Pharmacovigilance – Data Entry and Quality Control
Once the paper based Case Report Form (CRF) is accepted and distributed by the single person with appointed obligation regarding completeness of information entry. The process of entering the information into an electronic database can be initiated.
GAP has the procedure by which information is deciphered from the CRF into this spreadsheet. This is to be depicted in the DMP and may acquire any of the forms listed:
- Including double information entry.
- Single information entry with second look.
- Single information entry with perusing distinctly.
- Single information entry with source information check.
- Appropriate Clinical Trial Management System (CTMS),
- In- line query system to directly follow the Good Clinical Practices (GMP).
- Best Clinical Practices in a Turn Around time (TAT) is assured.
These projects are not generally accessible and hence, it is more regularly situated by a technique for entering the information once and then checking it for accuracy. It can be done by:
- Having a visual investigation of the information (second look),
- Perusing the information distinctly (perusing with an elevated volume)
- Checking the information against the source information (source information check).
- Appropriate oversight may be followed by our in-line professionals to assist any clinical trial management systems.
Utilizing best practice suggestions for information section will guarantee quality. GAP is known for providing quality services worldwide.
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