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ACRP-CP CERTIFICATION EXAM NEWEST ACTUAL EXAM WITH COMPLETE QUESTIONS AND DETAILED ANSWERS, Exams of Clinical Medicine

Who is most responsible for the appropriate monitoring of clinical trials? - ✔ ✔ ✔ Correct Answer > Sponsor You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want to see which of the following - ✔ ✔ ✔ Correct Answer > 1. Unobscured original entries 2. Traceable source documents 3. An Audit trail A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and vomiting. When is a CRC allowed to do this task? - ✔ ✔ ✔ Correct Answer > Only when the CRC is a qualified physician and has been delegated this responsibility by the PI

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Download ACRP-CP CERTIFICATION EXAM NEWEST ACTUAL EXAM WITH COMPLETE QUESTIONS AND DETAILED ANSWERS and more Exams Clinical Medicine in PDF only on Docsity!

ACRP-CP CERTIFICATION EXAM NEWEST

ACTUAL EXAM WITH COMPLETE

QUESTIONS AND DETAILED ANSWERS

GRADED A | BRAND NEW!!!

Who is most responsible for the appropriate monitoring of

clinical trials? - ✔✔✔ Correct Answer > Sponsor

You are asked to monitor a study for another Coordinator. In looking for the changes made in the source document you want

to see which of the following - ✔✔✔ Correct Answer > 1.

Unobscured original entries

  1. Traceable source documents
  2. An Audit trail A Clinical Research Coordinator (CRC) adjusted the dose of the Investigation Product (IP) for a subject as the subject was suffering from Adverse Events (AEs) like headaches and

vomiting. When is a CRC allowed to do this task? - ✔✔✔

Correct Answer > Only when the CRC is a qualified physician and has been delegated this responsibility by the PI

You are in the role of Study Manager for the Sponsor. One of your monitors reports significant noncompliance at a Site. The first course of action you implement is that a __________ be

conducted. - ✔✔✔ Correct Answer > Root Cause Analysis

A subject: who has been 100% compliant thus far has forgotten to bring her medication back to the clinic for her regular visit. She reports that she has not missed any doses and has been fully compliant with the protocol. What is the most appropriate action for the investigator/clinical research coordinator to

take? - ✔✔✔ Correct Answer > Document that the subject has

forgotten to return her medication in the source document and ask her to bring the medication back to the clinic as soon as possible or during her next visit If sponsor's attempts to secure compliance have failed: and the monitoring/auditing identifies serious and/or persistent noncompliance on the part of an investigator/institution: the

sponsor should - ✔✔✔ Correct Answer > 1. Promptly notify the

regulatory authority(ies)

  1. Terminate the investigator's/institution's participation in the trial

Essential documents should be retained at least ______ after the last approval of a marketing application: or formal discontinuation of clinical development of the investigational

product. - ✔✔✔ Correct Answer > 2 years

What is the purpose of the IRB/IEC? - ✔✔✔ Correct Answer >

Safeguard the rights: safety: and well-being of all trial subjects Which of the following should the investigator do FIRST if a

Serious Adverse Event (SAE) occurs? - ✔✔✔ Correct Answer >

Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form

(ICF)? - ✔✔✔ Correct Answer > 1. The person who conducted

the informed consent interview

  1. The subject or the subject's legal representative A non-English speaking subject has responded to a recruitment ad to participate in a trial for treatment of her diabetes. She arrives at the site with her daughter who is fluent in English. The informed consent forms are only available in English. What

actions are compliant with GCP? - ✔✔✔ Correct Answer > Call

the sponsor to request a translation of the informed consent

Per ICH GCP E6: the purpose/elements of trial monitoring differ

from trial auditing. Which apply to trial auditing ONLY? - ✔✔✔

Correct Answer > 1. The sponsor should appoint individuals: who are independent of the clinical trials/systems

  1. Regulatory authority(ies) should not routinely request this type of reports* *(they may seek access to reports on a case by case basis when evidence of serious GCP non-compliance exists: or in the course of legal proceedings) As per ICH E6 GCP: which groups of potential subjects could be

defined as "vulnerable subjects?" - ✔✔✔ Correct Answer > 1.

