CCDM Practice Questions

A.  

To standardize recording of medications taken by patients across sites

B.  

To facilitate the reporting and analysis of possible drug interactions

C.  

To identify differences in medication components based on country of source

D.  

To improve safety monitoring of patients in a clinical trial setting

A.  

Comparison to the measurement from the previous visit

B.  

Programmed edit checks to detect out-of-range values upon data entry

C.  

Reviewing data listings for illogical changes in range of motion between visits

D.  

Independent assessment by a second physical therapist during the visit

A.  

Entering data into the database from CRFs

B.  

Loading a large lab data file into the database

C.  

Executing a properly designed database query

D.  

Making updates to data previously entered into the database

A.  

Tracking case report forms

B.  

Updating the in-house database

C.  

Resolving queries

D.  

Retrieving case report forms

A.  

Discrepancy not explained by the protocol

B.  

Discrepancy not explained by the CRF completion guidelines

C.  

Discrepancy not explained by the data handling conventions

D.  

Discrepancy not explained by the data quality control audit plan

A.  

Data entry staff should be able to enter a value into the database just as it appears in the paper CRF

B.  

There is no need to alert the site personnel immediately about a data issue, as the study has happened already

C.  

There are approvals required to raise a Data Clarification Form which could take time

D.  

Data review can be performed at a later time due to the paper-based studies being smaller in size

A.  

CRF “wire-frames” created, CRFs reviewed, CRFs printed, CRFs distributed to sites

B.  

Protocol finalized, Database created, Edit Checks created, Database tested, Sites trained

C.  

Database created, Subjects enrolled, Database tested, Sites trained, Database released

D.  

Database created, Database tested, Sites trained, Protocol finalized, Database released

A.  

Both the central lab and the CRF have data present for a visit

B.  

The CRF has data for a visit but the central lab has missing data for the visit

C.  

The central lab has data for a visit but the CRF has missing data for the visit

D.  

Both the central lab and the CRF data have missing data for a visit

A.  

Longer than the patient table

B.  

Shorter or of equal length than the patient table

C.  

Narrower than the patient table

D.  

Wider than the patient table

A.  

Medical Document for Regulatory Activities

B.  

Biomedical Research Domain Model

C.  

Individual Case Safety Report

D.  

Submission Data Tabulation Model