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CCRP PRACTICE EXAM 2025 / 110 QUESTIONS AND
ANSWERS|100% VERIFIED |ALREADY GRADED A+
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - ANS:->>> PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANS:->>>The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - ANS:->>> The subject inclusion and exclusion criteria During a multi-site clinical study, whose responsibility is it to report subject recruitment rate? - ANS:->>> The CRA A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be: - ANS:->>>Phase II What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? – ANS:->>> IB When considering participation in a study, the investigator should determine if he/she: - ANS:->>> sees enough patients who would qualify for the study.
When would an impartial witness be needed during the consent process for an illiterate subject? - ANS:->>> 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? - ANS:->>> 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? - ANS:->>> 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? - ANS:->>> Wording indicating that there is no expected benefit should be included. A research subject's responsibilities for study participation should be described in the: - answe r ICF
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: - ANS:->>> validation, accuracy, reliability, and completeness. When should a research study involving human subjects be registered in a publicly accessible database? - ANS:->>> 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: - ANS:->>>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? - ANS:-
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: - ANS:- 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? - ANS:->>>PI Part of a sponsor's responsibility pertaining to electronic trial data handling is to
- ANS:->>>maintain an audit trail, data trail, and edit trail. Which entity is primarily charged with considering subject rights and well- being during clinical trials? - ANS:->>>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? - ANS:->>>1. Medical, pharmacy, dental, and nursing students
- Prisoners
- Serving military personnel T or F: The terms "serious" and "severe" are synonymous according to ICH - ANS:->>>False An Unexpected Adverse drug reaction is: - ANS:->>>A reaction that is not consistent with the applicable product information
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: - ANS:->>>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? - ANS:->>>By their subject identification number In which scenario would unblinding typically occur? - ANS:->>>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? - ANS:->>>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: - ANS:->>>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: - ANS:->>>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)? - ANS:-
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? - ANS:-
- A de-identified autopsy report, if available
- Cause of death, and a comment on its possible relationship to the suspected drug reaction What is the purpose of an initiation visit? - ANS:->>>1. To review the protocol
- To review research site's SOPs
- 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: - ANS:->>>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. - ANS:-
Unobscured original entries
- Traceable source documents
- 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? - ANS:->>>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. - ANS:->>>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? - ANS:->>>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: - ANS:->>>1. Promptly notify the regulatory authority(ies)
- 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. - ANS:->>>2 years What is the purpose of the IRB/IEC? - ANS:->>>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? - ANS:->>>Inform the Sponsor per protocol and regulatory requirements According to ICH E6 Who must sign the Informed Consent Form (ICF)? - ANS:->>>1. The person who conducted the informed consent interview
- 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
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: - ANS:->>>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. - ANS:->>>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. - ANS:->>>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? - ANS:->>>Phase One Characterization of a drug's absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as: - ANS:-
Pharmacokinetics
The study subject asks you why the study is called a double blind study. You will explain double blind as: - ANS:->>>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 - ANS:->>>Therapeutic Confirmatory Your Investigator wants to participate in a Phase 3 Pharmacokinetics study. Pharmacokinetic studies are commonly conducted in later phases to ANS:->>> what questions? - ANS:->>>1. Food effects on bioavailability
- Information in sub-populations such as patients with impaired elimination
- Drug to drug interactions A trial where the treatment assignment is not known by the study participant According to ICH E8, "Formulations used in clinical trials should be well characterized, including information on whenever feasible." - answerBioavailability
address the use of specific statistical procedures or methods. - ANS:->>>True For a randomized trial, the following is true: - ANS:->>>-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? - ANS:->>>-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? - ANS:-
Double-dummy Which variable in a study should be used to determine the sample size? - ANS:- Primary variable what questions? - ANS:->>>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 According to ICH E8, "Formulations used in clinical trials should be well characterized, including information on whenever feasible." - answerBioavailability address the use of specific statistical procedures or methods. - ANS:->>>True For a randomized trial, the following is true: - ANS:->>>-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? - ANS:->>>-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? - ANS:- >>>Double-dummy Which variable in a study should be used to determine the sample size? - ANS:- >>>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? - ANS:->>>-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 - ANS:->>>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? - ANS:->>>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
True or False: All new medications should have generated data on the use in the pediatric population? - ANS:->>>False True or False: Medicinal products may affect physical and cognitive growth and development, and the adverse event profile may differ in pediatric patients. - ANS:->>>True What is it called when a child is given information about a trial and asked if he or she wishes to participate? - ANS:->>>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). - ANS:->>>TRUE T or F: Pharmacokinetic Phase 1 studies in the pediatric population are generally conducted in healthy pediatric subjects. - ANS:->>>False T or F: Pharmacokinetic studies in the pediatric population are generally conducted in patients with the disease. - ANS:->>>True The two ways to minimize the number of samples obtained from each pediatric
patient are: - ANS:->>>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.
- ANS:->>>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: - ANS:-
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? - ANS:->>>-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. - ANS:->>>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? - ANS:->>>Children
