ACRP CCRC FINAL EXAM 2025 ACTUAL
EXAM 300 QUESTIONS WITH DETAILED
VERIFIED ANSWERS (100% CORRECT
ANSWERS) /ALREADY GRADED A+
A 22y/o male was entered into a clinical study for treatment of schizophrenia The study
drug was administered orally, BID. One week later, the subject visited the investigator
complaining of sever sore throat. The IB lists this as an occurrence reported by 1% of
subjects receiving drug. How should this severe throat be classified? - answers>>- An
adverse event
- An adverse drug reaction
A number of attributes are considered of universal importance to source data and the
records that hold those data. These include that data records are? - answers>>-
Accurate and legible
-Contemporaneous and original
- Attributable and consistent
A patient cannot recall the name of the heart condition medication he took a few years
ago. This is important information for deciding whether the patient may be enrolled in a
clinical trial (IC/EC). What's your best course of action? - answers>>You attempt to
retrieve the patients medical history by contacting previous caregivers and you wait for
additional information before enrollment.
A person with LEP? - answers>>Limited ability to read, write, and/or speak english.
A protocol amendment was issued for a trial. Your site received IRB approval for the
amendment and wants to implement the increase in PO dose for your trial subjects as
identified in the amendment trial subjects. As delegated consenting duties you must re-
consent trial subjects before being able to administer the adjusted dose. You decide to
only re-consent trial subjects who are still taking the IP and not from the subjects woh
already completed their drug intake period. Is this allowed according the E6 Guideline
for GCP? - answers>>No, these subjects are still enrolled in the trial and therefore need
to be updated on any changes to the protocol.
A report prepared by marketing-authorization holder describing the worldwide safety
experience with medicine at defined time after authorization is called? -
answers>>Periodic Safety Update Report (PSUR)
A site struggles with the conduct of a phase III trial due to lack of site staff to be able to
conduct all visits and collect required data as identified in the protocol. Upon
completion, the investigator tells the CRA and site staff during a follow-up meeting that
