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CCRP Practice Questions and Answers Latest 2024
Typology: Exams
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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: - ✔PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ✔The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - ✔The subject inclusion and exclusion criteria During a multi-site clinical study, whose responsibility is it to report subject recruitment rate? - ✔The CRA A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be: - ✔Phase II What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ✔IB When considering participation in a study, the investigator should determine if he/she: - ✔sees enough patients who would qualify for the study. When would an impartial witness be needed during the consent process for an illiterate subject? - ✔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? - ✔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? - ✔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? - ✔Wording indicating that there is no expected benefit should be included. A research subject's responsibilities for study participation should be described in the: - ✔ICF
New safety information has become available from the Sponsor about the IP being used in a clinical trial. The Investigator must: - ✔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? - ✔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? - ✔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? - ✔ICF Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - ✔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? - ✔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: - ✔validation, accuracy, reliability, and completeness. When should a research study involving human subjects be registered in a publicly accessible database? - ✔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: - ✔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? - ✔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: - ✔a signed clinical trial agreement between the site and sponsor is in place.
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: - ✔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? - ✔By their subject identification number In which scenario would unblinding typically occur? - ✔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? - ✔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: - ✔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: - ✔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)? - ✔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? - ✔1. A de-identified autopsy report, if available
and ethics of the proposed trial. It is recommended that the IRB/IEC should include: - ✔1. At least five members
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. - ✔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? - ✔Phase One Characterization of a drug's absorption, distribution, metabolism, and excretion that continues throughout the development plan is defined as: - ✔Pharmacokinetics According to ICH E8, "Formulations used in clinical trials should be well characterized, including information on ___________ whenever feasible." - ✔Bioavailability The study subject asks you why the study is called a double blind study. You will explain double blind as: - ✔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:
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)? - ✔True What is the purpose of the "Data and Safety Monitoring Board (DSMB)?" - ✔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. - ✔True For a randomized trial, the following is true: - ✔-The procedure to be followed, the necessary documentation, and the subsequent treatment and assessment of the subject should all be described in the protocol
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.