Structured Data Capture (SDC) All Hands Meeting

Structured Data Capture (SDC)All Hands Meeting

January 31, 2013

Meeting Etiquette

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• Remember: If you are not speaking, please keep your phone on mute

• Do not put your phone on hold. If you need to take a call, hang up and dial in again when finished with your other call o Hold = Elevator Music = frustrated speakers and

participants• This meeting is being recorded

o Another reason to keep your phone on mute when not speaking

• Use the “Chat” feature for questions, comments and items you would like the moderator or other participants to know.o Send comments to All Panelists so they can be

addressed publically in the chat, or discussed in the meeting (as appropriate).

From S&I Framework to Participants:Hi everyone: remember to keep your phone on mute

All Panelists

Agenda

Topic Time Allotted

Welcome and AnnouncementsWorkgroup Meeting StructureSDC Wiki IntroPlan for the coming weeks

10 minutes

SDC Project Charter ReviewReview ScopeHomework: Review and Comment on other sections

20 Minutes

FITBIR Presentation (Matt McAuliffe) 20 minutes

Next Steps / Contact Information 5 Minutes

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Welcome and Announcements

• Structured Data Capture (SDC) Initiative will hold weekly community meetings on Thursdays at 3:25 pm Eastern. – Please see the “All Hands Meeting Information” section of the

SDC Wiki Page– http://wiki.siframework.org/Structured+Data+Capture+Initiative

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Please check the meeting schedule weekly as the meeting link and call in numbers will change.

Weekly Meetings

All Hands Meeting Structure

• Our Community Meetings are scheduled for one hour a week. We believe your time is valuable and appreciate your participation in this initiative.

• In order to make the most of our short time together, we will start the meeting software for all community meetings at 3:25 pm Eastern.

• This gives attendees time to log in to the WebEx and Dial-In to the teleconference and address any technical issues they may have prior to the meeting start.

• We will begin the All Hands Meetings at precisely at 3:30 pm Eastern with administrative items and meeting announcements.

• Thank you for your participation and we look forward to working with you in the coming months.

SDC WikiOrientation

Weekly Meetings

Community Announcements

Contacts

Calendar

Quick Links

Join the SDC Initiative

• You’re Invited! We need experts to develop standards, organizations ready to drive towards implementation, innovators to push the envelope, and patients and providers willing to provide their perspective.

• Your commitment and participation are critical to our success!

• To join the Structured Data Capture (SDC) Initiative, go here: http://wiki.siframework.org/Join+Structured+Data+Capture+Initiative, read about the commitment process, and fill out the “Join the Initiative” form at the bottom of the page.

Plan for the Coming Weeks

• Over the next few weeks, we will hold All Hands Meetings to finalize the project charter

– All Hands Meetings will be held Thursdays from 3:30 to 4:30pm Eastern

– SDC wiki page will be updated with meeting information

• In Week 4, we will launch workgroups as agreed by the community, beginning with Use Case development

• We are planning to host a series of presentations from related projects and initiatives

– Similar to ‘concert series’ hosted by other S&I Initiatives

– If you have an interest in participating, please contact the support team: Evelyn Gallego (evelyn.gallego@siframework.org) and Jenny Brush (jennifer.brush@esacinc.com )

SDC Project Charter Review

• This is your opportunity to provide input!• Updates will made to the wiki after the meeting.

– http://wiki.siframework.org/Structured+Data+Capture+Charter+and+Members

• Please also review and comment on the wiki after the meeting.

• Comment form is at the bottom of the Charter & Members Page.

Review and Comment

SDC Project Charter Review

• Switch to Word Doc• Notes / comments / edits will be recorded in-line in the word

document.

