ACRP CCRC Exam Prep Questions 100% SOLUTION

ACRP CCRC Exam Prep Questions 100% SOLUTION What are expected or possible consequences of over-estimation of recruitment potential? - ANSWER - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical trial? - ANSWER Subject welfare When is the investigator allowed to deviate from the protocol? - ANSWER When there is an immediate hazard to a patient. If the investigator wanted to deviate from the protocol for an immediate hazard to a patient, according to ICH E6 guidelines who world they need to report the deviation and rationale to, if appropriate? - ANSWER - The Sponsor - IRB/IEC - Regulatory Authorities Which conditions should be fulfilled when enrolling a subject into your trial? - ANSWER - Subject meets all inclusion criteria - Subject has given written informed consent You've been delegated to handle the storage and inventory of IP. The study drug must be stored below 25C/77F. On a summer Monday morning you discover that the temperature recording machine in the storage room has failed so you doin't know what the temperature has been over the weekend. You check the current temperature; it's 24C/75F. What should you do? - ANSWER - Contact the Sponsor, explain what happened and ask for instructions - Set up a site staff meeting to conduct a root cause analysis A protocol amendment was issued for a trial. Your site received IRB approval for the amendment and wants to implement the increase in PO dose for your trial subjects as identified in the amendment trial subjects. As delegated consenting duties you must reconsent trial subjects before being able to administer the adjusted dose. You decide to only re-consent trial subjects who are still taking the IP and not from the subjects woh already completed their drug intake period. Is this allowed according the E6 Guideline for GCP? - ANSWER No, these subjects are still enrolled in the trial and therefore need to be updated on any changes to the protocol. A trial subject informs you she no longer wants to participant in the trial. What should your course of action be? - ANSWER You ask if the patient wishes to share the reason why she wants to leave the trial. If not, you exclude the subject from the trial immediately. 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? - ANSWER 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? - ANSWER The principle investigator. A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB? - ANSWER No What statements are true concerning an adverse drug reaction? - ANSWER - 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)? - ANSWER - 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? - ANSWER 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? - ANSWER 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 the subject died of pulmonary embolism. What should your next course of action be? - ANSWER - Record these events in case report form - Immediately notify sponsor about serious adverse events When asked by a regulatory body why they received SAE related information on 12/2013 from an incident that occurred in 5/2013, the sponsor explained the reason being they received the trial related SAE information from the investigator in 12/2013. Is the sponsor correct in only holding the investigator accountable for their late reporting? - ANSWER No, the sponsor should support the conduct QC activities with the sites to help them ensure timely SAE reporting. A trial subject in a cardiology trial is admitted to hospital with heart attack. The investigator considers this event possibly related to the study drug even though this is not listed in the IB as a potential adverse reaction. What would the investigator report this event to the sponsor as? - ANSWE