ACRP CCRC Certification Exam Questions and CORRECT Answers

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 is noncompliant with the protocol. B. Notify the data management department that the CRF entries are incorrect and may need to be queried. C. Ask the investigator if the blood pressure procedure outlined in the protocol is being followed. D. Contact the sponsor's medical monitor to discuss closing the site due to 10 protocol violations. - C