ACRP CCRC Exam Prep Questions with solutions correct
What are expected or possible consequences of over-estimation of recruitment potential?
What
... [Show More] should be the first consideration when conducting a clinical trial?
When is the investigator allowed to deviate from the protocol?
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?
Which conditions should be fulfilled when enrolling a subject into your trial?
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?
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 re-consent 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?
A trial subject informs you she no longer wants to participant in the trial. What should your course of action be?
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?
Who has ultimate trial responsibility for each subject?
A trial subject suffers from severe repeat headaches. Should this adverse event be reported to the IRB?
What statements are true concerning an adverse drug reaction?
What Adverse Events (AEs) are Serious Adverse Events (SAEs)?
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?
What data points minimally need to be reported by the site when reporting an SAE, so that the sponsor can process the event?
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?
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?
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?
A 22y/o male was entered into a clinical study for treatment of schizophrenia The study drug was administered orally, BID. One week later, the subject visited the investigator complaining of sever sore throat. The IB lists this as an occurrence reported by 1% of subjects receiving drug. How should this severe throat be classified?
In regards to AE and ADR reporting, what statements are true?
What determines the causality of an adverse event? [Show Less]