CDISC Standards Webinar Latest Updates and Additions 31 Jan 2013

Transcription

1 CDISC Standards Webinar Latest Updates and Additions 31 Jan 2013

2 CDASH-SAE Domains CDISC CDASH SAE Team Update Rhonda Facile, CDISC Gary Walker, Quintiles CDISC

3 Agenda Background Mapping CDASH to E2B New Domains and Variables Timeline to publication Acknowledgements CDISC

4 Background The project started in 2010 Initiative sponsors: Barry Burnstead, Rhonda Facile Initial goal was to identify and describe the E2B fields that are collected at investigational sites. CDASH-E2B team officially formed CDISC

5 CDASH-E2B: Why? Reporting serious adverse events (SAEs) to regulatory bodies in a timely manner during the course of a clinical study is critical for Sponsors. However, in most cases, clinical data is not captured in line with the E2B industry safety standard, leading to a disconnect between clinical and safety databases. CDASH being the first standard applied to clinical data at point of capture needs to take account of all data requirements and destinations. CDISC

6 Our Goals To eliminate duplication of data collection enter data once, use when and where needed To provide the needed (and standardised) metadata that will assist and support drug safety in meeting regulatory reporting requirements CDISC

7 Mapping E2B to CDASH fields E2B R2 vs. CDASH 1.1 CDISC 2013

8 Gap Analysis A total of 235 E2B fields have been identified. 150 fields are not typically collected at site or do not have a CDASH identity 16 fields could/should be known or collected eg, causality assessment, reporter comments, country where the event occurred 85 fields are collected at site 68 fields already have CDASH identity 19 fields need a CDASH identity developed primarily regarding Parent and Death areas CDISC 2013

9 New Domains and Variables New CDASH identities recommended for the 35 identified gap fields Additional 15 identified during the F2F Meeting New SAE CDASH domain recommended SAE Addendum to CDASH being drafted Fields currently excluded from the CDASH-E2B mapping will be reviewed in future versions CDISC 2013

10 CDASH Data Elements DM, CM, MH, etc. CRF Domains data Investigator provides information through a single interface. ( combo form, linked forms, conditional forms) CDASH Data Elements: AE Domain AE CRF Data SAE Domain SAE Form Data All relevant clinical and related information including patient characteristics, therapy details, medical history, clinical course of the event, laboratory evidence and any other information that supports or refutes causality. Research Database Sponsor Safety Database Submit study data in SDTM format to regulators as needed. Report in E2B format to Health Authorities and other recipients in required timeframe

11 Examples of SAE domain data not already collected in CDASH CDASH SAE-specific variables SAERPTRFNM (SAE reporter s family name) ICSRID (Sender s safety case report unique ID) Subject data that could map to SDTM domains AUCDTH (DDORRES when DDTEST= Autopsy determined cause of death ) AUPERF (PROCCUR when PRTERM= Autopsy ) Data for Associated Persons that could map to SDTM domains APDM.AGE (APDM.AGE when DMRELSUB = Father, Biological ) APMH.MHTERM (APMH.MHTERM when MHRELSUM = Father, Biological ) CDISC

12 TENTATIVE TIMELINE TO PUBLICATION Submit to SRC for approval to post for public comment (February) Public review (March) Submit to SRC for approval to publish (April) Testing Initial Consensus Version TLC Review Harmonized Version OK CDISC Internal Review OK Reviewed Version Public Review Released (Production) Version (1.0) comments addressed by team SRC Review (For approval to post for public review) CDISC

13 CDASH-E2B Team Name Region Affiliation Address Gary Walker US Quintiles Barry Burnstead EU Select CRO Lauren Shinaberry EU Business & Decision Life Sciences Sonia Araujo EU Medidata Solutions Sean Neak EU Medidata Solutions Roland Franke EU PRA International Tracy Sanders US Foresight Group Ling Chin, MD, MPH US Consultant, GCP Clinical Trials Monica Mattson US Celgene Shannon Labout US CDISC Rhonda Facile US CDISC CDISC 2013

14 Questions Rhonda Facile Gary Walker CDISC

15 CDISC Online Training Saad Yousef, CDISC 15

16 Online Courses coming soon! Courses split into modules Technical and Therapeutic Area courses will be offered TA courses offered online only Technical courses still offered via public and private training First few modules to be available in early February. 16

17 How to sign up? Each registrant must create account by going to Same discounts available for GOLD (20%) and PLATINUM (40%) members. Discount codes are case sensitive. Each course contains an exam. Certificates available for passing candidates (automatic). 17

18 Advantages/Disadvantages Advantages Take courses from comfort of own office/home Self-paced Automatic certificate after test successfully passed Disadvantages No opportunity for discussion or to ask questions to an instructor Still have option of signing up for public and private courses. Click here for more info. No opportunity to network with others had you registered for public course offering. Click here for public course offering. 18

19 Questions? Please start sending in questions pertaining to CDASH-SAE or CDISC Online Training. 19

20 CDISC Education and Communications Updates Presented by: Saad Yousef, CDISC, Associate of Education and Operations 20

21 Read the Latest CDISC News Join our list Read our monthly e-newsletter See the CDISC home page: for all current events Read our Blogs: Follow us on social media! 21

22 What s New on the CDISC Website Subscribe to RSS Feeds Clear and easy display of the CDISC Standards and Innovations 22

23 What s New on the CDISC Website Rotating Banner at the bottom of the Home page and the Newsletter page to value our Platinum Members

24 Inaugural Asia-Pacific Interchange

25 Interchange Details Asia-Pacific Interchange in Singapore, Feb 2013 Deadline to register is 8 Feb 2013 Sponsorship opportunities available Education courses offered: ADaM, CDASH, Controlled Terminology, and SDTM 25

26 CDISC European Interchange

27 Interchange Details Europe Interchange in Germany, April 2013 Registration is now open Sponsorship opportunities available Education courses offered: ADaM, BRIDG Deep Dive, CDASH, Controlled Terminology, ODM, and SDTM 27

28 Other Public Education Opportunities Morrisville, NC from February 2013 South San Francisco, CA from 5-8 March 2013 St. Louis, MO from May 2013 Cambridge, MA on 17 July 2013 Full schedule and registration at Early registration discounts available for select public training events. Please click on the above link to access event registration details. 28

29 CDISC In-House Education Schedule in-house authorized CDISC education for your company - designed to meet your CDISC education needs. For more information: Visit our website or fill out private education request form found here (form can also be found at above webpage). 29

30 CDISC Authorized Instructors Find out who our instructors are at

31 Upcoming CDISC Webinars Watch for more CDISC Team Updates and other topics in our Webinar Series in the coming months CDISC Webinar schedule published at: Next webinar is scheduled for 7 March Visit the CDISC website (link above) for info on next year s webinars. 31

32 Get Involved! Become a CDISC Member Participate in Public Reviews Attend the Interchanges and authorized training Be a key collaborator Adopt the standards ask partners to do so Spread the word Volunteer For more information about CDISC please visit our website: 32

33 Any more questions? Thank you for attending this webinar. CDISC s vision is to: Inform Patient Care & Safety Through Higher Quality Medical Research 33