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ACRP-CP Certification Exam study guide with a complete solution
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ACRP-CP Certification Exam study guide with a complete solution
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ACRP-CP Certification Exam study guidewith a complete solution
What would be the first priority for an investigator when a subject wishes to withdraw
prematurely from the trial? - ANS 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 - ANS Validation
Accuracy
Reliability
Completeness
Part of a sponsor's responsibility pertaining to electronic trial data handling is to - ANS
maintain an audit trail, data trail, and edit trail.
A research subject's responsibilities for study participation should be described in the - ANS
ICF
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? - ANS Investigators brochure
During a multi site clinical study: whose responsibility is it to report subject recruitment rate? -
ANS 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 - ANS 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... - ANS 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? - ANS 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? - ANS 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? - ANS 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?
- ANS PI
Which of the following required elements should be included in a clinical trial protocol? - ANS
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 - ANS 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? - ANS Electronic medical record
When considering participation in a study: the investigator should determine if he... - ANS
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 - ANS 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? - ANS 3 Years
When would an impartial witness be needed during the consent process for an illiterate subject?
- ANS 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 - ANS 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? - ANS 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? - ANS ICF
When should a research study involving human subjects be registered in a publicly accessible
database? - ANS Before recruiting the first subject
, In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
- ANS 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?
- ANS Consenting in the presence of figure of authority
The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers -
ANS Phase I
Who is ultimately responsible for all aspects of the research conducted at a site? - ANS
Principal investigator
An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of
trials and credibility of data - ANS GCP
What event resulted in the Nuremburg Cod of 1949 - ANS Nazi Medical Experiments
Prior to archiving a study: documentation of IP destruction at the site should be filed in the study
files of the - ANS PI and Sponsor
In the case of an incapacitated subject: who should receive a copy of the signed and dated ICF?
- ANS The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? - ANS
The subject inclusion and exclusion criteria
During a multi-site clinical study: whose responsibility is it to report subject recruitment rate? -
ANS The CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat
hypothyroidism is considered to be - ANS Phase II
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? - ANS IB
When considering participation in a study: the investigator should determine if he/she - ANS
sees enough patients who would qualify for the study
When would an impartial witness be needed during the consent process for an illiterate subject?
- ANS To observe the consent process
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