01
01
CLINICAL OPERATIONS
CLINICAL OPERATIONS
Study conduct inputs, protocol milestones, and operating status.
Study conduct inputs, protocol milestones, and operating status.
REGULATORY DISCLOSURE
One public record. Every milestone aligned.
One public record. Every milestone aligned.
One public record. Every milestone aligned.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
CLIENT AUTHORITY REMAINS EXPLICIT AT EVERY RELEASE POINT.
CLIENT AUTHORITY REMAINS EXPLICIT AT EVERY RELEASE POINT.
FIVE DISCLOSURE DOMAINS
FIVE DISCLOSURE DOMAINS
01
01
PLANNING & COORDINATION
PLANNING & COORDINATION
→
→
02
02
REGISTRATION & RECORDS
REGISTRATION & RECORDS
→
→
03
03
CTIS & RESULTS
CTIS & RESULTS
→
→
04
04
REDACTION & CONFIDENTIALITY
REDACTION & CONFIDENTIALITY
→
→
05
05
QUALITY REVIEW & READINESS
QUALITY REVIEW & READINESS
→
→
REGULATORY DISCLOSURE
One public record. Every milestone aligned.
KARAMATA coordinates approved sources, accountable ownership, review points, and disclosure milestones from planning through release. You retain final authorization and release authority.
CLIENT AUTHORITY REMAINS EXPLICIT AT EVERY RELEASE POINT.
THE OPERATING PROBLEM
Disclosure work fragments where decisions meet.
Disclosure work fragments where decisions meet.
Disclosure work fragments where decisions meet.
Disclosure work fragments where decisions meet.
Multiple functions, sources, and handoffs introduce gaps, delay, and version confusion. The result: extra cycles and risk at release.
Multiple functions, sources, and handoffs introduce gaps, delay, and version confusion. The result: extra cycles and risk at release.
Multiple functions, sources, and handoffs introduce gaps, delay, and version confusion. The result: extra cycles and risk at release.
SIX CONTRIBUTING FUNCTIONS
SIX CONTRIBUTING FUNCTIONS
02
02
REGULATORY AFFAIRS
REGULATORY AFFAIRS
Registrations, submissions, correspondence, and approvals.
Registrations, submissions, correspondence, and approvals.
03
03
MEDICAL WRITING
MEDICAL WRITING
Summaries, tables, figures, and narrative deliverables.
Summaries, tables, figures, and narrative deliverables.
04
04
BIOSTATISTICS
BIOSTATISTICS
Analysis plans, datasets, tables, listings, and outputs.
Analysis plans, datasets, tables, listings, and outputs.
05
05
PRIVACY
PRIVACY
Personal-data and confidentiality questions; redaction decisions.
Personal-data and confidentiality questions; redaction decisions.
06
06
EXTERNAL VENDORS
EXTERNAL VENDORS
CROs, laboratories, and specialists with defined handoffs.
CROs, laboratories, and specialists with defined handoffs.
FIVE DISCLOSURE DOMAINS
Five domains. One unified public record.
Five domains. One unified public record.
Five domains. One unified public record.
Five domains. One unified public record.
DISTINCT DOMAINS / CONNECTED SOURCES, DECISIONS, QUALITY, AND RELEASE
DISTINCT DOMAINS / CONNECTED SOURCES, DECISIONS, QUALITY, AND RELEASE
DOMAIN LEDGER
DOMAIN LEDGER
DOMAIN
DOMAIN
KEY INPUTS
KEY INPUTS
KARAMATA OUTPUTS
KARAMATA OUTPUTS
CLIENT DECISION POINTS
CLIENT DECISION POINTS
01
01
Disclosure planning & coordination
Disclosure planning & coordination
Disclosure obligations, protocols, milestones, sources, roles, tools.
Disclosure obligations, protocols, milestones, sources, roles, tools.
Work plan, milestone map, source inventory, assignment matrix, decision log.
Work plan, milestone map, source inventory, assignment matrix, decision log.
Confirm scope and milestones. Approve plan and ownership.
Confirm scope and milestones. Approve plan and ownership.
02
02
ClinicalTrials.gov registration, results & record maintenance
ClinicalTrials.gov registration, results & record maintenance
Protocol, SAP, CSR, results datasets, approved documents, change logs.
Protocol, SAP, CSR, results datasets, approved documents, change logs.
Registration package, results summary, updates, correction packages.
Registration package, results summary, updates, correction packages.
Authorize registration. Approve updates and corrections.
Authorize registration. Approve updates and corrections.
