2. Definition SpecIfIcatIons
An annotated case report form (CRF) is a blank CRF with annotations that document the location of the data with the corresponding names of the datasets and the names of those variables included in the submitted datasets.
SpecIfIcatIons
The annotated CRF is a blank CRF
Maps each item on the CRF to the corresponding variables in the database
Should provide the variable names and coding for each CRF item included in the data tabulation datasets
All of the pages and each item in the CRF should be included
Ratilan Technologies Inc - SMART aCRF -

3. WHAT ARE THE CHALLENGES
CRF Annotation is manual and time consuming.
Time and effort spent in Annotation is not transferable to subsequent annotation efforts (Studies in same therapeutic area) .
Annotation effort is not customizable and repeatable.
WHY Smart aCRF
The Tool significantly reduces the manual effort in CRF Annotation via the Annotation Repository.
The Annotation Repository will be a growing body of Keyword–Annotation pairs.
Annotations and Annotation attributes can be created/modified easily and saved into the Annotation Repository for repeat usage.
Smart learning within the application and practical use augment the repository the more the application is used.
The Tool facilitates Reverse Engineering of existing Annotated CRF’s to Learn Keywords and Annotations for storage and future usage.
Storage of Annotated CRF’s generated facilitates future full Re-Use and Comparison.
Comes preloaded with CDISC/Sponsor defined Metadata and the recommended default Text and Annotation attributes.
Ratilan Technologies Inc - SMART aCRF -

4. Types of Annotations Domain with Domain Label Variable
Descriptive/Comment
Associative
Free Form
Reference
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5. AnAtomy of an annotation
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6. Anatomy of an annotation
KeyWord
Domain
Variable
Annotation
CDISC
Sponsor
CDISC
Sponsor
Annotation Attributes DB
Annotation Repository
Annotation
Location Attributes
Ratilan Technologies Inc - SMART aCRF -

7. What is the Annotation Repository
It is a combination of a Keyword with its associated Annotation and its Physical and Locational attributes.
Example –
Keyword DEMOGRAPHY
DOMAIN DM
Annotation
Physical Attributes Font color: Dark Blue
Fill-in color: Light Blue
Font Type: Arial Bold Italic
Font size : 12-point
Border: Yes
Location Attributes ,0 (Top of Page).
The full inventory of Keywords with Annotations of a/any blank CRF represents the Annotation Repository
How does it Work
User uploads a blankCRF document
Application analyses/reads the CRF for any/all matches of Keywords
Application automatically applies the associated Annotations to Keywords found in the blankCRF
Using Application User can highlight new Keywords and create Annotations with attributes. This Keyword-Annotation pair is saved into the Annotation Repository for repeat usage.
Drag and Drop and Modify an Annotation as is relevant
Save it for repeat future use.
Ratilan Technologies Inc - SMART aCRF -

8. TOOL
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9. What are the Key ASPECTS of SMART aCRF
Reports
Matched Keywords Reports
Un-Matched Keywords Reports
Un-Matched Annotation Reports
Duplicated Pages Summary
What are the Key ASPECTS of SMART aCRF
Annotation Repository – A Growing body of Keywords and Annotations (with attributes).
Custom/Sponsor Metadata can be easily integrated into the database.
Reverse Engineer existing Annotated CRF to Machine Learn both Keywords and Annotations.
Annotation Repository can be built with/using File Based input.
Comes Pre-Loaded with the CDISC Metadata and default Annotations.
Eliminates manual task significantly and progressively.
Ratilan Technologies Inc - SMART aCRF -

10. Ratilan Technologies Inc - SMART aCRF - www.smartacrf.com
QUESTIONS
Ratilan Technologies Inc - SMART aCRF -

12. Ratilan Technologies Inc - SMART aCRF - www.smartacrf.com

13. WHAT ARE THE CHALLENGES
Technical
Understanding of XML and thorough understanding of the CDISC-specific XML structure of Define.xml.
Manual and time consuming.
In-Effective reuse of existing/previous Study Metadata.
Mapping and Re-Use of Metadata between CDISC Metadata & Sponsor designed standards (including metadata, IE Version, PDF Version, Controlled terminologies etc..)
Administrative
FDA Binding Guidance in effect from December Sponsors whose studies start after December 17, 2016 must submit data in FDA-supported formats listed in the FDA Data Standards Catalog -
WHY DEFINE R3
Meets all the above challenges.
Comes preloaded with CDISC/Sponsor defined Metadata and Control Terminologies.
Ease of upload on various versions of CDISC Metadata with Sponsor Defined Metadata for use across changes in versions.
Easy Integration of new CDISC Metadata Standards/sponsor defined standards and Control Terminologies versions/releases.
Facilitates Consistent and Predictable time/effort from Study Creation to Define XML.
Facilitates Use and Re-Use of existing/previous Study and Project Metadata.
Define XML can be ‘quickly’ generated for single datasets or multiple.
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14. Our Process
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15. Application
Ratilan Technologies Inc – Define R3 -

16. What are the differentiators
Application can be installed as a Standalone Client Application or accessed as a Cloud based Web Application supporting study types - SDTM/ADaM.
Comes Pre-Loaded with the CDISC Metadata and Control Terminologies
Easily map and Re-Use Sponsor Defined Metadata standards with CDISC Metadata.
Supports single user and multi user environments with connectivity to a variety of databases.
Create Study / Upload XPT's & Annotated CRF / Process and View as Define XML - in minutes.
Reverse Engineer Define XML from related studies for Re-Use in Study Metadata.
Progressively Add XPT's/Edit Study Metadata/Edit Exception Report and view in Define XML specification format.
View and Edit all Exceptions, Study Metadata - Domain, Variable, Value, WhereClause, Codelist, External Codelist, Computation Methods and Reference Docs in place
Eliminate manual task significantly
Ratilan Technologies Inc – Define R3 -