Exam (elaborations)

ACRP Practice Exam Questions and Answers All Correct

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ACRP

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ACRP

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Uploaded on January 8, 2025
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Written in 2024/2025
Type Exam (elaborations)
Contains Questions & answers

acrp
acrp practice exam
acrp practice exam questions and answers

Institution ACRP
Course ACRP

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ACRP Practice Exam Questions
and Answers All Correct

What is the investigator's first priority when a subject wishes to withdraw prematurely
from the trial - Answer-to obtain the subject's reason for withdrawal

CRC's can't adjust IP dose, even if they are a qualified physician (T/F) - Answer-False.
If a CRC is a qualified physician they can adjust IP dose

Following unblinding in the case of a suspected serious unexpected adverse drug
reaction, the treatment assigned to the subject turns out to be the comparator product.
Who should the sponsor inform? - Answer-The manufacturer of the product and/or the
regulatory authorities

If there is a a serious unexpected adverse drug reaction in a blinded trial, when should
the investigator unblind the subject? - Answer-The investigator unblinds before reporting
the SUADR, in order to determine a safe treatment

If a subject experiences a heart attack or other unexpected SAE that wasn't
documented in the IB, Who must the event be immediately reported to? - Answer-The
sponsor and the IRB/IEC

The study protocol does not need to include statistical analysis methods (T/F) - Answer-
False

Subjects can be enrolled using lab results predating when the ICF was signed (T/F) -
Answer-True

What must be done, at the site level, if the protocol is altered during the trial - Answer-
the subjects must be reconsented and the irb/iec should be informed and approve the
changes if the trial is to continue

If a person is in a life threatening situation that necessitates the test article, and
they/their LAR cannot provide consent... what must the PI do to properly enroll the subj
per required measures described in the protocol - Answer-Receive documented

, approval/favorable opinion by the IRB/IEC prior to enrollment. Then ensure the subjs
LAR is informed asap to continue the consent

Pre-Trial Meetings Discuss: - Answer--subject availability
-competing studies
-lab requirements
-sponsor expectations

DSMB - Answer-(Data and Safety Monitoring Board)
-Assesses the progress of a clinical trial, the safety data, and the critical efficacy
endpoints
-Can recommend that sponsors modify, end, or continue a trial. But cannot recommend
they start a new trial

Incapacitated subjects can provide consent as soon as capacity is regained (T/F) -
Answer-True

The signature page is a required section of the IB - Answer-False

All trial phases assess safety (T/F) - Answer-True

Phase I - Answer--Focuses on safety and dose in healthy subjects
-Determine metabolic and pharmacologic action of the drug in humans
-Investigates human pharmacology
-The most typical study
-Initial administration or IND into humans

Phase II - Answer--Focuses on efficacy and side effects in subjects of that specific
indication
-A study which seeks to determine the ideal dose and regimen of a new IP to treat the
indicated condition

Phase III - Answer--Compares new tx to existing tx for that indication
-a study which seeks to evaluate the IP to similar treatment options or placebo if there
are no current tx's for the indication
-determines therapeutic benefit and is done in a larger, specific population. Can be
reffered to as a therapeutic confirmatory trial, pivotol trial, or comparative efficacy trial
-Phase III trials usually have fewer subjects than Phase IV trials

Phase IV - Answer--Therapeutic use, begins after drug approval
-Tx is approved and available, but still evaluating for long term effects
-Phase IV trials usually require more subjects and data collection than phase III trials

Post Market - Answer--Analysis conducted after drug approval aka Phase IV
-Provides the most significant amount of safety and efficacy in pediatrics trials with ltd.
Number of participants

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Exam (elaborations)

ACRP Practice Exam Questions and Answers All Correct

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