What are the Effective Solutions for Clinical Data Management?
For the health care of patients around the world, any new medical product (or different uses of an already established technology) must complete clinical trial procedures to ensure safety and quality. Bringing new solutions to the market is a complex process and consists in the application of several determinate activities, one of those is Clinical Data Management.
CDM is responsible for informing and statistically interpreting sound data, collected through trials, for the reduction of time between development and marketing, while following regulatory standards for production. Throughout the entire clinical trial stages, CDM is involved.
For the matter of importance related to the subject, it is essential to understand Clinical Data Management, as well as know how to rely on partnerships that can provide experienced analytical personnel to help move your product forward in the medical industry.
What is Clinical Data Management?
The medical and pharmaceutical market, today, demands fast approaches to the distribution approval process, at the same time that expects high standards for the new products. Clinical Data Management is the portion of the process that makes easier delivering both. Early in the trial process, soon after a protocol is established, CDM activities start by designing the strategy for collecting high-quality data and meet regulatory requirements.
The true goal of CDM is to assemble concrete data to support the claims of a medical or pharmaceutical technology, leading to a positive conclusion to its safety and effectiveness. Though the entire research period, the data management team must guarantee that all data is collected, validated, complete and consistent.
Many roles are included in CDM activities, they are assessed for quality, at regular intervals, during a trial. You will learn more about those aspects in this article.
Key CDM Activities
- Data Managing
- Database Programming
- Design
- Medical Code
- Clinical Data Coordinating
- Quality Control
- Data Entry
How do we Define "High-Quality" Data?
To say a collection of data is "high-quality" is a matter of accuracy and statistical analysis, what means two things:
- Data integrity: Data should never be lost, and if it is, the number must be minimal
- Statistical consistency: Data should exhibit a level of variation that is deemed acceptable and does not impact the study's conclusion or statistical analysis
That being said, in some situations, results that aren't in conformity with the expected can also be of value for regulatory authorities.
Regulations, Guidelines, and Standards in Clinical Data Management
CDM follow guidelines and standards, similarly to other areas in clinical research, to ensure the integrity, authenticity, and confidentiality of data. Compliance with 21 CFR Part 11 is essential for electronic records, which are created, modified, maintained, archived, retrieved, or transmitted. Validated systems are used to ensure data accuracy, reliability, and consistency, accompanied by secure, computer-generated, timestamped audit trails.
The Society for Clinical Data Management (SCDM) published the Good Clinical Data Management Practices (GCDMP) guidelines, consisting of 20 chapters that outline minimum standards and best practices for CDM processes. These instructions serve as a valuable resource for maintaining high-quality data management practices.
The CDM Roles in Clinical Trials
All key aspects and activities of Clinical Data Management involves the efficient and accurate handling of the information extracted from practical studies. The CDM process consists of:
Data Collection
The team designs and implements collecting strategies, often incorporated into electronic data capture (EDC) systems. They determine the types of data to be gathered, develop case report forms (CRFs), and choose data entry guidelines.
CRF Tracking
The CRF entries are monitored and handed over to the CDM team, who check them for missing pages and lost data to ensure completeness.
Data Entry & Validation
Managers oversee the entry of data into the designed systems, using validation checkmarks and resolving discrepancies to ensure accuracy.
Database Designing
Clinical software applications facilitate CDM tasks and comply with regulatory requirements. Study details are used to validate data when incorporated into the software for tests.
Discrepancy Management
CDM reviews discrepancies and investigates possible reasons. They gather documented evidence for resolving problems, with regular intervals to ensure fixes are implemented.
Medical Coding
Using electronic medical dictionaries and knowledge of disease entities, drugs, and pathological processes, medical terms on the CRF are detected and ordered to achieve data consistency.
Database Locking
Afterthorough quality checks, final data validation occurs. Once discrepancies are resolved and all activities are complete, the database is locked to prevent further changes.
The Case Report Form (CRF)
The CRF should be concise, self-explanatory and user-friendly. This document must record all information on each patient/subject enrolled in a clinical research study, serving as the foundation for accurate data collection.
Key Takeaways: Clinical Data Management Essentials
- CDM is critical for reducing time between development and marketing while maintaining regulatory compliance
- High-quality data requires minimal data loss and acceptable variation that doesn't impact statistical analysis
- Compliance with 21 CFR Part 11 is essential for electronic records and data integrity
- GCDMP guidelines provide 20 chapters of minimum standards and best practices for CDM processes
- Data collection strategies are designed early in the trial process, soon after protocol establishment
- Case Report Forms (CRFs) must be concise, self-explanatory, and user-friendly
- CRF tracking ensures completeness by monitoring for missing pages and lost data
- Data validation uses checkmarks and discrepancy resolution to ensure accuracy
- Database design incorporates study details to validate data before real data capture
- Discrepancy management requires regular review intervals and documented evidence for resolution
- Medical coding uses electronic dictionaries to achieve data consistency and avoid duplication
- Database locking occurs only after thorough quality checks and resolution of all discrepancies
- Validated systems ensure data accuracy, reliability, and consistency with secure audit trails
- CDM activities are assessed for quality at regular intervals throughout the trial
- Clean data is extracted for statistical analysis only after database lock is complete
Trust Eclevar as Your Clinical Data Management Team
CDM is a vital part of any clinical study, and for that reason it must be conducted by specialists. Eclevar is an experienced CRO with extensive knowledge in regulation and performance of clinical trials. Our team is ready to perform under your specific research, data and documentation needs to put your product closer to your target markets.
We are committed to verify and protect access to the data collected, complying with our Protection & Privacy Policy. For more information on Clinical Data Management and how we can work together, contact us.
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