eSource: Data Capture Simplified - Uncover Time and Cost Saving Possibilities

May 5, 2015

William Gluck, PhD, VP Clinical Knowledge

Program Director CTRA and MSP Programs - Durham Technical

Community College

eSOURCE: Data Capture Simplified –

Uncover Time and Cost Saving

Possibilities

Agenda

1. Streamlining Data Capture in Clinical Trials

2. eSource Guidance Overview

3. Practical Applications – A Tale of Three Studies

Indulge Me – A Brief Walk Down

Memory Lane

Ah…the good old days…..

The Dawn of Remote Data Entry…..

and Dial-up

Electronic Data Capture = Change!!

Today…….

► Technology seems to advance faster than we

can keep up

► EDC has been accepted industry-wide

• Success driven by technology and process

optimization

► We can still improve…..optimize…..build the

better mousetrap!

How Do We Optimize Data

Capture?Start at the Source

eSource: Guidance Overview

Conceptually - What is eSource?

Simply put (from the Guidance Document):

“Electronic source data are data initially recorded

in electronic format.”

eSource studies pertain to clinical trials where

direct data entry into an electronic data capture

system (EDC) is used in contrast to paper

source studies where data are transcribed from

a paper source into EDC.

Guidance Document Addresses the

Following:

► Identification and specification of authorized source data originators

► Creation of data element identifiers to facilitate examination of the audit trail by sponsors, FDA, and other authorized parties

► Ways to capture source data into the eCRF using either manual or electronic methods

► Clinical investigator(s) responsibilities with respect to reviewing and retaining electronic data

► Use and description of computerized systems in clinical investigations

Associated Guidance

Documents/Regulations

► FDA Guidance Document: Computerized

Systems Used in Clinical Investigations

► FDA Regulations on Electronic Records and

Electronic Signatures (see 21 CFR Part 11)

Definitions

► Electronic Record: any combination of text, graphics, data, audio, pictorial, or any other information represented in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system (21 CFR 11(.3(b)(6)) An eCRF is an example of an electronic record

► Source Data: all information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical investigation used for reconstructing and evaluating the investigation ( 21 CFR 312.62(b), ICH E6)

Why eSource? – Potential benefits

Capturing data via eSource and transmitting it to

the eCRF should:

• Eliminate unnecessary duplication of data

• Reduce transcription errors

• Encourage entering source data at a subject visit

• Eliminate transcription of source data prior to eCRF

data entry

• Facilitate remote monitoring of data

• Promote real time access for data review

• Facilitate the collection of accurate and compete data

Data Capture:

Electronic Source Data Origination

► Security and Integrity: List of authorized source data originators should be developed and maintained by the sponsor and made available at each clinical site

► Examples of Data Originators:• Clinical investigator(s) and delegated staff

• Clinical investigation subjects or their legally authorized representatives

• Consulting services

• Medical devices

• Electronic Health Records

• Automated laboratory reporting systems

• Other technology

What are We Capturing?

Data element – represents the smallest unit of

observation captured for a subject in a clinical

investigation

Source Data Capture

• Direct entry of data into the eCRF

• Automatic transmission of data directly into

the eCRF

• Transcription of data from paper or electronic

sources to the eCRF

• Direct transmission of data from EMRs/EHRs

to the eCRF

• Transmission of data from PRO instruments

to the eCRF

Data Element Identifiers, Modifications

and Corrections, and Use of Data Quality

Checks► Data Element Identifiers

• Originators of the data element

• Date and time of the element

• Clinical investigation subjects to which the element

belongs

► Modifications and Corrections

► Use of electronic prompts, flags, data quality

checks in the eCRF

Data Review

► Clinical Investigators

• Clinical Investigator(s) review and electronic signature

• Data exempt from investigator(s) review

► Modifications and Corrections

During Review of the eCRF

Retention of Records by Clinical

Investigator(s)

