SCDM Data Reconciliation and Validation 3

Question 1

Which document formally defines the edit checks and validation rules to be programmed into an EDC system?

Accepted Answer

Data Validation Plan (DVP) or Edit Check Specification

Answer

Clinical Study Report (CSR)

Answer

Informed Consent Form (ICF)

Answer

Statistical Analysis Plan (SAP)

Question 2

What is the purpose of User Acceptance Testing (UAT) in the context of EDC validation?

Accepted Answer

To confirm that the EDC system functions as specified before going live with data collection

Answer

To obtain IRB approval for the study protocol

Answer

To validate lab reference ranges for a specific therapeutic area

Answer

To train site staff on adverse event reporting procedures

Question 3

A completeness check in data validation is designed to:

Accepted Answer

Confirm that all required fields have been filled in

Answer

Verify that lab values are within the normal reference range

Answer

Ensure that adverse events are coded to the correct MedDRA term

Answer

Check that dates are entered in the correct format

Question 4

During IRT (Interactive Response Technology) reconciliation, which data element is most critical to verify?

Accepted Answer

Subject randomization numbers, treatment assignments, and kit dispensation records

Answer

Site investigator signatures on paper CRFs

Answer

Sponsor financial payment records to sites

Answer

IRB approval dates for each participating site

Question 5

What is the significance of maintaining an audit trail throughout the data validation process?

Accepted Answer

It provides a chronological record of all data changes, supporting data integrity and regulatory compliance

Answer

It reduces the cost of data management activities

Answer

It eliminates the need for source data verification by monitors

Answer

It automatically resolves all open data queries

Question 6

In the context of medical coding reconciliation, what is the most important check to perform?

Accepted Answer

Verifying that coded terms match the verbatim terms in the CRF to appropriate MedDRA or WHODrug dictionary entries

Answer

Ensuring that all coding was performed by a certified biostatistician

Answer

Confirming that all adverse events were coded before the first subject was enrolled

Answer

Checking that coding software versions are identical across all sites

Question 7

Prior to database lock, a final data review is conducted. Which of the following is a standard component of this review?

Accepted Answer

Confirming that all open queries have been resolved and no outstanding data issues remain

Answer

Re-randomizing subjects with incomplete data

Answer

Removing outlier data points from the dataset

Answer

Converting the database to a paper-based archive