Study Task Management Internal

Communication Secured Sharing

Built-in Compliance

Innovative Approach to Study Management: Ensuring Regulatory Compliance in a Paperless Environment

PROBLEM STATEMENT

Electronic data collection and management has

become the industry norm in human research.

However, the process of converting from paper to

electronic continues to raise questions and concerns.

Among them are “perceived” high implementation cost

associated with various electronic platforms and

insufficient FTEs to manage the increased

documentation flow an electronic system may bring.

Finding the best suited, user-friendly, low maintenance,

and low cost system that can facilitate study

management and remote monitoring has been the

obstacle for many academic and commercial

institutions.

Stanley Estime, MSCI, CIP; Leslie Howes, MPH, CIP;

Alyssa Speier, MS, CIP; Lisa Gabel, BA, CIP; Delia Wolf, MD, JD, MSCI

About the Harvard Chan School’s Quality

Improvement Program:

The Quality Improvement program is a unit within the Office

of Human Research Administration (OHRA), independent of

the IRB. QIP’s mission is two fold:

1) Liaise between investigators and the IRB

2) Provide institutional regulatory compliance

SOLUTION

In response to these challenges, the Harvard T.H.

Chan School of Public Health’s Quality Improvement

Program (QIP) sought to implement an electronic study

management platform that would meet these needs.

QIP started off with exploring REDCap and SharePoint

as potential platforms for maintaining regulatory

documentation. As a result of the university’s end-user

demands, QIP expanded the platform to utilizing Box

as an alternative. QIP was able to further customize

Box and expand its use to include monitoring patient

level data as well as regulatory documentation.

The content of this poster reflects solely the opinions and experiences of the authors and does not necessarily represent and/or is intended to promote any of the platforms utilized: REDCap, SharePoint, and Box. The authors do not have any financial interests and/or affiliations with any of the customized study management platforms.

• Real-time, remote, multi-user

access to study documentation

• Streamlined monitoring process

• Potential reduction of protocol

non-compliance

• Real-time reporting and/or

follow-up on suspected non-

compliance, adverse events,

and various reportable new

information to the IRB and/or

other regulatory bodies

• Conduct remote monitoring of study

documents

• Perform rapid quality checks for

data completeness, integrity and

accuracy

• Conduct faster searches for source

data and regulatory documentation

• Customize study management

tools, CRFs, and built-in

guidance/best practice

recommendations to ensure

regulatory compliance

• Create custom queries for

generating reports to view or

download

• Each platform can have limited

customization capabilities (e.g. ‘out of

the box’ built in features)

• External customer support services

may be required (e.g. server

maintenance data recovery,

username/password management)

• Not all versions are created equal –

select what’s right for you

• Institutional policies may limit/restrict

use of remote system – data security

provisions (e.g. storage of high risk,

identifiable information not allowed)

• Implementation/ Utilization of certain

advance features may require

additional technical skills,

Administrative or IT support (e.g.,

REDCap)

Rationale for implementation Benefits Challenges

Electronic Study Management Overview

1 2 3 4

KEY FEATURES:

Innovative Approaches

QIP utilized off-the-shelf, low cost electronic solutions to

provide high-level support and customizations:

• Customized CRFs to help reduce non-compliance

risks that may be associated with poor CRF design

(e.g. missing signature lines, no fields to document

investigator’s assessment or follow-up reporting on

events)

• Built-in study management tools (Logs and

Checklists) to help promote tracking and timely

reporting – Utilize these tools to take a risk-based

approach to monitoring and facilitate investigator

self-assessments

• Built-in regulatory guidance and best practice

recommendations to assist investigators and study

teams with minimizing areas of non-compliance and

correcting them when/if they do occur

• Real-time communication between monitors/auditors

and the study team for tracking resolution of

observations - reduce the need for lengthy

monitoring reports and provides an audit trial for the

study team and monitors/auditors

To learn more about the Office of Human Research Administration:

http://www.hsph.harvard.edu/ohra

To learn more about QIP or their electronic study

management platforms, contact Stanley Estime at

617-432-2164 or

e-mail:sestime@hsph.harvard.edu

90 Smith Street, Boston, MA 02120

• Create and design

custom study

management tools and

data collection

instruments quickly and

securely (REDCap Global

Library)

• Ad hoc reporting

• Auto validation/branching

logic

• Customized Case Report

Forms and Study Management

Tools

• Utilized ‘Box Note’ for note-to-

files and Regulatory Tips and

Best Practice

Recommendations

• Task Management with

completion status notifications

• Office 365 integration with One Drive

syncing and sharing

• Document repository with easy

access and sharing

Examples of Key Features