Presentation - FITBIR

• Presenter: Dr. Matt McAuliffe• FITBIR (Federal Interagency Traumatic Brain Injury Research)• http://fitbir.nih.gov/

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Building a Federated TBI Informatics System

Federal Interagency

Traumatic Brain Injury Research

(FITBIR) Informatics System

Program Co-directorMatthew J. McAuliffe, PhD, Chief, Biomedical Imaging Research Services Section (BIRSS) CIT

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• Funded By DMRDP/MRMC

Stakeholders

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Challenges

1. Research

• Small sample size• Studies of the same subject at multiple locations• Lack of detailed visibility in all available research data• Unable to easily validate other’s results

2. Data accessibility

• Data takes months/years to get into papers/journals• Data is typically summarized and rarely complete• Data acquired not using CDEs• Data lost after grant ends• Meta-analysis difficult

1515

Why do we bring all this data together?

to replicate experiments

to ask new questions

to simulate

to model

to share

to publish

to teach

to search

to analyze

to visualize

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BRICS Components

Clinical Trial / Research• Defining electronic case

report forms• Scheduling and collecting

clinical data• Exporting, analyzing and

reporting on collected data.

Study Management and Data Submission• Defining and managing

study information and access

• Contributing, uploading, and storing the research data

• Define federated data stores

Querying, Reporting and Exporting Data• Include locally collected

research data• Include research data

from defined, federated sites.

Defining and Validating Data• Creating, managing, and

searching data elements and form structures

• Validating research data against the defined validation rules

Global Unique Identifier System• Allows researchers to share data

specific to study participants• Correlate participants across

studies without exposing personally identifiable information (PII)

User Account Management• Creating, approving, and

managing user accounts• Managing access controls,

roles & permissions• Single sign on

MIPAV Imaging Tool• Image submission tool• Image analysis tools• 3D Image visualization

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Generic

Forms Tool

(eCRF)

ProFoRM

(eCRF+)

RESTFUL API

GUIDRepository

ManagerData Access

GUID Webstart

Client

Data Dictionary

NINDS CDEs,

Unique DE

Validation Webstart Tool

Upload Tool Download MgrQuery Tool

Meta

DataRaw Data

Export

Package

Query

Results

Data Submission Data Access

FITBIR Arch

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Submission Dataflow

• VALIDATE & SUBMIT • RESEARCHER USE • COLLABORATION • QUALIFIED ACCESS• CAPTURE

• NEUROIMAGING

• GENOMICS

• ASSESSMENT DATA

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Generic

Forms Tool

(eCRF)

FITBIR

RESTFUL API

Data Dictionary

NINDS CDEs,

Unique DE

FITBIR Arch Evolution

CNRM

OneMind

Single Signon

Account

Management

Account

Management

Access to published CDEs and forms

Parkinson Account

Management

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• The Interagency CDE Project for TBI was launched in 2008 and involves multiple agencies (NIH/NINDS, NIH/NICHD, NIH/CIT, DOD/MRMC, DOD/DOE, DOD/NICOE, DVBIC, VA, ED/NIDRR, CDC) and hundreds of scientific experts from around the world.

• Endorsed by the International Neurosurgical Society and by the International TBI Research (InTBIR) Initiative.

• Version 2.0 is posted on the NINDS CDE and FITBIR websites with input from NLM.

• What’s needed?

- Translation into other languages (e.g. Spanish, French and Chinese)

- Pre-clinical CDEs (in progress).

Common Data Elements

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Image Analysis Tool

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Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

• Researcher logs into GUID client on their university PC and enters in subject PII

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

• GUID client (on university computer) uses personally identifiable information to derive a series of one way hashes which securely encrypt PII information

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

• One way hashes are sent off to the GUID server for reference and storage. No personally identifiable information is sent to the system

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

• GUID server returns a GUID identifier. If the one way hashes match a known subject, an existing GUID will be returned. If this is a new subject, a new GUID will be returned.

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

• Once the researcher has a GUID, s/he may submit data associated with this subject. No data may be submitted to the system without a GUID.

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GIUD + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

Researcher System GUID client application

Researcher/ Clerk

PII3

4

5

CIT Hosting (Bldg 12)

GUID Server

GUID

Public Data Repository

Public DBGUIDa + DataGUIDb + Data

...

