MTN-025/HOPE Protocol Team Meeting. SCHARP Update. September 26, 2016 Melissa Peda Jen Berthiaume

Size: px

Start display at page:

Download "MTN-025/HOPE Protocol Team Meeting. SCHARP Update. September 26, 2016 Melissa Peda Jen Berthiaume"

Annabella Nichols
5 years ago
Views:

1 MTN-025/HOPE Protocol Team Meeting SCHARP Update September 26, 2016 Melissa Peda Jen Berthiaume

2 Presentation Overview Medidata Rave Overview Benefits of EDC Impacts of EDC Implementing HOPE in Rave HOPE Rave Database Update Study Materials/Reports Update Fred Hutchinson Cancer Research Center 1

3 Medidata Rave What and Why? SCHARP has selected Medidata Solutions as our partner for EDC (Rave) Medidata Rave Features Sites can enter data straight from source document into Rave Sites can check and resolve errors, inconsistencies, missing data, etc., in real time at the point of site data entry Communication, query guidance applied by DM to sites directly within Rave (rather than via ) Audit trail captures all changes made to an ecrf within Rave 2

4 Why Electronic Data Capture (EDC)? DATA ACCURACY ORGANIZATION EFFICIENT DATA MANAGEMENT DATA SECURITY REGULATORY COMPLIANCE Real-time data & consistency checks Legible entries Automatic calculations Better data management quality performance User-friendly navigation Search and filter options Unified database Reports Greater visibility Data entry at sites SDMC data entry process Real-time data access Unified database Less time managing queries Data protected Data backed-up User and rolespecific permissions Validated system Data integrity 21 CFR Part 11 (Electronic Records, Electronic Signatures) Electronic source data verification (monitors) CDISC/SDTM output Submission-ready data Fred Hutchinson Cancer Research Center 3

5 Summary - Medidata Less data queries Less data streams Cleaner data More efficient data cleaning Efficient closeout Data availability Analysis of high quality data Fred Hutchinson Cancer Research Center 4

6 HOPE Database Timeline March 13, 2016 HOPE is a GO! CRF Forms Development April 25, 2016 Signed contract with Medidata Rave June 6, 2016 EDC Programmer and CDMs begin building forms in database June 14, 2016 CRF content forms stable Edit Checks begin being programmed into Rave TRAIN database is deployed UAT process begins July 16, 2016 Verulam is first site to activate for HOPE August 12, 2016 HOPE production database is deployed! Set up Medidata accounts Sites begin e- Learnings and determine data entry & QC workflow UAT Fred Hutchinson Cancer Research Center 5

7 Impacts of Medidata MTN-025/HOPE is first study to be launched in Medidata Rave at SCHARP Many changes to existing practices/processes for SCHARP and sites Establish Medidata user accounts and roles (SCHARP, Sites) Develop study database design (SCHARP) Program HOPE clinical database in Rave (SCHARP) Assess site technical infrastructure (SCHARP and sites) Redevelop workflows, processes, SOPs (SCHARP and sites) Adapt data cleaning procedures and workflows (SCHARP and sites) Develop new materials and trainings for sites (SCHARP) 6

8 Impacts of Medidata on Sites Set-up user accounts for Medidata Complete e-learnings Develop workflows for data collection and data QC processes Updated Data Management SOP and Source Documentation SOP 7

9 What does HOPE look like in Rave? 198 user accounts 84 forms > 1,000 programmed edit checks System queries Manual queries > 35 Custom Functions 8

10 A closer look at HOPE in Rave CRS Participant Folders Task Summary PTID List 9

11 A closer look at HOPE in Rave PTID Task Summary Participant Folders Visit Calendar 10

12 ecrf Workflow within Rave Form never touched Form data entry and query resolution PPD monitor verification Complete - Form Clean IoR Signature Data Lock

13 HOPE Data Update Study Data Update (as of 9.25) 20 PTIDs generated 258 CRF pages entered 5 Screening and Enrollment Visits Main Study 1 Screening and Enrollment Visit Decliner Population 1 Screen out per eligibility 13 Pre-Screening Outcomes received 12

14 HOPE Database Migrations Database Migration #1: September 13, 2016 The MTN-025 database was updated to incorporate a number of CRF updates, as outlined in Data Communique #1 (19 SEP 2016) Applicable paper CRFs have been versioned to 2.0 within visit packets and are available on Atlas with these changes Database Migration #2: planned for Fall, 2016 New ecrf to provide sites with residual drug data per participant Additional item to specify the associated AE term and onset date for an abnormal value that meets AE reporting criteria Any other additional updates, as identified 13

15 Atlas/study materials Update 14

16 Report Update First open reports to be posted on Atlas Screen-out Report Enrollment Report Available soon in Rave Query Details (QC) Report This online report will replace the monthly QC Reports that were sent by SCHARP via to study sites during previous studies Unresolved clinical product hold, social harms, and ongoing AE cumulative listings (will no longer be ed) 15

17 Data Metric Tools in Rave Query Details Report (by site)

18 Rave Reports Assigned Reports

Data Management Quality Metrics New, standard data management quality metrics are being identified for Medidata Rave studies across HVTN, MTN, and HPTN and other DAIDS Networks are forthcoming

19 Data Management Quality Metrics New, standard data management quality metrics are being identified for Medidata Rave studies across HVTN, MTN, and HPTN and other DAIDS Networks are forthcoming Focus on: Timeliness of data entry Timeliness of query resolution Timeliness of AE entry Total # of QCs and QC rate/forms entered in Rave will not be used as a metric to assess site performance

20 SCHARP Team Data Management Unit Ed Slezinger Ravi Gunnam Jen Berthiaume Melissa Peda Kris Donaty Carol Tranfaglia Laboratory Data Operations April Randhawa Jeremy Shaver Anisa Tracy Lisa Bunts Business Support Services Karen Patterson Melissa Bravo Rahul Gupta Administration Melissa Cummings Data Analytics Unit Jason Pan Marla Husnik Danny Syzdlo Haixiao Huang Janne Abullarade Clinical Affairs Ning Jiang Elaine Dinnie Clinical Programming Brad Fischer Cathy Kirkwood Drew Edwards SDMC Elizabeth Brown Jen Balkus Peter Guarino 19

21 Questions? 20

Welcome! A few things to go over before we get started

Welcome! A few things to go over before we get started 1 Medidata Rave Training SCHARP March 19, 2017 Karen Patterson Jen Berthiaume Melissa Peda Medidata Rave Overview Medidata Rave and EDC User roles