一所大学是如何克服实际操作和文化挑战来实施 CDISC 合规性的

CDISC compliance wasn’t on the university’s radar until CDISC standards became mandatory for academia in recent years. The university did have internal standards in place, but there were some problems with these:

• Some standards conflicted, for example the same field in multiple standards used different code lists and terminology.
• There was no governance over the standards, which meant there were differences between content and studies, and no robust method of recording changes.
• While the standards met National Institutes of Health (NIH) requirements, they did not align with SDTM, therefore were not CDISC compliant.

As they had no real experience of CDISC standards internally, the university sought expert help to assist with the adoption of the standards. They first connected with us at the 2019 CDISC US Interchange in San Diego. After speaking with our team, they realized quickly that we could help them achieve their standardization goals.

Our Business Development Manager, Ryan Miller, worked closely with the university to understand their needs.

Ryan says: “They do really important work—many of their studies involve drug discovery in the treatment of children. They had in place thorough study protocols and an electronic data capture (EDC) system, but due to funding constraints and a high staff turnover, were struggling with this new requirement to collect data in a CDISC-compliant way. We had the knowledge they needed to review the protocol and bring their data collection process in line with standards.”

Stage 1: By performing a gap analysis, we identified how often each existing internal standard was used, where studies strayed from core standards, and where content was missing. We then worked with them to develop new standards from existing NIH content.

Stage 2: We reviewed the university’s existing case report forms (CRFs), gave feedback on the design, and aligned them to CDISC’s CDASH standard. Form content was made consistent with NCI controlled terminology, so that collected data could be mapped to SDTM. Now the university had a set of standardized CRFs they could then use in future study builds.

Stage 3: We reviewed existing data with CDISC models in mind, to identify any potential validation issues, such as missing or blank fields, and to bring the content in line with CDISC standards.

Stage 4: Finally, we provided CDISC standards training and introduced a change management and governance process to ensure metadata quality going forward.

The university’s investment in learning and implementing CDISC standards means they can now more successfully navigate data collection, SDTM mapping, and submission. It also means they are no longer recreating the wheel with new content for every trial.

They have realized many benefits since implementing standardization, including:

• Faster and easier study build
• Better reuse of data
• Better interoperability between studies
• Confidence that they are compliant with CDISC standards