Clinical Metadata A complete metadata and project management solu6on. October 2017 Andrew Ndikom and Liang Wang

Transcription

1 A complete metadata and project management solu6on. October 2017 Andrew Ndikom and Liang Wang 1

2 Agenda How is metadata currently managed within the industry? Five key problems with current approaches. Introduc=on to the Product. How solves problems with exis=ng approaches. Ques=ons 2

3 Current approaches to CDISC CDISC formed in 1997 Ever increasing number of founda=onal and therapeu=c area standards. Conforming with CDISC standards now mandatory for submissions. CDISC business case describes a poten=al 50% reduc=on in analysis and repor=ng =me (Roswell et al 2009) CDISC, data standardisa=on and metadata management poten=ally offer huge efficiency savings. The pharmaceu=cal industry has not realised these efficiencies because of inefficient systems and workflows. 3

4 Current approaches to CDISC Current implementa=ons of CDISC consist of disconnected files. Consider a poten=al implementa=on of CDISC within a study. 12 spreadsheets, a word document and PDF. 4

5 Key problems with current approaches 1. Study metadata consists of disconnected metadata silos. 2. Difficult to understand the rela=onships between metadata elements. 3. Reading and wri=ng informa=on directly from the metadata is complicated. 4. Difficult for mul=ple users to collaborate. 5. Addi=onal tools outside system needed to manage standards and check CDISC compliance. 5

6 A metadata and project management solu6on Amazon Web services Two-step verifica=on D3 C# Security Cloud based Technology Visualisa- =ons Metadata Re-use Annotated CRFs User privilege levels Copy down Governance process SQL HTML Metadata traceability Submission deliverables Define.xml Promote metadata Standards management Clinical Metadata Dataset shells Input verifica=on Compliance reports CDISC compliance Dataset status Chat func=ons Project management Variable status Real-=me reports SAS code genera:on Variable mappings 6

7 #1 No more metadata silos provides an end-to-end solu=on Planning Data collec=on Data tabula=on Analysis Deliverables List of TFLs* CDASH metadata SDTM metadata ADaM metadata SAS Code T-domain input * Titles and footnotes* Define.xml Analysis Results Metadata* Annotated CRF Standards governance Codelists Communication Project management 7

8 #1 No more metadata silos Variables are o`en repeated in both SDTM and ADaM Tradi=onal system SDTM and ADaM metadata stored in separate spreadsheets Manually copy SDTM variables into ADaM Use a point and click system to indicate that the ADaM variable is a direct copy of the SDTM variable. Establish a permanent link between variables 8

9 #2 Understanding metadata rela6onships u=lises the latest visualisa=on tools Tradi=onal system: Metadata exists in a series of disconnected flaciles Hard to understand the rela=onship between elements. Important informa=on lost within free text fields. : Interac=ve visualisa=ons explain the metadata flow. Establish a permanent link between variables 9

10 #2 Understanding metadata rela6onships 10

11 #3 Making programma6c use of metadata generates SAS code and submission deliverables directly from the metadata. Example: Map from ADSL.COUNTRY to ADSL.ACOUNTRY Tradi=onal system 1. Manually created the COUNTRY codelist 2. Manually created the ACOUNTRY codelist 3. Manually created the metadata for the ADSL.COUNTRY variable. 4. Manually created the metadata for the ADSL.ACOUNTRY variable, as well as defined a pseudocode deriva=on rule. 5. Manually created the SAS code required to perform the mapping. 11

12 #3 Making programma6c use of metadata 1. Imports the COUNTRY variable from SDTM.DM. 2. Imports the ACOUNTRY variable from a project library. 3. Creates the ACOUNTRY codelist. 4. Uses a point and click system to define the mapping. 12

13 #4 Facilita6ng collabora6on between users Tradi=onal systems: Informa=on fragmented across mul=ple documents. Users at different stages do not understand each others work. All users always access the latest version of the specifica=ons. In-built communica=on tools Project management u=li=es so that users can clearly understand the status of each stage of the project. 13

14 #4 Facilita6ng collabora6on between users An example: Informa=on exchange Uses inbuilt chat func=on. The status of each metadata element is captured within the system and summary level informa=on is available for managers. 14

15 #5 Managing standards and CDISC compliance Tradi=onal systems: Corporate standard Therapeutic area 1 Project 1 Study 1 Study 2 Analysis 1 Analysis 2 Analysis 1 Analysis 2 15

16 #5 Managing standards and CDISC compliance Metadata inheritance Metadata promo=on Metadata comparisons 16

17 Summary is an end-to-end metadata and project management solu=on. It uses the latest visualisa=on tools to help users understand their metadata. Metadata should be created once and re-used many =mes. Generates SAS code and submission deliverables. Steers users towards CDISC compliance. 17

18 Ques6ons 18