Operational views
Review work, evidence, exceptions and authorised decisions within a defined operating scope.
Pharmaceuticals & biotechnology / APPLICATION BLUEPRINT
Clinical Research Services Sponsor Deliverable Acceptance Portal
Publishes agreed milestones for trial sponsors and sites, links evidence to approved study versions and records acceptance criteria.
14 workspace menus · 13 business workflows · 5 role profiles
Application blueprint only. This is a proposed design, not a deployed or production-tested system. Screens and sample figures are illustrative; workflows, business rules, approvals, permissions and integrations require confirmation before build.
Designed for programme coordinators and the responsible business owners
Explore an illustrative interface.
Illustrative workspace and record review. Select a concept screen to inspect it in full.
Operational dashboards and work queues.
Dashboard measures
- Active service movements
Count of all records in the selected workspace. - Review queue
Records at the third stage of the business workflow. - Needs attention
Records with an assigned review requirement. - Final-stage records
Records in the fourth business workflow stage.
Business workflow and operating scope
Publishes agreed milestones for trial sponsors and sites, links evidence to approved study versions and records acceptance criteria. Tracks reviewer questions, corrections and sign-off, retaining rejected deliverables and unresolved limitations before the study package is formally accepted.
The end-to-end business journey.
From intake to authorised completion, with evidence at each decision.
Prepare the service requirement
Establish the scope of milestones, capture the required records and assign the accountable team.
Review documents and capacity
Coordinate sites, acceptance criteria, with linked evidence and visible outstanding actions.
Coordinate execution and handover
Review the relevant conditions and exceptions. Record the authorised outcome and its supporting evidence.
Resolve exceptions and completion
Confirm the resulting records and handovers. Track remaining obligations, later changes and follow-up actions.
Business workflows
Select a workflow to review the steps, responsibilities, approval and exception handling.
01 · Publish agreed milestones
Coordinate agreed milestones within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Agreed milestones requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register agreed milestones and its operating scope
- Coordinate the required specialist and business review
- Accept the release version and permitted recipients
- Record distribution, acknowledgement and later revisions
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Content conflicts, missing review or a changed recipient permission prevents release.
Outcome
An accepted content version with distribution and revision history.
02 · Link evidence
Coordinate evidence within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Evidence requires a new record, an agreed review or a controlled change.
Responsible role
Evidence reviewer
- Register evidence and its operating scope
- Collect the linked records and qualified evidence
- Assign the responsible reviewer and record findings
- Accept the outcome or assign corrective follow-up
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.
Outcome
A review finding, its accepted evidence and any accountable corrective actions.
03 · Record acceptance criteria
Coordinate acceptance criteria within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Acceptance criteria requires a new record, an agreed review or a controlled change.
Responsible role
Evidence reviewer
- Register acceptance criteria and its operating scope
- Collect the linked records and qualified evidence
- Assign the responsible reviewer and record findings
- Accept the outcome or assign corrective follow-up
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.
Outcome
A review finding, its accepted evidence and any accountable corrective actions.
04 · Track reviewer questions
Coordinate reviewer questions within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Reviewer questions requires a new record, an agreed review or a controlled change.
Responsible role
Evidence reviewer
- Register reviewer questions and its operating scope
- Collect the linked records and qualified evidence
- Assign the responsible reviewer and record findings
- Accept the outcome or assign corrective follow-up
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.
Outcome
A review finding, its accepted evidence and any accountable corrective actions.
05 · Track corrections
Coordinate corrections within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Corrections requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register corrections and its operating scope
- Assign the accountable owner and required actions
- Review the relevant evidence and unresolved conditions
- Confirm the accepted outcome and retain its history
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Required information or responsibility is missing, or an operating condition changes.
Outcome
A completed operating record with its linked evidence and remaining obligations.
06 · Track sign-off
Coordinate sign-off within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Sign-off requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register sign-off and its operating scope
- Assign the accountable owner and required actions
- Review the relevant evidence and unresolved conditions
- Confirm the accepted outcome and retain its history
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Required information or responsibility is missing, or an operating condition changes.
Outcome
A completed operating record with its linked evidence and remaining obligations.
07 · Track retaining rejected deliverables
Coordinate retaining rejected deliverables within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Retaining rejected deliverables requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register retaining rejected deliverables and its operating scope
- Assign the accountable owner and required actions
- Review the relevant evidence and unresolved conditions
- Confirm the accepted outcome and retain its history
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Required information or responsibility is missing, or an operating condition changes.
