1. Electronic Data Capture: Introducing Medidata Rave
Leslie Cottle
SCHARP
Fred Hutchinson Cancer Research Center

2. Presentation Overview
Why EDC? Why Medidata Rave?
Getting started in Rave
What does Rave look like?
HPTN 083 Rave highlights
PTN 083 eCRFs
Reports

3. Why Electronic Data Capture (EDC)?
DATA ACCURACY
Real-time data & consistency checks
Legible entries
Automatic calculations
Better data management quality performance
ORGANIZATION
User-friendly navigation
Search and filter options
Unified database
Reports
Greater visibility
EFFICIENT DATA MANAGEMENT
Data entry at sites
SDMC data entry process
Real-time data access
Help Options onscreen
Less time managing queries
DATA SECURITY
Data protected
Data backed-up
User and role-specific permissions
REGULATORY COMPLIANCE
Validated system
Data integrity
21 CFR Part 11 (Electronic Records, Electronic Signatures)
Electronic source data verification (monitors)
CDISC/SDTM output
Submission-ready data
First let’s step back and consider – why do we want EDC?
Real-time data access: sites can see their own data and their own queries at anytime (don’t have to wait for QC reports; no faxing; no managing paper CRFs)
Data consistency checks – options to add constraints on a form that prevent inaccurate or illogical values from being entered
Using a computerized system enables legible entries and automatic calculations for cleaner data
Search and filter options help user find exactly what they need easily
Unified database=data in one location (vs. separate datastreams; coding capabilities within the database)

4. What is Medidata Rave? Why Medidata Rave?
Industry-leading electronic data capture (EDC) and management platform for the capture, management and reporting of clinical, operational and safety data.
Hosted on-line with a web-based interface
Globally recognized EDC leader
In business since 1999
Supports over 400 clients, 9,000 trials, and 200,000 sites
Why Medidata Rave?
All Networks, including ACTG & IMPAACT, will be using Rave
Proven track record with partner organizations (e.g., Gilead, Janssen, Johnson & Johnson)

5. Getting Started To access and use Medidata Rave, you need:
Internet-enabled computer/laptop/tablet
Internet Connection
Web browser

6. User Accounts
Sites will receive a form from SCHARP to add site staff names, contact information, and site roles for access to Rave.
Each person listed then receives invitation from Medidata to set up a user account.

7. Account Activation
Click on link in to get to account activation page

8. iMedidata Portal Click “Activate” and iMedidata portal appears
Log on using your user name and password
Remember for future access:

9. Bookmark as a favorite on your web browser for easy access.
iMedidata Portal
Recommended!
Bookmark as a favorite on your web browser for easy access.

10. Complete eLearning Modules
Assigned eLearning modules are user-specific, based on role assigned by SCHARP
Links to eLearning modules will appear on screen

11. Complete eLearning Modules
Click each module to run the course
Completion is required to access the HPTN 083 database
Exercises are included in each module
Credit for completion applies across studies in Medidata Rave (only need to complete each module once)

12. Site Roles in Medidata
Assigned modules and Rave permissions based on roles assigned in Medidata
Clinical Research Coordinator
Add participants into Rave
Enter data
Log adverse events and unscheduled visits
Edit saved data
Answer queries
Principal Investigator
Responsible for the overall conduct of a study
Review and sign eCRFs
Respond to queries
Enter or edit subject data
Site Pharmacist
Retrieves participant arm information

13. Site eLearning Modules
Module for Study Coordinators / Data Managers
EDC Essentials for Clinical Research Coordinators (required) – 45 minutes
Module for Investigators
EDC Essentials for Investigators (required) – 20 minutes

14. HPTN 083 TRAIN Database
After successful completion of e-Learning courses, SCHARP sends users an invitation to the HPTN 083 development (TRAIN) database
Users accept invitation to test database

15. Accept Test Database Invitation
Become familiar with database structure, practice completing eCRFs, resolve queries, ask questions

16. Medidata Rave What does it look like?

17. Log-in Screen
Based on your role you will get role-specific view

18. Navigation Tab: Study Name and Your Site
Site View: Home Screen
Navigation Tab: Study Name and Your Site

19. Participant ID (PTID) List
Site Home Screen
Participant ID (PTID) List

20. Last 10 Participants List
Site Home Screen
Last 10 Participants List

21. Task Summary or To-Do List
Site Home Screen
Task Summary or To-Do List

22. Resources and eLearning
Site Home Screen
Software training
Required to be able to use
Modules or links such as the DAIDS Tox Tables, links to network pages
Resources and eLearning

23. Site Home Screen
Assigned Reports

24. Questions?

25. HPTN 083 Database Highlights
Creating a PTID
How to randomize
Visit Folders
Log Forms
Interim Visits
Responding to queries

26. Creating PTIDs in HPTN 083
PTIDs are randomly assigned by Rave when you click ‘add subject’.
You must have internet access to receive a new PTID.

