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. The eCRFs are examples and are not meant to imply that any particular layout or collection plan is preferable over another.
The following information is applicable to the CDASHIG v2.1 eCRFs:
To facilitate broad use, these eCRFs were developed based upon data management best practices, rather than features or limitations of any specific EDC system. The following guiding principles were followed:
- The Controlled Terminology publication from December 2019 was used.
- The layout shows one field per row on the eCRF. If the EDC system being used can accommodate more than one field per line, the layout may be adjusted accordingly
- Some fields (study ID, site ID, subject ID) were not included on the eCRFs because most EDC systems capture these as standard fields.
- For single check boxes, the text is shown, rather than the coded value
- Some codelists are subsetted. Users should create codelists based on their study parameters.
- Codelist order may be updated depending on user preference.
- In the Metadata Specification Excel files, the OID column format is IT.Name of the variable. The IT is a prefix appended during the creation of the Metadata Specification files and can be removed or amended once imported into the EDC system.
CDISC has partnered with OpenClinica and REDCap to make CDASH IG v2.1 eCRFs and Crohn’s Disease eCRFs from the Crohn’s Disease v1.0 TAUG available in their respective Libraries for system users to leverage in their work. To access these eCRFs, please visit:
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