Members of the armed forces

  1. Junior members of the medical profession
  2. Employees of the pharmaceutical industry Which phase determines therapeutic benefit: usually in wider

populations? - ✔✔✔ Correct Answer > Phase 3

What phase of a clinical trial involves a heavy emphasis on safety and tolerability: Pharmacokinetics: Pharmacodynamics

and early measurement of drug activity? - ✔✔✔ Correct

Answer > Phase 1 The principles and practices concerning protection of trial subjects are stated in the ICH Guideline on Good Clinical Practice (ICH E6). These principles have their origins from -

✔✔✔ Correct Answer > Declaration of Helsinki

The main goal of this phase of drug development is to explore therapeutic efficacy in patients. It is important during this phase to determine the dose(s) and regimens that will be used

for later trials. - ✔✔✔ Correct Answer > 1. Selection of the

initial human dose

  1. Safe duration of drug exposure
  2. Physiological and toxicological effects of a new drug T or F- The intention of ICH E8 is to describe internationally accepted principles and practices in the conduct of both individual clinical trials and overall development strategy for

new medicinal products. - ✔✔✔ Correct Answer > True

Dose-tolerance studies: single and multiple dose PK and/or PD studies: and drug interaction studies are examples of what

phase of clinical research? - ✔✔✔ Correct Answer > Phase One

Characterization of a drug's absorption: distribution: metabolism: and excretion that continues throughout the

development plan is defined as - ✔✔✔ Correct Answer >

Pharmacokinetics According to ICH E8: "Formulations used in clinical trials should be well characterized: including information on ___________

whenever feasible." - ✔✔✔ Correct Answer > Bioavailability

The study subject asks you why the study is called a double

blind study. You will explain double blind as - ✔✔✔ Correct

Answer > When the Investigator and sponsor staff who are involved in the treatment or clinical evaluation of the subjects and analysis of data are unaware of the treatment assignments According to ICH E8 what type of study would have the following elements? Adequate: and well controlled studies to

establish efficacy - ✔✔✔ Correct Answer > 1. Randomized

parallel dose response studies

  1. Clinical safety studies
  2. Studies of mortality/morbidity outcomes
  3. Large simple trials
  • Therapeutic Confirmatory Your Investigator wants to participate in a Phase 3 Pharmacokinetics study. Pharmacokinetic studies are commonly conducted in later phases to answer what

questions? - ✔✔✔ Correct Answer > 1. Food effects on

bioavailability

  1. Information in sub-populations such as patients with impaired elimination
  2. Drug to drug interactions A trial where the treatment assignment is not known by the study participant because of the use of placebo or other methods of masking the intervention: but the study team

knows - ✔✔✔ Correct Answer > Single blind

A new study is investigating a new IND "glue" that can be used to hold skin cuts together and decrease the chance of scaring. You know children should be included because ICH E8 considers them a special population. In designing the protocol you should

expect to - ✔✔✔ Correct Answer > Include children in the

general plan from the beginning Per ICH E8: methods used to evaluate patient usage of the test

drug should be - ✔✔✔ Correct Answer > Specified in the

protocol and actual usage documented Which trial design is used for the specific purpose of examining

the interaction of A and B? - ✔✔✔ Correct Answer > Factorial

design T or F- The Data and Safety Monitoring Board (DSMB) is a separate entity from an Institutional Review Board (IRB) or an

Independent Ethics Committee (IEC)? - ✔✔✔ Correct Answer >

True What is the purpose of the "Data and Safety Monitoring Board

(DSMB)?" - ✔✔✔ Correct Answer > To assess the progress of a

clinical trial: the safety data: and the critical efficacy endpoints T or F- The focus of ICH E9 is on statistical principles: however: it does not address the use of specific statistical procedures or

methods. - ✔✔✔ Correct Answer > True

For a randomized trial: the following is true - ✔✔✔ Correct

Answer > 1. The procedure to be followed: the necessary documentation: and the subsequent treatment and assessment of the subject should all be described in the protocol

