ACRP CP CERTIFICATION EXAM NEWEST
ACTUAL EXAM COMPLETE QUESTIONS AND
CORRECT DETAILED ANSWERS (VERIFIED
ANSWERS) |ALREADY GRADED A+
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from
the trial? - -----ANSWER---->Try to obtain the subject's reason for withdrawal.
CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established
requirements for - -----ANSWER---->Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - -----ANSWER----
>maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the - -----ANSWER----
>ICF
,What document would an investigator reference to learn more about the previous clinical and nonclinical
results of studies of the IP? - -----ANSWER---->Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate? - -----
ANSWER---->The CRA
An unconscious adult subject was enrolled in a study after obtaining consent from an LAR: and protocol
therapy was initiated. The subject showed significant improvement in his clinical
condition: and regained consciousness. The Investigator should inform the subject
about the study and - -----ANSWER---->Obtain consent from the subject for the study
A site is in the start up phase of an industry sponsored phase 3 trial: and has received IRB approval. The
site can begin enrolling subjects after... - -----ANSWER---->A signed clinical trial
agreement between the site and sponsor is in place.
A site is screening potential subjects for a study looking at mild cognitive impairment. One of the inclusion
criteria is a score of 25 or less on a psychometric test: a research specific tool which
measures cognitive ability. Which of the following individuals can administer the
psychometric test to the potential subjects? - -----ANSWER---->A research assistant
who is certified to administer the psychometric test
A research study: in which there is no intended clinical benefit to the subject: is being submitted to the
IRB. What benefit information should be included in the ICF? - -----ANSWER----
>Wording indicating that there is no expected benefit should be included
A CRA notices during an onsite visit that the date on IRB approval letter for a protocol is prior to the
effective date indicated on the cover page of the protocol and the signatures of the
, investigator and sponsor. What should the CRA do FIRST? - -----ANSWER---->Confirm
dates of initial receipt of the sponsor protocol and the IRB submission dates.
In a multi arm: randomized clinical trial: one arm of the protocol was terminated due to an increased risk
of cancer in subjects. Who is responsible for providing a written report to the IRB? - --
---ANSWER---->PI
Which of the following required elements should be included in a clinical trial protocol? - -----ANSWER----
>Subject inclusion and exclusion criteria
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study files of
the - -----ANSWER---->PI and Sponsor
During a monitoring visit: what records would a CRA reference to verify a subject's compliance to the
study visit schedule and assessments? - -----ANSWER---->Electronic medical record
When considering participation in a study: the investigator should determine if he... - -----ANSWER----
>Sees enough patients who would qualify for the study
New safety information has become available from the Sponsor about the IP being used in a clinical trial.
The investigator must - -----ANSWER---->Submit a revised ICF to the IRB noting the new
safety information
Per ICH: an IRB must keep correspondence for at least how long after the completion of a clinical trial? - -
----ANSWER---->3 Years
, When would an impartial witness be needed during the consent process for an illiterate subject? - -----
ANSWER---->To observe the consent process
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is
considered to be - -----ANSWER---->Phase II
After completion of a study: the final trial close out monitoring report prepared by the CRA should be filed
in which of the following stakeholder files? - -----ANSWER---->The sponsors files
A blood sample collection is required to screen for bloodborne pathogens before subject could be enrolled
in a study. Where will subjects find information of the procedures and any foreseeable
risks or inconveniences? - -----ANSWER---->ICF
When should a research study involving human subjects be registered in a publicly accessible database? -
-----ANSWER---->Before recruiting the first subject
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF? - -----
ANSWER---->The subjects legally acceptable representative
A medical student is approaches by a faculty member for possible participation in a cricothyroidotomy
simulation research study. Which of the following increases risk to the study? - -----
ANSWER---->Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers - -----
ANSWER---->Phase I
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