Researcher

6

One-WayHashes

Query

7 Data

GUID + Data

GUID DBGUIDa + HashesGUIDb + Hashes

...

2

1

• Researchers are able to access data across studies, without revealing personally identifiable information, while correlating study data across different studies AND uniquely sorting between distinct and redundant datasets

Shared

Shared Data

Repository

GUID

• Once data is in the database, a researcher may query this data. The GUID allows researchers to distinguish between unique subjects and recurrent subjects across all datasets.

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GUID Client

25

Validation Tool

26

27

ProFoRMSStudy Listing Page (in My Workspace)

28

ProFoRMS

Build Form Page

29

ProFoRMS

Subject Listing Page

30

Technical Timeline

July 2012FITBIR v1.0

Nov 2012FITBIR v1.5

April 2013FITBIR v2.0

• Outreach/Training for Grantees and Other Submitters

• ProFoRMS v1.0 (Electronic Form Capture )

• Query Tool (Beta)

• Data Dictionary Tool

• Data Validation Tool

• GUID Tool• Data Contribution• NIH Single Sign-

On• NINDS TBI

Version 2.0

• Data Download Tool

• Centralized DDT• Data Attribution• Outreach/Training

for Grantees

• Query Tool V1.0• Meta-Study

Analysis

Jan 2013FITBIR v1.6

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Public access site

• Website http://fitbir.nih.gov

• Access to portal and tools- GUID, - Data Dictionary, - Upload tool, - Query

• SOPs Defining, Contributing, and Accessing

• Policy

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Summary

Ensuring the Integrity, Accessibility, and Stewardship of Research

Data in the Digital AgeCommittee on Ensuring the Utility and Integrity of Research Data in a Digital Age;

National Academy of Sciences ISBN: 978-0-309-13684-6, 188 pages, (2009)

http://www.nap.edu/html/12615/12615_EXS.pdf (Executive Summary)

Policy

User Requirements

Implementation

Governance

Presentation – FITBR Q&A

• Question (J. Michael Fitzmaurice (AHRQ)): Would it be feasible for us to adopt what you’ve done and apply it to our use cases?– Though we are more focused on research than clinical, there is a large overlap.

• Question (same): In your data dictionary, do you recommend codes at patient-level (e.g., gender, BP, diagnoses)?– Yes, we have data values and permissible values (e.g., gender coded

male/female, though we’d like to also support an alias mechanism to record 0s and 1s)

– Another step would be introducing LOINC. We link to CDASR’s ID for gender (and they in turn link to CDISC). We will also include a CDISC field/data element.

• Question (Mark Pilley): Codification of information – are you looking to use certain coding systems?– We’ve identified data elements for TBI that were defined through SNOMED.

Our scope is more research-oriented, but could potentially support more detailed systems.

• Question: Landon B: Hybrid EHR system?– We’ve tried to incorporate elements that allow better support of research.

Next Steps

• HOMEWORK: Comment on the Project Charter: – http://wiki.siframework.org/Structured+Data+Capture+Charter+a

nd+Members

• Next Work Group Meeting• Thursday, February 7, 2013 from 3:30pm - 4:30pm Eastern

– http://wiki.siframework.org/Structured+Data+Capture+Initiative

• Reminder• All SDC Announcements, Meeting Schedules, Agendas, Minutes,

Reference Materials, Use Case, Project Charter and general information will be posted on the SDC Wiki page– http://wiki.siframework.org/Structured+Data+Capture+Initiative

Contact Information

• For questions, please contact your support leads– Initiative Coordinator: Evelyn Gallego (evelyn.gallego@siframework.org)– Project Manager: Jenny Brush (jenny.brush@esacinc.com)– PM Support: Zachary May (zachary.may@esacinc.com)– Use Case/Requirements Lead: Jennifer Sisto (jennifer.t.sisto@accenturefederal.com)– Standards Development Lead: Caryn Just (caryn.k.just@accenturefederal.com)