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Systems Used in Clinical Data Management 1727317588

A Clinical Data Management System (CDMS) is essential software for collecting, managing, and processing clinical trial data, ensuring reliability and compliance with regulatory standards. Key tools within CDMS include Electronic Data Capture (EDC), which enhances data quality, centralizes information, and improves compliance and oversight in clinical trials. Case Report Forms (CRFs), whether paper-based or electronic, are crucial for recording protocol-required information for each trial subject.

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58 views2 pages

Systems Used in Clinical Data Management 1727317588

A Clinical Data Management System (CDMS) is essential software for collecting, managing, and processing clinical trial data, ensuring reliability and compliance with regulatory standards. Key tools within CDMS include Electronic Data Capture (EDC), which enhances data quality, centralizes information, and improves compliance and oversight in clinical trials. Case Report Forms (CRFs), whether paper-based or electronic, are crucial for recording protocol-required information for each trial subject.

Uploaded by

Mohammad
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© © All Rights Reserved
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Systems used in Clinical Data Management

Clinical Data Management System (CDMS)

A Clinical Data Management System (CDMS) is a specialized software used to collect,


manage, store, and process clinical trial data efficiently and securely. It is a critical tool in
the field of Clinical Data Management, ensuring that clinical trial data is reliable,
accurate, and compliant with regulatory standards.

Tools used in Clinical Data Management System:

Electronic Data Capture (EDC)


Electronic Patient Reported Outcomes (ePRO)
Interactive Response Technology (IRT)
Randomisation and Trial Supply Management (RTSM)
Safety gateway system
Coding system
Lab modules integration system

Electronic Data Capture (EDC)

An Electronic Data Capture (EDC) system in Clinical Data Management is a software


platform that facilitates the electronic collection, management, and storage of data in
clinical trials. Researchers use EDC software or systems to design electronic case report
forms (eCRFs), collect data from study sites, manage and monitor data, and analyze
results.

Key benefits of an EDC System:

Improved Data Quality: EDC systems have real-time data validation checks and rules
to identify issues as soon as data is entered which helps to improve the data quality.
Centralized Data: EDC allows clinical trial data to be captured and stored centrally in
a consistent format. EDC offers unified data across all investigational sites in one
accessible electronic system following standardized collection methods. Researchers
can instantly check data from any site and access full audit trails showing the
complete history of every data item.
Cost and Resource Savings: EDC yields significant time savings that translate into
resource efficiencies. Automatic validation checks alleviate the burden of manual
data cleaning and querying required for paper records. Personnel also save time by
not having to physically track down or collate paper forms for review.
Enhanced Compliance: EDC systems ensure compliance with global regulatory
standards and maintain comprehensive audit trails, simplifying regulatory
submissions.
Real-Time Oversight: Sponsors and CROs (Contract Research Organizations) can
track study progress, patient recruitment, and data quality in real-time, enabling
better decision-making and quicker responses to issues.

Some widely used EDC systems in clinical trials include:

Medidata Rave
Oracle Clinical
Veeva Vault EDC
Medrio
Viedoc
IBM Clinical Development
REDCap

Case Report Form (CRF)

Case Report Form (CRF) is a printed, optical, or electronic document designed to record
all of the protocol required information to be reported to the sponsor on each trial
subject. They help capture study-specific information as outlined in the clinical trial
protocol and serve as a primary data source for clinical data management.

CRFs are either paper-based or electronic (eCRFs), with eCRFs being more commonly
used in modern clinical trials due to their efficiency and real-time data validation
capabilities.

Key Components of a Case Report Form (CRF):

Informed Consent
Demographic Data
Medical History
Baseline Data
Study Treatment Information
Efficacy Assessments
Safety Data
Concomitant Medications
Visit Information
End-of-Study Data

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