CCRA Data Management and Source Document Verification 3

Question 1

When a laboratory value is flagged outside the reference range, the investigator must:

Accepted Answer

Clinically evaluate the result, document their assessment, and determine whether it is clinically significant

Answer

Immediately discontinue the subject from the trial

Answer

Delete the value from the CRF and re-draw the sample

Answer

Report it as an SAE regardless of clinical significance

Question 2

The ALCOA+ principles add which additional attributes beyond ALCOA?

Accepted Answer

Complete, Consistent, Enduring, and Available

Answer

Auditable, Linked, Consistent, Organized, Alphabetical

Answer

Certified, Legal, Organized, Approved

Answer

Cross-referenced, Evaluated, Authenticated

Question 3

A 'data reconciliation' process between the safety database and the clinical database is performed to:

Accepted Answer

Ensure all adverse events captured in the safety system are accurately reflected in the clinical database and vice versa

Answer

Match financial invoices with subject visit data

Answer

Reconcile laboratory values with imaging data

Answer

Confirm randomization assignments match enrollment logs

Question 4

What is the minimum required retention period for clinical trial essential documents under FDA regulations?

Accepted Answer

2 years after a marketing application is approved, or 2 years after the IND is terminated if no application is filed

Answer

2 years after the last subject's last visit

Answer

5 years after database lock

Answer

10 years after study completion

Question 5

Which practice best ensures blinding integrity during data management activities?

Accepted Answer

Limiting access to randomization codes to only those who need them for safety monitoring, with all others remaining blinded

Answer

Sharing treatment assignments with data managers for context

Answer

Unblinding all data before database lock for quality review

Answer

Allowing site coordinators to access treatment assignment codes in the EDC

Question 6

In electronic clinical trials, 21 CFR Part 11 governs:

Accepted Answer

The use of electronic records and electronic signatures, ensuring they are trustworthy and equivalent to paper records

Answer

The format of IND application submissions

Answer

The clinical pharmacology requirements for investigational drugs

Answer

The IRB review process for online-recruited subjects