Capturing New Lesion Measurements in iRECIST

Hi All,

 

We are wondering whether anyone with experience in developing CRFs/database structure for iRECIST would be willing to discuss their design with us?  We are using MACRO EDC and with our existing RECIST forms the site only need to enter the lesion name, site etc. once at baseline and we then derive that info into subsequent visits.  Since new lesions can present at any visit, and we need to capture measurements at each visit from that point onwards, we haven’t found a simple way to derive the info forward in MACRO and would therefore rely on sites re-entering this data at each subsequent visit.  More work for them and potentially more data cleaning for us.

We are toying with the idea of taking the RECIST data out of the visits into a separate section of the CRF and splitting Target, non-target, New lesions etc. onto separate repeating forms. One per lesion, with the lesion ID, location etc. entered only once at the top of the form and a row per visit to capture the measurements.  However, we’d love to hear whether anyone else has a different approach.

Thanks

Steph Foster

Clinical Trial Data Management Specialist

ICR-CTSU.

 

Steph Foster
Clinical Trial Data Management Specialist

[Author]

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