CCRP Practice Questions
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.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANSWER-The subject's legally ...
CCRP Practice Questions
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.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANSWER-The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? - ANSWER-The subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate? - ANSWER-
The CRA
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
What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - ANSWER-IB
When considering participation in a study, the investigator should determine if he/she: - ANSWER-sees enough patients who would qualify for the study.
When would an impartial witness be needed during the consent process for an illiterate subject? - ANSWER-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? - ANSWER-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? - 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/IEC. What benefit information should be included in the ICF? - ANSWER-Wording indicating that there is no expected benefit should be included.
A research subject's responsibilities for study participation should be described in the: - ANSWER-ICF
New safety information has become available from the Sponsor about the IP being used in a clinical trial.
The Investigator must: - ANSWER-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? - ANSWER-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? - ANSWER-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? - ANSWER-ICF
Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - ANSWER-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? - ANSWER-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: - ANSWER-validation, accuracy, reliability, and completeness.
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