Informatics Outsourcing Release: Case Report Form Designing in Clinical Trials

September 14, 2011 -- Case Report Form: 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. A CRF is used to record all relevant individual subjects or study patient data. The Sponsor will use this data to perform statistical analysis; the resultant analysis are included in the medical report. The CRF is designed by the Study Sponsor, possibly in collaboration with the Investigator, and is based on the Study Protocol.

Our Case Report Form Designing Services:

1. Creating Data Entry screens for capturing Patient data

2. Programming Edit Checks

3. Query work flow

4. Defining a Role based User access system

5. Standard/Customized Report generation

6. Integrating with MedDRA/WHODD for auto coding

7. Audit Trail

8. Exporting data in different file formats

9. Client specific requirements

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