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Quintiles Clinical Management Plan
Good Clinical Practice
Lilly-isms
Quintilian Trivia
Quintiles Clinical Management Plan
100
Within how many business days must a SIV occur after Lilly establishes Regulatory Readiness?
What is 10 business days (with a target of 5 business days)?
100
Who is is responsible for evaluating a trial to determine, among other things, whether "[r]isks to subjects are minimized" and "[r]isks to subjects are reasonable in relation to anticipated benefits" (21 CFR 56.111(a)).
What is The Institutional Review Board?
100
What would a CRA do, if they find a subject has been enrolled in a clincial trial without signing the informed consent document?
What is "to escalate" the issue to their PTL and Line Manager?
100
Who is the Founder, Chairman and CEO of Quintiles?
Who is Dr. Dennis Gillings?
100
This is not permitted by Lilly, and it is proactively allowing deviations to selection or randomization criteria, or any other key efficacy or safety parameter for the trial?
What is a waiver?
200
What patient identifiers are allowed to be documented on monitoring trip reports?
What is ZERO? A: NONE- Patient Initials, Gender and/or Date of Birth may NOT be on any monitoring reports/docuemnts.
200
What FDA Regulation applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted under any records requirements set forth in Agency regulations. This Regulation also applies to electronic records submitted to the Agency under the Federal Food, Drug, and Cosmetic Act (the Act) and the Public Health Service Act (the PHS Act), even if such records are not specifically identified in Agency regulations (ยง 11.1). The underlying requirements set forth in the Act, PHS Act, and FDA regulations are referred to in this guidance document as predicate rules.
What is Part 11?
200
What should you do if you are having trouble meeting with your Principal Investigator after a few monitoring visits?
What is to "loop in" your CDL?
200
Who is the Vice President of Clinical Operations for Large Scale Functional Resourcing Group in the North Americas?
Who is Teresa Lamantia?
200
This is identified by a Line Manager upon review of Site Visit Report, and completed to document significant issues; i.e., extreme temperature fluctuations, PI absense for more than 2 monitoring visits, etc.
What is the issue escalation log?
300
Who should be contacted (by PTL or LM) to report site noncompliance such as ICF never being obtained by the subjects, subjects not meeting study inclusion/exclusion critiera (and not being discontinued by the investigator), subjects dosed with expired drug or wrong drug or incorrect dosages, etc?
Who is the Lilly AQC/CDA?
300
Who remains ultimately responsible, even when delegating the task of obtaining informed consent to another individual, for ensuring that informed consent is obtained from each research subject before that subject participates in the research study?
Who Is the Principal Investigator?
300
What is a term used to include someone else in a discussion, or, to ask for assitance with a matter?
What is to "Reach Out?"
300
Where is Quintiles New GREEN World Headquarters located?
What is QRTP?
300
What guidelines do you follow for Storage and monitoring of CT material at the Investigator Site ?
What are Lilly protocol and Quintiles SOPs/Quintiles Monitoring plans?
400
When does the CRA notify the PTL/MRA/CDL/CDA of closeout visit date?
When is, two weeks prior to close out visit?
400
What is a document that states the elements of informed consent required by 50.25 have been presented orally to the subject or the subject's legally authorized representative.
What is a short form written consent docuement?
400
What field in the Protocol Deviation Log do you indicate as "NA"?
What is a protocol Waiver?
400
What is the name of Quintiles Wellness website?
What is Healthy U, Healthy Q?
400
Which report must the CRA pull prior to each monitoring report to verify which drug was shipped to the site and confirm the site has confirmed receipt of IP?
What is an eCTS report?
500
How many years should all study documents be archived for, per the Master Service Agreement?
What is 15 years?
500
What type of IRB review must take place if a clinical investigator decides at a later date to advertise for subjects if the advertising may be considered an amendment to the ongoing study?
What is an expedited approval? (by IRB chair or designated IRB member)
500
Who is the CEO of Eli Lilly & Company?
Who is John C. Lechleiter?
500
What country are Q employee's working in, when you call Global IT Service Desk after 7pm Central Time?
Where is Ireland?
500
This is what a must CRA submit if an action item/issue is resolved in inFORMant after the COV report submission.
What is an addendum?