Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: Correct Answer: PI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? Correct Answer: The subject's legally acceptable re...
CCRP Practice | 109 Questions | GRADED A
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study
files of the: Correct Answer: PI and Sponsor.
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?
Correct Answer: The subject's legally acceptable representative
Which of the following required elements should be included in a clinical trial protocol? Correct
Answer: The subject inclusion and exclusion criteria
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate?
Correct 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: Correct Answer: Phase II
What document would an investigator reference to learn more about the previous clinical and
nonclinical results of studies of the IP? Correct Answer: IB
When considering participation in a study, the investigator should determine if he/she: Correct
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?
Correct 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? Correct 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? Correct 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? Correct 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: Correct
Answer: ICF
New safety information has become available from the Sponsor about the IP being used in a
clinical trial. The Investigator must: Correct 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? Correct 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? Correct 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? Correct Answer: ICF
Per ICH, an IRB/IEC must keep correspondence for at least how long after the completion of a
clinical trial? Correct 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? Correct 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: Correct Answer: validation, accuracy, reliability, and
completeness.
When should a research study involving human subjects be registered in a publicly accessible
database? Correct Answer: 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: Correct Answer: 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? Correct Answer: 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: Correct Answer: 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? Correct Answer: PI
Part of a sponsor's responsibility pertaining to electronic trial data handling is to Correct Answer:
maintain an audit trail, data trail, and edit trail.
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