How to design a database for electronic data capture in

Transcription

1 How to design a database for electronic data capture in 1

2 Outline REDCap background REDCap features - System features - Database design features - Data Entry(DE) & management features Real- Bme CRF creabon CRF creabon using a template DE overview REDCap modules overview 2

3 Research Electronic Data Capture (REDCap) Background secure web- based applicabon designed & developed exclusively for research studies by Vanderbilt University (VU) ( redcap.org) available at no cost to REDCap consorbum partners Currently 228 consorbum partners 3

4 Data from REDCap Consor8um 4

5 Features of REDCap System Features Secure and web- based - Input data or build database from anywhere - secure web connecbon with authenbcabon & data logging. - Installed on server(s) & configured for intranet and/ or internet access. 21 CFR part 11 Capable - server can be configured to ensure compliance 5

6 Fully customizable - total control to shape database and features - wriren in php source code available to partners - Support RDBMS but for opbmal performance MySQL database is recommended. Well Supported by partners - Online mailing lists/ forum - Weekly web- seminar/ conferences - Online tutorials 6

7 Database Design Features Stream- lined process for rapidly building a database - Point/Click & drag for real- Bme CRF CreaBon - Or upload from csv file. Database changes easily implemented - database field(s) can be modified or added when study is in progress. 7

8 Data Entry & Management Features Supports following Advanced features: - Auto- validabon (Range/ data checks) - Branching/skip logic - Data calculabon (e.g. can automabcally calculate value for Body Mass Index (BMI)) - File uploading and sending of files (links) from REDCap database with link expiring opbon - Can set database to allow double data entry 8

9 MulI- site access - Researchers from mulbple sites and insbtubons can access same database. Export data to common staisical packages - Exports raw data and syntax files to SAS, Stata, R, and SPSS. 9

10 REDCap Database design Summary Point/Click Drag (Ajax) For Real- 8me CRF Crea8on or Uploading from csv file. Create Blank database with no ecrf Op8onal Longitudinal CRF Mapping Op8onal Par8cipant Scheduling Setup Screens 10

11 New Database name 11

12 Click To Start ecrf Design 12

13 ecrf name 13

14 Field type on ecrf Field type in database if Text Box 14

15 database field name QuesBon on ecrf 15

16 defining range check and data type validabon Defining field note to aid clarity during DE 16

17 defining coded response for radio burons 17

18 defining coded response for drop- down list 18

19 creabng check responses 19

20 creabng auto- calculabons 20

21 Using date difference and rounding funcbons in calculabons 21

22 defining branching or skip logic (quesbon available when condibon is true) 22

23 creabng field that allows to upload files 23

24 Allow value to be retrieved from REDCap or other database based on query e.g. pull list of medicabons from SPINE 24

25 Define SecBon heading on ecrf 25

26 csv data dicbonary file opened in Excel 26

27 csv data dicbonary upload module 27

28 Data Entry Overview ecrfs 28

29 PDF download opbon for ecrf with or without Data ecrf ready for DE 29

30 pop- Up Calendar 30

31 radio burons drop- down list check Boxes 31

32 file upload dialogue 32

33 data check pop- up message during DE (value no with range) 33

34 data check pop- up message during DE (required field values not specified) 34

35 completed ecrf buron for viewing data field history 35

36 giving reason for change 36

37 data field history/ log 37

38 Only sends download link for specified file 38

39 REDCap modules overview - Dynamic project status REDCap Modules - ParBcipant scheduling - Data Export and Import - Data Comparison Tool 39

40 - User rights & acbvity Logging - File Repository - Data visualizabon/ Cleaning and Reports - Record locking & e- Signatures - API & Shared Library - Online Tutorials & CiBng REDCap in publicabons 40

41 Dynamic project status A user can only view project(s) for which s/he has Read/ Edit rights 41

42 Dynamic database stabsbcs 42

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44 SelecBng field for Export 44

45 Data Export + De- ID Tools Embedded De- Iden8fica8on Tools

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49 REDCap Project Owners Autonomously Control Access To Their Applica8ons REDCap Module Access ecrf access rights

50 Database expirabon date 50

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52 Login account Reason(s) for data field changes 52

53 Project File Repository Project- Specific Files Uploaded Here Project- Specific Files Downloaded Here 53 Data Export Files Auto- Saved

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56 Data VisualizaBon / Cleaning Automa8cally Graphs Categorical & Con8nuous Variables Primary Use Case: Data Cleaning - - Requires R- Apache Server Connec8on 56

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59 REDCap API - allows programmers to customize REDCap tasks like Export/ Import of data using programming plagorms of choice e.g. php,.net, Python. 59

60 Repository for REDCap ecrfs that can be used by other insbtubons 60

61 Online Video resource accessed through Internet 61

62 How to cite REDCap in Study manuscript that used it for DE & DM 62

63 Acknowledgements - Paul Harris, Vanderbilt University ( redcap.org) - REDCap project ( redcap.org) Thank you 63