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
The benefits of buying summaries with Stuvia:
Guaranteed quality through customer reviews
Stuvia customers have reviewed more than 700,000 summaries. This how you know that you are buying the best documents.
Quick and easy check-out
You can quickly pay through credit card or Stuvia-credit for the summaries. There is no membership needed.
Focus on what matters
Your fellow students write the study notes themselves, which is why the documents are always reliable and up-to-date. This ensures you quickly get to the core!
Frequently asked questions
What do I get when I buy this document?
You get a PDF, available immediately after your purchase. The purchased document is accessible anytime, anywhere and indefinitely through your profile.
Satisfaction guarantee: how does it work?
Our satisfaction guarantee ensures that you always find a study document that suits you well. You fill out a form, and our customer service team takes care of the rest.
Who am I buying these notes from?
Stuvia is a marketplace, so you are not buying this document from us, but from seller perfectdoctor. Stuvia facilitates payment to the seller.
Will I be stuck with a subscription?
No, you only buy these notes for $17.99. You're not tied to anything after your purchase.
