1 Building an eSubmissions System Ed Tripp Program Director Abbott Laboratories.
-
Upload
silvester-sharp -
Category
Documents
-
view
215 -
download
0
Transcript of 1 Building an eSubmissions System Ed Tripp Program Director Abbott Laboratories.
1
Building an eSubmissions System
Ed TrippProgram Director Abbott Laboratories
2
Pharmaceutical Drug Applications
Typical drug product is 10 years in development Must apply for approval by Regulatory Authority (such as FDA) before marketing Must show both safety and efficacy Typical approvals approximately 1 year
after submission
Exclusivity determined by patent life
3
Size of a Submission
10 years of data and document Typical 1,000 volumes In paper that stack is 16 stories tall
7 to 20 gigabytes of documents and data Reviewer expects to be 3 mouse clicks from any data Heavily bookmarked and hyperlinked
4
Cost Model
IntroductoryStage
GrowthStage
MaturityStage
Decline Stage
TotalMarketSales
Time
End of Patent Life, Generic Competition Enters Market
Regulatory Approval
• Average Drug ends exclusivity at about $400MM/year• Delay in submission approval compresses curve• Cost of delay $1MM per day ($12.68/second)
5
Key Documentum Functions
Workflow and Electronic Signature Speed and Accuracy
Organization (Indexing/Folders) Key to putting together successful NDA for
the FDASecurity regarding Documents Patient Records – Insider Information
Multiple document types Word, Excel, SAS, Image, + others all need
to be combined in a easy to read format
6
Current State?
How do you store documents and data and how do you process Submissions?
7
Source Documents
Check all that apply
CMC Clinical Non clinical
Regulatory
DMS
File share
Local discs
Paper system
Are your Document Management Practices–Well documented?
–Disciplined?
–Ad hoc?
How are they managed today?
8
Source Documents
Check all that apply
CMC Clinical Non clinical
Regulatory
US
EU
Japan
Canada
Caribbean
India
China
Where are they located?
9
What Will You Keep in the Submission System?
A. Only documents to be submitted?B. Documents that may be submitted?C. Submission and Trial Master file
documents?D. Documents and data sets?E. XML Labeling?F. All of the above
10
Submissions: What Regions Will Be Supported?
USEUJapanCanadaAustraliaOthers?
For Submissions?For Document Management?
11
Submissions: What Process Do You Currently Use?
Submissions in Paper Printed from electronic files Xerox and Paginate
Submissions Electronic eCTD eNDA eBLA eIND Other electronic formats
What do you want to support with your new system?
Submission types Products: Only Drugs? Include Vet Meds? Device?
12
Migration
Will you be migrating documents into the new system From retiring docbase? From File Share? From Local Files? From system you acquired?
Migration can be 10%-20%of your total project cost!
13
Security Model
Who has access in the new system?
14
Document Based
By Document Most management
overhead Who Decides?
By Doctype
State
Clinical Ops
Clinical CMC RA Non Clin
Draft Version
Read Browse Browse Browse
Approved Read Read Read Read Read
Superseded Read Read Read Read Read
Obsolete Browse
None None None None
Example: ClinSupply Doctype
15
Function Based Security
All in function have same rights Example: Everyone in clinical function
can view and edit draft documents
Moderate number of groups to manage Provided you think of functions
broadly Harmonize processes where possible
16
Role Based
All in a given role have same rightsExample:
State
Author Reviewer Approver
Draft Version
Relate Read
Approved Read Read Read
Superseded Read Read Read
Obsolete Browse
Browse Browse
17
System Ownership
Most documents by created by R&DSubmissions responsibility of RADocument Ownership
2%
8%
15%
75%
ClinicalNon clinicalQualityRegulatory
Typical percentages
18
Deployment
How do you deploy the system? Thick Client? Thin Client? Application Delivery Software?
Do you deploy the same way everywhere?What is your enterprise bandwidth for each site?
19
Document Repository Structure
How to best configure a for users?
20
Document/Folder Structure
By Product? How development thinks and works
By Submission? How regulatory thinks and works
Who creates structure? IT request? User tool to create from a template? Created from metadata?
21
How Many States?
DraftFormattedReviewedRoutingApprovedFDA ApprovedSupercededObsolete
22
How Many Different Lifecycles?
LabelingCorrespondenceSubmission documentsData setsTemplatesCompiled publicationsVirtual Documents
23
How Will You Handle Draft Versions?
Deletion on approval or retain?Start with v0.1 or v1.0?Does a change in properties trigger a new version?
24
Will You Use Electronic Signatures?
Is an eSigned document identified vs non signed but approved document?Will you use SAFE?Will you use UID and Password?
25
Do All Documents Process Through Workflows?
Can you delegate a workflow?Can priorities be assigned?Can you add workflow participants?What will trigger user notification? When they have a task? When documents become approved? When documents change state? When one person rejects a document?
