CCRA Clinical Trial Monitoring Techniques 2

Question 1

Centralized monitoring differs from on-site monitoring in that it:

Accepted Answer

Involves remote review of accumulating data to identify trends and signals

Answer

Requires CRAs to be physically present at the site

Answer

Is performed only for Phase IV trials

Answer

Replaces all on-site monitoring activities

Question 2

Which of the following is an example of a critical process that should be prioritized during risk-based monitoring?

Accepted Answer

Informed consent process and documentation

Answer

Number of typos on non-critical CRF fields

Answer

Sponsor logo placement on patient materials

Answer

Office hours of site administrative staff

Question 3

A 'trigger' in risk-based monitoring refers to:

Accepted Answer

The signal that prompts an unplanned site visit or escalated review based on predefined thresholds

Answer

The activation of the randomization system

Answer

The date the site submits the first CRF page

Answer

A sponsor instruction to increase enrollment pace

Question 4

At a Site Closeout Visit (COV), which activity is MOST critical for the CRA to confirm?

Accepted Answer

All trial materials are accounted for and essential documents are complete and archived

Answer

Subject enrollment targets were met

Answer

The site's financial invoices are paid

Answer

Future trial opportunities are discussed with the investigator

Question 5

When performing source document verification, the CRA confirms that source data is ALCOA+. What does 'ALCOA' stand for?

Accepted Answer

Attributable, Legible, Contemporaneous, Original, Accurate

Answer

Accurate, Legible, Contemporaneous, Original, Attributable

Answer

Accurate, Logged, Complete, Original, Attributed

Answer

Attributed, Legal, Current, Official, Accurate

Question 6

A CRA identifies that a site coordinator has been backdating data entries in the EDC system. This should be classified as:

Accepted Answer

Data fraud requiring immediate escalation to the sponsor and possibly regulatory authorities

Answer

A minor protocol deviation

Answer

An administrative error requiring a simple correction

Answer

A finding documented in the next routine monitoring report only