What are expected or possible consequences of over-estimation of recruitment potential? - CORRECT 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? - CORRECT ANSWER Subject welfare When is the investigator allowed to deviate from the protocol? - CORRECT 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? - CORRECT ANSWER - The Sponsor - IRB/IEC - Regulatory Authorities Which conditions should be fulfilled when enrolling a subject into your trial? - CORRECT 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? - CORRECT 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 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? - CORRECT 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? - CORRECT 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? - CORRECT 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? - CORRECT ANSWER The principle investigator.