CRP 109 Lecture 2

Question 1

“Environments” in an EDC System

Answer 1

 Specifies what type of setting you are working in
 DEVELOPMENT – to test eCRFs and data validations as
they are built; holds dummy data
 USER ACCEPTANCE TESTING (UAT) – to test and validate
eCRFs that have been built for a specific research project
 PRODUCTION – to capture clinical data for real patients.
Holds real data that is used for analysis or submitted to
regulatory authorities.
 TRAINING – to train end users how to fill in eCRFs for a
specific research project

Question 2

Case Report Form (CRF / eCRF) definition

Answer 2

A printed, optical, or electronic document designated to record all of the protocol-
required information to be reported to the sponsor on each trial subject

Question 3

CHRIS Rule for Case Report
Forms

Answer 3

Critical – The data you are collecting is just the data you need
to answer the question(s)
Helpful – The questions and information provided to the
participant lets them know how they are being helpful, and why
their data is important
Respectful – The questions and the information need to be
asked and handled in a respectful way.
Inclusive – The phrasing of questions and options needs to be
as inclusive as possible.
Sensitive – Be sensitive in questions etc. People are giving up
potentially very personal information

Question 4

Forms

Answer 4

Consists of rows containing questions and data entry fields to
answer those questions

Question 5

Data Fields

Answer 5

 Each piece of data on the front-facing side of the EDC system
 Called ‘Variables’ on the administrator back end of the EDC
system

Question 6

Matrix of Fields

Answer 6

 Matrix allows you to display a group of similar multiple choice fields in
a very compact area on a page
 Makes data entry forms and surveys much shorter and organized

Question 7

Investigator eSignature

Answer 7

 Allow for investigator signature on all fields
 Ensures timely documentation of the investigator’s review of
the data:
 as it is represented, and
 Breaking signature - in the event data are subsequently changed

Question 8

Participant Questionnaires

Answer 8

 CRFs based on rating instruments created by an independent
source e.g. Health Status Questionnaire, Quality of Life Questionnaire, etc.
 May require special licensing agreements prior to use
 May require that prescribed formats be used or specific
copyright information appear on the CRF

Question 9

Units of Measure

Answer 9

 Don’t build fields with units hardcoded
 Allow users to enter their own site’s custom units of measure
 Statistician/data management team can do the conversions
afterwards

Question 10

Coded Responses

Answer 10

 Data should be in a coded format (data dictionaries) as much
as possible
 Minimizes errors, blank responses, and variation in data that is
entered

Question 11

Referential Questions

Answer 11

 Questions where the answer to one question depends on the
answer to another question
 Dependent relationship

Question 12

CRFs - Best Practices

Answer 12

 Develop a library of standard forms
 Multidisciplinary team to provide input into CRF design
 Ensure CRFs do not collect data that will not be used for analysis or will not
support analyzed data
 Ensure CRFs are easily understood and used (layout, wording)
 Checkboxes, option buttons and menus enable users to enter data that is less
likely to be erroneous/queried
 Allow users to record data in their site’s customary units of measure
 Specify formats where necessary (i.e. dd/Mmm/yyyy or HH:MM)
 Data like adverse events or concomitant medications can be collected on logs
to prevent redundant data entry

Question 13

Data Standards

Answer 13

 Involves the use of standardized names, codes, structures, formats for
data across different locations, studies and organizations
-used to optimize the collection, transport, and storage of data,
and to simplify the submission of data to regulatory bodies
-goal: researchers everywhere to use the same standards and
naming conventions for their studies

Question 14

Benefits of using Standards

Answer 14

 Reduce time and costs of setting up a study
 Streamline process of data transfer and analysis
 Data can be more easily and accurately compared and
combined across different studies
 Data sharing made easier (i.e. “open science”)
 Shorten the duration of time between clinical trial to market

Question 15

DRAFT Tri-Agency Research Data
Management Policy

Answer 15

• Each institution administering TriAgency funds is required to create an institutional data management strategy.
• Data Management Plans (DMPs) are encouraged to be included in
  grant applications as an essential step in research project design

Question 16

CDASH

Answer 16

Clinical Data Acquisition Standards
Harmonization
 Basic set of data collection fields (variable name, definition, metadata)
that are common to many case report forms
 Standardized way to collect data in a similar manner across studies
and sponsors so that data collection formats and structures provide
clear traceability of submission data
 Delivering more transparency to regulators and others who conduct
data review
-standard variable names

Question 17

How Does a Project Become an
EDC Study?

Answer 17

1. create new project
2. configure environment
3. create new draft/use existing template for CRFs
   4.configure CRFs
4. configure data validations (automatic edit checks)
5. assign sites/users to study
   7.test eCRF (UAT)
6. make adjustments
7. push to production environment