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Question 1

What are the key deliverables for User Acceptance Testing?

Options :

A : Project Plan

B : Training

C : Test Plan/Script/Results

D : eCRF Completion Guidelines

Answer: C

Question 2

Query rules were tested with test data for each logic condition within each rule. Which of the following types of testing was conducted?

Options :

A : User box testing

B : White box testing

C : Black box testing

D : T box testing

Answer: C

Question 3

Which of the following SOPs are required for management of an EDC system?

Options :

A : Management of vendors

B : Measurement of data quality

C : Maintenance of coding dictionaries

D : Change control

Answer: D

Question 4

An organization conducts over fifty studies per year. Currently each study is specified and set-up from scratch. Which of the following organizational infrastructure options would streamline database setup and study-to-study consistency?

Options :

A : Adopting an ODM compliant database system

B : Maintaining a library of form or screen modules

C : Improving the form or screen design process

D : Implementing controlled terminology for adverse events

Answer: B

Question 5

Which of the following is a best practice for creating eCRFs for a study?

Options :

A : Set up coded terms so they are available to the site user

B : Set up features that automatically enter data into fields when bypassed

C : Develop eCRFs with cross-functional team members

D : Develop eCRFs that closely follow paper CRF standards

Answer: C