How Vault CDMS Streamlines Data Collection For Oncology Trials

By Richard Young, Vice President, Vault CDMS

Response evaluation criteria in solid tumours (RECIST) is a set of published rules that define when tumours in cancer patients improve (“respond”), stay the same (“stabilize”), or worsen (“progress”) during treatment. As data managers, we issue countless queries on RECIST forms, trying to reconcile tumour assessments from one visit or cycle to another. In Vault EDC, we are tackling these challenges by enabling users to create different collection solutions – focusing on a chronological approach (e.g. assessment by visit) or by tracking the tumour / lesion across visits – in essence treating RECIST data like a log page. We also observe that the options available for measurements and assessments vary with methodology, meaning we need to verify some of the key individual entries. Again, simple built-in logic guides the user effectively through data entry and will catch simple entry mistakes at the source.