► Retain control of the records

• Completed and signed eCRF

• Certified copy of the eCRF

► Be able to provide inspectors with access to the

records that serve as electronic source data

► When transcription from paper occurs – the

paper is the source and must be retained

Data Access

► Viewing Data

• Sponsors, CROs, DSMBs and other authorized

personal can view data before and after the clinical

investigator has signed the completed eCRF

– Allow for early detection of study-related problems

– Missing data

– Data Discrepancies

► CDMP should list individuals with authorized

access to the eCRF

Use and Description of Computerized

Systems

► Adequate controls must be in place

• Note: determination of whether a computer system is

suitable may not be under the control of the clinical

investigator or sponsor (EHRs for example) – see 45

CRF Part 170

► Documentation – if computerized systems are to

be used

• Protocol/CDMP/Investigational plan

• Description of security measures employed to protect

the data

• Description/Diagram of the electronic data flow

Practical Application of the

Guidance

eSource Case Studies

Three Different eSource Studies:

► Study 1:

• Phase 2, 160 subjects and 24 sites

► Study 2:


► Study 3:


Why eSource?

► Companies are reluctant to move away from

paper-based source documentation

• It is very familiar and is today’s standard

• It is well documented and has a clear audit trail

• It has well documented security measures

► eSource

• Higher data integrity = Streamlined Data Review

Process

• Real-time accessibility

eSource Case Studies

The three studies provided insights

into:

1. Challenges initiating eSource Studies

2. Benefits realized from the eSource

Studies

3. A view of the future of eSource

Challenges of the eSource Studies

► Workflow process at the site and between

monitoring and data management groups

► Defining protocol-specific system checks

► Understanding and ensuring compliance to the

FDA guidelines pertaining to data originator

elements for transcribed assessments

► Training the site staffs and monitors to ensure

compliance to the guidance

Challenges of Workflow Process

Workflow process at the sites and between monitoring and data management

• Study: Cross-comparison of all three studies

• Problem #1: How to adapt site workflows for eSource data capture

• Solution #1: Comprehensive review of site practices and workflow and taking a holistic approach to defining a ‘whole-study’ an educational and workflow process

Challenges of Workflow Process

Workflow process at the sites and

between monitoring and data

management

• Study: Cross-comparison of all three

studies

• Problem #2: How to document the

review between monitors and data

management

• Solution #2: Modify the EDC application

to include an additional data review flag

Challenges of Protocol-Specific

Checks

Defining Protocol-Specific System Checks

• Study: Progression of all three studies

• Problem: Number of protocol-specific

system checks

• Solution: Identification of integral

protocol checks, help prompts and

additional electronic case report forms

(eCRFs)

Challenges of FDA Guidelines

FDA Guidelines pertaining to data originator

elements for transcribed assessments

• Study: Study 3

• Problem: Coordinator entering

information into eCRF that is being read

off by PI and the conflict with the data

originator in EDC.

• Solution: additional review fields on

eCRF that correspond to authorized

data originator

Challenges of FDA Guidance

► Site Compliance of FDA Guidance of

electronic source data

• Study: Study 1

• Problem: Sites writing study information

on paper

• Solution: Note-to-File regarding paper

sources and retraining of site

Realized Benefits of eSource

Studies

► Higher Data Integrity (fewer auto and manual

queries)

► Real-Time Data Availability (rapid entry and

access)

► Increased Throughput at All Levels for Data

Review

Some Comments on the Future of

eSource

►Similar to the history of EDC

• eSource requires a learning curve

• With familiarity and optimization of workflows, study

initiation time decreases and study benefits become

realized

►Not all studies are optimized for eSource….yet

►Impacts Remote Monitoring and RBM

►EMR/EHR’s will continue to impact eSource

studies

Conclusions

1. eSource has been recognized as an accepted means of capturing clinical data during clinical investigations by the FDA

2. The FDA has provided guidance to industry for its implementation and use

3. Case studies demonstrate the benefits of incorporating eSource as part of the data collection/capture plan:• Higher data integrity

• Real-Time accessibility

• Streamlined Data Review and Accessibility

Questions