Term
| Blinded and Unblinded CRAs will write combined reports in order to make sure everyone on the study has the current information. T or F |
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Definition
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Term
| Is it necessary to complete a separate PAR report or update an ongoing PAR report each time you speak to a site during the start up process? A) Yes, this is required, B) this is not required but is an option for CRAs c) No, this should never be done |
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Definition
| B) this is not required, but is an option for CRAs |
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Term
| What would you do if during study start up the site is not receiving the required documents, study supplies, vendor equipment, etc. in a timely manner? A) best to reach out to your LCRA first b) go directly to the OSL/CIL/DQL c) do nothing, supplies will get there eventually |
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Definition
| a) best to reach out to your LCRA first |
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Term
| For the purposes of a co-monitoring visit, can a CRA already assigned to the site request InForm access via AMF for another CRA or MM coming to that visit? |
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Definition
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Term
| Printed EMR records need to be documented as being accurate and complete - T or F |
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Definition
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Term
| You have a subjects chart for a study - the subject is Spanish speaking and was consented in Spanish with English translation provided. The shadow chart contains email correspondence to and from the subject that are only in Spanish. I do not speak Spanish and no translation of the correspondence is provided. Since I do not read/speak Spanish how would I know if the patient is discussing inclusion, or AE etc. What would you do? |
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Definition
| ICH E6, 8.3.13 Essential Documents – Source Documents, along with the ICH statement, “Any or all of the documents addressed in this guideline may be subject to, and should be available for, audit by the sponsor’s auditor and inspection by the regulatory authority(ies).” The site would need to have the documented correspondence translated into English by a Certified Medical Interpreter. |
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Term
| What needs to be done whenever a CRA has been assigned to perform functions outside of their job description - for example, UAT? |
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Definition
| Failure to identify, assign and monitor the completion of relevant role-based training can potentially lead to non-compliance with company policies and standards, financial loss, delays in studies and damage to company reputation. |
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Term
| Your site tells you that they have a new policy that requires you to have received the current flu vaccine. Do you need to comply with their policy? |
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Definition
| Neither we nor our sites can force you to receive a particular immunization. Should it be a monitor’s choice not to receive the requested immunization, then the monitor is obligated to comply with the site’s alternate requirement to wear protective apparel. |
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Term
| You find out that your site is shipping IP directly to a subject's home - is this allowed under any circumstances? |
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Definition
| These shipping processes are not allowed, and corrective actions must be implemented immediately. A crisis situation (natural disaster) is the only exception |
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Term
| You remember the importance of tracking five key milestones at the site level. What are they? |
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Definition
| Center Initiated; FSFV; LSFV; LSLV (SE); Center Closed |
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Term
| What shipments (cold or non-cold chain) is the new in-transit temperature monitoring process applicable for? |
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Definition
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Term
| Do we provide InForm access to external auditors? |
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Definition
| No, with reason being the following: inability to demonstrate control over our system. |
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Term
| How soon after a user is entered in eTrack and associated with center, does he/she show up in eDX permission app? |
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Definition
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Term
| Where do I find newly assigned SARs and site assignments? |
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Definition
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Term
| What are the requirements for filing emails through SSR into PIER? |
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Definition
| 1) Check study-specific SSR plan, 2) if not available, continue to file the appropriate e-mails |
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Term
| Where can I get the most updated list of INDSRs? PIER doesn't seem to be up to date |
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Definition
| On US Clinical Development website |
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Term
| What Effort Track code(s) do I use for this meeting? |
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Definition
| Training Prep/Delivery = 221220-44611; Travel = 221220-44609; Training Attendance = 221800-39256 |
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