User friendly data capture instruments

Transcription

1 User friendly data capture instruments OPIS - Fabio 27/09/ User friendly data capture instruments - Fabio

2 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 K-I-S-S = Keep it simple, Stupid! Or better K-I-S-S = Keep it short and simple! 2 User friendly data capture instruments - Fabio

3 Bad user interfaces: examples Chaotic user interface Non clear dialog box Incomprehensible error messages 3 User friendly data capture instruments - Fabio

4 Usability: standards and ISO ISO/TR 16982:2002 is a standard that provides information on humancentered 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 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. 4 User friendly data capture instruments - Fabio

5 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 5 User friendly data capture instruments - Fabio

6 Usability: relationships 6 User friendly data capture instruments - Fabio

7 Usability: models 7 User friendly data capture instruments - Fabio

8 Usability: benefits More efficiency More productivity More security Less errors Less training Less help-desk 8 User friendly data capture instruments - Fabio

9 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 9 User friendly data capture instruments - Fabio

10 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 The user s experience must be continuously evaluated! 10 User friendly data capture instruments - Fabio

11 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 11 User friendly data capture instruments - Fabio

12 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 12 User friendly data capture instruments - Fabio

13 User friendly forms The relation between labels and fields must be clear to simplify the completion Unit measures must be clear Calculated fields Multilanguage 13 User friendly data capture instruments - Fabio

14 User friendly tools: study documents Each user can access the study documents section 14 User friendly data capture instruments - Fabio

15 User friendly tools: newsletter Each user can access the study newsletter section 15 User friendly data capture instruments - Fabio

16 User friendly tools: Reports Enrolment graph Enrolment report 16 User friendly data capture instruments - Fabio

17 User friendly tools: Reports Patient calendar tool 17 User friendly data capture instruments - Fabio

18 User friendly tools: toolbars and buttons Navigation menu: useful to split the study visits and phases in a more readable format 18 User friendly data capture instruments - Fabio

19 User friendly tools: toolbar and buttons Patient Menu: useful to identify the status of completion of each patient s CRF 19 User friendly data capture instruments - Fabio

20 User friendly tools: toolbar and buttons Toolbars: clarify the function of each button using legend and tooltip 20 User friendly data capture instruments - Fabio

21 User friendly tools: toolbar and buttons Status bar: information about connected user and system always available 21 User friendly data capture instruments - Fabio

22 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 22 User friendly data capture instruments - Fabio

23 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 23 User friendly data capture instruments - Fabio

24 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 Alwayes use a pre-loader when time is necessary to complete an action 24 User friendly data capture instruments - Fabio

25 Fast randomization tool 25 User friendly data capture instruments - Fabio

26 Laboratory normal range 26 User friendly data capture instruments - Fabio

27 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 27 User friendly data capture instruments - Fabio

28 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. 28 User friendly data capture instruments - Fabio

29 Data Lyfe Cycle The data life cycle should be as close as possible to the paper practice! Entered On-line checks INVESTIGATOR Signed SDV MONITOR Validated Cleaning Sessions DATA MANAGER Locked 29 User friendly data capture instruments - Fabio

30 Future challenges 30 User friendly data capture instruments - Fabio

31 Any questions? Thank you! Fabio OPIS S.r.l. Via Matteotti, 8 Desio (MB) Tel: 0362/ Mobile: / User friendly data capture instruments - Fabio