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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.