Using CDASH data collection forms for automated SAE reporting

Transcription

1 Using CDASH data collection forms for automated SAE reporting Andrew Newbigging Vice President, Integrations Development 21 st July 2010 Medidata Solutions, Inc. Proprietary - Medidata and Authorized Clients Only. This document contains proprietary information that shall be distributed, routed or made available only within Medidata, except with written permission of Medidata.

2 Agenda Introduction CDASH to E2B mapping Automated E2B transfer Future changes E2B (R3)

3 Introduction CDASH 1.0 released in September 2008 describes the basic recommended (minimal) data collection fields for 16 domains, including demographic, adverse events, and other safety domains that are common to all therapeutic areas and types of clinical research ICH Electronic Transmission of Individual Case Safety Reports Message Specification E2B message format released in February

4 CDASH 1.0 specification AE domain

5 ecrf form based on CDASH AE domain

6 E2B specification example reactions

7 E2B example - reaction

8 E2B Structure medical history past drug patient death parent reaction test drug summary

9 E2B CDASH mapping medical history CDASH DOMAINS patient past drug death parent reaction test drug summary MH CO CM DM VS DA EG AE IE LB EX PE DV SC SU DS Medical history Comments Prior and concomitant medications Demographics Vital signs Drug accountability ECG results Adverse reactions Inclusion and exclusion criteria Laboratory test results CM Exposure Physical examination Protocol deviations Subject characteristics Substance use Disposition

10 E2B / CDASH overlap E2B death parent MH CM DM VS AE LB EX CO DA EG IE PE DV SC SU DS CDASH

11 Example mapping Reactions / AE

12 Problem domain - VS CDASH recommends use of normalized data structure Difficult to map to E2B

13 Current SAE Manual/Paper Practice EDC Fax / Print Out Safety System Regulatory Agency Site Practice Separate data collection and submission processes Print out and/or fax to safety team Manual transfer of data into safety system Challenges Error prone, duplicate effort EDC SAE data reentered into safety system Time consuming & resource intensive Manual comparisons for follow-up reports Queries for missing/illegible data (no visibility to EDC data) Reconcile safety and study databases at end of study 13

14 A Configurable EDC-to-Safety-System Interface EDC Automatic transfer Safety System Regulatory Agency E2B compatible safety systems Site Manage and automate SAE reporting within EDC: Send notifications to pre-identified personnel Associate one or more SAEs into a single safety case Collect supporting information (e.g., demog., con-med) Handle follow ups and any supporting information Generate and transmit E2B Plus files manually or automatically 14

15 Configurable data selection rules Automatic filtering of clinical data to remove irrelevant data from safety case

16 E2B (R3) New version of E2B expected to be released in 2011 for implementation in Messages based on HL7 version 3 standards Changes to message content and structure much more complicated than R2!

17 Backwards compatability with E2B(R3) Forwards and backwards conversion rules will be provided Receiving systems must apply conversion