Clinical Data Management
The clinical data management(CDM) is responsible for case report form (CRF/eCRF) design, database design and setup, data entry, data cleaning, data coding, data quality control(QC), and providing the clinical trial(CT) data for analysis.
The Clinical Data Management (CDM) plays an essential role in setting up and conducting a clinical trial. The evidence obtained during a clinical trial emphasis the foundation for the eventual protection and effectiveness review, which in effect guides decision-making in the pharmaceutical industry on drug growth.
Cleaning of the clinical data involves purgation of the data programmatically and manually.
Coding of data means applying generic codes to free form of text fields using dictionaries (WHO DD, MEDRA and COSTART) for adverse events(AEs), medications, and medical histories.
Quality control(QC) of the clinical data involves auditing the data to make sure that it was entered properly.
Finally, the data management team provides the data to the statistical programmers through some kind of relational database management system(RDBMS), which can then be imported into SAS/R.
CDM save time when data management gives a well cleaned and coded clinical database.
The clinical data management(CDM) plan provides data entry instructions, coding instructions, data review instructions, and a data QC plan.
OBJECTIVES:
EDC Tool Navigation
CRF/eCRF Designing (on EDC Tool)
CRF Tracking
Development of Specifications for CRFs
Data Entry
Data Validation
Coding (MEDRA, COSTART, and WHO)
Test Data Preparation
User Acceptance Testing (UAT)
Batch Validation Procedures
Lab and SAE Reconciliation
Export Data Extraction
Vendor Management
Database Lock
Happy Learning !!! :)
