PL Workshop Knowledge Test - Day 2
PL Workshop Knowledge Test - Day 2
Welcome to the PL Workshop Knowledge Test designed to assess your understanding of the IRT system and related processes. Prepare yourself to answer key questions that cover fundamental aspects of IRT systems, eCOA, drug accountability, and study protocols.
Test your knowledge and see how well you understand the critical components of the organization:
- IRT Lead responsibilities
- Study DTS roles
- eCOA development process
- Coding standards and protocols
The IRT Lead will become the main point of contact for post go live IRT issues and questions?
A. True
B. False
Which of the below elements should NOT be included in IRT systems?
A. Calculations that sites can perform themselves
B. Elements to help enforce protocol compliance
C. Collection of duplicate, unnecessary or extraneous data
D. All of the above
Which data transfer is accessible via the vendor’s sftp only and not transferred via Axway?
A. Drug Accountability
B. Cytel (Axio)
C. RN / RNKIT
D. All of the Above
As part of the future of Start up process, when is the DTS lead assigned to the study?
A. No DTS lead exists for a study
B. DTS lead is assigned when a DTS request is submitted
C. DTS lead is assigned during study stat-up phase
D. DTS lead is assigned during conduct phase
Does DTS lead needs to be invited to DSS workshops and x-f (cross-functional) meeting?
A. Yes
B. No
Who requests Vendor for Drug Accountability, RN, RNKIT data when Master DTS is used?
A. DTS
B. PL
Is a Study specific DTS created when a system integration is in place, like ABBIOS to LSH for ECG data?
A. Yes
B. No
When does the eCOA team start building the English Screens for Medidata studies?
A. As soon as the PRO Request Form is submitted to the PRO Management Team
nagement Team releases the Vault binder after the PRO Confirmation Meeting
C. As soon as the instruments are provided by HEOR or the SPM
D. After the 80:20 meeting takes place
When does the CDSO PL take over for eCOA?
A. Once the vendor SOW is fully executed and the English Build is finalized
B. As soon as the PRO confirmation is conducted
C. Never
D. Once EDC goes live
With regards to eCOA redesign, what is the PL still responsible for?
A. Attending and filing study specific meeting minutes
B. Uploading sources documents to the localization trackers
C. eCOA Device Inventory
D. Managing timelines for eCOA system builds
What does RACI stand for?
A. Responsible, Accountable, Consult, Informed
B. Responsible, Attributable, Communicate, Instruct
C. Responsible, Accountable, Communicate, Informed
D. None of the above
Which of the below describes the “what” of what needs to be done for the study?
A. Operations Manual
B. Protocol
C. Both Protocol and Operations Manual
All Functions need to wait for an approved protocol to begin certain downstream activities
A. True
B. False
Which of these is NOT true in regards to Coding?
A. MedDRA and WHOdrug are up-versioned annually
B. Medidata Rave-X studies are using Rave Coder
C. CSA and/or TA MD receive coding listings monthly or as scheduled through the life of the trial
D. There will be a rollout of a new Coding Request Portal
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