CDISC Europe Interchange Abstracts

Maturing standardisation; the switch from spreadsheet-based standards to an MDR

by Louella Schoemacher & Jasmine Kestemont

In order to work consistent, structured, and time efficient throughout multiple studies, standardisation is key. Standardisation can be relatively simple with having the company standards in a spreadsheet and using this spreadsheet to share study-specific metadata requirements. However, with a growing number of compounds, indications, studies, and number of CRO’s involved in creation of the SDTM package (aCRF, SDTM datasets Define-XML and SDRG), it gets harder and more important to have and maintain the standards. Furthermore, individual studies can have specific requirements which may result in deviations even within a compound or indication. When the number of studies grows, a simple spreadsheet may no longer be sufficient to capture all subsets of metadata requirements. When the standards cannot keep up with the growing number of studies, this can result in an overgrowth of different annotated CRFs and Define-XML files leading to undesirable inconsistencies.

Do It Yourself: Case Report Form (CRF) Annotation

by Caro Sluijter

There is more than one way to skin a cat; and there is also more than one way to annotate a Case Report Form (CRF).
As the regulatory authorities and CDISC have guidelines to deal with metadata submission, we do have a roadmap to create an annotated CRF. However, some of these guidelines contradict each other, and what do you do when your CRF cannot adhere to all the guidelines?