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ACRP CP Exam Review (Complete Solution) Adverse Drug Reaction (ADR) - All noxious and unintended responses to a medicinal product related to any dose (causal relationship is at least a reasonable possibility). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function Adverse Event (AE) - Any untoward medical occurren...

ACRP CP Practice Questions and Answers () With Complete Solution What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? - Try to obtain the subject's 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 sponsor's responsibility pertaining to electronic trial data handling is to -...

ACRP ICH Exam Challenge (100% Solved) Who is responsible for providing the trial protocol - The Sponsor Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced are called..? - Essential documents All information in original records and certified copies of original records of critical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial are called..? - ...

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