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 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.