26
Workflow Considerations
Can you include multiple documents? Will multiple documents have
individual outcomes?
Can documents be promoted without workflows? Who can promote documents?
27
Workflow Example
SupersededvX.0
DraftApproved*
vX.0DraftvX.Y
ForReview
Workflow
PendingvX.Y
For Approval Workflow
*Becomes superseded if a newer version is approved starting at 2.0.
ObsoletevX.0
Rejected
w/Comments
New Draft Version
Manual transition performed by user
Automatic transition performed by system
For eSignature Workflow
User Promote
User edits
28
What Will You Audit Trail?
All actions taken?Approval functions only?Are audit trails available to the user?
29
How Will You Handle Amendments and Errata?
Do you need to change your current practice to version the whole document?How do you relate an errata page to the document?Do all both Clinical and Non Clinical have the same process?
30
Can You Annotate Documents in Review?
Can all reviewers see all annotations?Can you annotate off line?Do annotations get purged? When?
31
Content Creation
Scan Content OCR or not?
Create with Templates Will you manage templates in the system Will you make them available outside the system Who owns the templates
Create from blankCreate from copy of existing DocumentVirtual DocumentsImport ContentAre there document relationships
32
Content Creation Continued
When is a rendition triggered? Upon check in? Only if content is changed? Only when moving beyond draft state? What file formats?
Who can create content?Who can edit content? Centralized Medical Writers?
33
What File Types and Applications Do You Support?
Documents MS Word (what version) Adobe Acrobat (FDA requires v1.4 PDF) XML Text files
Graphics JPG
Data SAS Transport XML
Others?Need to specify application version and service packs
34
Bookmarks and Hyperlinks
Will your system create bookmarks from Word document styles? Training implications
Who creates bookmarks for scanned documents?How do you create and manage hyperlinks? Internal to documents Cross document hyperlinks
35
Where Will You Store a Submission?
You need to publish to a fileshare Consider eCTD, other electronic submissions, files to generate a paper submission Docbase?
Do you want active links? How do you move all folders and files?
File Share? Need a security process
36
Metadata Management
Its not just about the content
37
Metadata
Will you create a doc unique ID? You WILL migrate in the future, so think
about a unique ID that does not change from Docbase to Docbase.
Will you utilize value assist?Are there non required fields? Why?Can changes be made to metadata without versioning a document? Submission number may not be known at
time of submission
38
Will You Utilize Dictionary Files?
Who manages the files?What is the update process?Are there relationships? Example: a Clinical Study has one Number and
many investigators
Document the authoritative source of terms ICH specification NCI EVS Thesaurus Snomed or Medra Other
39
How Will You Use Metadata?
Do you pass metadata to submission software? DocID for filename eCTD leaf title Species Indication Other STF metadata
What metadata do you expose for searching Is the out of the box search tool sufficient Full text indexing? Is it worth performance issues?
Do you need a reporting tool?
40
External Interface Needs
Do you work with Partners? Provide access to part of your
system? Work through FTP? Internet Portal?
Who manages access and content?
41
Internal Interfaces
Bulk import solutionScanning solutionSubmission tracking systemCommitment tracking systemEmail systemOther docbasesRendering servicesReporting toolsPublishing software
Will published submission reside in the docbase
42
Training Considerations
How savvy is your organization?
Secretary has to do my e-mail
IT comes to me for help
How do they learn best? ILT CBT Webcasts
43
Training Continued
How familiar is the organization with electronic submissions? eCTD?Docbase related topics
More complex Security Version Management Meta Data Search functions
Authoring related topics Submission Ready Documents Template use Software restrictions
44
Sample Architecture
Inside Firewall
File Share
Documentum
Development Environment
Documentum
Training Environment
Documentum
QA/Val Environment
Documentum
Production Environment
Paper Publishing
eCTD Publishing
Development Environment
Paper Publishing
eCTD Publishing
QA/Val Environment
Paper Publishing
eCTD Publishing
Production Environment
Docs and DataSubmission
Sub
missio
n
Electronic Submission Gateway
Web Portal for Partners
Rendering Software
User Tools
MS Office
Templates
Adobe
Annotation
SPL Labeling
Scanning Software
Bulk Import Tool
Future Integration:Submission TrackingCRF TrackingInternal collaborative space
45
Build vs. Buy
Not all configurations are created equal Configurations you can do internally Configurations that must be delivered
What is your internal IT expertise?Do you keep up with releases or keep systems as is for several years?
46
The Environment Is Not Stable
eCTD r3.3.3RPS r2XML ProtocolsXML datasetsSPL r4Electronic clinical data capture
Make sure you can react to
changes for the next 5-8
years
Make sure you can react to
changes for the next 5-8
years