Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS)

@arockley
www.rockley.com©2015 The Rockley Group, Inc.

@arockley
Managing the Complexities
of the Core Data Sheet
Ann Rockley, President
The Rockley Group

@arockley
The Rockley Group
• More than 15 years’ experience in
Healthcare
• Clinical
• Labeling
• Promotional
• Industry experts
• Structured content strategy
• Content reuse
• Structured content management systems
• Content globalization strategy
• Multichannel delivery

@arockley
Rockley Customers

@arockley
Ann Rockley
• Known as the “mother of content
strategy”
• Forefront of content strategy, reuse,
structured content management,
multichannel delivery (print, Web,
eBook, mobile)
• Passionately committed to defining
and sharing industry best practices
• Master of Information Science
• Fellow of the Society for Technical
Communication

@arockley
Disclaimer
• This presentation is not a recommendation for content for
your core data sheet or associated labeling, only your
regulatory group and other authorized personnel can
specifically identify your requirements.
• This presentation is designed to provide an understanding
of how you can more effectively create and manage your
core data sheet

@arockley
What is a core data sheet?
A document prepared by the applicant containing, in
addition to safety information, material relating to
indications, dosing, pharmacology, and other information
concerning the drug substance (biological product for
proposed Sec. 600.80(a)). The only purpose of this
document is to provide the company core safety information
(CCSI) for periodic safety update reports (PSUR), interim
periodic safety reports (IPSR), and certain individual case
safety reports – semiannual submissions (i.e., if PSURs are
submitted for the product).
[Technical Requirements for Registration of Pharmaceuticals for Human Use, the ICH E2C Rev. 1]

@arockley
• A primary reference document that contains:
• Indications
• Dosing requirements
• Method(s) of administration
• Patient population concerns
• Packaging and storage
• Incompatibilities
• Pharmacological properties

@arockley
“Your core data should represent the up-to-minute
information for a particular product as it concerns
indications, pharmacology and safety information.”
Perfecting Your Company Core Data Sheets http://bit.ly/1EINLOG

@arockley
• The core source for your labeling

@arockley
CDS as source

@arockley
USPI
• United States Package Insert (Prescribing Information)

@arockley
USPI structure

@arockley
SmPC
• Summary of Product Characteristics (SmPC)
• Also referred to as SPC
• Used by healthcare professionals

@arockley
SmPC structure

@arockley
PIL
• Patient Information Leaflet (PIL)
• Also called:
• Package Leaflet (PL)
• Package Insert (PI)
• Patient friendly version of the Summary of Product
Characteristics

@arockley
Medication Guide
• Paper-based guide for patients
• Patient friendly version of the USPI
• Required when FDA determines:
• Certain information is necessary to prevent
adverse effects
• Patient should be informed about a serious side effect
• Patient adherence to directions are essential to
effectiveness

@arockley
What should go into your CDS?
• FDA recommends:
• Indications
• Dosing requirements
• Method(s) of administration
• Patient population concerns
• Packaging and storage
• Incompatibilities
• Pharmacological properties
• Leaves a lot to the organization to determine exactly what
goes into the CDS

@arockley
What should go into your CDS?
• Content needed to provide an efficient approach to
evaluating safety
• Generate:
• USPI
• SmPC

@arockley
Compare USPI and SmPC sections

@arockley
• Some sections may map directly to each other
• Some sections may be buried (e.g., don’t have a separate
header/title) in another
• Some sections may not be present in both
Compare USPI and SmPC sections

@arockley
Compare content
• Compare content in common sections
• Probably find that the content is similar, but expressed
differently
• Could the content be identical regardless of Health
Authority?
• If there is a very good reason for the content to be similar
not identical, can part of it be the same?

@arockley
Creating the CDS
• Develop a consistent structure for the CDS
• Identify which sections are required and which are optional
• Identify which sections may be unique to one Health
Authority versus another
• Work towards identical use/reuse of content in each label

@arockley
Components not documents
• Each section in the CDS becomes a separate component
• Order doesn’t matter. Order, and associated numbering is
applied as the content is assembled and published
• Content is reused, not copy and pasted

@arockley
Reuse

@arockley
Structured content management system
©Nathan Sawaya http://www.fastcocreate.com/1682144/making-lego-into-art-
nathan-sawayas-impossible-brick-sculptures#1
• Manages content at a granular
(component) level of content, rather
than at the page or document level.
• Each component represents a
single topic, concept, or asset (such
as an image or table).
• Components are assembled into
multiple content assemblies
(information products) such as a
CDS, USPI, SmPC.
• Each component has its own
lifecycle (owner, version, approval,
use) and can be tracked individually
or as part of an assembly.

@arockley
Control
• Elimination of manual processes
• Content is managed in source, not output
• Change in CDS results in notification of change
• Content is tracked at every point in the lifecycle
• Strict attention to version control, permission for change

@arockley
Auto-population
• You could automatically generate the content for the USPI
or SmPC
• Review and approval would of course be necessary, but
no more copy/paste or subjective rewriting the content

@arockley
Identical vs. derivative
• Identically reuse content where possible
• While identical content in all outputs is desirable it isn’t always
possible due to Health Authority feedback
• Derivatively reuse content when necessary
• Content is reused from the common CDS then a variation on the
source is created (derivative)
• A relationship exists between source and derivative, when the
source changes the creator/owner of the derivative is notified of the
change
• The creator/owner can choose to incorporate the changes or not
• Complete audit trail of changes and derivatives
• Authors can only reuse source not derivatives unless the derivative
is promoted to alternate source (e.g., common regions)

@arockley
Collaboration
• Authoring is collaborative, many authors can put content
into the CDS and see each others’ input
• Requests for change can be identified in the regions and
potentially incorporated globally
• Review is collaborative, reviewers can review
simultaneously and see and comment on others’ review
comments

@arockley
Resistance to change
• Perceived differences in requirements
• Everyone starts with the same then if required,
derivative content can be created
• Not being created by the region
• If input and creation of the CDS is collaborative, these
issues diminish
• Loss of control
• Control is collaborative
• Reduced workload due to reuse enables region to
focus on real value-add for their region, not mechanical
tasks

@arockley
Overcoming resistance
• Educate
• Welcome participation and input
• Expect problems, deal with them and move on

@arockley
Beyond the basics
• Derivative versions of content can be created for patients
(Medication Guide, PIL). Change in core can automatically
identify changes required elsewhere
• Reusable content (e.g., indications, storage and handling)
can be automatically reused into:
• Packaging
• Promotional (sell sheets, reimbursement details, web
site, speaker decks)
• Learning (in-service training)
• Wherever the same content appears it can be reused from
the CDS

@arockley
Summary
• Don’t handcraft your core data sheet. Create and manage
it intelligently:
• Structured
• Modular (components not documents)
• Reusable
• Controlled

You can watch this webinar with
Ann Rockley on the BrightTalk Channel at:
https://www.brighttalk.com/webcast/9273/146091

Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS)

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS)

Similar to Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS) (20)

More from Ann Rockley

More from Ann Rockley (11)

Recently uploaded

Recently uploaded (20)

Ann Rockley — Managing the Complexities of the Core Data Sheet (CDS)