Term
| The Clinical Return Form is used for IP return or on-site IP destruction or both? |
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Definition
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Term
| Where would you look for guidance concerning the naming conventions in eTrack? |
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| At the end of the study, the IP dispensing logs should be sent to the study manager by the unblinded CRA. T or F |
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Term
| With the new SAR template in place, you still need to utilize the SFAF - True or False |
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| Anti-corruption laws and regulations are for a) employees only b) our third parties c) A and B d) Senior Management |
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| The PI has provided you with a "no" to all three ABAC questions, however you are aware that the PI is signing Medicare. What should you do? A) raise your concerns to the PI b) document what you believe is true c) state "no" in your MVR and discuss during the site selection call d) do nothing |
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Definition
| c) state "no" in your MVR and discuss during the site selection call |
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Term
| Your site tells you that they are required to destroy IP on site - what should you do? |
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Definition
| SOP_52822 Return of Unused Clinical Trial Material from US Clinical Study Sites |
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Term
| It is not necessary to wait for the Xpress notification before you initiate a site if the site has told you all regulatory documents have been submitted to us? T or F |
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Definition
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Term
| What would be the best step to take if you’ve searched in myLesson for site personnel training and it looks like no modules have been completed, yet you know that they have recently participated in other studies with us? A) let the person know that they need to re-take all of the modules b) ask the site to send you documentation of training completed c) search by the person's name in myLesson rather than by study number |
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Definition
| c) search by the person's name in myLesson rather than by study number |
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Term
| Risk-Based Monitoring (RBM) is the same as Adaptive Site Monitoring (ASM), we just changed our acronym to conform to the one being used by the FDA. T or F |
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Definition
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Term
| A site wants to transport IP from their current location to their new location "down the street" - this is never allowed. T or F |
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Definition
| False - SOP WWD 7002 and special form Inter-site Transfer of Clinical Trial Material |
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Term
| What are the expectations of a monitor who is covering a site for a colleague on holiday? |
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Definition
| The same as if it were their site responsibility |
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Term
| How do you document the training for your sites? |
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Definition
| You need to verify that training is documented within the Investigator files and also for the central files (MVR) |
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Term
| Can you use the Computer Assessment Checklist for evaluating an EMR at the site? |
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Definition
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Term
| A site wants to help you out by packaging IP for return so that it is ready to be shipped when you arrive - is this acceptable? |
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| You have asked your PI the following anti-bribery/corruption question: “Do you or a member of your immediate family have ownership in a healthcare entity doing business with the government or entity providing service/products to us” - the PI wants to know if he should answer yes since he owns his private practice and submits Medicare claims to the government? How should you respond? |
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Definition
| Legal confirms that the best option is mark this question as YES in eTrack and provide the PIs comments as this will provide transparency over the Medicare claims. Per the ABAC training, you should also send this information to the ethical compliance officer so they may guide you on what the team needs to do next. |
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