ProtoType Fellows Presentation - ippcr.nihtraining.com Web Based Protocol Writing System ProtoType:...
Transcript of ProtoType Fellows Presentation - ippcr.nihtraining.com Web Based Protocol Writing System ProtoType:...
A Web Based Protocol Writing SystemA Web Based Protocol Writing System
ProtoTypeProtoType::A New Tool for AuthoringA New Tool for Authoringand Managing Clinicaland Managing ClinicalProtocols Developed at the CCProtocols Developed at the CCPresented by Philip LightfootPresented by Philip Lightfoot
National Institutes of Health, Clinical CenterDepartment of Clinical Research Informaticsand Protocol Management ServicesBethesda, MarylandFebruary 22, 2010
Agenda Agenda –– Topics to DiscussTopics to Discuss
- What is ProtoType?
- Overview of ProtoType’s Features
- Value Added for the Researcher
- Usage Statistics
- Where We’re Going - Future Development
Why Why ProtoTypeProtoType??ProtoType was created for several reasons…
- Writing a clinical protocol is hard work.
- Currently, there is little standardization between
protocols.
- NIH policies and regulations can change requiring
updates to several forms in the protocol.
- Paper protocols are large, and costly to print out
many times.
- Training tool – Learning how to write a protocol is
awkward and difficult.
What is What is ProtoTypeProtoType??
Features of Features of ProtoTypeProtoType- Fully customized documents tailored toward
individual IRBs.
- Investigators focus on authoring - ProtoType takes
care of the rest.
- Full version history of the entire protocol for both
internal and external review.
- Support for full collaboration among investigators in
every aspect of protocol authoring.
Customization and FlexibilityCustomization and Flexibility
- Format is NIH IRB-specific- Only relevant fields appear (e.g. Natural
history study vs. Clinical Trial study)- Recommended language cassettes can be
designated for all parts of the protocol- Rapidly integrates new NIH policies.
Ease of UseEase of Use
-- Single SignSingle Sign--on (NIH standard login).on (NIH standard login).
-- Full Microsoft Word Compatibility.Full Microsoft Word Compatibility.
-- Portable images (cut & paste from anywhere).Portable images (cut & paste from anywhere).
-- Protocol image library for use throughout the Protocol image library for use throughout the protocol.protocol.
-- Robust Reference Management.Robust Reference Management.
-- Supports import from Supports import from QuosaQuosa Reference Manager, and Reference Manager, and PubMedPubMed..
Creating a ProtocolCreating a Protocol
Protocol LayoutProtocol Layout
Using Standard LanguageUsing Standard LanguagePrePre--Loaded Standard LanguageLoaded Standard Language
Principal InvestigatorPrincipal InvestigatorWelcome to Welcome to ProtoTypeProtoType
My ProtocolsMy Protocols
Edit FeaturesEdit FeaturesOpening the EditorOpening the Editor
Edit FeaturesEdit FeaturesEditor OverviewEditor Overview
Edit FeaturesEdit FeaturesAdding a ReferenceAdding a Reference
To add a reference, mouse over the
reference and click.Reference added to the text.
Edit FeaturesEdit FeaturesAdding an ImageAdding an Image
Images can be pasted into the text, or from your image library. To add an image click on the
“Insert Image” button.
Clicking this button
displays images
specific to this protocol.
Images can be chosen from
your computer.
Protocol images are listed here.
Click Okay to Insert
the image.
Edit FeaturesEdit FeaturesAfter the Edits Before the EditsAfter the Edits Before the Edits
Help FeaturesHelp FeaturesOpening Help LanguageOpening Help Language
Click the Help button to get
context specific help.
A new window opens with help specific to that
section.
Track Changes and FeedbackTrack Changes and Feedback
ProtoTypeProtoType supports three different methods for supports three different methods for reviewing the protocol and providing feedbackreviewing the protocol and providing feedback……
-- Integrated track changes in the editor.Integrated track changes in the editor.
