CCRP Practice Questions | 100% Correct Answers | Verified | Latest 2024 Version
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CCRP
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 fol...
CCRP Practice Questions | 100% Correct Answers | Verified | Latest 2024 Version 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 indivi duals 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.
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