User friendly data capture
instruments
OPIS - Fabio Renna – 27/09/2012
KISS Principle
KISS is an acronym for the design principle coined by Kelly Johnson, lead engineer at the Lockheed Skunk Works and creator of the Lockheed U-2 and SR-71 Blackbird spy planes
Or better…
K-I-S-S = Keep it short and simple! K-I-S-S = Keep it simple, Stupid!
Bad user interfaces: examples
3 User friendly data capture instruments - Fabio
• Chaotic user interface • Non clear dialog box
Usability: standards and ISO
ISO/TR 16982:2002
is a standard that provides information on human-centered usability methods that can be used for design and evaluation
ISO 9241
ISO 9241 is a multi-part standard that covers a number of aspects of people working with computers.
Parts 110 and parts 11–19 deal with usability aspects of software
W3C – WCAG 1.0 – WAI
The World Wide Web Consortium, also known as W3C, is an international NGO that aims to develop the full potential of the World Wide Web. The main activity carried out by the W3C is to establish technical standards for the World Wide Web and related markup languages as communication protocols.
Usability: definition
The effectiveness, efficiency and satisfaction with which specific users achieve specific goals in particular environments.
• effectiveness: the accuracy and completeness with which users interact with the environment
• efficiency: the resources expended in relation to the accuracy and completeness of goals achieved
• satisfaction: the comfort and acceptability in which the users and other people operate
Usability: models
Usability: benefits
• More efficiency
• More productivity
• More security
• Less errors
• Less training
• Less help-desk
Usability: objectives
Lund, A. M. (1997). Expert ratings of usability maxims. Ergonomics in Design
• Every action should have a reaction
• Error messages should actually mean something to the user and tell the user how to fix the problem
• The user should always know what is happening
• The more you do something, the easier it should be to do • Color is information
• Minimize the need for a mighty memory • Don’t overload the user’s buffers
• Everything in its place, and a place for everything
• Make transparent the underlying technology • Reduce the user's cognitive efforts
• Simplify the tasks
• Make clear and brief user interfaces
Usability: In summary…
In order to obtain user-friendly systems, it is necessary to know and engage the final users during the design phase.
The concept of “user-friendly system” must be considered and evaluated in every moment of the design: during the analysis phase, during the release and ongoing.
During each phase different tools are used: user requirements specifications, interviews, comparisons, tests, questionnaires and evaluations on samples of target users
Usability applied on eCRF
eCRF system as clinical trial web portal where each user can find the information they need:
• Investigator • Sponsor
• Project manager • Clinical Monitor • Data Manager
What they can find:
• Patient’s Case Report Form • Enrolment status
• Reports • Newsletters
• Clinical trials milestones • Study documents
• Study drug supply management
User friendly forms
Minimal implementation forms Data capture while performing clinical activities
Plain and simple layout Clear labels
Data capture instruments with relationship with the captured data type (radio button,
dropdown, list and textbox) Conditional fields to drive the form completion
Use colors and style-sheets use
User friendly forms
The relation between labels and fields must be clear to simplify the completion
Unit measures must be clear Calculated fields
Multilanguage
User friendly tools: study documents
User friendly tools: newsletter
Each user can access the study newsletter section
User friendly tools: Reports
Enrolment graph
User friendly tools: Reports
Patient calendar tool
User friendly tools: toolbars and buttons
Navigation menu: useful to split the study visits and phases in a more readable format
User friendly tools: toolbar and buttons
Patient Menu: useful to identify the status of completion of each patient’s CRF
User friendly tools: toolbar and buttons
User friendly tools: toolbar and buttons
Status bar: information about connected user and system always available
Simplify the eCRF filling
The context MUST always be clear to the user
Show the user ONLY the
functionalities useful in the specific context
Follow the user step by step
The user should not be confused or distracted by features that are not useful in the specific context
Popup and pre-loader
The W3C generally discourages the use of the popup… …but sometimes popup are useful !
• Avoid the use of pop-up outside of the main application window • Use rather modal popup in order to guide the user’s actions
Popup and pre-loader
The W3C generally discourages use of the popup… …but sometimes popup are usefull !
• Avoid the use of pop-up outside of the main application window • Use rather modal popup in order to guide the user’s actions
Fast randomization tool
On-line checks
Data Entry Errors:
This kind of check arises when the investigator click on the “SAVE” button in order to send data to the centralized database. Data Entry Check does not allow data to be saved. The error message
immediatly identifies the items that have thrown the exception. Investigator must change uncorrect data immediatly
On-line checks
Post-Submit Check (or Warning):
this kind of check arises when the data are already saved into the database.It creates a “discrepancy” that will be visible to the
investigator directly on the top of the page containing errors until the investigator has modified data or confirmed the discrepancy. If the discrepancy is not solved, then the Data Manager will evaluate it and produce a Query from it.
Data Lyfe Cycle
Entered Signed Validated SDV Cleaning Sessions INVESTIGATOR On-line checks MONITOR DATA MANAGER LockedThe data life cycle should be as close as possible to the paper practice!
Any questions?
Thank you!
Fabio Renna OPIS S.r.l.
Via Matteotti, 8 – Desio (MB) Tel: 0362/633410
Mobile: +39 349/8635086
