CDISC Collaboration Opportunity - Extending the Foundations of Beginning to End Data Integrity.

The CTR2 (Clinical Trial Registration) project will utilize and extend CDISC Clinical Research Standards to create richer and more integrated beginning-to-end data sets that will meet many complex competitive, regulatory and research demands. CTR2 will extend and enrich CDISC CTR-XML by including summary results, a new Protocol Standard and by harmonising the CDISC Foundational Standards with the ISO IDMP Standards.

The resulting standards from this project will be made available free as with all CDISC standards to support all clinical trials, both academic and industry. The updated CTR-XML will follow the WHO and ICMJE recommendations and the project will seek to harmonise requirements on Protocol and Results where ever achievable allowing for global clinical trial registries to be auto-populated with structured and consistent high quality information. The project includes ISO Identification of Medicinal Products (IDMP) harmonisation of CDISC standards to meet global regulatory compliance further enriching clinical trial datasets to support more effective research, regulatory and business informatics.

CDISC is now calling for sponsor contributions and stakeholders to join a steering committee to help get this work off the ground by Q2 2017.

Please have a look at the project page https://www.cdisc.org/ctr2-project and fill out the survey for more information or to get involved.

If you cannot contribute but agree that this project should be delivered please at least share this notice with your contacts so we can start this important work.

Thank you very much!

Just a few anticipated Benefits of the project:

1. Improve clinical trial registry information for researchers, regulators, and the public
2. Wider global regulatory compliance with IDMP harmonisation (Initially Europe then beyond)
3. Improved analytics with extended information and granularity within the clinical trial data standards
4. Reinforced beginning to end data integrity; from preclinical to post marketing and from the beginning stage of a clinical trial to the end
5. Aid regulatory review
6. Create efficiencies and minimise human error in the registering of clinical trials