Customised In-house Courses are designed for organisations wishing to train a group of your employees at a location of your choice.
Duration:
1 Day
Overview and Challenges of the Data Management (DM) process
- Data retrieval
- Data Entry
- Data Cleaning
- Coding
- SAE reconciliation
- Lab data
- QC
- Data Transfers
Key DM Documents for Clinical Operations to be aware of:
Tracking and Communication (internal and with CROs)
- Status reports
- how often
- what to check
- how to use reports
- Query resolution
- how to handle common and redundant queries
- Internal and External Communication
- what, when, how, common pitfalls
- Use of clean data transfers
Close / Lock Procedure
- Final data retrieval
- Final cleaning
- QC
- Sign Off procedure – what, when, who
- Blind review
- Close and lock
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