03
03
CTIS transparency & results preparation
CTIS transparency & results preparation
Agreed pathway requirements, approved clinical data and summaries.
Agreed pathway requirements, approved clinical data and summaries.
Agreed preparation package, source set, open-decision and readiness record.
Agreed preparation package, source set, open-decision and readiness record.
Confirm applicability and submission role. Approve content before submission.
Confirm applicability and submission role. Approve content before submission.
04
04
Redaction, anonymization & confidentiality review
Redaction, anonymization & confidentiality review
Source documents, privacy rules, confidential fields, approved policies.
Source documents, privacy rules, confidential fields, approved policies.
Redacted/anonymized versions, justification log, review notes.
Redacted/anonymized versions, justification log, review notes.
Approve redaction standard. Approve release version.
Approve redaction standard. Approve release version.
05
05
Disclosure quality review & readiness
Disclosure quality review & readiness
Agreed disclosures, validations, checklists, and review notes.
Agreed disclosures, validations, checklists, and review notes.
Quality-review summary, issue log, readiness and handoff record.
Quality-review summary, issue log, readiness and handoff record.
Approve readiness. Authorize release.
Approve readiness. Authorize release.
WORKFLOW
A disciplined workflow from baseline to release.
A disciplined workflow from baseline to release.
A disciplined workflow from baseline to release.
A disciplined workflow from baseline to release.
Every stage makes its input, action, output, and approval point visible. No release authority is implied or transferred.
Every stage makes its input, action, output, and approval point visible. No release authority is implied or transferred.
Every stage makes its input, action, output, and approval point visible. No release authority is implied or transferred.
WORKFLOW LEDGER
WORKFLOW LEDGER
STAGE
STAGE
INPUT
INPUT
KARAMATA ACTION
KARAMATA ACTION
OUTPUT
OUTPUT
APPROVAL
APPROVAL
01
01
Establish the baseline
Establish the baseline
Known obligations, sources, milestones
Known obligations, sources, milestones
Confirm scope, owners, roles, access, dependencies
Confirm scope, owners, roles, access, dependencies
Baseline and source map
Baseline and source map
Client confirms scope and roles
Client confirms scope and roles
02
02
Prepare the blueprint
Prepare the blueprint
Approved baseline, source inventory
Approved baseline, source inventory
Map deliverables, review points, and dependencies
Map deliverables, review points, and dependencies
Disclosure plan and milestone map
Disclosure plan and milestone map
Client approves plan and milestones
Client approves plan and milestones
03
03
Execute & coordinate
Execute & coordinate
Approved sources, agreed work products
Approved sources, agreed work products
Coordinate content, updates, comments, packaging
Coordinate content, updates, comments, packaging
Controlled work products and log
Controlled work products and log
Client resolves retained decisions
Client resolves retained decisions
04
04
Quality assurance
Quality assurance
Draft outputs, source and decision log
Draft outputs, source and decision log
Review completeness, consistency, and open items
Review completeness, consistency, and open items
Quality summary and issue record
Quality summary and issue record
Client approves readiness
Client approves readiness
05
05
Support the release
Support the release
Approved package, release instructions
Approved package, release instructions
Support final checks, handoff, and reconciliation
Support final checks, handoff, and reconciliation
Release-support and handoff record
Release-support and handoff record
Client authorizes submission or release
Client authorizes submission or release
AUTHORITY BY DESIGN
Clear ownership. Defined boundaries.
Clear ownership. Defined boundaries.
Clear ownership. Defined boundaries.
Clear ownership. Defined boundaries.
We coordinate and quality-review the agreed work. You authorize decisions, submission, and public release.
We coordinate and quality-review the agreed work. You authorize decisions, submission, and public release.
We coordinate and quality-review the agreed work. You authorize decisions, submission, and public release.
AUTHORITY MATRIX
AUTHORITY MATRIX
KARAMATA OWNS
KARAMATA OWNS
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—
Assess agreed requirements and risks
Assess agreed requirements and risks
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—
Build milestone and source maps
Build milestone and source maps
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—
Coordinate content, review, and evidence
Coordinate content, review, and evidence
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—
Perform agreed quality checks
Perform agreed quality checks
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—
Document open decisions and handoffs
Document open decisions and handoffs
CLIENT RETAINS
CLIENT RETAINS
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—
Applicability and legal/privacy judgment
Applicability and legal/privacy judgment
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—
Authorization of registration or submission
Authorization of registration or submission
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—
Approval of content, redaction, and updates
Approval of content, redaction, and updates
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—
Authorization of public release
Authorization of public release
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—
Accountable ownership of retained decisions
Accountable ownership of retained decisions
SHARED / APPROVAL POINT
SHARED / APPROVAL POINT
—
—
Confirm scope, roles, access, and milestones
Confirm scope, roles, access, and milestones
—
—
Resolve privacy and confidentiality questions
Resolve privacy and confidentiality questions
—
—
Agree escalation and comment resolution
Agree escalation and comment resolution
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—
Reconcile final package and open items
Reconcile final package and open items
—
—
Record the approved handoff
Record the approved handoff
SYSTEM & SECURITY BOUNDARIES
Approved sources. Controlled environments.
