Gemstone
Which gemstone is known as the birthstone for January
Garnet
This book explores the constraints of traditional bureaucratic organizational structure and proposes a shift toward more human centric models
Humanocracy
Another name for the CD&O Transformation project is…
'Cutting Edge'
Where is the "critical data" for a study documented?
Integrated Data Review Plan (IDRP)
What does FDOM stand for
Flexible Development Opportunities Marketplace
What is the one application of Veeva Vault Clinical that is NOT implemented in Bayer?
Veeva Vault Payments
This core principle of DSO shifts leaders from manager to visionary
VACC
Give 3 examples in which COAM has 'busted' bureaucracy
simplified CDA process, risk based MQAVs, retirement of MARS system, etc...
The game of RISK was invented in what year:
A. 1957
B. 1965
C. 1971
A. 1957 by Albert Lamorisse a French filmmaker
How many books does Amazon offer on the topic of Leadership?
A. >1000
B. >10,000
C. >100,000
C. >100,000
Name 2 systems integrated with Gemstone
IMPACT, BRAVE, Azure Active Directory, Site Vault
This US based company shifted from subscription to production based content resulting in the #1 business transformation of the last decade
Netflix
Identify the 2 companies that have contributed compounds to Bayer's Neuro & Rare Disease pipeline
Blue Rock & AskBio
True or False - If a subject's data is not being SDV'd, the CRA does not need to review the eCRF for that subject.
False, CRAs should still check eCRF, and other data sources like IxRS/labs/Vendors for data completeness. This can be done remotely.
MyLearning focuses on mandatory & compliance related business training content. Name Bayer's other learning platform focusing on aspirational interests & skills.
GoLearn
True or False - only TMF - relevant documents can be filed in Gemstone
False. Non-TMF documents can also be filed in Gemstone and are not visible by auditors/inspectors
A complex structure with multiple layers and procedures is an example of…
Bureaucracy
As part of the CD&O transformation, 4 scientific nuclei were created to replace the TAs. Name them.
Cardiovascular/Renal, WHC & Acute Chronic Care & Peds
What are the 3 parameters that need to be evaluated for each study risk?
probability, detectability, impact
What is the difference between STA, STM, LTA
STA: 3-12 month, 100% FTE, cross-country, position change w/HR;
STM: local or cross country move >=3 mos & >=50 % FTE, no change w/HR;
LTA: 13-36 months, 100% FTE, cross country, position change w/HR
Name two functionalities available within Site Vault
eISF, eRegulatory, remote monitoring, document exchange
Bayer recently launched a six module learning series covering the principles of DSO. What is the banner name for this series?
'DSO in a Box'
Name all functions that make up Clinical Operations
Site Management, CPM (1-8), DCT, TSO, IMM, Study Support services
What are SDR percentages based upon?
Study and site risk level
As of Dec 2023, the entry of these items into HR systems was deemed optional
Development Dialogues, Individual Development Plans & Check Ins
Name 3 ways users can learn more about the Gemstone system
Gemstone Sharepoint, Gemstone Manuals, Spotlight Calls, Monthly LM Calls, Help option w/I Gemstone, Gemstone Learning Platform, Yammer
Name 3 front runner teams in Pharma
Pharma Mexico, Nordic Pharma, Pharma Japan, NUBEQA, Early Clinical Development Oncology, RED preMED,
The first controlled clinical trial resulted in a remedy for what ailment?
Navel surgeon James Lind conducted the first controlled clinical trial resulting in a remedy for Scurvy
Name a site risk indicator that is available in RAVEN for oversight but is NOT part of the OSRL calculation?
Changes due to SDV, Unreported Data Entry, Drop Out Rates
Name the learning platform introduced as part of the RDLA TRAIL initiative
PLATO. PLATO was introduced as a supplementary resource for both formal and informal 'Just in Time' learning. (PLATO=Platform for Learning At Time Of need)