ACRP CP EXAM NEW UPDATE NEWEST ACTUAL EXAM COMPLETE 300 QUESTIONS WITH DETAILED VERIFIED ANSWERS (100% CORRECT ANSWERS) / ALREADY GRADED A+

What are expected or possible consequences of over-estimation of recruitment
potential? - ANSWER- The trial will overrun its projected timeline
- The recruitment period will be prolonged and more sites may be needed
- The study will not have sufficient data within the required timeframe and will be
stopped because of lack of budget
What should be the first consideration when conducting a clinical trial? -
ANSWERSubject welfare
When is the investigator allowed to deviate from the protocol? - ANSWERWhen there is
an immediate hazard to a patient.
If the investigator wanted to deviate from the protocol for an immediate hazard to a
patient, according to ICH E6 guidelines who would they need to report the deviation and
rationale to, if appropriate? - ANSWER- The Sponsor
- IRB/IEC
- Regulatory Authorities
Which conditions should be fulfilled when enrolling a subject into your trial? - ANSWERSubject meets all inclusion criteria
- Subject has given written informed consent
You've been delegated to handle the storage and inventory of IP. The study drug must
be stored below 25C/77F. On a summer Monday morning you discover that the
temperature recording machine in the storage room has failed so you doin't know what
the temperature has been over the weekend. You check the current temperature; it's
24C/75F. What should you do? - ANSWER- Contact the Sponsor, explain what
happened and ask for instructions
- Set up a site staff meeting to conduct a root cause analysis
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 reconsent 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? - ANSWERNo, these subjects are still enrolled in the trial and therefore need
to be updated on any changes to the protocol.