Acrp ce - Study guides, Class notes & Summaries

Adverse Event (AE)/Adverse Experience - Answer- Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) - Answer- All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction - Answer- An adverse reaction, the nature or severity of which is not consistent with the a...

Adverse Event (AE)/Adverse Experience Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product i...

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ACRP CCRA-CCRC Certification Exam prep

A protocol requires that subjects in a hypertension trial have two consecutive sitting diastolic blood pressure readings performed and the average of the two recorded on the CRF. The CRA discovers that only one blood pressure reading is recorded in the source documents, which is the same as the reading recorded in the CRF for the 10 enrolled subjects. Which of the following would the CRC expect the CRA to do FIRST? A. Contac the sponsor's medical monitor to report that the investigator...