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? - ✔✔CORRECT 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? - ✔✔CORRECT ANSWER ✔✔Subject welfare
When is the investigator allowed to deviate from the
,protocol? - ✔✔CORRECT ANSWER ✔✔When 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? - ✔✔CORRECT ANSWER ✔✔- The
Sponsor
- IRB/IEC
- Regulatory Authorities
Which conditions should be fulfilled when enrolling a subject
into your trial? - ✔✔CORRECT ANSWER ✔✔- Subject 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? - ✔✔CORRECT 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 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? - ✔✔CORRECT ANSWER ✔✔No, these subjects are
still enrolled in the trial and therefore need to be updated on
any changes to the protocol.
A trial subject informs you she no longer wants to
participant in the trial. What should your course of action
be? - ✔✔CORRECT ANSWER ✔✔You ask if the patient wishes
to share the reason why she wants to leave the trial. If not,
you exclude the subject from the trial immediately.
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? -
✔✔CORRECT ANSWER ✔✔You attempt to retrieve the
patients medical history by contacting previous caregivers
and you wait for additional information before enrollment.
Who has ultimate trial responsibility for each subject? -
✔✔CORRECT ANSWER ✔✔The principle investigator.
A trial subject suffers from severe repeat headaches. Should
this adverse event be reported to the IRB? - ✔✔CORRECT