ACRP CP PRACTICE QUESTIONS WITH ANSWERS 2024, Exams of Law

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ACRP CP PRACTICE QUESTIONS WITH ANSWERS 2024

What would be the first priority for an investigator when a subject wishes to withdraw prematurely fromthe trial? - Correct 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 theestablished requirements for: - Correct answer-Validation, accuracy, reliability, completeness

Part of a sponsor's responsibility pertaining to electronic trial data handling is to - Correct answer-maintain an audit trail, data trail, and edit trail.

A research subject's responsibilities for study participation should be described in the: - Correct answer-ICF

What document would an investigator reference to learn more about the previous clinical andnonclinical results of studies of the IP? - Correct answer-Investigators brochure

During a multi site clinical study, whose responsibility is it to report subject recruitment rate? - Correctanswer-The CRA

An unconscious adult subject was enrolled in a study after obtaining consent from an LAR, and protocoltherapy was initiated. The subject showed significant improvement in his clinical condition, and regained consciousness. The Investigator should inform the subject about the study and - Correct answer-Obtainconsent 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. Thesite can begin enrolling subjects after... - Correct 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 theinclusion 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 thepotential subjects? - Correct 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 theIRB. What benefit informatiom should be included in the ICF? - Correct 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 theeffective date indicated on the cover page of the protocol and the signatures of the investigator and sponsor. What should the CRA do FIRST? - Correct answer-Confirm dates of initial receipt of the sponsorprotocol and the IRB submission dates.

In a multi arm, randomized clinical trial, one arm of the protocol was terminated due to an increased riskof cancer in subjects. Who is responsible for providing a written report to the IRB? - Correct answer-PI

Which of the following required elements should be included in a clinical trial protocol? - Correctanswer-Subject inclusion and exclusion criteria

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files ofthe - Correct answer-PI and Sponsor

During a monitoring visit, what records would a CRA reference to verify a subject's compliance to thestudy visit schedule and assessments? - Correct answer-Electronic medical record

When considering participation in a study, the investigator should determine if he... - Correct 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: - Correct 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? -Correct answer-3 Years

When would an impartial witness be needed during the consent process for an illiterate subject? -Correct answer-To observe the consent process

Phase I - Correct answer-The clinical trial phase that focuses on safety and human pharmacology inhealthy volunteers

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

Define GCP - Correct answer-An international quality standard that is provided by ICH E6(R2) describingsafety, accuracy of trials and credibility of data

What event resulted in the Nuremburg Cod of 1949 - Correct answer-Nazi Medical Experiments Which ICH Guideline is known as the GCP guideline? - Correct answer-E6(R2) What are the basic ethical principles of the Belmont Report? - Correct answer-Beneficence, Respect forpersons, Justice

Define CBER, and full title - Correct answer-Center for Biologics Evaluation and Research

FDA center that regulates blood, vaccine, gene therapy and tissue What is the International Conference on Harmonization (ICH) Guidelines? - Correct answer-A unifiedstandard to facilitate the mutual acceptance of clinical data by the regulatory authorities in the European Union, Japan and United States. To be a qualifying clinical trial, which three requirements must be met? - Correct answer-TherapeuticIntent Enrolls patients with diagnosed diseaseEvaluates an item/service that falls within a Medicare Benefit Category

Define informed consent - Correct answer-A process by which a subject voluntarily confirms his or herwillingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subjects decision to participate. Primary purpose of IRB - Correct answer-To ensure the protection of the rights and welfare of thehuman subjects

When can IRB waive informed consent? - Correct answer-IRB has the ability to waive the informedconsent requirement if the research is no more than minimal risk and involves no procedures for which consent is required outside of the research context and in emergency research An investigational New Drug (IND) Application becomes effective ___ days after receipt by the FDA(barring a hold, request for additional information, or rejection of an application); is valid one year; and must be updated within ___ days of taking effect. - Correct answer-30, 60 Phase II - Correct answer-Focuses primarily on safety and effectiveness, is dose-ranging and occurs insubjects with the disease or condition.