  1. Helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments Data and Safety Monitoring Boards (DSMBs) have the power to

recommend which of the following? - ✔✔✔ Correct Answer >

  1. That the sponsor should continue the trial 2.That the sponsor should modify the trial
  2. That the sponsor should stop the trial You need to maintain the blind in a clinical study. Which of the following options might you use when administering supplies in

the clinical trial? - ✔✔✔ Correct Answer > Double-dummy

Which variable in a study should be used to determine the

sample size? - ✔✔✔ Correct Answer > Primary variable

You are writing an Investigator-initiated clinical research protocol and you need to limit the occurrence of conscious and unconscious bias. Which of the following methods may be

used? - ✔✔✔ Correct Answer > 1. Single-Blind

  1. Masking
  2. Double-Blind You are reading the findings of a clinical trial on hair loss and use of shampoo. You note in the final analysis that data was extrapolated from the subjects who participated in the trial to a broader patient population and a broader range of clinical

settings. This is known as - ✔✔✔ Correct Answer >

Generalization The Investigator at your site asked you to review a protocol. The investigational product listed in the protocol already has proven clinical benefits for the disease under study. This is

considered what type of trial? - ✔✔✔ Correct Answer >

Confirmatory Trial You are designing a cross-over study. Cross-over designs have a number of problems that can invalidate their results. The chief difficulty concerns __________: that is: the residual influence

of treatments in subsequent treatment periods. - ✔✔✔ Correct

Answer > Carryover effect Missing data points (values) represent a potential source of bias

in a clinical trial. (True or False) - ✔✔✔ Correct Answer > True

What study variable takes in the consideration the decision making process of the treating physician: who must weigh

benefit and risk in making product use decisions. - ✔✔✔

Correct Answer > Global Assessment Variable True or False- You are working on a Phase 1 clinical trial. The sponsor tells you that the study will be carried out in three different research centers. Multi-center trials can be carried out

at any stage of clinical development. - ✔✔✔ Correct Answer >

True You are helping your Investigator write a protocol for a new combination of drugs for treatment of Irritable Bowel Syndrome. Since this is an Investigator Initiated Study you know

you will need to establish a/an - ✔✔✔ Correct Answer >

Independent Data Monitoring Committee

When writing an early phase clinical study plan which of the following do you want to pay attention to if you wish to maximize the chance of observing specific clinical effects of

interest? - ✔✔✔ Correct Answer > The target population

True or False- All new medications should have generated data

on the use in the pediatric population? - ✔✔✔ Correct Answer

> False True or False- Medicinal products may affect physical and cognitive growth and development: and the adverse event

profile may differ in pediatric patients. - ✔✔✔ Correct Answer

> True What is it called when a child is given information about a trial

and asked if he or she wishes to participate? - ✔✔✔ Correct

Answer > Assent T or F- Although initial safety and tolerability data is usually obtained in adult trials: some products may reasonably be studied only in the pediatric population even in the initial phases (e.g.: when studies in adults would yield little useful

information or expose them to inappropriate risk). - ✔✔✔

Correct Answer > True

T or F- Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric

subjects. - ✔✔✔ Correct Answer > False

T or F- Pharmacokinetic studies in the pediatric population are

generally conducted in patients with the disease. - ✔✔✔

Correct Answer > True The two ways to minimize the number of samples obtained

from each pediatric patient are - ✔✔✔ Correct Answer > 1.

Population PK & Sparse sampling

  1. Use of indwelling catheters T or F- It is common to extrapolate efficacy from studies in adults or even in older pediatric patients to the preterm

newborn infant to decrease the amount of blood taken. - ✔✔✔

Correct Answer > False The current protocol for a study in pediatrics is asking for all new patients to have stages of pubertal development assessed.

