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ACRP CP FINAL EXAM 2025/ACRP CP CERTIFICATION EXAM LATEST 2025 ACTUAL EXAM WITH COMPLETE QUESTIONS AND CORRECT DETAILED ANSWERS (100% VERIFIED ANSWERS) |ALREADY GRADED A+| ||PROFESSOR VERIFIED|| ||BRANDNEW!!!|| What phase of a clinical trial involves a heavy emphasis on safety and tolerability: Pharmacokinetics: Pharmacodynamics and early measurement of drug activity? - 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 - 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. - ANSWER-1. Selection of the initial human dose
- Safe duration of drug exposure
- 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. - 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? - ANSWER-Phase One Characterization of a drug's absorption: distribution: metabolism: and excretion that continues throughout the development plan is defined as - ANSWER-Pharmacokinetics According to ICH E8: "Formulations used in clinical trials should be well characterized: including information on ___________ whenever feasible." - ANSWER-Bioavailability The study subject asks you why the study is called a double blind study. You will explain double blind as - ANSWER-When the Investigator and sponsor staff who are involved in the treatment
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 - 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 - 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 - 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? - 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)? - ANSWER-True What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" - 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. - ANSWER-True For a randomized trial: the following is true - 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
- Helps to avoid possible bias in the selection and allocation of subjects arising from the predictability of treatment assignments
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 - 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? - 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. - ANSWER- Carryover effect Missing data points (values) represent a potential source of bias in a clinical trial. (True or False) - 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. - 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. - 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 - 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? - ANSWER-The target population
T or F- Pharmacokinetic studies in the pediatric population are generally conducted in patients with the disease. - ANSWER-True The two ways to minimize the number of samples obtained from each pediatric patient are - ANSWER-1. Population PK & Sparse sampling
- 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. - 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 - 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? - ANSWER-
- 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. - 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? - ANSWER-Children Non-compliance is a special problem in this age group. - 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? - ANSWER-1. Recruitment
- Consent and Assent
more control treatments: such as placebo and/or an active comparator - 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? - ANSWER-Non-Inferiority What type of clinical trial most likely requires enrollment of the largest number of research subjects? - ANSWER-Therapeutic confirmatory (aka Pivotal Trial: Ph III: or Comparative Efficacy) Minimum number of membors on an IRB/IEC - ANSWER-5 (... lay people and medical professionals can be part of the IRB/IEC) Who is responsible for providing the protocol - ANSWER-The Sponsor
The purpose of the SIV is to - ANSWER-1. review standard procedures
- review the protocol
- review the blank eCRFs: Minimum SAE reporting requirements
- 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 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
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 information 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
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? - ANSWER-The 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 The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers - ANSWER-Phase I Who is ultimately responsible for all aspects of the research conducted at a site? - ANSWER-Principal investigator An international quality standard that is provided by ICH E6(R2) describing safety: accuracy of trials and credibility of data - ANSWER-GCP What event resulted in the Nuremburg Cod of 1949 - ANSWER- Nazi Medical Experiments
