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Volunteering for CDISC: How to get Involved
June 6, 2013
10:00-11:30 CDT
An Orientation on how to get involved in CDISC projects.
Volunteering for CDISC: How to get
Involved
 Purpose of Webinar - Rhonda
 Top priorities for 2013 - Wayne
 How to Participate – Katie
 CDISC Website Tour - Rhonda
 Resource needs by project team – Katie/Dan
 Q&A – All
© CDISC 2013
2
Purpose of Webinar
Rhonda Facile
© CDISC 2013
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Volunteering for CDISC: How to get
Involved
CDISC depends on volunteers to develop, use and
maintain our freely open standards.
Our goal is to create a responsive community that can:
 efficiently review and comment on draft standard
documents as they become available
 build up membership on teams that develop new standards
Participating in the public review process is a necessary
first step to becoming involved in CDISC team activities.
© CDISC 2013
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Top Priorities for 2013
Wayne Kubick
© CDISC 2013
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Volunteering for CDISC: Where to get
Involved
CDISC Standards & Innovations
© CDISC 2013
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Volunteering for CDISC: Technical Plan
CDISC0213.cdpz : Gantt Chart : CDISC Technical Projects
#
1
Name
4th Quarter 2012
Protocol Concepts Guide
3
Ex tended ODM PRM XML Schem a
4
CDASH E2B SAE IG
5
CDASH V2 Update
6
SDTM v1.4
7
SDTM v1.5
8
SDTMIG v3.1.4
9
SDTM Associated Persons IG v1.0
1st Quarter 2013
Dec
Jan
Feb
2nd Quarter 2013
Mar
Apr
May
3rd Quarter 2013
Jun
Jul
Aug
4th Quarter 2013
Sep
Oct
Nov
1st Quarter 2014
Dec
Jan
Feb
2nd Quarter 2014
Mar
Apr
May
3rd Q
Jun
Ju
Batch 2 - Batch 3/ SDTM
10
SDTMIG v3.1.5
11
SDTM QS Supplem ents
12
SDTM Devices IG v1.1 (Com ponents)
13
SDTM Device Subm ission Pilot
14
Pharm acogenomics v1
15
SEND v3.0.1 Errata Update
16
SEND v3.1 IG (SafetyPharm , ReproTox )
17
ADaM Metadata Guide
18
ADaM IG v1.1
19
ADaM General Occurrence Model v1.0
20
ADaM Integration IG v1.0
21
Defi ne.x m l 2.0
22
SDTM.x m l 1.0
23
Defi ne- x m l IG, Validation
24
Clinical Trials Registration Schem a v1.0
4/ 2/ 13
2/ 26/ 13
Sem antics
26
Term inology Qrtly Updates
27
BRIDG v4.0
28
BRIDG User Guide v2
29
SHARE
30
Nov
Foundational Standards
2
25
Oct
11/ 28/ 13
11/ 28/ 13
RFP
Model
Im plem entation
New Profi les
Healthcare Link
© CDISC 2013
HC Link Kit
7
CDISC INTRAchange:
July 30-Aug 1, 2013
 Bringing together active CDISC volunteers
for internal discussions and to make
progress on cross-team topics
 No conference frills; few plenary talks
 Plenty of hard work
8
How to Participate
Katie Carothers
© CDISC 2013
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Volunteering for CDISC: How to Participate
How can you contribute?
 Participate in the review process
• Review draft standards posted to CDISC.org
• Record comments for documents via public comment tracker
 Join a CDISC project team
• Submit new volunteer registration form indicating which project
teams/sub-teams you have interest in joining
 Future opportunities
• Opt in for news announcements and reviews through mail lists
• Develop and contribute to a wiki for use cases and examples –
share your experiences with the CDISC Community
• Collaborate to develop better team tools (Sharepoint, lists,
wikis, trackers, etc.)
© CDISC 2013
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Volunteering for CDISC: How to Participate
Our standards are achieved by means of public consensus – all draft
documents are posted to the CDISC website:
http://cdiscportal.digitalinfuzion.com/CT/Review%20Documents/Forms/AllItems.aspx
List of items
out for review
© CDISC 2013
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Volunteering for CDISC: How to Participate
Provide feedback for drafts in CDISC public comment tracker:
1. Note – you need a portal account (set up through link on website)
2. Microsoft Internet Explorer is preferred browser
3. Read guidance document for how to use the tracker posted at
http://cdiscportal.digitalinfuzion.com/CT/Pages/CCTT-Help.aspx
4. Record your comments in the tracker:
Scroll to
bottom of
page to add
new comment
© CDISC 2013
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Volunteering for CDISC: How to Participate
Joining a CDISC project team….it all starts here!
