any possible visibility condition on item, form, role, visit, site, and country-level. These conditions allow site staff entering data to easily follow the workflow for the respective subject independent of the cohort, treatment, or cycle as only the applicable visits and forms will appear for the particular participant. This flexibility is crucial in complex oncology studies where subjects can have several different workflows depending on one of the previously mentioned factors. Additionally, most Viedoc template catalog forms have built-in edit checks (both simple and complex), which the designer can easily edit to fit the specific protocol requirements.
The Viedoc eClinical suite and the template catalog allow clients to tackle any complex study and handle the setup faster and with better quality than ever before. Blank and annotated CRFs, the study workflow report, formats, edit checks, as well as a complete configuration report, are of course, also included in PDF, Excel, and ODM.
Why not try it out for your next study?
If you want to know more about the world's fastest-growing eClinical suite, don't hesitate to contact us today.
Enjoy your trial!
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