eSOURCE STAKEHOLDERS GROUP MEETING Silver Springs, MD 18Mar2016 10.00am - 3.00pm EST

These slides were presented at the 18Mar2016 eSource Stakeholders Group meeting by Michael Ibara. The slides were accompanied by narrative and discussion by the group.

If you’d like to learn more about the eSource Stakeholders Group and what we’re about, please email me at mibara@cdisc.org.

"...the attention of the right expert at the right time is often the single most valuable resource one can have in creative problem solving. Expert attention is to creative problem solving what water is to life in the desert: it’s the fundamental scarce resource."

Reinventing Discovery Michael Nielsen Princeton University Press

Michael A. Ibara, Pharm.D.Head of Digital Healthcare CDISC

Alana St.Clair Project Manager CDISC

Please connect! ●mibara@cdisc.org ●www.linkedin.com/in/ibara/●@michaelibara ●Twitter hashtag #eSOURCE

Agenda / Goals / Methods 10.15 - 10.45

10.00 - 10.15 Welcome and Introductions

10.15 - 10.45 Agenda / Goals / Methods

10.45 - 11.15 Review of FDA Guidance

11.15 - 12.00 Charter / Topics / Examples

12.00 - 12.30 Lunch (Bring back to room)

12.30 - 1.30pm Discussion / Agree on Charter

1.30 - 2.30pm Discussion (and Parking Lot Questions)

2.30 - 3.00pm Review / Actions / Next Steps

3.00pm Adjourn

Stakeholders in the room...• Academic med centers • Biotech • Consulting• CROs• EHRs / EDCs • Medical devices • Biopharmaceutical • Technology service providers • Regulators • Non-profit • …

Goals

• Take an inclusive and realistic approach to the challenges of implementing eSource projects in regulated research

• Align a diverse group of stakeholders to make progress in a way that will help everyone involved and inform future efforts

• Focus on producing specific deliverables (see next)• Avoid the dreaded meeting fate (lots of talk, no action)• “Think Globally, Act Locally” (Rene Dubos)

• Man-made

• Evolved historically

• Multiple physical layers

Supports diverse purposes

Rationale

• With such a complex problem - and such diverse stakeholders, we need to decompose it into component parts which can be focused on separately by different groups of people

• Periodically we will share information in order to adjust and align, so that each group informs the other groups and we advance together

• At the end we will use all groups to inform a single coherent view of eSource from start to finish - in other words, an implementable view

• For each part we’ll identify gaps and make suggestions for how to address them

Deliverables

• Create a primer that lays out, beginning to end, the process of creating, using, and submitting eSourced data

• Publish gaps challenges/proposed solutions to each of 5 topics which address an aspect of the eSource process

• Create in-depth opinion/suggested methods pieces (optional)• Publicize/publish descriptions and results of demonstration

projects • Create a white paper on lessons learned, challenges and

solutions to implementing eSource projects for regulated research

Methods

• Decompose the problem into components (5 topics) • Teams for each (ideally 2 co-leads for each team) • Primer team is an additional (separate) team • Quarterly (?) meetings to integrate • White paper summarizes all findings

We’ll cover this in more detail in the Charter section

Review of FDA Guidance 10.45 - 11.15

Charter / Topics / Examples11.15 - 12.00pm

Deliverables (redux)

• Create a primer that lays out, beginning to end, the process of creating, using, and submitting eSourced data

• Publish gaps challenges/proposed solutions to each of 5 questions which address an aspect of the eSource process

• Create in-depth opinion/suggested methods pieces • Publicize/publish descriptions and results of demonstration

projects • Create a white paper on lessons learned, challenges and

solutions to implementing eSource projects for regulated research

5 Topics

• Provenance (Data, process) • “eCRF” (concept, implementation)• System Validation / Privacy • Economics / Cost vs Benefit • Scalability requirements (technical, regulatory, political)

The goal...• Data is captured in the

EHR or some other electronic source

• <d> is a single piece of data

• <d> is somehow moved to the researcher, where it may be transformed in some manner, to become d-prime <d’>

• It is then submitted to the regulator, where it has become d-double-prime

The Regulator’s Dilemma...

