1. Clinical data management Made by:- ShrayJali

3. Serves as a basis for submission, approval, labelling and marketing of a compound

4. Sources:

5. Subject-investigator interaction at sites (e.g. Remote Data Capture (RDC) technology)

6. Laboratories

7. Directly from subjects and partners (e.g. Contract Research Organizations - CROs)

9. Health Authority/Ethics Committee approval is necessary

10. Often a clinical trial is managed by an outsourced partner such as a CRO

13. Clinical trial data gathered at the investigator site in the case report form are stored in the CDMS

15. Standard dictionaries of these terms can be loaded into the CDMS

16. Some systems allow for the storage of synonyms to allow the system to match common abbreviations and map them to the correct termExample: ASA could be mapped to Aspirin

18. Ensures that human error will be kept to a minimum

19. Software systems of this type also file data and screen data for any illogical patterns

23. High data security

24. Affordable rates

25. Efficient validation procedures

26. Advanced technology

27. Flexibility

29. Also known as metadata (Data table restricted to information about data elements) repository

31. Clinical database search

32. Dictionary management

34. Get an accurate, real-time view of clinical trial forecasts and budgets

35. Effectively use critical information and collaboratively assess performance.

36. Aggregation of data and its Dissemination via an open framework