Clinical Data Management (CDM) deals specifically with the information that is collected during the clinical trial. Its aims are to ensure quality, data, integrity and compliance with regulations and protocols.
There are many clinical data management systems available and it can be difficult to select one to utilise. Comparing a few allows for an informed decision to be made. Look out for features like
- The pricing of the software
- Technical support
- Document management
- Electronic data capture (EDC)
- Participant database
- Number of users the software can handle
- Payment portal
- Recruiting management
Data Management Stages
There are several areas of responsibility when it comes to data management. These responsibilities can either be split into smaller groups or assigned to the principal data manager. These roles include:
- Planning: The database, forms and overall plans are prepared by the Data Manager
- Data collection and management: Data collection, and conversion to digital (if required), coding and standardisation
- Assure: The Data Manager determines if the data plan and tools meet the necessary requirements
- Identity: Any risks are identified by the staff
- Data review and analytics: Quality management, auditing and statistical analysis of the collected information
- Data standards: Comparing the data collected against regulatory requirements
- Innovation: Use new tools and theories that are developed around the field of medical research and clinical trials
- Lock: The database is locked for integrity by the Data Manager
Different Types of Data Management
Data Management Plan Design
A Data Management Plan (DMP) is a document that outlines all the tasks, processes, milestones and deliverables that are required throughout the Clinical Data Management process. It is a clear guideline on how to work with the information gathered during the clinical trial and how to handle any possible risks.
The Data Manager and Database Designer are usually in charge of the DMP. The DMP must be completed during the trial design stage.
The DMP involves the following aspects:
- The data to be collected from the clinical trial participants
- Data formats
- Any existing information that can be integrated
- Storage and backup
- Data quality processes
- Responsibilities of each team member
- Cost of data preparation
- Compliance with relevant laws and regulations
Electronic Case Report Form Design (eCRF)
The Case Report Form is a digital or printed survey that collects important data from clinical trial participants and is shared with the trial sponsors. The document is created in accordance with the trial protocol and the recommendations of the Clinical Data Acquisitions Standards Harmonisation (CDASH).
The Data Manager and Database Designer are responsible for the Case Report Form. There are several reviews of the design before one is finalised.
The information included in the Case Report Form includes:
- Demographics (gender and age)
- Basic measurements (height and weight)
- Vital signs (temperature and blood pressure, etc)
- Medical history
- Lab exams
- Any adverse events
Electronic Data Capture
In recent years a digital system was created to collect participant data in an electronic format. More Clinical Research Organisation’s (CROs) and pharmaceutical companies are turning towards EDCs as it is usually user-friendly and minimises any errors. The data is collected from:
- Electronic Health Records (EHRs)
- Medical devices (blood pressure monitors and ECG machines, etc)
- Patient-reported outcomes (PROs) or information that comes directly from the participant
Clinicians, Data Managers, Data Entry Associates and Medical Coders are in charge of Electronic Data Capture.
Traditional Data Capture Methods
Traditional data capture is comprised of data being manually entered into a database in a consistent manner so that it can easily be retrieved and searched. Data entries may consist of a single entry or double entries which increases the accuracy of the data.
Data Entry Screen Design
The design of the data entry screen determines the speed at which data can be entered. The more similar the screen looks to the original CRF page, the easier it is for data to be entered into the system efficiently.
Another important factor to consider when designing the data entry screen is to keep consistent formatting throughout
Integrating Data From an External Database
More companies are choosing to connect to external databases to simplify the transfer of large amounts of data to their own database. Data files can be copied onto a disc and uploaded directly to the sponsor database.
Ensuring that the two databases are compatible and validating both systems to maintain data integrity and security is crucial.
Fax-Based Data Capture
The use of faxes to transfer CRFs is a good middle ground between more traditional paper-based data capture and full electronic data capture. It requires a simple re-engineering of the paper CRF process.
Tracking the data and duplicates must be considered.
Remote Data Entry (RDE)
Capturing data at the point at which it is generated. If an electronic transfer of the data to the sponsor’s system occurs on a regular basis, it means that it can be accessed and reviewed more quickly. The data is validated as it is entered into the system which minimises any errors.
The pros of using remote data entry include better data quality, speed, and access to data.
The potential users of the system should be considered before investing in a remote data entry system.
Once the data has been uploaded to the system, sponsors and CROs can access the information immediately. The edit history can be checked from the date stamps and once all edits and checks have been completed, the eCRF can be printed out and returned to the site by the CRA where it is signed by the investigator after the final data verification check.
RDE is most effective for simple clinical trials with a large number of participants recruited at a limited number of sites.
Data can be collected remotely from electronic diaries that have been given to participants. These diaries can be programmed to remind participants to follow the treatment schedule and regularly reviews their compliance. It also allows for adverse reactions to be picked up faster.
Participants will need to be trained on how to use these diaries and will also need to remember to bring them with them on each visit.
Data Validation is a group of quality tests that ensure the accuracy, legibility, consistency and integrity of information.
The Data Manager, Database Designer and Quality Control Associate are responsible for data validation.
It includes the following steps:
- Electronic edit checks: Established by a Database Designer and embedded into Electronic Case Report Forms which compare inputs against numerical and logical data.
- Source data verification (SDV): A process of checking Case Report Forms against medical records and other records. This ensures that the eCRF contains all the relevant information and a participant’s profile is fleshed out.
- Data anonymisation: Before it’s submitted to the clinical trial sponsors, the data must be made anonymous.
Database Lock and Data Archiving
Once a clinical trial has been completed, the database needs to be locked so that no edits can be made. The data is then sent to stakeholders for analysis, reporting and publication of the results.
All documents have to be archived for at least three years to allow for post-trial monitoring and trial follow-up to facilitate further research.
The Data Manager and Database Designer are in charge of locking the database and archiving the information.