ACRP CP FINAL EXAM LATEST 2023 REAL EXAM 150 QUESTIONS AND CORRECT ANSWERS|AGRADE

ACRP CP FINAL EXAM LATEST 2023 REAL

EXAM 150 QUESTIONS AND CORRECT

ANSWERS|AGRADE

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 informatiom 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? - ANSWERElectronic 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? - ANSWERThe 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

Phase I - ANSWER- The clinical trial phase that focuses on safety and human

pharmacology in healthy volunteers

Who is ultimately responsible for all aspects of the research conducted at a site? -

ANSWER- Principal investigator

Define GCP - ANSWER- An international quality standard that is provided by

ICH E6(R2) describing safety, accuracy of trials and credibility of data

What event resulted in the Nuremburg Cod of 1949 - ANSWER- Nazi Medical

Experiments