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, a new Protocol Standard and by 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. The project needs to kick off by Q2 2017 to meet the IDMP-related regulatory compliance deadlines in Europe and to secure this recent window of opportunity for the new CTR&R standard to populate Clinicaltrials.gov and the upcoming EMA CT database.
The CTR2 Project will be split into two stages:
Stage 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. Stage 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.
Stage 2 – CDISC CTR2 & CDISC Protocol
In Stage 2, two new standards will be created:
- CTR&R (Clinical Trial Registration & Results)
- CDISC Protocol (The project will adopt and harmonise with existing work where possible)
Both standards will map to and utilise the Stage 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).
The CTR2 project did not make the CDISC strategic roadmap, therefore it cannot be funded fully by Membership dues. However due to the recent spotlight explained above, the project is now perfectly aligned to meet core strategic goals for CDISC and add immense value to CDISC Members.
CDISC is looking for sponsorship from stakeholders to help with the funding and a core team of supporting external experts are on standby to start this important project ASAP.
CDISC is creating a steering group for CTR2 stakeholders and sponsors. The total budget requirement is USD $150k for 2017 (Stage 1) and $150k for 2018 (Stage 2). CDISC will match this figure with internal staffing resources as well as a financial contribution. Once the Stage 1 funding has been agreed on, this project should kick off in Q2 2017.
Sponsorship examples: 10 companies at $15K or 6 companies at $25K per year.
CTR2 – Project Timeline for stages 1 & 2
Figure 2 – CTR2 Timeline
For more information or to join the Steering Committee, contact Paul Houston, CDISC Head of Europe Operations, firstname.lastname@example.org. To indicate your interest in participating or contributing to this project, please complete the CDISC CTR2 Survey.