SCDM 2017 ANNUAL CONFERENCE. September I Orlando

Transcription

1 SCDM 2017 ANNUAL CONFERENCE September I Orlando

2 CDASH 2.0 What s New and How Does It Impact Me? Panel Discussion Moderator: Dawn M. Kaminski Director, Clinical Data Strategies Accenture

3 Before We Get Started... Please silence all cell phones We will be using the SCDM App for interactie polls during the presentation, so download the app if you hae not already done so and get ready! Format of this presentation will be a panel discussion with a few slides from each presenter followed by questions/open disussions Please isit the ealuation stations at the back of the room post presentation so that you can proide feedback! PPT slides will be shared with attendees within 2 weeks of the conference

4 Today s Speakers Mike Ward Consultant-Data Standards, Eli Lilly The CDASH Model 1.0 and How it Impacts Me Dan Crawford Director, Clinical Data Strategies, Accenture Updates to the Metadata Table and How it Impacts Me Deborah Rittenhouse Clinical Standards Goernance Officer, CSL Behring CDASHIG 2.0- How does it impact Me?

5 IT s FINALLY HERE!

6 01. CDASH Model

7 Principles of the CDASH Model The CDASH Model: Proides naming conentions for the CDASHIG ariables Includes metadata for the CDASHIG ariables used in Identifier Variables Timing Variables Special Purpose Domains (e.g., DM, CO) SDTM General Obseration Classes Domain-specific ariables Defines the framework for sponsors to simplify creation of non-cdisc defined data collection ariables

8 Relationships between SDTM and CDASH CDASH Model 1.0 aligns with SDTM Model 1.4 CDASHIG 2.0 aligns with SDTMIG 3.2 CDASH Model 1.0 SDTM Model 1.4 CDASHIG 2.0 SDTMIG 3.2

9 CDASH Model Findings Class Excerpt

10 Use Case : Using the CDASH Model to Create a Sponsor Domain Determine the Class of data (Interentions, Eents, Findings) Access the Class metadata from the CDASH Model Add appropriate Identifier and Timing fields Determine the 2-character domain code CDISC Terminology DOMAIN or SPONSOR-defined code Global replace from -- to new domain code Logical walkthrough of all the ariables Drop those that do not apply to the new domain Walkthrough of the rest of the Question text and Prompt and update to reflect specific language for this domain Reiew the rest of the metadata and update as needed Refer to Section 3.4 of the CDASHIG for further details

11 Use Case : Using CDASH Model to create a Findings Class domain at Lilly

12 Use Case : Using CDASH Model to create a Findings Class domain at Lilly

13 02. Metadata Table

14 CDASHIG Metadata Table CDASHIG Metadata includes: Description/Oeriew of the Domain Proides information of what the domain should contain Specifications for each domain defined in the Metadata spreadsheet Mappings from CDASH to SDTM 67% of CDASH 2.0 maps directly into SDTMIG

15 Domain Class Domain Data Collection Scenario Denormalized Options Eents AE N/A N/A Order Number CDASH Variable CDASH Variable Label CDASH Definition 8 AETERM Aderse Eent Reported Term The reported or pre-specified name of the aderse eent

16 Question Text Prompt Data Type CDASHIG Core What is the aderse eent term? Aderse Eent Char Highly Recommended CRF Completion Instructions SDTMIG Target Mapping Instructions SDTMIG Core Record only one diagnosis sign or symptom per line (e.g., nausea and omiting should not be recorded in the same entry, but as two separate entries). Using accepted medical terminology enter the diagnosis (if know known); otherwise enter a sign or symptom AETERM Maps directly to the SDTMIG ariable listed in the column with the heading "SDTMIG Target" Required

17 Controlled Terminology Codelist Name Subset Controlled Terminology/CDASH Codelist Name N/A N/A Implementation Notes Can be represented either as an open entry field to capture erbatim terms reported by subjects or could be preprinted in the situation where solicited AEs of interest are captured. In most cases, the erbatim term (i.e., inestigatorreported term) will be coded to a standard medical dictionary such as MedDRA or WHO ART, after the data hae been collected on the CRF

18 Summary CDASHIG Metadata Table proides: What to collect How to collect it Shows you the relationship to SDTMIG Leerage the metadata to create CRFs

19 03. CDASH Implementation Guide (CDASHIG) 2.0

20 CDASHIG 2.0 Section 1.1 Purpose CDASH establishes a standard way to collect data in a similar way across studies and sponsors, so that data collection formats and structures proide clear traceability of submission data into the Study Data Tabulation Model (SDTM), deliering more transparency to regulators and others who conduct data reiew. CDASHIG 2.0 aligns with SDTMIG 3.2 Refer to Section 3.1 How CDASH and SDTM Work together

21 The CDASH Standards The CDASH standards include the CDASH Model CDASHIG containing general information on the implementation of CDASH standards CDASHIG Metadata Table comprised of commonly used ariables (as supplied by organizations/companies that proided information/examples) The textual content of the CDASHIG and content of the metadata table must be referenced together

22 Organization of the CDASH Implementation Guide (CDASH IG) 2.0 CDASHIG 2.0 is a familiar format similar to the SDTMIG 8.3 CDASH Findings Domains 8.2 CDASH Eents Domains 1. Orientation 2. How to Use the CDASH Standard 8.1 CDASH Interentions Domains 7 CDASH Special-Purpose Domains 3. General Assumptions for Implementing CDASH 4. Best Practice Recommendations 5. Conformance to the CDASH Standard 6. Other Information 7.1 General CDASH Assumptions 7.2 CO 7.3 DM

23 CDASHIG 2.0 CRF Examples Generally throughout the document, CRF refers to both paper Example CRF for the Interentions Class Domain CM with CDASH and SDTM field annotations: and electronic formats CDASHIG 2.0 CRF Examples are built from metadata in the Metadata Table for the domain

24 CDASH Conformance Use standardized CDASH Question Text or Prompt to ask the question. Data alue and format as expected for corresponding SDTM field Use CDASHIG ariable naming to assure traceability from CDASH to SDTM CDASH assumptions clarify use case, for example the collection of partial dates

25 CDASH Conformance (continued) Use CDISC Controlled Terminology Follow CDASH Best Practices Create Variable names using Test Code codelist terms (when applicable) Include Highly Recommended (HR) and Recommended/ Conditional (RC) fields

26 Company Standards Use the CDASH assumptions, best practices, and metadata model to deelop company standards Deelop the data collection tools using the published, standard domains first The CDASHIG Metadata Table attributes proide building blocks for the deelopment of a case report form Take into considerations that a new collection field is often constrained by business rules, management processes, and EDC systems as well as by the data standards themseles CDISC recommends CDASHIG users establish a Goernance process for maintaining company standards

27 Questions/Open Discussion