CCDM Practice Questions

A.  

CCGs are designed from the perspective of the Study Biostatistician to ensure that the data collected can be analyzed

B.  

CCGs must be signed before database closure to include all possible protocol changes affecting CRF completion

C.  

CCGs must include a version control on the updated document

D.  

CCGs are developed with representatives of Data Management, Biostatistics, and Marketing departments

A.  

Clinical Data Manager

B.  

Site Coordinator

C.  

Clinical Research Associate

D.  

Investigator

A.  

No time was allocated for maintenance of the DMP

B.  

Forty hours is too much time to budget for DMP creation

C.  

There is no problem with the approach

D.  

Forty hours is too little time to budget for DMP creation

A.  

Storing the computer used at the clinical investigational site

B.  

Paper copies of the source documents

C.  

PDF images of the final eCRF screens for each patient

D.  

ASCII files of the site's data and related audit trails

A.  

Proportion of patients for which two visit periods have passed without data by site

B.  

Number of late visits per site

C.  

Proportion of late visits by site

D.  

Number of patients for which two visit periods have passed without data

A.  

System tools in EDC do not remove the need for UAT

B.  

Data should not be collected in a production environment until UAT is completed

C.  

Every rule should be tested with at least one "pass" and one "fail" scenario

D.  

The extent of UAT (i.e., the number of test cases and rules) cannot be risk-based

A.  

To ensure the data from the CRF can be analyzed for safety and efficacy

B.  

To ensure the header fields will provide a unique key for each subject

C.  

To ensure the layout will make a logical, useful programming guide

D.  

To ensure the variable names conform to statistical programming standards

A.  

Planned versus actual enrollment

B.  

Site staffing changes

C.  

Percent data entered and clean

D.  

Serious and unexpected safety events

A.  

Continue to re-query until the site changes the data

B.  

Gently lead the site to the correct response

C.  

Escalate the issue to the appropriate site contact personnel

D.  

Do nothing, the data will remain inconsistent

A.  

LLT, HLGT, PT, HLT, SOC

B.  

LLT, PT, HLGT, HLT, SOC

C.  

LLT, HLGT, HLT, PT, SOC

D.  

LLT, PT, HLT, HLGT, SOC