ArchiTech IT

Course information

Clinical Data Management Services: Clinical Data Management (CDM) covers the process of collecting, validating, and preparing the data towards statistical analysis for clinical trials. This starts with setting up a clinical data collection tool(s) or a clinical database based on study protocol to collect and store data. Once data is stored, implementing data validation steps is crucial to ensure accurate data is collected and complies with ICH-GCP and all applicable global and local regulatory requirements. Once the data collected is fit for analysis, the database is locked to avoid any modification and datasets are delivered to statistics and programming teams for analysis.

 

• By choosing LEO SOFT IT to manage your Clinical Data Management, you can be confident your clinical trial will be delivered on time with the highest quality data collected. We use multiple industry-leading electronic data capture (EDC) technologies suited to your requirements and adapted to a decentralized/virtual trial approach.
• We offer an end-to-end Clinical Data Management solution including, rapid database launch; integrated clinical data sources; expert medical coding, query management and resolution, effective external vendor data management, database lock; and clean, quality clinical trial data.
• We provide bespoke solutions and provide real time, quicker access to data, meaning faster decisions can be made and patients are safe at all times.

Domain
Clinical research Process
Data management Advanced
Study Protocol Briefing and Extraction
CRF design
Database spec and Edit check preparation
OC/RDC
Administration
PL/SQL basics
Users, Roles, Assigning user roles, User specific screens management
PSUB, batch jobs administration
Glib Admin – Reference codelists
Study Plan
Design – Create and maintain – Studies, Investigators, Sites,Visits and patients
Definitions
DVGs
Questions, Question Groups
DCM
DCI
Validation programming
Data extract views administration
Test a study
Test Data entry
Conduct
Data validation (Discrepancy management)
Execute – Batch jobs, Procedures, DCF forms.
Data Extract
Batch data, Out of study data load
Conduct security
Patient lock and freeze, study lock and freeze
Mass changes
Data entry (first pass, second pass), update, browse and key changes.
Lab data load and administration
RDC Administration
RDC Workflow and discrepancy management
TMS
Integration OC AE term, MT term and conmed terms with TMS and medical coding and review
TMS dictionary and maintenance