Issues in CT.gov mapping file

[BSnoeijerCD]

While doing backward mapping (CT.gov to USDM) the following items seemed to be incorrect in the CT.gov mapping file:

• ReadMe worksheet: multiple references to CTIS and M11 instead of CT.gov
• Study Identification, secondary ID, description mapped from name attribute instead of label (note name is supposed to be a computerized name and not for presentation purposes)
• Study description and conditions can be added to mapping
• Study Design, Interventional Study Design, enrollment is still mapped to plannedEnrollmentQuantity. This attribute is not in the v4.0 model as such.
• Study Design, Observational Study Design, Biospecimen retention and description are not correctly mapped.
• Outcomes Measures, secondary Measure Information in first column includes the word 'Primary' as well.
• Eligibility Sex/Gender, Gender based - content is misunderstood in initial mapping. This is not covered by USDM so mapping should be removed.
• Masking: also blinding/masking type is a response in the json file extracted from CT.gov. Now the mapping to 'DOUBLE BLIND', 'SINGLE BLIND' etc is not included. Note that CT.gov also seems to have a 'TRIPLE BLIND' response type.