Key Considerations for Report
Generation & Customization
Richard Wzorek
Director, Production IT
Confidential © Almac Group 2012
Agenda
Introduction
Review the Pros and Cons of Varying Report Types
The Effects of Downstream Workflows on Reporting Standards
Levels of Reports Customization
Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting
Q&A
Introduction
Q: Why is report customization an important topic?
– A: 85-90% of a sponsor user’s time within an IVR/IWR
system is spent in reports
Q: Who can be impacted by reports customizations
and the information they produce?
– A: Clinical team, operations, data management,
informatics, logistics, etc.
Introduction
Q: What impact does reports user roles play in
implementing customizations?
– A: Reports have some of the highest potential for multipatient unblinding when the wrong user role is assigned
Q: How is the information in the report used?
– A: This is crucial to flesh out during requirements to
ensure usability
Introduction
Review the Pros and Cons of Varying Report Types
The Effects of Downstream Workflows on Reporting Standards
Levels of Reports Customization
Unique trial designs that require heavily customized or ad-hoc reporting
Q&A
Categories of Reports
Static flat reports
– A report that outputs fixed results and offers little
to no dynamic adjustments (i.e., PDF files, Excel
spreadsheets, HTML)
Dynamic flat reports
– A report that outputs fixed results and offers dynamic filtering and
sorting (i.e., web reports that require input form the user before they
rerun)
Fully interactive reports
– A report that supports filtering, sorting, grouping, drill down, and drill
through (i.e., a web based dashboard)
Static Flat Reports
PROS
Easy requirements
acquisition process and
training
CONS
Lack of flexibility
Reports will generate the
same output (format &
content)
Often require post live
amendments
Good for situations where
the data will be imported
into a downstream
system or process
A sponsor will often
require a large number
of these type of reports
to address their needs
Dynamic Flat Reports
PROS
The ability to dynamically
filter reduces the number
of report needed
CONS
More involved
requirements acquisition
process
Data can be exported as
static and some of the
after export effort is
reduced
Increased need for user
training
Output format stays
consistent
Data must be modeled
correctly to ensure high
performance
Fully Interactive Reports
PROS
The user can identify and
focus on outliers quickly
CONS
Requirements
acquisition requires
more engagement
Ability to “drill” into
details in real time
Requires more training
and burn in time
Filtering and sorting are
context sensitive
Requires data to be
modeled and preaggregated to deliver high
performing reports
Introduction
Review the Pros and Cons of Varying Report Types
The Effects of Downstream Workflows on Reporting Standards
Levels of Reports Customization
Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting
Q&A
Effects of Workflow
How is the information in the report used?
Results viewed on the screen drive real-time actions in the IVR/IWR
system
Printed and brought into meetings
Saved to PDF and emailed to a distribution list
Exported to excel and additional information and formatting is
added
Exported to excel and the results are added into another
spreadsheet or system
Effects of Workflow
Results viewed on the screen drive real-time actions in the
IVR/IWR system
Printed and brought into meetings
A report is the correct tool
Saved to PDF and emailed to a distribution list
Should this be an automated process?
Exported to excel and additional information and formatting is added
What are the chances of manual errors?
Exported to excel and the results are imported into another system
Should this be a data transfer or integration?
Effects of Workflow
Understanding how the reports and the information
they provide are used will pave the way to achieving
effective standardized reporting.
Reduced study level
customizations
Easier
requirements
acquisition
process
Reduced need
for re-training
on every study
Effective
Standardized
Reporting
Introduction
Review the Pros and Cons of Varying Report Types
The Effects of Downstream Workflows on Reporting Standards
Levels of Reports Customization
Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting
Q&A
Types of Customizations
Simple Customizations
Using the standard or core reports offered with the
small changes necessary to make them work with the
specific protocol. These types of changes do not
typically necessitate changes in reports standards.
Examples:
• Addition and removal of data points
• Changes to static sorting
• Changing labeling of data points, etc.
Types of Customizations
Moderate Customizations
Using a standard or core report with more than 30% of
the functions within the report changed. These types of
changes may necessitate changes in reports standards
to help contain costs.
Examples:
• Changes to the way the data is grouped
• Adding custom calculations
• Using custom sort lists, etc.
Types of Customizations
Custom Reports
This entails starting from scratch or customizing more than
50% of the functions within the report. These types of
changes should drive standards discussions. This is the most
important area to understand the differences between needs
and wants.
Examples:
• Custom dashboards
• Repurposing part of a report
• Predictive analytics
Introduction
Review the Pros and Cons of Varying Report Types
The Effects of Downstream Workflows on Reporting Standards
Levels of Reports Customization
Unique Trial Designs That Require Heavily Customized or Ad-hoc Reporting
Q&A
Ad-hoc Reporting
Q: Do I need Ad-hoc reporting capabilities?
– A: With a well defined and built suite of interactive reports
this will most often not be necessary.
Q: How do I know when this
functionality will be needed?
– A: In data collected from over 500 trials, the biggest users
of Ad-hoc functionality are from global logistics when they
are working across a large program of studies.
Unique Trial Designs
& Reporting
• Multiple treatment arms with each arm having a
different visit schedule
• Adaptive trials that add or drop treatment arms
• Unique cohort management methods
• Complex site and IP hierarchy
– Sites: Region, Cluster, Country, Site
– IP: Lot, box, kit, vial
Key Takeaways
Understand the workflows the data within the
reports will be used to support
Ask yourself who needs to be involved in reporting
requirements acquisition
Balance cost savings and value when
determining the correct solution
Thank You!