27. Creating PTIDs in HPTN 083 `

28. Creating PTIDs in HPTN 083 `

29. Creating PTIDs in HPTN 083 `
A PTID is automatically generated and the Screening and Enrollment folders are created

30. Creating PTIDs in HPTN 083 `
If the participant enrolls all follow up visit folders will automatically be added.

31. Randomizing a Participant
After PTID has been generated, the Randomization form appears in the Enrollment folder

32. Randomizing a Participant`
After confirming eligibility, click “Yes” and save the form to randomize the participant
Study Pharmacist and designated site staff receive an
Pharmacist logs in to Medidata to retrieve participant’s arm information

33. Required Forms in a Visit
Each folder lists all required CRFs

34. When on PTID tab you can click on “Grid View”` `
When on PTID tab you can click on “Grid View”

35. Grid View
Lists all expected CRFs at each visit for a PTID; similar to Schedule of Forms

36. Clicking on any ‘page’ icon takes you to that form in that visit.
Grid View `
Clicking on any ‘page’ icon takes you to that form in that visit.

37. Log Forms `
Each type of log has a Yes/No form, including AE, Con Meds, etc. If marked yes, then the associated log form appears in the folder.

38. Log Forms ` `

39. Log Forms `
Add a new log line to document another condition

40. Log Forms
Repeat the process for additional conditions and hit ‘save’.

41. Adverse Events (AEs) ` Add new log line Log form
Add multiple events by clicking on “add a new Log line” link
Visibility across visits – see at a snapshot what is still ongoing vs. resolved
Add new log line

42. Concomitant Medications

43. AE must be entered and saved before it can appear in the dropdown box.
Concomitant Medications
AE must be entered and saved before it can appear in the dropdown box.

44. Site Entry of Lab Data Out of range low Clinical significance optional
Lab form
Automatic calculations of severity grading – can populate as locked or editable field
Ranges are programmable and can be site-specific

45. Interim Visits `

46. Interim Visits ` `

47. Interim Visits
Complete the Interim Visit Summary by entering the visit date; mark other CRFs needed for that visit; click save ` ` `

48. Hit “Save” and the needed CRFs appear in the visit folder.
Interim Visits
Hit “Save” and the needed CRFs appear in the visit folder. `

49. Help Text `

50. Medidata Icons ` `

51. Medidata Icons

52. Data Entry Icons
Non-conformant data: data not entered in expected format (e.g., entering “25” for month). Resolved when valid response (i.e., expected format) is entered and saved. Help icon next to a variable can be used to provide additional information/guidance as to what is expected.

53. Resolving a Query
NonConformant Data – e.g., lab results out of range, age out of range;
Open Queries – can be automated system queries or manually added queries from SCHARP

54. Resolving a Query The line is pink and there is a query icon.`
The line is pink and there is a query icon.
Click anywhere on that entry to bring you to the form for correction.

55. Resolving a Query
Query Text

56. Resolving a Query
Enter correct information and choose ‘reason’ for correction from drop down menu.

57. Resolving a Query `
In some cases a site response may be required, e.g. if SCHARP clinical affairs asks for additional information

58. Resolving a Query `
Once you make the correction and save the page the line is no longer pink and the query icon goes away.

59. Data Lock

60. Site IoR View - eSignature`
IoR signs off once on one form per PTID. Last step needed to lock a given ppt’s data; all ppts need this sign off to lock the entire database.

61. Site IoR View - eSignature`
IoR enters password, hits ‘save’, and e-signature is applied.

62. HPTN 083 eCRFs

63. Workflow Example
MEDIDATA RAVE
Data entry from
PAPER CRFs
Site staff complete clinical and admin. CRFs (pelvic, physical, etc.)
SOURCE DOCS
non-CRF
Local lab (reports, testing logs, LDMS Tracking Sheet, etc.)
DIRECT DATA ENTRY
Log CRFs (Medical History, CM, AE, etc.)
Site interviewer/designee completes behavioral surveys
Recommend that log forms, lab forms, and behavioral forms are directly data-entered (i.e., no paper CRF completion first)

64. Reports, Old and New
Standard
Ad hoc

65. Sample Report (SDMC View) – Page Status
Sites will see only their own data; useful as an overall view of what work is outstanding or complete.

66. Data Management Quality Report

67. New: Data Quality Metrics
Harmonizing with other networks
Focus on:
Timeliness of data entry
Timeliness of query resolution
Timeliness of AE entry
Note: Query resolution will not include data entry or data consistency corrections.

68. QC Reports

69. Replaced with Query SummaryReport

70. Other Reports Available on Atlas Screening Outcomes Enrollment
Retention
Randomization Summary
Distributed via
Unresolved AEs
Ongoing Product Holds