What is the purpose of
Clinical Data Management?
Clinical Data Management?
Generally, a clinical trial is meant to seek out answers to the research question by means of generating data for proving or disproving a hypothesis.
The purpose of Clinical data management (CDM) is to handle the data that results from clinical trials which all aspects of processing study data are a part. To support the gathering, cleaning, and management of subject or trial data, including designing and maintaining software systems, and databases by following necessary procedures and protocols.
The role of clinical data management is to provide and maintain high-quality data from data entry through analysis. Performed correctly, the results of clinical data management may be a dataset that's accurate, secure, reliable, and prepared for analysis at the top of a study.
Why is Clinical Data Management Important?
Clinical data management is essential for supporting the assessment of regulated products (e.g., pharmaceuticals, medical devices, cosmetics). In addition to ensuring that these goods are safe, clearly perform their functions, and adhere to regulatory standards, clinical data management offers the following advantages:
- Assurance of data quality
- Expedited development
- Protection from data loss
- Reduced costs
- Security
Clinical data management also ensures:
- Clean study dataset to support the statistical analysis and reporting
- Complete and accurate collection of data
- Data formatted for optimal usability on time
- Integrity and quality of data transferred from trial subjects to study database
- True representation of trial in the study’s database
3 Objectives of Clinical Data Management
Clinical data management is essential for supporting the assessment of regulated products (e.g., pharmaceuticals, medical devices, cosmetics). In addition to ensuring that these goods are safe, clearly perform their functions, and adhere to regulatory standards, clinical data management offers the following advantages:
Clinical data management is essential for supporting the assessment of regulated products (e.g., pharmaceuticals, medical devices, cosmetics). In addition to ensuring that these goods are safe, clearly perform their functions, and adhere to regulatory standards, clinical data management offers the following advantages:
- 1Data CollectionCapturing data from paper and electronic documents
- 2Data IntegrationIntegrating all of the data into a single database to ensure consistency and correctness
- 3System and Data ValidationUser acceptance testing (UAT), quality controls (QC), data validation with edit checks, and manual review
Rols and Responsibilities in CDM
Different duties and responsibilities are given to the team members in a CDM team. The minimum educational requirement for a team member in CDM should be graduation in bioscience and data of computer applications. Ideally, medical coders should be medical graduates.
However, paramedical graduates are hired by the sector to work as medical coders. Some key roles are essential to all or any CDM teams. The list of roles given below are often considered as minimum requirements for a CDM team:
- Data ManagerThe data manager is accountable for supervising the complete CDM process. The data manager prepares the DMP, append proves the CDM procedures, and every internal document associated with CDM activities. Controlling and allocating the database access to team members is additionally the responsibility of the data manager.
- Database ProgrammerThe study database is made, the CRF annotation is done, and the edit checks for data validity are programmed by the database programmer. He/she is additionally accountable for designing data entry screens within the database and validating the edit checks with dummy data.
- Database DesignerThe creation of the study database, completion of CRF annotation, and programming of data validity edit checks are tasks undertaken by the database designer. Furthermore, this individual is responsible for crafting data entry interfaces within the database and verifying the accuracy of edit checks using placeholder data.
- Medical CoderAdverse events, medical histories, concurrent diseases, and concurrent medications given during the trial will all be coded by a medical coder.
- Clinical Data CoordinatorThe clinical data coordinator designs the CRF, prepares the CRF filling instructions, and is accountable for developing the DVP and discrepancy management. The clinical data coordinator creates all other checklists, guideline documents, and documentation relating to CDM.
- Quality Control AssociateThe quality control associate checks the accuracy of data entry and conducts data audits. Sometimes, there's a separate quality assurance person to conduct the audit on the data entered. The quality control associate also confirms the paperwork regarding the protocols being followed.
Tools for CDM
There are numerous software programs available for data management; these are referred to as clinical data management systems (CDMS). In multicenter trials, a CDMS has become essential to handle the massive amount of data. The majority of CDMS used by pharmaceutical companies are commercial products, although there are also some open-source tools accessible.
In terms of functionality, these software tools are more or less similar and there's no significant advantage of 1 system over the opposite.
Additionally, a few global pharmaceutical behemoths use CDMS solutions that are specifically tailored to their operating requirements. Among the open-source tools, the foremost prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM softwares are available free of cost and are nearly as good as their commercial counterparts in terms of functionality. These open-source software may be downloaded from their respective websites.
In regulatory submission studies, maintaining an audit trail of data management activities is of paramount importance. These CDM tools make sure of the audit trail and help with the management of discrepancies. per the roles and responsibilities (explained later), multiple user IDs may be created with access limitations to data entry, medical coding, database designing, or quality checking. This ensures that every user can access only the respective functionalities allotted to its user ID and can't make the other change within the database.
