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Add to cartWhat would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial?
Try to obtain the subjects reason for withdrawal.
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CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for:
Validation, accuracy, reliability, completeness.
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Part of a sponsors responsibility pertaining to electronic trial data handling is to:
Maintain an audit trail, data trail, and edit trail.
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A research subjects responsibilities for study participation should be described in the:
What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP?
During a multi-site clinical study, whose responsibility is it to report subject recruitment rate?
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.
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A site is in the start-up phase of an industry-sponsored phase 3 trial and has received IRB approval. The site can begin enrolling subjects after:
A signed clinical trial agreement between the site and sponsor is in place.
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Create quizHere are 32 practice questions and answers for the ACRP CP Final Exam. These questions cover various topics related to clinical research and will help you prepare for the actual exam. Each question is followed by the correct answer.
What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial?
Try to obtain the subjects reason for withdrawal.CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for:
Validation, accuracy, reliability, completeness.Part of a sponsors responsibility pertaining to electronic trial data handling is to:
Maintain an audit trail, data trail, and edit trail.A research subjects responsibilities for study participation should be described in the:
ICF.What document would an investigator reference to learn more about the previous clinical and nonclinical results of studies of the IP?
Investigators brochure.During a multi-site clinical study, whose responsibility is it to report subject recruitment rate?
The CRA.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.A site is in the start-up phase of an industry-sponsored phase 3 trial and has received IRB approval. The site can begin enrolling subjects after:
A signed clinical trial agreement between the site and sponsor is in place.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 that measures cognitive ability. Which of the following individuals can administer the psychometric test to the potential subjects?
A research study, in which there is no intended clinical benefit to the subject, is being submitted to the IRB. What benefit information should be included in the ICF?
A CRA notices during an onsite visit that the date on IRB 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?
In a multi-arm, randomized clinical trial, one arm of the protocol was terminated due to an increased risk of cancer in subjects. Who is responsible for providing a written report to the IRB?
Which of the following required elements should be included in a clinical trial protocol?
Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the:
During a monitoring visit, what records would a CRA reference to verify a subjects compliance to the study visit schedule and assessments?
When considering participation in a study, the investigator should determine if he...
New safety information has become available from the Sponsor about the IP being used in a clinical trial. The investigator must:
Per ICH, an IRB must keep correspondence for at least how long after the completion of a clinical trial?
When would an impartial witness be needed during the consent process for an illiterate subject?
A study which seeks to determine the ideal dose and regimen of a new IP to treat hypothyroidism is considered to be:
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?
A blood sample collection is required to screen for bloodborne pathogens before a subject could be enrolled in a study. Where will subjects find information on the procedures and any foreseeable risks or inconveniences?
When should a research study involving human subjects be registered in a publicly accessible database?
In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF?
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 study?
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?
A blood sample collection is required to screen for bloodborne pathogens before a subject could be enrolled in a study. Where will subjects find information on the procedures and any foreseeable risks or inconveniences?
When would an impartial witness be needed during the consent process for an illiterate subject?
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?
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:
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?
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?