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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:[email protected]
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