RA Industry Best Practices 2

Question 1

In the ALCOA+ data integrity framework, what does the added "C" stand for?

Accepted Answer

Complete

Answer

ALCOA+ adds Complete, Consistent, Enduring, and Available to the original Attributable, Legible, Contemporaneous, Original, Accurate.

Question 2

A research assistant notices an incorrect blood pressure value on a paper source document. What is the correct way to fix it?

Accepted Answer

Draw a single line through the error, write the correction, and initial and date it

Answer

GCP-compliant corrections keep the original entry legible and are attributable and dated.

Question 3

Who is ultimately responsible for signing the delegation of authority log that assigns study tasks to site staff?

Accepted Answer

The principal investigator

Answer

The PI delegates trial-related duties and stays responsible for supervising those individuals.

Question 4

Which step must be completed before any study-specific screening procedure is performed on a potential participant?

Accepted Answer

Obtaining documented informed consent

Answer

No protocol-specific procedure may be performed until informed consent is obtained and documented.

Question 5

The temperature log shows that the investigational product refrigerator went above its allowed range overnight. What should the research assistant do first?

Accepted Answer

Quarantine the affected product and notify the sponsor before any further dispensing

Answer

Product exposed to an excursion is quarantined until the sponsor decides whether it can still be used.

RA - Certified Research Assistant Practice Test

RA - Certified Research Assistant Practice Test

RA Industry Best Practices 2