• Can I go from <d’’> back to <d>? • What information do I need to determine <d> in the original

context? • Can I look at the EHR as it appeared on the day that <d> was

extracted?• How do I know that the <d’’> that I see is equivalent to <d>?

Provenance

“Data provenance refers to the ability to trace and verify the creation of data, how it has been used or moved among different databases, as well as altered throughout its lifecycle.” [http://itlaw.wikia.com/wiki/Data_provenance]

• “What”, “When”, “Why”, “Who”, etc. vs other definitions • Metadata necessary? • Human vs computer readable?

The firewall...• The site or ‘owner’ of

the data will not allow raw data to pass outside or others to pass inside the firewall...

The Researcher’s Dilemma...

• How do I get <d> without violating patient privacy, privacy laws, etc.?

• Do I execute a business agreement, then can I reach in? • Do I wait for something to be pushed to me? • How will this affect provenance?

The eCRF...• A possible solution to

the firewall challenge is to use an eCRF

eCRF Concept

• What is the eCRF? Which data fields? The C-CCD? • What happens to the data in the form that is not needed for the

study data? • What happens to the form itself, is it destroyed, archived, routed

to someone? • Who ‘owns’ the process and where does ownership change -

what are the lines of demarcation?

Validation...• Sponsors are required

to satisfy 21CRFPart11 • There are other GCP,

validation, etc. requirements for the systems and processes involved

System Validation / Privacy

• What are the boundaries of validation? • How does validation interact with provenance? • How does privacy interact with both?

Economics / Cost vs Benefit

• What are the benefits to the site(s) and how and at what level are the measured?

• What are the benefits to the researcher / sponsor? • What are the costs to realize these benefits? • How do these apply in a heterogeneous environment?

Scalability Requirements (tech, reg, political)

• How do the economics scale? • How does a solution scale in a technologically heterogeneous

environment?• What are the gaps (tech, reg, political, other) that need to be

addressed to achieve scalability?

Lunch - short break 12.00 - 12.30pm

Discussion / Agree on Charter12.30 - 1.30pm

Charter

• Purpose (support FDA effort, provide feedback, seek implementation)

• Duration and time commitment (initial one year)• Scope (see previous)• Members (contributing vs observing) • Desired end result (see previous)• Supporting resources (CDISC, will require volunteers)• Reporting plan (every 2 weeks)• Deliverables (see previous)

Charter Agreements

• Information is shared as much as possible and as directed in the charter with the goal of creating value to Healthcare as a whole

• Team leaders will encourage open discussion • Teams will review and account for comments made by others

outside of teams proper • Politics and posturing will be kept to a minimum

Charter Groups (ideally 2 co-leads for each)

Group 1: PrimerGroup 2: Provenance Group 3: eCRF concept (M.Ibara, M.Rocca)Group 4: System Validation / Privacy Group 5: Economics / Cost vs Benefit Group 6: Scalability requirementsAd hoc: Demonstration projects (write ups addressing provenance,

etc.)

Charter Methods / Timing• Each group has a leader and members • Each group updates work to all members every 2-4 weeks • Each group will track a percentage score of how complete their work

is and publish it every 2 weeks• Only group members can edit, but everyone can comment • Initial proposed deadline for completing group drafts: October • Groups will meet in person twice before deadline to ‘hash out’ how to

integrate approaches with each other • After October white paper will be drafted which incorporates each

group’s work

Discussion1.30 - 2.30pm

Parking Lot Questions

Review / Actions / Next Steps2.30 - 3.00pm

Face to Face Meetings

• Need to plan 2 by October (more?)• Next meeting July?

• Venue?

• October meeting• Venue?

You will receive

• These slides• Membership list • Group leaders’ contact information

Collaborative Tools - What should we use?

• E.g., Google docs, Trello, Smartsheet, Slack, …

Adjourn3.00pm

Adjourn3.00pm