ELVIS CF: Physical Storage Overview
ELVIS Central Files Document Matrix and Naming Conventions
ERES: Basic Part 11 Awareness
Expanded Access Programs
Safety Foundations SO Systems Quick Reference Guide
100

TRUE or FALSE

Physical Storage of hard copy batches is managed in each Customer Project Workspace.

FALSE

100

What is the most-subscribed YouTube channel?

T-Series

100

What is the name of S

FALSE

The audit trail must operate at all times.

100

TRUE or FALSE

Ethics/IRB approval is required for all Expanded Access Program study design options.

TRUE

100

What holiday is celebrated on August 30, 2021


National Heroes Day

200

Who is the imaginary friend of Riley in the Pixar movie Inside Out?

Bing Bong

200

MULTIPLE CHOICE

What is the meaning of DIA? 

A. Drug Information Accessibility 

B. Device Information Association 

C. Drug Information Association  

D. Device Information Accessibility 

C  

200

MULTIPLE CHOICE

It is an important process for documenting the accuracy, reliability, and consistent intended performance of a computer system. 

A. Computerized System validation 

B. Computer System validation

C. Computer Safety validation 

D. Computerized System validation 

B

200

Who are the seven members of BTS?

RM, Jin, Suga, J-Hope, Jimin, V, Jungkook

200

MULTIPLE CHOICE

Where is the location of Learning Curve? 

A. IQ Home Page  

B. Quintiles Company Directory 

C. WebEx 

D. None of the Above 

A

300

MULTIPLE CHOICE

How is paper batch linked to ELVIS CF? Select the best answer. 

A. The paper batch is automatically linked when it is successfully uploaded to ELVIS CF from EEL-C 

B. The batch’s location is entered on the 205 unboxed batch tracking report 

C. The ELVIS CF folder location is written on the cover of EEL Cover Sheet 

D. The bar code on the batch’s EEL Cover Sheet is scanned into ELVIS CF 

D

300

Who is the chairman and CEO of IQVIA?

Ari Bousbib

300

What is the name of the main character in Orphan and what is her ethnicity?

Esther 

Russian

300

MULTIPLE CHOICE

The following requirements for an Expanded Access Program, except: 

A. The product must be unauthorized 

B. The subject has as serious/chronic illness (e.g cancer, HIV) 

C. Used for an authorized product for an authorized indication 

D. NOTA

C

300

What mythical creature is on the Starbucks Logo?



Mermaid

400

MULTIPLE CHOICE

Why is Physical Storage used? Select all that apply. 

A. To track the location of hard copy study documents that have been processed through EEL-C

B. To identify which batches are ready for indexing 

C. To determine the number of images in a batch 

D. To link the hard-copy batches filed at an RM Hub with the electronic batch in ELVIS CF

A & D

400

What is the name if the town hit by a comet in the movie Your Name?

Itomori

400

What FDA Guidance includes a list of FDA recommended procedures that should be available (either remotely on on-site) at clinical trial sites for controls over computer systems?

A. FDA Guidance, Scope and Application

B. FDA Guidance: Computerized Systems Used in Clinical Investigations

B

400

What is the name of Ed Sheeran's next album?

Clue: Previous album names are + "Plus", × "Multiply", and ÷ "Divide"

= "Equals"




400

MULTIPLE CHOICE

What is the meaning of OBIEE?

A. Oracle Business International Enterprise Edition 

B. Oracle Business Intelligence Enterprised Edition 

C. Oracle Business Intelligence Enterprise Edition  

D. Oracle Business International Enterprised Edition

C

500

What are colors of the Google icon in order?

Choices - Blue, Red, Yellow, Green

Blue, Red, Yellow, Blue, Green, Red

500

IDENTIFICATION

The pre-DIA Matrix structure consist of these? (Select 4)

A. Document Class  

B. Document Group 

C. Artifact Name  

D. Document Type 

E. Document Zone 

F. Document Section 

G. Document Subtype 


A, B, D, & G  


500

Give 5 DOH-approved herbal medicines. There are a total of 10.

Sambong

Akapulko

Niyog-niyogan

Tsaang Gubat

Ampalaya

Lagundi

Ulasimang Bato

Bawang

Bayabas

Yerba buena

500

IDENTIFICATION

What is the simplest Expanded Access Program design/approach, but limited to few countries such as France and Italy?

Cohort Approach

500

In the movie Legally Blonde, how did Elle Woods win her case?

Chutney's curls were still intact because she was not in the shower and shot. It is a forbidden rule to wet your hair for 24 hours because of the risk of inactivating the ammonium thioglycolate.

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