Outcome
A completed operating record with its linked evidence and remaining obligations.
08 · Track unresolved limitations
Coordinate unresolved limitations within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Unresolved limitations requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register unresolved limitations and its operating scope
- Gather the relevant evidence and review options
- Route the case to the delegated decision owner
- Record the outcome, conditions and follow-up obligations
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
The case exceeds delegation, contains a conflict or has disputed evidence.
Outcome
An authorised decision or escalation with accountable resolution actions.
09 · Register the operating requirement
Coordinate operating requirement within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Operating requirement requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register operating requirement and its operating scope
- Compare options, dependencies and operating constraints
- Review the selected option with its accountable owners
- Accept the plan and track its delivery conditions
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
An assumption changes, prerequisites are missing or stakeholders cannot accept the proposed commitment.
Outcome
An approved operating plan and owned actions for its accepted conditions.
10 · Resolve operating exceptions
Coordinate operating exceptions within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Operating exceptions requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register operating exceptions and its operating scope
- Gather the relevant evidence and review options
- Route the case to the delegated decision owner
- Record the outcome, conditions and follow-up obligations
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
The case exceeds delegation, contains a conflict or has disputed evidence.
Outcome
An authorised decision or escalation with accountable resolution actions.
11 · Verify completion and follow-up
Coordinate completion and follow-up within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Completion and follow-up requires a new record, an agreed review or a controlled change.
Responsible role
Evidence reviewer
- Register completion and follow-up and its operating scope
- Collect the linked records and qualified evidence
- Assign the responsible reviewer and record findings
- Accept the outcome or assign corrective follow-up
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.
Outcome
A review finding, its accepted evidence and any accountable corrective actions.
12 · Review controlled operating changes
Coordinate controlled operating changes within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Controlled operating changes requires a new record, an agreed review or a controlled change.
Responsible role
Evidence reviewer
- Register controlled operating changes and its operating scope
- Collect the linked records and qualified evidence
- Assign the responsible reviewer and record findings
- Accept the outcome or assign corrective follow-up
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Evidence is incomplete, disputed, expired or outside the reviewer’s authority.
Outcome
A review finding, its accepted evidence and any accountable corrective actions.
13 · Prepare scoped operational reports
Coordinate scoped operational reports within Clinical Research Services Sponsor Deliverable Acceptance Portal.
Trigger
Scoped operational reports requires a new record, an agreed review or a controlled change.
Responsible role
Programme coordinator
- Register scoped operational reports and its operating scope
- Assign the accountable owner and required actions
- Review the relevant evidence and unresolved conditions
- Confirm the accepted outcome and retain its history
Approval
Authorised release reviewer records the decision when the action changes an accepted commitment or requires delegated authority.
Exception handling
Required information or responsibility is missing, or an operating condition changes.
Outcome
A completed operating record with its linked evidence and remaining obligations.
Governance and control
- Role permissions reflect the agreed responsibilities and restricted record access.
- Required information and evidence are checked before the relevant decision or handover.
- Exceptions have a named owner, recorded reason and an authorised resolution.
- Approved changes retain their previous values, accountable decisions and linked evidence.
- Integration mappings, business rules and acceptance criteria are reviewed with the customer.
Operating rules by business workflow
- For agreed milestones, the released version and authorised audience remain traceable to the accepted review.
- For evidence, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
- For acceptance criteria, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
- For reviewer questions, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
- For corrections, the record retains an accountable owner, its supporting evidence and accepted outcome.
- For sign-off, the record retains an accountable owner, its supporting evidence and accepted outcome.
- For retaining rejected deliverables, the record retains an accountable owner, its supporting evidence and accepted outcome.
- For unresolved limitations, a decision retains its authority, reason, supporting evidence and resulting obligations.
- For operating requirement, the accepted plan records assumptions, rejected alternatives, dependencies and conditions.
- For operating exceptions, a decision retains its authority, reason, supporting evidence and resulting obligations.
- For completion and follow-up, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
- For controlled operating changes, evidence, reviewer authority and acceptance conditions are visible before a reviewed outcome is accepted.
- For scoped operational reports, the record retains an accountable owner, its supporting evidence and accepted outcome.
Data, interfaces and operating requirements.
