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

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

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)

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)

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

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 email invitation from Medidata to set up a user account.

Account Activation Click on link in e-mail to get to account activation page

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

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.

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

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)

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

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

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

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

Medidata Rave What does it look like?

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

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

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

Last 10 Participants List Site Home Screen Last 10 Participants List

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

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

Site Home Screen Assigned Reports

Questions?

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

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.

Creating PTIDs in HPTN 083 `

Creating PTIDs in HPTN 083 `

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

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

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

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

Required Forms in a Visit Each folder lists all required CRFs

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

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

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.

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.

Log Forms ` `

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

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

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

Concomitant Medications

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.

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

Interim Visits `

Interim Visits ` `

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

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

Help Text `

Medidata Icons ` `

Medidata Icons

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.

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

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.

Resolving a Query Query Text

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

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

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

Data Lock

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.

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

HPTN 083 eCRFs

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)

Reports, Old and New Standard Ad hoc

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.

Data Management Quality Report

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.

QC Reports

Replaced with Query SummaryReport

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