New volunteers
enroll on CDISC
website
© CDISC 2013
13
Volunteering for CDISC: How to Participate
 Step 1: Enroll as new volunteer via online registration page:
Posted draft
documents
Team member
responsibilities
Information
about TA
standards
CDISC
Technical
Plan
Select
your
project
team(s)!
© CDISC 2013
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Volunteering for CDISC: How to Participate
 Step 2: Submit volunteer form to CDISC
When form is
submitted, email
will reach CDISC
coordinator
© CDISC 2013
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Volunteering for CDISC: How to Participate
Things to remember….
 Registration form
 Not all active CDISC project teams are currently recruiting new volunteers
 We have indicated which projects are in need of additional resources
 Some project teams (Devices, Terminology, etc.) include a list of subteams
 If you select a project team with sub-teams on the form, if possible please
indicate which sub-team(s) interest you
 Once your registration is submitted you will be contacted by a
CDISC representative to discuss next steps
 Project needs vary based upon their deliverable schedule
 Just because the team is not recruiting today does not mean they will not
need help in six months! Check the CDISC website often.
 Regardless of project status, there is always a need for
document reviewers
© CDISC 2013
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CDISC Website Tour
Rhonda Facile
© CDISC 2013
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Volunteering for CDISC: Website Tour
Where to find:
 The CDISC Technical Plan
 Recently posted documents
 Therapeutic Area (TA) Standards
Information
 Summary Table of Published TA Standards
 Published Foundational Standards
© CDISC 2013
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Where to Find the Technical Plan
Pathway: www.CDISC.org > Standards & Innovations > Technical Plan Project Schedule
Technical
Plan Project Schedule (GANTT Chart)
CDISC0213.cdpz : Gantt Chart : CDISC Technical Projects
#
1
Name
4th Quarter 2012
2
Protocol Concepts Guide
3
Ex tended ODM PRM XML Schem a
4
CDASH E2B SAE IG
5
CDASH V2 Update
6
SDTM v1.4
7
SDTM v1.5
8
SDTMIG v3.1.4
9
SDTM Associated Persons IG v1.0
10
SDTMIG v3.1.5
11
SDTM QS Supplem ents
12
SDTM Devices IG v1.1 (Com ponents)
13
SDTM Device Subm ission Pilot
14
Pharm acogenom ics v1
15
SEND v3.0.1 Errata Update
16
SEND v3.1 IG (SafetyPharm , ReproTox )
17
ADaM Metadata Guide
18
ADaM IG v1.1
19
ADaM General Occurrence Model v1.0
20
ADaM Integration IG v1.0
21
Defi ne.x m l 2.0
22
SDTM.x m l 1.0
23
Defi ne- x m l IG, Validation
24
25
Nov
1st Quarter 2013
Dec
Jan
Feb
2nd Quarter 2013
Mar
Apr
May
3rd Quarter 2013
Jun
Jul
Aug
4th Quarter 2013
Sep
Oct
Nov
1st Quarter 2014
Dec
Jan
Feb
2nd Quarter 2014
Mar
Apr
May
3rd Quarter 2014
Jun
Jul
Batch 2 - Batch 3/ SDTM
4/ 2/ 13
2/ 26/ 13
Clinical Trials Registration Schem a v1.0
Sem antics
26
Term inology Qrtly Updates
27
BRIDG v4.0
28
BRIDG User Guide v2
29
SHARE
30
Oct
Foundational Standards
Healthcare Link
11/ 28/ 13
11/ 28/ 13
RFP
Model
Im plem entation
New Profi les
HC Link Kit
Page 1 of 1
http://www.cdisc.org/techical-plan-
© CDISC 2013
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Where to Find Recently Posted Documents
• “What’s New” on homepage
• CDISC Standards Latest Updates
• Individual Project team pages or the Newsroom
http://www.cdisc.org
© CDISC 2013
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Where to Find Therapeutic Area Pages
http://www.cdisc.org/therapeutic
© CDISC 2013
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Where to Find a Summary Table of
Available TA Standards
• Pathway: www.CDISC.org > Standards & Innovations > Implementations >
Therapeutic Area Standards
Click on link
to download
documents
© CDISC 2013
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Where to Find Published Foundational
Standards
See the CDISC project team pages….
http://www.cdisc.org/site/index.php
© CDISC 2013
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CDISC Project Team Resource
Needs
Katie Carothers
Dan Godoy
© CDISC 2013
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Volunteering for CDISC: Resource Needs
CDASH (Clinical Data Acquisition Standards Harmonization)
List of
CDASH
sub-teams
© CDISC 2013
High level
deliverables
25
Volunteering for CDISC: Resource Needs
CDASH
Where do we need help?
