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CCRP PRACTICE EXAM 2025/110 QUESTIONS AND ANSWERS|100% VERIFIED |ALREADY GRADED A+
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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
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
Unobscured original entries
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)
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
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:
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
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
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
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