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PLAYBOOK TEMPLATES

Clinical Trial Agreement

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.

Change Management

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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