For responsibilities where changes are permitted to be made within the data, the software will record the change made, the user ID that made the change, and also the time and date of the change, for audit purposes (audit trail). During a regulatory audit, the auditors can verify the discrepancy management process; the changes made and may confirm that no unauthorized or false changes were made.
There are numerous software programs available for data management; these are referred to as clinical data management systems (CDMS). In multicenter trials, a CDMS has become essential to handle the massive amount of data. The majority of CDMS used by pharmaceutical companies are commercial products, although there are also some open-source tools accessible.
In terms of functionality, these software tools are more or less similar and there's no significant advantage of 1 system over the opposite.
Additionally, a few global pharmaceutical behemoths use CDMS solutions that are specifically tailored to their operating requirements. Among the open-source tools, the foremost prominent ones are OpenClinica, openCDMS, TrialDB, and PhOSCo. These CDM softwares are available free of cost and are nearly as good as their commercial counterparts in terms of functionality. These open-source software may be downloaded from their respective websites.
In regulatory submission studies, maintaining an audit trail of data management activities is of paramount importance. These CDM tools make sure of the audit trail and help with the management of discrepancies. per the roles and responsibilities (explained later), multiple user IDs may be created with access limitations to data entry, medical coding, database designing, or quality checking. This ensures that every user can access only the respective functionalities allotted to its user ID and can't make the other change within the database.
For responsibilities where changes are permitted to be made within the data, the software will record the change made, the user ID that made the change, and also the time and date of the change, for audit purposes (audit trail). During a regulatory audit, the auditors can verify the discrepancy management process; the changes made and may confirm that no unauthorized or false changes were made.
Conclusion
CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to place quality systems on site to ensure the generation of high-quality data for accurate drug evaluation.
To satisfy these expectations, there's a gradual shift from paper-based to electronic systems of data management. Developments on the technological front have positively impacted the CDM process and systems, thereby resulting in encouraging leads to the speed and quality of data being generated. At the same time, CDM professionals should make sure of the standards for improving data quality.
CDM, being a specialty in itself, should be evaluated using the systems and processes being implemented and the standards being followed. The most significant challenge from the regulatory perspective would be the standardization of the data management process across organizations, and also the development of regulations to define the procedures to be followed, and also the data standards.
From the industry perspective, the most important hurdle would be the design and implementation of data management systems in an exceedingly changing operational environment where the rapid pace of technology development outdated the prevailing infrastructure.
Despite these, CDM is evolving to become a standard-based clinical research entity, by striking a balance between the expectations from and constraints within the existing systems, driven by technological developments and business demands.
STATECS is a Contract Research Organization (CRO) helping pharmaceutical companies achieve their desired outcomes by providing top-notch and personalized CDM solutions.
Within our long years of practice, we have worked on numerous big and small projects, from the early stages of research and analysis to the successful submission and confirmation by the FDA. Our list of successful cooperations includes several large industry organizations from all over the world, including Europe, the USA, and other major markets.
In case you are interested in our Clinical Data Management Services, email us via info@statecs.com
CDM has evolved in response to the ever-increasing demand from pharmaceutical companies to fast-track the drug development process and from the regulatory authorities to place quality systems on site to ensure the generation of high-quality data for accurate drug evaluation.
To satisfy these expectations, there's a gradual shift from paper-based to electronic systems of data management. Developments on the technological front have positively impacted the CDM process and systems, thereby resulting in encouraging leads to the speed and quality of data being generated. At the same time, CDM professionals should make sure of the standards for improving data quality.
CDM, being a specialty in itself, should be evaluated using the systems and processes being implemented and the standards being followed. The most significant challenge from the regulatory perspective would be the standardization of the data management process across organizations, and also the development of regulations to define the procedures to be followed, and also the data standards.
From the industry perspective, the most important hurdle would be the design and implementation of data management systems in an exceedingly changing operational environment where the rapid pace of technology development outdated the prevailing infrastructure.
Despite these, CDM is evolving to become a standard-based clinical research entity, by striking a balance between the expectations from and constraints within the existing systems, driven by technological developments and business demands.
STATECS is a Contract Research Organization (CRO) helping pharmaceutical companies achieve their desired outcomes by providing top-notch and personalized CDM solutions.
Within our long years of practice, we have worked on numerous big and small projects, from the early stages of research and analysis to the successful submission and confirmation by the FDA. Our list of successful cooperations includes several large industry organizations from all over the world, including Europe, the USA, and other major markets.
In case you are interested in our Clinical Data Management Services, email us via info@statecs.com
FEBRUARY, 20 / 2024
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