Quality documentation practices ALCOAC stands for - Correct answer-Attributable, Legible,Contemporaneous, Original, Accurate, Complete

After the New Drug Application is approved, the responsibility for reporting safety issues to the FDArests with - Correct answer-The sponsor

To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? - Correctanswer-Contract Research Organization

Define role of CDRH and abbreviation - Correct answer-Center for Devices and Radiological Health FDA center that assures that patients and providers have timely and continued access to safe, effective,and high-quality medical devices and safe radiation-emitting products.

Define Adverse Drug reaction - Correct answer-all noxious and unintended response to a medicinalproduct related to any dose.

How many days does a sponsor have to report non-fatal IND safety report to the FDA - Correct answer-15 calendar days

What are examples of hidden costs in a study budget - Correct answer-Unexpected equipment failure Four types of monitoring visits are: - Correct answer-Qualification, Initiation, Routine, Close-out Define Protocol - Correct answer-A document that describes the objective(s), design, methodology,statistical considerations and organization of a trial.

Phase III - Correct answer-Phase of trial that primarily focuses on confirming effectiveness andestablishing a safety profile in subjects with the disease or condition and other concurrent illnesses and medications. Case Report Forms (CRFs) are typically developed by the ____ and the ____ performs source documentverification - Correct answer-Sponsor, Monitor

Define BIMO and abbreviation - Correct answer-Bioresearch Monitoring Program Information

FDA center that ensures the protection of research subjects and the integrity of data submitted to theagency in support of a marketing application.

Define AE - Correct answer-An untoward medical occurrence in a patient or clinical investigation subjectadministered a pharmaceutical product and which does not necessarily have a causa relationship with this treatment. Define UADE - Correct answer-Unanticipated, adverse device effect. Must be serious, related andunexpected

Crossover - Correct answer-when each subject is randomized to a sequence of two or more treatmentsand hence acts as their own control for treatment comparisons

Parallel - Correct answer-when subjects are randomized to 1 of 2 or more arms, each arm beingallocated 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 A sponsor is developing an IP for treatment of a medical condition where there is one additionalmarketed 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 designthey 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 professionalscan 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--review standard procedures

-review the protocol -review the blank eCRFs Minimum SAE reporting requirements - Correct answer-- Subject details (ID not name)- IP

• Interventions for the event that is being reported- Details of the event
• Details on the reporter of the event- Admin and sponsor or company details/

Vulnerable subjects - Correct answer-- Junior members of the medical profession

• Employees of a pharmaceutical company- Military personnel
• Pregnant Women- Prisoners

IRB/IEC Evaluates - Correct answer-- The rights, safety, and well-being of the subjects participating in thetrial

• The subject selection procedure
• The scientific tenability of the trial Serious Adverse Event (SAE) - Correct answer-- results in death, is life threatening, requires inpatientadmission, prolonged admission, congenital anomaly, or persistent incapacity -death itself is not neccessarily an sae- Seriousness does not equal severity in that Serious requires reporting while severe may not.. Severe may just be used to describe an AE- Must be reported by sponsor to authorities within 15 calendars days from sponsors first knowledge of the event

Adverse Drug Reaction (ADR) - Correct answer-- All noxious and unintended response that is related toany dose

• If the reaction is possibly, probably, or definitely related to the drug, it is considered an ADR
• All ADRs must be documented- ADRs are not always AEs

Unexpected Event - Correct answer-Not observed before. Or the Event occurred more often than previously observed Adverse Event (AE) - Correct answer-- Any untoward medical occurrence that does not necessarily havea causal relationship with treatment.

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

Non-Clinical Study - Correct answer-- Not conducted on human subjects. -Provide preliminary safety and pharmacokinetic data needed to support studies in human Data Safety and Monitoring Board (DSMB) - Correct answer-- Assesses the progress of a clinical trial, thesafety data, and the critical efficacy endpoints

• Can recommend that sponsors modify, end, or continue a trial. But cannot recommend they start anew 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 i.e.: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 subjects3. 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 unifiedstandard 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 presenton previous and preclinical trials

Contents of the site TMF - Correct answer-- IP accountability records

• Subject screening log- 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 thesource 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 theCRAbe filed - Correct answer-in the Sponsor's files

During a multi-site clinical study, Whose responsibility is it to report subject recruitment rate - Correctanswer-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 aqualified physician they can adjust IP dose

Following unblinding in the case of a suspected serious unexpected adverse drug reaction, thetreatment 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 investigatorunblind 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, Whomust 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-thesubjects 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 cannotprovide 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 toenrollment. Then ensure the subjs LAR is informed asap to continue the consent

Pre-Trial Meetings Discuss: - Correct answer--subject availability -competing studies-lab requirements -sponsor expectations DSMB - Correct 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 newtrial

Incapacitated subjects can provide consent as soon as capacity is regained (T/F) - Correct answer-True The signature page is a required section of the IB - Correct answer-False All trial phases assess safety (T/F) - Correct answer-True Phase I - Correct 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 - Correct 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 indicatedcondition

Phase III - Correct 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 - Correct 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 - Correct answer--Analysis conducted after drug approval aka Phase IV -Provides the most significant amount of safety and efficacy in pediatrics trials with ltd. Number ofparticipants

Pediatric Trials - Correct answer--can be prepared for by developing a program for use in children

• experience with use in children so far should be included in the development plan-conduct pharmacodynamic/pharmacokinetic studies in children if there is no relevant information available from similar compounds Study design must include: - Correct answer--clear endpoints-Appropriate comparators -Adequate # of subjects All SAE's must be life-threatening to be considered an SAE opposed to AE (T/F) - Correct answer-True Any changes to an IB are not required to be submitted to the IRB/IEC (T/F) - Correct answer-False.changes to safety language must be submitted to the IRB

Prior to archiving a study, where should documentation of site IP destruction be filed? - Correct answer-in the study files of the PI and Sponsor

Centralized monitoring supports clinical data review by examining data trends (T/F) - Correct answer-True

A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval.When can the site begin enrolling subjects? - Correct answer-after a signed clinical trial agreement between the site and sponsor is in place Factorial Study - Correct answer-A randomised controlled trial ( RCT ) that lets you carry out 2 or moretreatment comparisons at the same time. while multiple factors are manipulated

Non-Inferiority Study - Correct answer-When the aim of the randomized controlled trial (RCT) is to showthat the new treatment is not inferior to an already active treatment that is commonly used for patients of that indication Superiority Study - Correct answer-When the aim of the randomized controlled trial (RCT) is to showthat one treatment is superior to another

Dose Response Study - Correct answer-When the aim of the trial is to assess the patients reaction tovarying doses

Equivalence Study - Correct answer-When the aim of the randomized controlled trial (RCT) is to showthat two treatments are not too different in characteristics

Estimand - Correct answer--Treatment effect estimate-Specifies 5 target attributes: TreatmentPopulation Variable/endpoint

Population level summary Handling of intercurrent events (IECs) CSR - Correct answer--Clinical Study Report-To summarize study methods, results and conclusions typically using appropriate statistical analyses -To account for all subjects and all data, using tables and graphs, including p values-To draw conclusions

What do sensitivity analyses test? - Correct answer-data robustness. -needed to estimate treatment risk and benefits for larger population Data Vulnerabilities - Correct answer--Data variations-Confounders

Exploratory Trial - Correct answer-gathers data without a hypothesis stated before starting trial Confirmatory Trial - Correct answer--expected to provide strong clinical data evidence about safety andefficacy. -Trials tests if stated hypothesis, created before trial, is supported or not Pharmacokinetic Trial - Correct answer-the study of how the organism effects the drug for the durationof exposure

Pharmacaodynamic Trial - Correct answer-examines the drug's effect on theorganism for the duration ofexposure

Therapeutic Trial - Correct answer-provides a specific treatment to study its impact on cancer. Robust Data - Correct answer--clean -complete

-precise -protocol has been followed Confidence Interval - Correct answer-The degree of certainty in the sampling method. The wider the CI,the more data variability

Why do we need clinical trial statistical analyses - Correct answer-to estimate treatment risks andbenefits for a larger population

Intercurrent Event - Correct answer-An event occurring after treatment start that may complicateinterpretation of treatment effects during statistical analysis.. note, intercurrent events should not be actively avoided. Why is an estimand useful? - Correct answer-To specify target attributes How are treatment effects measured in a clinical trial? - Correct answer-Estimating outcomes, collectingand analyzing data

Whom should the sponsor notify of findings that affect the safety of the subjects? - Correct answer-Allparticipating investigators and the regulatory authority

According to the ICH GCP, who is responsible for ensuring that clinical trial site staff is trained on theprotocol, investigation product, and their trial-related duties, and functions - Correct answer-The PI

What is the primary difference between an AE and an ADR(advanced drug reaction) - Correct answer-AnADR is always related to the study drug and an AE may or may not be related to the study drug.

Define CDER and abbreviation - Correct answer-Center for Drug Evaluation and Research FDA center responsible for regulating over-the-counter and prescription drugs, including generic drugs At what frequency does an RIB need to conduct continuing review of each clinical trial? - Correctanswer-Intervals appropriate to the degree of risk to human subjects, but at least once per year.

The purpose of ____ is to document qualifications and eligibility to conduct a trial and/or providemedical supervision of subjects - Correct answer-Curriculum vitae

What are the requirements for conducting a study in the USA - Correct answer-A study conducted in theUSA needs to be compliant with both ICH GCP guidelines and FDA regulations

What documentation does the monitor provide the investigator and site staff for a monitoring visit? -Correct answer-Pre-visit letter, initiation monitoring report, post-visit letter.

Clinical Trial - Correct answer-Any investigation in human subjectes intended to discover or veryf theclinical, pharmacological and or other pharmacodynamic effects of an IP or to identify adverse reactions to an IP, or absorption, distribution, metabolism and excretion of an IP. Research - Correct answer-An activity designed to test a hypothesis, permit conclusions to be drawnand, thereby, to develop or contribute to general knowledge.

Clinical practice - Correct answer-intereventions that are designed solely to enhance the well-being ofthe individual and that have a reasonable expectation of success.

Patient-oriented research - Correct answer-IND/IDE Investment in new drug, biologics, ie vaccines. IND/ IDE: Invest Device Exemption IND - Correct answer-Investigational New Drug, any experiment in which a drug is administered ordispensed to, or used involving, one or more human subjects. Any use of drug except for the marketed intention of the drug.

IDE - Correct answer-Investigational Device Exemtpion: A clinical investigation or research involving thesafety or effectiveness of a device.

General Responsibilities of Sponsors: 21 CFR 312.50-.59 - Correct answer-Sponsors are responsible forselecting qualified investagors, providin gthem witht he information they need to conduct an investigation properly, ensuring proper monitoring of the investigations, ensuring that the investigationis conducted in accordance with the general investigational plan and protocols contained in the IND, maintianing an effective IND with respect to the investigations, and ensuring that FDA and allparticipating investigators are promptly informed.

IEC - Correct answer-Independent Ethics Committee (AKA IRB): An independent body constituted ofmedical professionals and non-medical member, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial CFR - Correct answer-Code of Federal Regulations: ------ ICH - Correct answer-International Council for HarmonizationE6(R2) = GCP Need to standardize regulationsEurope, Japan, US Safety, quality, efficacy

A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism isconsidered to be: - Correct answer-Phase II

After completion of a study, the final trial close out monitoring report prepared by the CRA should befiled in which of the following stakeholder files? - Correct answer-The sponsors files

A blood sample collection is required to screen for bloodborne pathogens before subject could beenrolled in a study. Where will subjects find information of the procedures and any foreseeable risks or inconveniences? - Correct answer-ICF When should a research study involving human subjects be registered in a publicly accessible database?- Correct answer-Before recruiting the first subject

In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - Correctanswer-The subjects legally acceptable representative

A medical student is approaches by a faculty member for possible participation in a cricothyroidotomysimulation research study. Which of the following increases risk to the study? - Correct answer- Consenting in the presence of figure of authority