The P21 Enterprise Trial Design module is available to all organizations using P21E v6.1.0 and later. Users can jumpstart trial design creation using scanned data or a standard as the starting point, then work collaboratively to ensure it is complete and compliant with both the standard and protocol.
One advantage of using P21E’s Trial Design tool is in-cell validation checks. Teams know immediately if the values in a cell are inconsistent with the standard. While the Trial Design checks do not include all checks that the P21E validation tools use when validating trial data, they do provide a visual indication of common warnings and errors in real-time.
Note: Datasets still must be validated; the Trial Design in-cell validation is not a comprehensive set of validation checks.
📋 In-cell validation checks
Validate cell values based on the data type & significant digits defined in the Data Package’s assigned standard. This check applies to all cells; however, TSVAL currently will not perform length checks where text has a maximum length of 200 due to TSVAL overflow fields.
Check that cell values do not exceed a variable’s maximum length as defined in the specification. This applies to all cells; however, if a variable does not have a length specified, this check will not fire.
Where variables have a specified codelist defined, the value will be checked to ensure it matches a value from the Data Package’s assigned codelist.
Check to ensure TSVALNF exists as required if TSVAL is empty.
Where IsMandatory = Yes for variables in a standard, check to confirm that a value exists, as it cannot be left blank.
✅ Coming soon: New checks for Trial Design
Look for the following warning updates in P21E 6.1.1 and later:
Check that when a value exists in TSVAL, then TSVALNF cannot be populated.
Check that TSVALCD is populated when, and TSVAL/TSVCDREF and TSVCDVER are ALL populated.
👣 Next Steps
Learn more about Trial Design datasets and options for adding Trial Design datasets.