Approved sources. Controlled environments.
Approved sources. Controlled environments.
Approved sources. Controlled environments.
SYSTEM BOUNDARIES
SYSTEM BOUNDARIES
01
01
CLIENT-CONTROLLED ACCESS
CLIENT-CONTROLLED ACCESS
Access, least-privilege expectations, and export controls are agreed for the engagement. Client approvals and release controls remain explicit.
Access, least-privilege expectations, and export controls are agreed for the engagement. Client approvals and release controls remain explicit.
02
02
APPROVED-SOURCE WORK
APPROVED-SOURCE WORK
Work proceeds from agreed source sets and versions. No independent source access or decision rights are assumed.
Work proceeds from agreed source sets and versions. No independent source access or decision rights are assumed.
03
03
RELEASE AUTHORITY RETAINED
RELEASE AUTHORITY RETAINED
The client authorizes submission and public release, as applicable, and retains the accountable record of those decisions.
The client authorizes submission and public release, as applicable, and retains the accountable record of those decisions.
WHEN TO ENGAGE
Engage when clarity and coordination matter most.
Engage when clarity and coordination matter most.
Engage when clarity and coordination matter most.
Engage when clarity and coordination matter most.
The useful starting point is the condition of the work—not the type of organization asking. Scope is then defined around sources, decisions, authority, and the next disclosure milestone.
The useful starting point is the condition of the work—not the type of organization asking. Scope is then defined around sources, decisions, authority, and the next disclosure milestone.
The useful starting point is the condition of the work—not the type of organization asking. Scope is then defined around sources, decisions, authority, and the next disclosure milestone.
ENGAGEMENT CUES
ENGAGEMENT CUES
01
01
Program taking shape
Program taking shape
02
02
Unclear starting point
Unclear starting point
03
03
Inherited portfolio
Inherited portfolio
04
04
Missed disclosure deadline
Missed disclosure deadline
05
05
Approaching results milestone
Approaching results milestone
06
06
Capacity constraint
Capacity constraint
07
07
Expanding CTIS workload
Expanding CTIS workload
FAQ
Common questions before the work begins.
Common questions before the work begins.
Common questions before the work begins.
Common questions before the work begins.
Scope, sources, authority, exceptions, access, and handoff should be understood before delivery begins.
Scope, sources, authority, exceptions, access, and handoff should be understood before delivery begins.
01
01
What types of disclosure work are in scope?
What types of disclosure work are in scope?
Scope is defined by the applicable pathway, approved source set, and the agreed authoring, coordination, quality-review, or release-support role. Final applicability and authorization remain with the client and appropriate advisors.
Scope is defined by the applicable pathway, approved source set, and the agreed authoring, coordination, quality-review, or release-support role. Final applicability and authorization remain with the client and appropriate advisors.
02
02
Which pathways and jurisdictions are in scope?
Which pathways and jurisdictions are in scope?
03
03
When should disclosure planning begin?
When should disclosure planning begin?
04
04
What source material is needed?
What source material is needed?
05
05
What can KARAMATA author or coordinate?
What can KARAMATA author or coordinate?
06
06
How are review comments and updates handled?
How are review comments and updates handled?
07
07
How are redaction, anonymization, CCI, and personal-data questions handled?
How are redaction, anonymization, CCI, and personal-data questions handled?
08
08
Can you work in client-controlled systems?
Can you work in client-controlled systems?
09
09
Who retains final approval, submission, and release authority?
Who retains final approval, submission, and release authority?
10
10
What remains at handoff?
What remains at handoff?
Bring the public record into one accountable workstream.
Bring the public record into one accountable workstream.
Bring the public record into one accountable workstream.
Bring the public record into one accountable workstream.
Start with the milestone, source set, or decision that needs clarity.
Start with the milestone, source set, or decision that needs clarity.
Start with the milestone, source set, or decision that needs clarity.