FAQ Interview Questions for CDM

Frequently Asked Questions in CDM                         

1.           What is CDM?

2.           What are the major steps in work flow process?

3.           What is meant by DMP? What is the significance of DMP in Clinical Study?

4.           What do you understand by Discrepancies in Clinical trial data?

5.           Give one example of a) Univariate b) Multivariate c) Manual discrepancy

6.           What do these terms stand for a) DCI b) DCM c) DVG d) DCF e) DMP f) DVP g) RDC                h) EDC i) OCRDC j) CDISC k) GCDMP l) SDTM m) ODM n) RDCI o) RDCM

7.           Who is responsible for raising the DCF?

8.           Enlist different type of validation checks which are performed to clean the data

9.           What is Metadata?

10.      What do you mean by locking the database?

11.      What do you mean by freezing the database?

12.      Enlist 5 hierarchies of MedDRA dictionary for coding adverse events.

13.      Expand CDISC and CDASH

14.      Enlist 5 activities for QA & QC in CDM.

15.      Enlist 4 different softwares which are used to manage Clinical Data.

16.      Differentiate between Paper CRF and e-CRF.

17.      What is the significance of e-clinical trial? Explain the significance with respect to EDC & RDC?

18.      Role of CDM in clinical Research.

19.      What is SAE reconciliation?

20.      What is new time line for  SAE reporting

21.      What is schedule –Y and what is appendix 5,7,8,10& 12?