Prior to archiving a study, documentation of IP destruction at the site should be filed in
the study files of the: - answerPI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed and
dated ICF? - answerThe subject's legally acceptable representative
Whic...
CCRP Practice Questions and answers correctly 2023
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - answerPI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - answerThe subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? - answerThe subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate? - answerThe CRA
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be: - answerPhase II
What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP? - answerIB
When considering participation in a study, the investigator should determine if he/she: - answersees enough patients who would qualify for the study.
When would an impartial witness be needed during the consent process for an illiterate subject? - answerTo 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? - answerElectronic 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? - answerA 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? - answerWording indicating that there is no expected benefit should be included.
A research subject's responsibilities for study participation should be described in the: - answerICF New safety information has become available from the Sponsor about the IP being used
in a clinical trial. The Investigator must: - answersubmit 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? - answerConsenting 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? - answerTry 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? - answerICF
Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a clinical trial? - answer3 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? - answerConfirm 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: - answervalidation, accuracy, reliability, and
completeness.
When should a research study involving human subjects be registered in a publicly accessible database? - answerBefore 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: - answerobtain 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? - answerThe 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: - answera signed clinical trial agreement between the site and sponsor is in place.
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