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

A US-based university with a nationally recognized academic health center implemented Clinical Data Interchange Standards Consortium (CDISC) standardization to ensure regulatory compliance and future funding success.

概况The need for CDISC compliance

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.

Challenge 1: Retrospective SDTM mapping

The need for CDISC compliance really became apparent for the university when they submitted a study for Mirdametinib, a MEK inhibitor, just before the CDISC mandate came into force. The Food and Drug Administration (FDA) noted that the collected data was not CDISC compliant.

The university was faced with retrospectively mapping the study to CDISC’s Study Data Tabulation Model (SDTM), which was no easy task. Because the data had been collected without SDTM in mind, they found terminology inconsistencies and gaps in the required data.

Challenge 2: A cultural shift towards CDISC compliance

The university faced many challenges on their journey to CDISC standards implementation:

Lack of CDISC knowledge internally – Particularly when it came to collection and submission requirements.
The cultural shift of adopting the new methods – CDISC standardization was a big shift away from the norm for the university, which had run things differently for many years.
Budget to invest in standardization, including budget for training – In departments with stretched budgets and busy staff, the amount of work and training required to implement standardization was a deterrent.

解决方案：Implementing CDISC standards

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.

Outcome: Faster, easier, and compliant study build

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

About Pinnacle 21

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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

概况The need for CDISC compliance

Challenge 1: Retrospective SDTM mapping

Challenge 2: A cultural shift towards CDISC compliance

解决方案：Implementing CDISC standards

Outcome: Faster, easier, and compliant study build

我们能帮您什么吗？

第 5 部分：Regulatory Outlook on Data Management

第 4 部分：Consequences of Improper Data Collection

第 3 部分：Ensuring Proper Data Collection

第 2 部分：Regulatory Challenges With Data Collection