This assessment is called - ✔✔✔ Correct Answer > Tanner

Staging

You are reading a Phase 2 protocol: which uses pharmacokinetic sampling in a pediatric population with Sickle Cell Disease. Which of the following options may be true in this

scenario? - ✔✔✔ Correct Answer > 1. The data may better

reflect clinical use

  1. This may lead to higher inter subject variability Dosing recommendations for most medicinal products used in the pediatric population are usually based on ________________ due to frequency of calculation errors. -

✔✔✔ Correct Answer > Mg/kg body weight

You are evaluating a pediatric protocol for a new drug. When reviewing the drug clearance data it is important to know that hepatic and renal functions are first mature in which of the

following defined group? - ✔✔✔ Correct Answer > Children

Non-compliance is a special problem in this age group. - ✔✔✔

Correct Answer > Adolescents The pediatric population represents a vulnerable subgroup. Therefore: special measures are needed to protect the rights of

pediatric study participants and to shield them from undue risk. Which of the following should be taken into consideration? -

✔✔✔ Correct Answer > 1. Recruitment

  1. Consent and Assent
  2. Minimize risk
  3. Minimize distress During clinical development: the timing of pediatric studies will

depend on - ✔✔✔ Correct Answer > 1. Medicinal produc

  1. Type of disease being treated
  2. Safety considerations
  3. Efficacy and safety of alternative treatments What does ICH E11 say about long-term surveillance of children

in clinical trials? - ✔✔✔ Correct Answer > It may be needed to

determine the possible effects on development When each subject is randomized to a sequence of two or more treatments and hence acts as their own control for treatment

comparisons - ✔✔✔ Correct Answer > Crossover

When subjects are randomized to 1 of 2 or more arms: each arm being allocated a different treatment. Each treatment will include their investigational product at one or more doses: and one or more control treatments: such as placebo and/or an

active comparator - ✔✔✔ Correct Answer > Parallel

A sponsor is developing an IP for treatment of a medical condition where there is one additional marketed product approved for treatment of the condition. The sponsor believes their product works as well or better than the current treatment with fewer side effects. What is the most-likely study

design they will use to test the efficacy of the IP? - ✔✔✔

Correct Answer > Non-Inferiority What type of clinical trial most likely requires enrollment of the

largest number of research subjects? - ✔✔✔ Correct Answer >

Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy)

Minimum number of membors on an IRB/IEC - ✔✔✔ Correct

Answer > 5 (... lay people and medical professionals can be part of the IRB/IEC)

Who is responsible for providing the protocol - ✔✔✔ Correct

Answer > The Sponsor

The purpose of the SIV is to - ✔✔✔ Correct Answer > 1. review

standard procedures

  1. review the protocol
  2. review the blank eCRFs: Minimum SAE reporting requirements
  3. Subject details (ID not name)
  4. IP
  5. Interventions for the event that is being reported
  6. Details of the event
  7. Details on the reporter of the event
  8. Admin and sponsor or company details

Vulnerable subjects - ✔✔✔ Correct Answer > 1. Junior

members of the medical profession

  1. Employees of a pharmaceutical company
  2. Military personnel
  3. Pregnant Women
  4. Prisoners

IRB/IEC Evaluates - ✔✔✔ Correct Answer > 1. The rights:

safety: and well-being of the subjects participating in the trial

  1. The subject selection procedure
  2. The scientific tenability of the trial

Serious Adverse Event (SAE) - ✔✔✔ Correct Answer > 1. Results

in death: is life threatening

  1. Requires inpatient admission
  2. Prolonged admission
  3. Congenital anomaly
  4. Persistent incapacity
  5. Death itself is not neccessarily an SAE*
  6. Must be reported by sponsor to authorities within 15 calendars days from sponsors first knowledge of the event *Seriousness does not equal severity in that Serious requires reporting while severe may not.. Severe may just be used to describe an AE

Adverse Drug Reaction (ADR) - ✔✔✔ Correct Answer > 1. All

noxious and unintended response that is related to any dose

  1. If the reaction is possibly: probably: or definitely related to the drug: it is considered an ADR
  2. All ADRs must be documented
  3. ADRs are not always AEs Not observed before. Or the Event occurred more often than

previously observed - ✔✔✔ Correct Answer > Unexpected

Event

Adverse Event (AE) - ✔✔✔ Correct Answer > 1. Any untoward

medical occurrence that does not necessarily have a causal relationship with treatment

