Global Clinical Trial Registry Alignment - ISO IDMP (Identification of Medicinal Products) Regulatory Compliance - Beginning to End Data Integrity
Project Background and Overview
In 2016, CDISC released the Clinical Trial Registration (CTR)-XML Standard. From one harmonized superset of registration data, CTR-XML can populate multiple registries, such as ClinicalTrials.gov, EMA’s (EudraCT) and any of the World Health Organization’s Primary Clinical Trial Registries.
The CTR2 (Clinical Trial Registration) Project will extend and enrich CTR-XML by including summary results, extending Protocol elements, and harmonising the CDISC Foundational Standards with the ISO IDMP Standards. In concert with the CDISC SHARE metadata repository, this project will utilize and extend CDISC Foundational Standards to create richer and reinforced beginning-to-end data sets that meet many complex competitive and regulatory demands. The CTR2 Project focuses on implementation and beginning-to-end standards harmonization, the top two issues identified by the CDISC Advisory Council during the face-to-face meeting at the CDISC 2016 International Interchange.
ClinicalTrials.gov has recently announced interest in using standards to autopopulate their registry and have already made efforts to harmonise with EMA’s EudraCT.
Project kick-off took place in September 2017, with the initiation of the Scoping and Planning Stage (Stage 0), following the CDISC Standards Development Process.
Scoping for the CTR2 Project will be split into two parts:
Part 1 – IDMP Harmonisation
ISO IDMP Standards will be mandated by EMA in late 2018; FDA are already using the terminologies with SPL (Structured Product Labelling). PMDA are looking to follow suit. These standards will add further granularity to the investigational product information, creating more robust data sets to drive better analytics within sponsor MDRs and EDCs. Part 1 will include a gap analysis and output recommendations for updates to the CDISC Foundational Standards, which will be defined in close concert with the stakeholder group and Foundational Standards teams.
Part 2 – CDISC CTR2 & CDISC Protocol
Part 2 consists of CTR&R (Clinical Trial Registration & Results)
- Protocol updates (The project will adopt and harmonise with existing work where possible)
- Results – to automatically feed the CTR&R ODM2.0 XML
- IDMP elements (taken from Part 1)
Both standards will map to and utilise the Part 1 IDMP elements. These new standards will be exposed through SHARE (Figure 1). The project will ultimately create numerous sponsor, regulatory and clinical trial registry benefits.
Key Business Benefits
- Efficiency and cost savings in disclosure of trials and results.
- Wider global regulatory compliance with IDMP harmonisation (Initially Europe then beyond)
- Improved business analytics with extended information and granularity.
- Reinforced beginning to end data integrity; from preclinical to post marketing and from the beginning stage of a clinical trial to the end
- Easier reuse of study design and protocol.
- More efficient EDC setup.
- Essential foundation for sponsors IDMP or MDR implementation projects.
- Aid regulatory review and submissions.
- SHARE exposed CTR&R and Protocol standard (Potential to merge with TransCelerate CPT)
- Easier mapping of external vocabularies with ODM 2.0
As with CDISC CTR-XML, the CTR&R will use an ODM backbone, but this project will also be one of two initial implementation projects for ODM 2.0. Part of the funding will go toward ODM 2.0, which will offer greater interoperability with external standards (i.e., HL7 FHIR and better external vocabulary support and extended web services, such as RESTful as illustrated in Figure 1).
Figure 1 – Overview of Project Scope Touching Points (in green).
We would like to thank the CTR2 Team volunteers for their commitment to this project and our sponsors: