CCRP PRACTICE QUESTIONS AND ANSWERS GRADED 100% PASS 2024-2025 LATEST UPDATED., Exams of Nursing

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CCRP PRACTICE QUESTIONS AND

ANSWERS GRADED 100% PASS 2024-

LATEST UPDATED.

Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - Solution PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - Solution The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - Solution The subject inclusion and exclusion criteria During a multi-site clinical study, whose responsibility is it to report subject recruitment rate? - Solution The CRA A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be: - Solution Phase II What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - Solution IB When considering participation in a study, the investigator should determine if he/she: - Solution sees enough patients who would qualify for the study. When would an impartial witness be needed during the consent process for an illiterate subject? - Solution To observe the consent process During a monitoring visit, what records would a CRA reference to verify a subject's compliance to the study visit schedule and assessments? - Solution Electronic medical record 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? - Solution 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/IEC. What benefit information should be included in the ICF? - Solution Wording indicating that there is no expected benefit should be included. A research subject's responsibilities for study participation should be described in the: - Solution ICF New safety information has become available from the Sponsor about the IP being used in a clinical trial. The Investigator must: - Solution submit a revised ICF to the IRB/IEC noting the new safety information. A medical student is approached by a faculty member for possible participation in a cricothyroidotomy simulation research study. Which of the following increases risk to the subject? - Solution Consenting in the presence of figure of authority What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - Solution Try to obtain the subject's reason for withdrawal. 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? - Solution ICF Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - Solution 3 years A CRA notices during an onsite visit that the date on IRB/IEC 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? - Solution Confirm dates of initial receipt of the sponsor protocol and the IRB/IEC submission dates.

A CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for: - Solution validation, accuracy, reliability, and completeness. When should a research study involving human subjects be registered in a publicly accessible database? - Solution Before recruiting the first subject 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: - Solution obtain consent from the subject for the study. 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? - Solution The sponsor's files A site is in the start-up phase of an industry-sponsored phase 3 trial, and has received IRB/IEC approval. The site can begin enrolling subjects after:

• Solution a signed clinical trial agreement between the site and sponsor is in place. In a multi-arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of breast cancer in the subjects. Who is responsible for providing a written report to the IRB/IEC? - Solution PI Part of a sponsor's responsibility pertaining to electronic trial data handling is to - Solution maintain an audit trail, data trail, and edit trail. Which entity is primarily charged with considering subject rights and well- being during clinical trials? - Solution Institutional Review Board (IRB)/Independent Ethics Committee (IEC) Which of the following would be considered a vulnerable population requiring special consideration by an IRB/IEC? - Solution 1. Medical, pharmacy, dental, and nursing students

2. Prisoners
3. Serving military personnel

T or F: The terms "serious" and "severe" are synonymous according to ICH

• Solution False An Unexpected Adverse drug reaction is: - Solution A reaction that is not consistent with the applicable product information ICH safety definitions can be found in - Solution ICH E2A An Adverse Event (AE) that is severe in intensity - Solution May not meet the definition of serious T or F: Information discovered during the course of a clinical investigation that might materially influence the benefit-risk assessment of the investigation/product may necessitate rapid communication to regulatory authorities. - Solution True Subject 3826 had to stay in the hospital for three extra days when his legs started swelling after participation in a cardiac drug study. Swelling of the legs was listed in the Investigator's Brochure as a possible side effect. This is considered a/an: - Solution Serious Adverse Drug Reaction T or F: A subject in your diabetes research study developed colon cancer, which the Investigator has determined to be unrelated to the study. The subject is currently asymptomatic. This will be considered a serious adverse event because it is life threatening. - Solution False In pre-market approval studies, all noxious and unintended responses to a medicinal product even possibly related to any dose should be considered:
• Solution Adverse Drug Reaction You were just informed that you have a research patient that is receiving intensive treatment in an emergency room for allergic bronchospasm. This should be considered as: - Solution A serious adverse event After a Serious Adverse Event (SAE) has occurred, how should you list the subject identification on the immediate and follow-up reports? - Solution By their subject identification number

In which scenario would unblinding typically occur? - Solution When the investigator wants to make sure a particular subject is not randomized to placebo in the case of a Serious Adverse Event (SAE) What is the timeframe for "expedited" reporting of serious, fatal or life- threatening, unexpected adverse drug reactions to regulatory authorities? - Solution As soon as possible, but no later than SEVEN calendar days after first knowledge of the event The term "severe" in ICH is used to describe: - Solution The Intensity of a specific event All cases judged by either the reporting health care professional or the sponsor as having a reasonable suspected causal relationship to the medicinal product qualify as: - Solution Adverse Drug Reactions Which of the following criteria is described in ICH-GCP as necessary for classifying an Adverse Event (AE) as an Adverse Drug Reaction (ADR)? - Solution That a causal relationship is at least a reasonable possibility A subject has a suspected serious adverse drug reaction with the outcome of death. Which are items that should be submitted to the Sponsor? - Solution 1. A de-identified autopsy report, if available

2. Cause of death, and a comment on its possible relationship to the suspected drug reaction What is the purpose of an initiation visit? - Solution 1. To review the protocol
3. To review research site's SOPs
4. To review the blank CRFs The process by which a subject voluntarily confirms his or her willingness to participate in a clinical trial is known as: - Solution Informed Consent Process T or F: The IRB/IEC may request additional information be given to subjects when, in the judgment of the IRB/IEC, it would add meaningfully to the protection of the rights, safety and/or well-being of the subjects. - Solution True

The IRB/IEC should consist of a reasonable number of members, who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. It is recommended that the IRB/IEC should include: - Solution 1. At least five members

2. At least one member whose primary interest is non-scientific
3. At least one member who is independent from the Institution/trial site Which of the following is NOT one of the required elements of an informed consent form? - Solution A listing of all site personnel who will be involved in the research How can an Adverse Drug Reaction (ADR) be defined? - Solution As a noxious and unintended response to the investigational drug Who is most responsible for the appropriate monitoring of clinical trials? - Solution 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: - Solution 1. Unobscured original entries
4. Traceable source documents
5. 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? - Solution 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. - Solution 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? - Solution 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: - Solution 1. Promptly notify the regulatory authority(ies)

2. 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. - Solution 2 years What is the purpose of the IRB/IEC? - Solution 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? - Solution Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form (ICF)? - Solution 1. The person who conducted the informed consent interview
3. 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? - Solution 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? - Solution -The sponsor should appoint individuals, who are independent of the clinical trials/systems -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?" - Solution 1. Members of the armed forces

2. Junior members of the medical profession
3. Employees of the pharmaceutical industry Which phase determines therapeutic benefit, usually in wider populations?

• Solution Phase 3 What phase of a clinical trial involves a heavy emphasis on safety and tolerability, Pharmacokinetics, Pharmacodynamics and early measurement of drug activity? - Solution 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: - Solution 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. - Solution 1. Selection of the initial human dose

2. Safe duration of drug exposure
3. 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. - Solution 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? - Solution Phase One Characterization of a drug's absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as: - Solution Pharmacokinetics According to ICH E8, "Formulations used in clinical trials should be well characterized, including information on ___________ whenever feasible." - Solution Bioavailability

The study subject asks you why the study is called a double blind study. You will explain double blind as: - Solution 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: -Randomized parallel dose response studies -Clinical safety studies -Studies of mortality/morbidity outcomes -Large simple trials - Solution 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? - Solution 1. Food effects on bioavailability

2. Information in sub-populations such as patients with impaired elimination
3. 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: - Solution 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: - Solution Include children in the general plan from the beginning Per ICH E8, methods used to evaluate patient usage of the test drug should be: - Solution 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? - Solution 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)? - Solution True

What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" - Solution 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. - Solution True For a randomized trial, the following is true: - Solution -The procedure to be followed, the necessary documentation, and the subsequent treatment and assessment of the subject should all be described in the protocol -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? - Solution -That the sponsor should continue the trial -That the sponsor should modify the trial -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? - Solution Double-dummy Which variable in a study should be used to determine the sample size? - Solution 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? - Solution -Single-Blind -Masking -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 - Solution 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? - Solution 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. - Solution Carryover effect True or False: Missing data points (values) represent a potential source of bias in a clinical trial. - Solution 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. - Solution 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. - Solution 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: - Solution 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? - Solution The target population True or False: All new medications should have generated data on the use in the pediatric population? - Solution False True or False: Medicinal products may affect physical and cognitive growth and development, and the adverse event profile may differ in pediatric patients. - Solution True

What is it called when a child is given information about a trial and asked if he or she wishes to participate? - Solution 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). - Solution TRUE T or F: Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects. - Solution False T or F: Pharmacokinetic studies in the pediatric population are generally conducted in patients with the disease. - Solution True The two ways to minimize the number of samples obtained from each pediatric patient are: - Solution 1. Population PK & Sparse sampling

2. 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. - Solution 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:

• Solution 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? - Solution -The data may better reflect clinical use -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. - Solution 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? - Solution Children

Non-compliance is a special problem in this age group. - Solution 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? - Solution -Recruitment -Consent and Assent -Minimize risk -Minimize distress During clinical development, the timing of pediatric studies will depend on: - Solution -Medicinal product -Type of disease being treated -Safety considerations -Efficacy and safety of alternative treatments What does ICH E11 say about long-term surveillance of children in clinical trials? - Solution It may be needed to determine the possible effects on development