ACRP CCRC Exam Prep Questions (Latest ) With Verified Answers

A patient cannot recall the name of the heart condition medication he took a few years ago. This is important information for deciding whether the patient may be enrolled in a clinical trial (IC/EC). What's your best course of action? - You attempt to retrieve the patients medical history by contacting previous caregivers and you wait for additional information before enrollment. Who has ultimate trial responsibility for each subject? - The principle investigator. A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? - No What statements are true concerning an adverse drug reaction? - - All noxious and unintended responses to a medicinal product related to any dose should be considered as an ADR - An ADR suggests a relationship to trail medication - All ADRs must be documented What Adverse Events (AEs) are Serious Adverse Events (SAEs)? - - Any AE that results in death - Any AE that results in inpatient hospitalization - Any AE that is a congenital anomaly During a study visit a patient tells the investigator that she visited an emergency room and received intensive treatment for allergic bronchospasm. Since the patient was in the emergency room for only three hours, the investigator did not assess the event as serious. Is this a correct assessment? - No, this would be a medically important event and should be considered serious What data points minimally need to be reported by the site when reporting an SAE, so that the sponsor can process the event? - Identification of event, product, and trial subject During a visit with investigator, a subject reported feeling heart palpitations for a brief period of time during the previous evening. The heart palpitations resolved without reoccurrence. The investigator considered these symptoms to be unrelated to study drug. The next day, the subject told a fellow student that he felt tired and was planning on taking a nap. Later, the subject was found dead. A preliminary report from the medical examiner indicated t