Pharmaceutical and biotechnology companies operate within a constantly evolving regulatory landscape, where adherence to standards set by organizations like the Clinical Data Interchange Standards Consortium (CDISC) is crucial for submitting clinical trial data. In the area of clinical trial data management, information can originate from various sources and be stored across different platforms, systems, and networks. This includes data stored in spreadsheets with edit checks and specifications, as well as PDF documents containing Case Report Forms (CRFs) and protocols, this list goes on and on. With the constant updates and creation of new versions, it becomes challenging to ensure utilization and access to the most up-to-date files/standards and use it effectively to map raw clinical data in standards-compliant datasets (such as CDISC-SDTM). GenInvo has leveraged use of Machine Learning to develop tool (ApoGI™) which offer a robust metadata repository framework (MDR Module) to address these issues.
ApoGI™ – Metadata Repository (MDR) Module
The ApoGI™ – MDR module helps users to set up project-specific metadata through an intuitive graphic user interface (GUI). The data transformation (ApoGI-DT™) module of the ApoGI converts trial-related information to CDISC or sponsor-specific data standards. The solution stores all metadata in a central registry, and automatically maps new study metadata with the existing database.
By utilizing ApoGI™ – MDR,
- One can easily track and manage the latest versions of files/standards, while also ensuring the integrity and quality of the data.
- This framework acts as a centralized hub responsible for capturing and managing the metadata associated with clinical studies.
- It efficiently manages various components such as source data, SDTM domain metadata, SDTM mapping specifications, and transformation rules etc…
- By consolidating these elements within a single platform, organizations can streamline their data management processes, enhance data integrity, and facilitate efficient data transformation and mapping activities.
Furthermore, this MDR module enhances collaboration and consistency among team members by offering a centralized repository for data transformations, serving as a single source of truth. It also provides the advantage of inheritability and scalability for future study creation, enabling organizations to efficiently build upon existing frameworks. By maintaining data integrity and traceability, the MDR module simplifies the validation process and expedites regulatory submission. The implementation of MDR module promotes transparency and facilitates efficient management of changes, ultimately resulting in the generation of accurate and standards-compliant datasets (such as CDISC-SDTM).
Key features of the ApoGI™ – MDR
- Workflow management: It automates workflows for creating new data standards or maintaining existing ones
- Automated study setup: Importing both Legacy/CDISC Metadata into ApoGI system with autorecognition of CDISC standards. Automatically maps new study metadata with the central library.
- Managing the Legacy/CDISC Metadata with any edits/updates to the domain/element.
- Governance model to support Governance process
- Impact Analysis: One of the key objectives of an MDR is to assess the potential impact of metadata changes before implementing them. This analysis involves evaluating all relevant standards and assets to let you know exactly what downstream and upstream metadata and processes that will be influenced by the proposed change.
- Change control: MDR allow users to initiate change requests for existing standard objects. This functionality enables users to log requests for modifications, such as updating a form. The change control process, which follows a pre-defined workflow, governs the approval process and the tracking and management of these change requests. All changes are tracked from inception to completion.
- Versioning
- Traceability
- Exporting functionality available for metadata.
- Reports and Dashboards: Intuitive dashboard to reflect on the KPIs used in standards. The flexibility to define customized reports based on user preference. Tracks any addition, deletion, or change in each object by maintaining an audit trail
- User management: Assigns roles and access privileges to users based on business needs
- 21CFR Part 11 Compliance
ApoGI™ – MDR Flow:
By Hitesh Raval, Principal Data Scientist & CDISC SME