 Team is currently performing gap assessment against other standards (SDTM,
CFAST TA’s, etc.) to assess changes needed for CDASH 2.0 & User Guide
scheduled for draft release in Q4
 Safety domain sub-teams as listed on project charter will be re-activated
 CRF Library sub-team
 External Review sub-team
 EX/EC sub-team
 Additional sub-teams TBD based on new SDTM 3.1.4 domains (Death Details,
Associated Persons, etc.)
 Foundational Team Liaisons (SDTM, ADaM, etc.)
 Therapeutic Area Liaisons (see Therapeutic Area updates on CDISC website to
find list of active projects + what is coming through pipeline)
© CDISC 2013
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Volunteering for CDISC: Resource Needs
Healthcare Link Initiative
 Invitation to comment on two new IHE profiles during
upcoming public review period:
• Research Marketing (RM)
• Data Element Exchange (DEX)
 Working on eligibility criteria to offer RM commenters who
have technical skills to attempt to express the conditions in RM
transactions
 Team will schedule a WebEx (or two) to present new profiles
to the healthcare link community and cover the following:
1. IHE and IHE process
2. Prior healthcare link work: RFD, CRD, etc.
3. New profiles: Research matching, Data Element Exchange
© CDISC 2013
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Volunteering for CDISC: Resource Needs
Controlled Terminology
 New CT packages are currently released on a quarterly
basis
• Frequent opportunities to participate in document reviews!
 There is an immediate need for additional team members
on the following CT sub-teams:
• Devices
• Lab
• Virology
 TA Standards Development work will also drive the need
for additional CT
• Please indicate terminology experience if you enroll for TA
teams on the volunteer registration page!
© CDISC 2013
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Volunteering for CDISC: Resource Needs
Devices
 There are 6 sub-teams beneath the Devices umbrella:
•
•
•
•
•
•
•
Terminology – will liaise with CDISC CT team
ADaM
Diagnostics
CRF & CDASH – focused on the data collection piece
Granularity & Components
Multiple Relationships & Actions
Pilot with CDRH
 Potential overlap between Devices and TA standards
 If you are unsure of which sub-team(s) to join, the project
leads can help you figure that out
© CDISC 2013
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Volunteering for CDISC: Resource Needs
CFAST Therapeutic Area Resource Needs
 Smaller work streams activated by development process
step (swat team approach)
 We will be looking for specific roles from time to time to
participate in new TAs in the future, as well as general
reviewers.
• New roles, e.g., Scoping Experts, Concept Modelers,
Metadata Analysts
• Participation will require a commitment to participate at
the necessary level within the timeframes specified in the
project plan.
 Interested volunteers
• Complete the online registration form and indicate TA(s) of
expertise
– Preference given to those with experience in the TA under development
• Be patient as resource will be matched to project needs as the TA
projects are identified and approved.
© CDISC 2013
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Volunteering for CDISC: Resource Needs
• There are opportunities to join other active CDISC
project teams (Pharmacogenomics, Questionnaires
Implementation, Protocol/Trial Design Model, etc.) –
you can find additional information on the CDISC website and
volunteer registration page
• Next up Dan Godoy will go into detail about the status
of resourcing for the SDS Team!
© CDISC 2013
31
Submission Data Standards (SDS)
Team
Dan Godoy
© CDISC 2013
32
Outline
Background
New Operating Model
Progress to-date (since 2012)
SDS Needs - 2013 and beyond
© CDISC 2013
Background
 The SDS Team develops standards for the submission of tabulation data from
Human Clinical Trials.
 Since its inception, the SDS Team has worked to develop data domain
models through Study Data Tabulation Model (SDTM), as well as its drugand-biologics-focused Implementation Guide (SDTMIG).
