eSource: Unlocking the Efficiencies of Electronic Source Data Capture

Ed Seguine, CEO, Clinical InkApril 15, 2014

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Faculty Disclosure

In compliance with ANCC Guidelines, I hereby declare:

I do not have financial or other relationships with the manufacturer(s)of any commercial service(s) discussed in this educational activity.

Ed SeguineCEO, Clinical Ink

Learning Objectives

• Understand current responsibility of sites for source data• Differentiate the various forms of clinical data capture• Distinguish the benefits of eSource for data capture• Suggest site involvement with eClinical Forum eSRA tool

FDA 2014: Promoting eSource

No Paper: Direct Entry into eCRF

Source: 2014 FDA “Promoting eSource Data Capture”

Source Data: Site Responsibility

Source data must be:AttributableLegibleContemporaneousOriginalAccurate

Inadequate case history is 2nd most common site audit finding

Clinical Research Today

Paper Process = Complexity, Errors, Cost

Day 0 Day 5-14+ Day 30-60+

Clinical Research Tomorrow

Real-Time Data Availability: No Paper, No Errors, No Travel

eSource vs Paper

eSource Paper

Original Record Secondary Copy

Comprehensive Content Limited Dataset

Clinical Focus (Workflow, Unstructured)

Data Focus(Standardized)

Investigator Control Sponsor Control

REVIEWED for context, safety, trends, compliance

VERIFIED for accuracy, validity, errors

Sites choose how to capture Source

Paper: Worst Case Scenario

EDC: Rarely Used as eSource

Inconsistent with site workflow Restrictive Data Entry

Inability to work offline

eSource: Best Case ScenarioTablet Portal

Server

Create eSourceCreate Source

Remote Monitoring

Review Source

Workflow Comparison

Create CRFs

Capture Patient Source Data

Onsite Validation

SDV & Query CRF

Review Source

Enter Patient Data in CRF

Xfer to Data Management

Create Source

Create CRFs

Onsite Validation

SDV & Query CRF

Review Source

Capture Patient Source Data

Enter Patient Data in CRF

Xfer to Data Management

Site Activity

Sponsor Activity

Today

Tom

orro

w

Clinical Ink Activity

Create Source

Create CRFs

Capture Patient Source Data

Electronic Source Records

Application: Portal Dashboard

Clickable Links

Search

Sortable Headers

Copy, Export, Print

Query List Form History

Validations

Interactive Document ViewClick field to add query

Application: Document View

Benefits of eSourceSource Data Verification

Data Queries (60-70%)

CRA Visits

Fraudulent, Erroneous Data

Remote Monitoring of Source

Documents

Site Interactions

Site Productivity, Satisfaction

Speed R&D Timelines, Dramatically Reduce Costs

Case Study: Novartis

55 MINUTESSite Assessment to DV Visualization

MONITORING TIME: -38%Source Data Reconciliation

vs. Source Data Verification

eSRA: eSource Readiness Assessment

We need assessment tool that can evolve, adapt for future needs

AUDIT TRAIL

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1) Does the system show the creation, alteration, or deletion of data/electronic health information with date, time, the patient identification, and the identification on the person who entered data?

Site must ensure that audit trail (audit log)functionality has been installed and is working correctly.

[Workaround: If an audit trail is not available additional process controls such as a signed and dated print out, will have to be introduced to maintain the information]

Y - to be confirmed by Site IT

Y N W

eClinical Forum: eSRA Tool

20Copyright eClinical Forum 2014

ASSESSMENT QUESTION Site responsibilities for meeting these requirements

Vendor Response

Does your site (system + processes)

meet this requirement?

Example for Site

2014: eSRA Implementation

Investigator Site

eSource-Readiness Assessment Tool

(eSRA)

Thank You!