Core records
Record fields and linked information
- Record identifier — Stable reference for the operating transaction.
- Site / programme — Business scope used for responsibility and reporting.
- Operating subject — The request, commitment or work item being handled.
- Accountable owner — Named responsibility for the next action.
- Workflow stage — Current position in the agreed business journey.
- Review requirement — Required review and outstanding decision.
- Due or review date — Agreed action window or review trigger.
- Linked evidence — Source records supporting the operating decision.
- Decision authority — The delegated authority relevant to the accepted outcome.
- Accepted outcome — Recorded decision and its business consequences.
- Follow-up obligation — Remaining responsibilities after an accepted action.
- Revision history — Trace of accepted changes and their evidence.
- Milestones reference — Link the relevant milestones to the operating transaction and its decision evidence.
- Evidence reference — Link the relevant evidence to the operating transaction and its decision evidence.
- Acceptance criteria reference — Link the relevant acceptance criteria to the operating transaction and its decision evidence.
- Reviewer questions reference — Link the relevant reviewer questions to the operating transaction and its decision evidence.
- Corrections reference — Link the relevant corrections to the operating transaction and its decision evidence.
Systems and interfaces
- Quality and controlled document records
- Laboratory, trial or product information interfaces
- Identity and role-based access services
- Approved document and communication services
Interface scope, data mapping and testing are agreed for each engagement.
Implementation requirements
Confirm the operating boundaries, milestones, responsible roles, review authority, record retention, interface mappings and acceptance scenarios.
Confirm the operating boundaries, milestones, responsible roles, review authority, record retention, interface mappings and acceptance scenarios.
Mobile and tablet access
Authorised users can review milestones, supporting records and assigned actions through mobile and tablet access. The relevant tasks and permissions are agreed for the deployment.
Access approved workflows through the Dalfin mobile app. Device tasks and permissions are confirmed for the deployment.
AI extensions
Core workflows and approval rules are defined with your business owners. Operational AI can be assessed separately against a specific business outcome and review requirements.
AI extensions are scoped around the required data, business outcome and review controls.
Engineered with Genesis.
Structured application engineering
Connect requirements, roles, records, workflows and interfaces through the agreed Genesis engineering process.
Controlled changes
Review dependency impact and validation requirements. Context Memory supports governed changes and accepted application revisions.
Deployment and support
Agree customer cloud or on-premises requirements, device access, implementation acceptance and ongoing engineering support.
Explore the platform
AN EXAMPLE OPERATING SCENARIO
What to validate in a scoped demonstration.
Start with milestones and follow the record through review documents and capacity. Introduce a missing item or operating exception, record the authorised resolution and inspect the final handover, evidence and history.
What to review
- A saved end-to-end transaction
- An exception and its authorised resolution
- Different operator, approver and reviewer permissions
- Final records, history and the relevant report
Questions before implementation.
What can we review in a tailored demonstration?
Review a representative service movement, its workflow stages, accountable roles, an exception and the resulting operational report. Bring the business process and existing system requirements that matter to your organisation.
How is the solution adapted to our organisation?
The operating scope covers your records, role permissions, review authority, business rules and integration boundaries. These requirements are agreed with the responsible business owners.
How does the solution connect with existing systems?
Connection design defines interfaces, data ownership, mapping, authentication and exception handling. The agreed implementation includes validation against the selected systems and workflows.
How are subsequent changes controlled?
The agreed engineering approach covers review of change impact, bounded implementation, validation and accepted revisions. Discuss the relevant Genesis Context Memory and support requirements during solution scoping.
Related enterprise solutions.
Interface previewPharmaceuticals & biotechnology
Clinical Research Services Laboratory Service Quotation & Acceptance
Builds quotations from protocol requirements and consent documentation, identifies required methods and agrees deliverables with trial sponsors and sites.
View blueprint →
Interface previewPharmaceuticals & biotechnology
Clinical Research Services Study Budget Variation & Sponsor Approval
Compares study expenditure with approved sponsored clinical study activities, identifies changed effort or materials and prepares variation evidence.
View blueprint →
Interface previewPharmaceuticals & biotechnology
Clinical Research Services Study Feasibility Cost & Capacity Review
Assesses proposed sponsored clinical study activities against qualified study teams and site capacity, records method and evidence prerequisites and compares delivery scenarios.
View blueprint →