25 September, 2015, by ClinCaptureTeam
Contract research organizations (CROs) always strive to enhance project oversight and decrease costs while adding value. As clinical trials are becoming more complex, multiple CRO partners often need to collaborate on a single project, and each CRO has its own portal and varying sets of reports, which means transferring information can be problematic. Even in the cases when the sponsor and CRO use the same CTMS, for example, APIs need to be set up for each trial. Simplifying data exchange is therefore crucial to fulfilling their trial-related duties.
Some find a workaround with CTMS by extracting data in spreadsheets, sending it to the sponsor and then importing it into their system manually. But they can run into problems such as inconsistent data requests or problems in mapping it to the sponsor’s back end data tables. Others use an SQL database or SharePoint for data entry, and skip CTMS altogether. That, however, presents many operational issues of providing consistent data extracts in the right format and manually managing their data.
Some sponsors also work with CROs on implementing CDISC clinical trial data models such as the Study Data Tabulation Model (SDTM) and the Analysis Data Model (ADaM). The CROs convert their studies into a common SDTM structure in support of eCTD and Integrated Summary of Safety analyses for a filing. Sometimes these studies were not done in-house which results in inconsistent eCRFs so the SDTM format benefits both internal data inspectors as well as the FDA. Using the SDTM structure has helped standardize the data structure (Treatment Names, Treatment Codes, Visit Names, Visit Numbers, MedDRA Encoding Version, and coding for Disposition Status). The table below further describes some materials that are helpful for the CRO to implement the SDTM conversion.
Credit: Outsourced Data Integration Project with CDISC SDTM and ADaM Deliverables
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