A Clinical Trial Agreement defines the conduct of research between a sponsor and study site. This playbook emphasizes regulatory compliance, data ownership, and subject safety responsibilities.
Why This Matters: Lack of structured change controls can lead to scope creep, cost overruns, and disputes.
Negotiation strategy
If you're the Sponsor:
Ensure the change management process is clearly defined and includes steps for submitting requests, impact assessments, and approvals. This will help maintain control over project scope and costs.
If you're the Institution:
Advocate for a flexible change management process that allows for necessary adjustments while ensuring mutual agreement on any changes to scope, pricing, or deliverables.
Essential elements
1
Change Request Process
Formal procedure for submitting changes.
2
Impact Assessment
Evaluation of change effects.
3
Approval Workflow
Steps for obtaining necessary approvals.
Action framework
ACCEPT
Propose edits when the process lacks clarity or completeness.
EDIT
Reject if the clause does not allow for mutual agreement on changes.
ADD
Add language if the clause is missing a structured process.
PRO TIP
Always ensure the change management clause aligns with regulatory requirements specific to your industry.
Example clauses
FAVORABLE
Standard Change Management Clause
"Any changes to the scope, pricing, or deliverables must be documented through a formal change request, which includes an impact assessment and requires approval from both parties."
NEUTRAL
Basic Change Management Clause
"Changes to the contract may be made upon mutual agreement of the parties."
UNFAVORABLE
Vague Change Management Clause
"Changes can be made as needed without formal documentation."
Fallbacks
High-Risk Projects
In high-risk projects, a detailed change management process is crucial to mitigate potential risks and ensure all changes are thoroughly evaluated and approved.
Regulatory Compliance Impact
If the change management clause involves regulatory compliance issues, consult with experts to ensure adherence to relevant laws and guidelines.
Agile Project Management
In agile projects, the change management process should be flexible to accommodate iterative changes while maintaining control over scope and budget.
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WEEK 2
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WEEK 3
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WEEK 4
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