ACRP Source Documentation and Data Integrity 3

Question 1

Which of the following best describes the clinical research coordinator's (CRC) primary responsibility regarding source documentation?

Accepted Answer

Ensuring all protocol-required clinical activities are accurately and contemporaneously documented in source records

Answer

Reviewing and formally approving all source documents prior to submission to the sponsor

Answer

Entering all clinical data directly into the sponsor's central clinical database

Answer

Auditing the principal investigator's files for completeness on a monthly basis

Question 2

In the context of ALCOA documentation principles, 'contemporaneous' means:

Accepted Answer

Documentation recorded at the time of the clinical event or immediately thereafter

Answer

Documentation completed by multiple team members simultaneously

Answer

Documentation completed within 30 days of the observed clinical event

Answer

Documentation reviewed and approved by the sponsor within the same quarter

Question 3

A database lock in a clinical trial signifies that:

Accepted Answer

All data queries have been resolved and the database is frozen to prevent further changes prior to statistical analysis

Answer

The EDC system has encountered a critical technical failure requiring IT intervention

Answer

The sponsor has made the decision to terminate the trial early

Answer

The IRB has placed an administrative hold on the study pending a safety review

Question 4

Data cleaning in clinical trials primarily involves:

Accepted Answer

Identifying, querying, and resolving data discrepancies to ensure accuracy and completeness prior to database lock

Answer

Permanently deleting duplicate participant records from the study database

Answer

Removing statistical outliers from the dataset before analysis

Answer

Archiving historical study records into long-term storage

Question 5

In clinical research, a data query is issued when:

Accepted Answer

There is a discrepancy, missing data entry, or unclear CRF field that requires clarification or correction by the site

Answer

The principal investigator formally requests additional protocol clarification from the sponsor

Answer

The IRB requests supplementary information about reported adverse events

Answer

The sponsor submits a formal protocol amendment to the FDA

Question 6

Why is the legibility of source data critically important in clinical research?

Accepted Answer

Illegible data cannot be reliably verified, audited, or used as credible evidence in regulatory submissions

Answer

Legible data reduces the physical storage space required at the investigative site

Answer

Legible data automatically reduces the number of required on-site monitoring visits

Answer

Legible data allows the sponsor to waive the source data verification requirement

Question 7

Which of the following scenarios would constitute a protocol deviation related to source documentation?

Accepted Answer

Failure to document a protocol-required clinical assessment in the source records at the time it was performed

Answer

A participant misses a non-critical phone check-in call that is not a protocol-required assessment

Answer

The investigator taking scheduled vacation during a non-critical phase of the study

Answer

A change in the study coordinator's contact phone number on the site delegation log