 Original Team maintained SDTMIG through large sub-teams that looked after the
3 Observation Classes
 All team members invited and attended bi-weekly meetings
 All domains in one Observation Class managed by same team
 But:




Number of domains became large, and did number of sub-teams
Membership also grew large (80+ members, not all active)
TCs insufficient to manage work and monitor progress of sub-teams
Last SDTM and SDTMIG, releases were published in 2008
© CDISC 2013
New Operating Model
 Starting February ’12, the SDS Team modified its organizational structure and
developed new processes to increase efficiency in managing the current and
expected demands for implementation advice. The integrated plans includes the
following:
 Revisions to team structures & meetings
• Fewer large-team TCs
• Creation of SDTM Areas with appointed Area Leads/Coordinators
• Incorporate/confirm all valid sub-teams and their deliverables
• More planned interaction within and across SDSLT, SDTM Areas, and
Area Sub-Teams
• All work aligned with SDTM/SDTMIG publishing schedule
 New SDS processes
• Provide more-frequent updates to the SDTM and SDTMIG
• Define the publication schedule for new releases
• Review and post new material, both internally and externally
• Develop a process for managing and communicating the use of
between-version publications
© CDISC 2013
New Operating Model
SDTM Publications & Schedule
 New Versions of SDTM and SDTM-IG released 1-to 2 times a year
 SDTM 1.3 and SDTM-IG 3.1.3 targeted for May July ‘12
 SDTM 1.4 and SDTM-IG 3.1.4 targeted for October Summer ‘13
 Versions after that may have different structure
 New domains/vars will be posted for comments as they become available
 New standards reviewed by internal Review Team prior to posting
 Two weeks for internal review (within CDISC community)
 New versions will link all previously published domains from last version
 Enables Provisional standards
 Useful for setting validation rules
 E.g., SDTM 1.3 and SDTM-IG 3.1.3 linked Amendment 1
© CDISC 2013
New Operating Model
Team Structure
 SDS Leadership Team
 Fred Wood, Dan Godoy, Diane Wold, Barrie Nelson, Wayne Kubick
 SDTM Areas
 An artificial grouping of domains based on similar characteristics of
the domains
 SDTM Area Lead:
• An appointed SDS Member with strong knowledge of SDTM
Area
• Responsible for interacting and coordinating alignment of
outputs within SDTM Area
Findings NEC
Leads: Randall Austin & Jan Hess
Interventions, Events & FA
Leads: Janet Reich & Adrienne Boyance
Lab Findings
Leads: Joyce Hernandez & Mona Oakes
Oncology
Leads: Barrie Nelson
Questionnaires
Leads: Gary Cunningham & Steve Kopko
Special Purpose
Leads: Tom Guinter & Mike Morozewicz
Trial Design & IE
Leads: Diane Wold & Melanie Fuellbeck
© CDISC 2013
New Operating Model
CDISC
Chief Technical Officer (CTO)
Team Structure
CDISC
Standards Review Council (SRC)
Submission Data Standards Leadership Team
(SDS LT)
General Activities
Lab Findings
SDTM Area
Special Purpose
SDTM Area
Oncology
SDTM Area
Questionnaire
SDTM Area
Trial Design & IE
SDTM Area
Events, Interventions & FA
SDTM AREA
Findings NEC
SDTM Area
= Non-SDS Team
© CDISC 2013
New Operating Model
CDISC
Chief Technical Officer (CTO)
Exploring an SDTM Area: Trial Design & IE
CDISC
Standards Review Council (SRC)
Submission Data Standards
Leadership Team
(SDS LT)
Trial Design & IE
SDTM Area
Subject Level Trial Alignment
SE
Subject Elements
SV
Subject Visit
Trial Design
TS
Trial Summary
TX
Trial Set
TI
Trial Inclusion/Exclusion Criteria
TE
Trial Elements
TA
Trial Arms
TV
Trial Visits
TD
Trial Disease Assesments
IE
Inclusion/Exclusion Criteria
= Non-SDS Team
© CDISC 2013
= Key domains/grouping
= Specific domains
New Operating Model
Why this new model: It is a complex environment
Foundational Standards Implementation Guides
(IGs)
SDTM
Area
Findings
NEC
Code
DA
DD
MI
MO
PE
RP
SC
SS
Title
Asso
ciate
d
Pers
on
(AP
IG)
Device
s
Human
Trials IG
(SDTMIG)
Drug
Accounta
bility
Y
Death
Details
Y
Microscop
ic
Findings
Y
Morpholo
gy
Findings
Y
Physical
Exam
Y
Reproduc
tive
System
Findings
Y
Subject
Character
istics
Y
Subject
Status
Y
= Released
© CDISC 2013
Pharm
aco
Genom
ics IG
SEN
D IG
Therapeutic Area Project User Guides (UGs)
Alzhei
mer's
Disea
se
(AD)
User
Guide
v1.1
Biom
arker
Cardi
ovas
cular
(CV)
User
Guid
e
Legac
y
Conv
ersion
Diabe
tes
Pa
in
Us
er
G
ui
de
Y
Parkin
son's
Disea
se
(PD)
User
Guide
Polycy
stic
Kidney
Diseas
e
(PKD)
User
Guide
Y
Y
Y
Y
Y
Schiz
ophre
nia
User
Guid
e
Tube
rculo
sis
(TB)
User
Guid
e
Y
Y
Y
Y
Y
= Draft
Y
Y
Y
Y
Y
Y
= Provisional
Y
Virolo
gy
User
Guide
Progress to-date
SDTM v1.3
SDTMIG v3.1.3
Timing
• Two-week public review April
• Final Posting July 2012
Criteria
Material had undergone public review and comments have been addressed.