  1. Can be mild moderate or severe
  2. Worsening of a pre-existing medical condition is an AE

Non-Clinical Study - ✔✔✔ Correct Answer > 1. Not conducted

on human subjects

  1. Provide preliminary safety and pharmacokinetic data needed to support studies in human

Data Safety and Monitoring Board (DSMB) - ✔✔✔ Correct

Answer > 1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints

  1. Can recommend that sponsors modify: end: or continue a trial. But cannot recommend they start a new trial

WMA - ✔✔✔ Correct Answer > World Medical Association

Declaration of Helsinki - ✔✔✔ Correct Answer > - Created by

WMA in 1964: - Defines the ethical principles for medical research involving human subjects

  1. Importance of ICF Requirement of ethical review and approval of research before it is undertaken:
  2. Acknowledgement and guidance of special protections for vulnerable subjects:
  3. Recommends trials are registered on public database

LAR - ✔✔✔ Correct Answer > Legally Acceptable

Representative. (regarding consenting procedures)

International Conference on Harmonization (ICH) - ✔✔✔

Correct Answer > Mission is to provide a unified standard for

Europe: US: and Japan to facilitate the acceptance of clinical trials

Expected AEs - ✔✔✔ Correct Answer > Those that are

consistent with the product information and were present on previous and preclinical trials

Contents of the site TMF - ✔✔✔ Correct Answer > 1. IP

accountability records

  1. Subject screening log
  2. Signed ICFs Per ICH: how long must an IRB/IEC keep correspondence for

after the completion of a clinical trial - ✔✔✔ Correct Answer >

at least 3 years

The signature page is an optional section of the IB (T/F) - ✔✔✔

Correct Answer > True Incapacitated subjects can provide consent as soon as capacity

is regained (T/F) - ✔✔✔ Correct Answer > True

Who should send Annual Progress Reports to the IRB/IEC -

✔✔✔ Correct Answer > The Investigator

The investigator is required to share names of subjects with the

IRB/IEC (T/F) - ✔✔✔ Correct Answer > False

CRAs(monitors) cannot review source documents of subjects who have withdrawn consent. Even if the source document

predates their consent withdrawal(T/F) - ✔✔✔ Correct Answer

> True When should research studies involving human subjects be

registered in a publicly accessible database - ✔✔✔ Correct

Answer > before recruiting the first subject Any changes to safety language in an IB should be submitted to

the IRB/IEC (T/F) - ✔✔✔ Correct Answer > True

All SAE's must be life-threatening to be considered an SAE

opposed to AE (T/F) - ✔✔✔ Correct Answer > True

After completion of a study: where should the final trial close-

out monitoring report prepared by the CRA be filed? - ✔✔✔

Correct Answer > in the Sponsor's files During a multi-site clinical study: Whose responsibility is it to

report subject recruitment rate? - ✔✔✔ Correct Answer > CRA

(Monitor) What is the investigator's first priority when a subject wishes to

withdraw prematurely from the trial? - ✔✔✔ Correct 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) - ✔✔✔ Correct 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? - ✔✔✔ Correct 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?

- ✔✔✔ Correct 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? - ✔✔✔ Correct Answer > The

sponsor and the IRB/IEC The study protocol does not need to include statistical analysis

methods (T/F) - ✔✔✔ Correct Answer > False

Subjects can be enrolled using lab results predating when the

ICF was signed (T/F) - ✔✔✔ Correct Answer > True

What must be done: at the site level: if the protocol is altered

during the trial? - ✔✔✔ Correct 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? - ✔✔✔ Correct 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 - ✔✔✔ Correct Answer > 1. subject

availability

  1. competing studies
  2. lab requirements
  3. sponsor expectations

DSMB (Data and Safety Monitoring Board) - ✔✔✔ Correct

Answer > 1. Assesses the progress of a clinical trial: the safety data: and the critical efficacy endpoints

  1. 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) - ✔✔✔ Correct Answer > True