Xtalk: Programming a CDASH Compliant eCRF Library with Biostatistics

Xtalk: Programming a CDASH Compliant eCRF Library with Biostatistics

Atlantic Research Group partnered with Medrio (a leader in providing eClinical technology for early-phase pharma, device, and diagnostics clinical trials) to present the Xtalk, Programming a CDASH Compliant eCRF Library with Biostatistics, on May 7, 2019.

The ARG presenting team, led by Marilee Newman (Director of Data Management) was comprised of Emilea Norris (Biostatistician), Claude Toney (Clinical Data Programmer) and Kevin Limlengco (Clinical Data Programmer).
Since clinical trial data vary on many parameters (participant demographics, study procedures, method of data collection, etc.), case report forms should be developed according to an accepted standard. The Clinical Data Acquisition Standards Harmonization (CDASH) outlines best practices for presenting data to maintain consistency and quality across different trial phases and therapeutic areas. The use of CDASH also provides significant cost and time saving benefits to organizations conducting clinical trials. These factors were the impetus for the webinar.

Key takeaways included:

• For a Clinical Data programmer, there are many “customers” in need of consideration; it is important to build relationships
• A CDASH-compliant library of eCRF can speed database development and result in DM cost efficiencies
• Developing a validated eCRF library in collaboration with Biostatistics minimizes study transfer programming
• A standardized eCRF CDASH-compliant library enables automated SDTM mapping to forms

After the presentation, the ARG team fielded questions from the audience. One listener wanted to know if any data had been captured to measure the value to the organization of moving to the CDASH standards. Marilee responded by explaining that on the front end (in building the database) the time saved is in the one to two week range; on the back end (in locking the database) it can range between three to four days, all the way to eight to 10 days.

For access to the Xtalk, please click here.