Content
• SDTM 1.2
• Amendment 1 variables
• Oncology data items (LNKID, LNKGRP,
ACPTFL, EVALID)
• SEND data items (additions to Tables
2.2.1-2.2.5 and DM), POOLDEF, Trial
Sets
• Enhanced TS
• RELSUB, RSUBJID
© CDISC 2013
July 2014
• SDTMIG 3.1.2
• Amendment 1 updates to DM and AE
• Oncology domains (TU, TR, RS)
• Enhanced TS
Progress to-date
SDTM v1.4
SDTMIG v3.1.4
Timing
Summer 2014
Criteria
Material Publicly Reviewed in 3 Batches (Batch 3 available in early June ’13)
Content
• SDTM 1.3
• New Device variables
• New EX variables
• Associated Person NSID
© CDISC 2013
• SDTMIG 3.1.3
• Death Details (DD)
• Exposure as Collected (EC) and EX
enhancements
• Healthcare Encounters (HO)
• Immunogenicity domains (IS/SR)
• Microscopic Findings (MI)
• Morphology (MO)
• Procedures (PR)
• Reproductive Details (RD)
• Subject Status (SS)
• Associated Person IG (AP IG)
• Virology User Guide (VR, VF, VP)
• PGx User Guide
SDS Needs – 2013 & Beyond
SDTM v1.5/SDTMIG v3.1.5
Timing
Summer 2014
Criteria
Material will be Publicly Reviewed in Batches
General
Administration
SDTMIG Publication
SDTM/SDTMIG Spreadsheet Maintenance
Project Tracking
Liaising between SDS and other teams (e.g., TA Projects)
General Internal Reviews
Volunteer for Resource Pool
Lab Findings
Biomarker Results development
Biospecimen Domains, currently doing BRIDG mapping of PGx concepts
Pharmacogenomics domains
Virology Terminology
Internal Reviews
Volunteer for Resource Pool
© CDISC 2013
SDS Needs – 2013 & Beyond
SDTM v1.5/SDTMIG v3.1.5
Timing
Summer 2014
Criteria
Material will be Publicly Reviewed in Batches
Findings NEC
NV (Nervous System Findings)
RE (Respiratory System Findings)
CV (Cardiovascular System Findings)
UR (Urinary System Findings)
Internal Reviews
Volunteer for Resource Pool
Events,
Interventions
& FA (Findings
About)
CM (Concomitant Medications) Enhancements
FA (Findings About) model clarification
PR (Procedures) domain
Timing Variables - Enhancements and Clarifications
Internal Reviews
Volunteer for Resource Pool
© CDISC 2013
SDS Needs – 2013 & Beyond
SDTM v1.5/SDTMIG v3.1.5
Timing
Summer 2014
Criteria
Material will be Publicly Reviewed in Batches
Special
Purpose
Errata - Errata Log
SUPPQUAL - Evaluation of current model vs. added horizontal variables in
observation classes
Internal Reviews
Volunteer for Resource Pool
Trial Design &
IE (Trial
Inclusion/Excl
usion Criteria)
A sub-team is developing Study Construction Concepts as part of the CDISC SHARE
project
SDM (Study Design Model)
HL7 RCRIM is developing a Study Design structured document standard.
PhUSE/FDA Workgroup 2 is working on a submission dataset useful for selecting
sites for auditing
BRIDG Mapping
Internal Reviews
Volunteer for Resource Pool
© CDISC 2013
SDS Needs – 2013 & Beyond
SDTM v1.5/SDTMIG v3.1.5
Timing
Summer 2014
Criteria
Material will be Publicly Reviewed in Batches
Oncology
BRIDG mappings currently outstanding
Discuss additional requirements to satisfy FDA analysis “panels” - SDTM 1.4 /
SDTM-IG 3.1.4
Internal Reviews
Volunteer for Resource Pool
Questionnaires
Standard Questionnaire Implementation
Modelling Questionnaire Results
Representing Questionnaire Metadata
Internal Reviews
Volunteer for Resource Pool
© CDISC 2013
Thank you!
Interested in Joining the SDS Team?
 Register through volunteer link on CDISC website
 Contact:
• Dan Godoy ([email protected])
• Barrie Nelson ([email protected])
© CDISC 2013
47
Question & Answer Session
All
© CDISC 2013
48