-- The ability to compare protocols at different The ability to compare protocols at different dates or different actions (i.e., comparing dates or different actions (i.e., comparing ‘‘07 CR 07 CR against an against an ’’08 CR).08 CR).
-- Fully featured feedback and comment system Fully featured feedback and comment system from cofrom co--authors, reviewers, etc.authors, reviewers, etc.
Editing the ProtocolEditing the ProtocolIntegrated Change TrackingIntegrated Change Tracking
Red Text has been edited by
Philip Lightfoot.
Blue text has been edited by John Doe,
M.D.
Version History ComparisonVersion History ComparisonComparing protocols across time.Comparing protocols across time.
Click here to compare versions.
Old Text Crossed Out And In Red.
New Text Colored Yellow.
Current Version of the
Protocol
Version Being Compared
Against
Protocol FeedbackProtocol FeedbackComment CreationComment Creation
Change tracked edition
ready for review.
Full comment chain directly in
body of protocol.
-- Recommended Language Cassettes for protocol body and consent Recommended Language Cassettes for protocol body and consent forms.forms.
-- Online archive of all Online archive of all PIPI’’ss protocols.protocols.
-- Amendments immediately incorporated into protocol.Amendments immediately incorporated into protocol.
-- Protocol moves electronically to IC, IRB, CC, etc.Protocol moves electronically to IC, IRB, CC, etc.
-- IRB can recommend language changes.IRB can recommend language changes.
-- Tracks states of the protocol, i.e. Amendment, Continuing RevTracks states of the protocol, i.e. Amendment, Continuing Review, and iew, and Termination.Termination.
-- Template updated based on NIH policies/regulatory changes, i.Template updated based on NIH policies/regulatory changes, i.e. COI.e. COI.
-- Continuing review report Continuing review report -- Summary of amendments and protocol Summary of amendments and protocol changes.changes.
Value Added for the ResearcherValue Added for the Researcher
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Coming SoonComing Soon
-- Integration with IC Systems.Integration with IC Systems.
-- Improved collaborating site interface to assist 1195 prep.Improved collaborating site interface to assist 1195 prep.
-- IND Wizard coIND Wizard co--developed with FDA.developed with FDA.
-- Adverse Event Reporting.Adverse Event Reporting.
-- Assisted Compliance with Public Law 110Assisted Compliance with Public Law 110--85.85.
-- NIDDK, NHGRI, and other templatesNIDDK, NHGRI, and other templates
-- …… and many more.and many more.
Where WeWhere We’’re Goingre Going
ProtoTypeProtoType ContributorsContributors
- Dr. Barbara Karp (NINDS)- Kim Jarema (CC)- Dr. Hans Ackerman (CC)- Dr. Richard Cannon (NHLBI)- Dr. Codrin Lungu (NINDS)- Dr. Robert Nussenblatt (NEI)- Philip Lightfoot (CC)- Dr. Jon McKeeby (CC)- Ryan Kennedy (CC)- Dr. Aviva Ellenstein (NINDS)
- Dr. Sara Hull (NHGRI)- Dr. Stephen Rosenfeld (CC)- Heather Bridge (NIAID)- Patricia Magno-Sweet (NHBLI)- Bill Barrick (NIAID)- Dr. Marcus Heilig (NIAAA)- Elaine Ayres (OD)- Dr. Ekaterina Tsilou (NEI)- Dr. Juan Lertora (CC)- Dr. James Cimino (OD)
And many more….!
ProtoTypeProtoType
We encourage you to use ProtoTypeProtoType
To visit ProtoType go to…http://prototype.cc.nih.gov
The link is also available from the OPS website…http://intranet.cc.nih.gov/ops/links.html
ProtoTypeProtoType ContactsContacts
Phil Lightfoot Kim Jarema(301) 496-3343 (301) 435-2401
[email protected] [email protected]
Ryan Kennedy(301) 402-4867