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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.

Scope of Services

Why This Matters: Ambiguous scope can lead to disputes, unexpected costs, and reputational risk, so precision mitigates operational and financial exposure.

Negotiation strategy

If you're the Sponsor:

Ensure the scope is comprehensive and aligns with business objectives. Clearly outline all roles, deliverables, timelines, and acceptance criteria to prevent scope creep and disputes.

If you're the Institution:

Use best efforts to deliver services as outlined, ensuring mutual agreement on timelines and acceptance criteria. Highlight any ambiguous language that could lead to misinterpretation.

Essential elements

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Service Deliverables

List of services to be provided.
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Timelines

Completion dates for deliverables.
3

Acceptance Criteria

Standards for deliverable approval.

Action framework

ACCEPT

Propose edits when roles or deliverables are unclear.

EDIT

Reject if the scope is too vague or incomplete.

ADD

Add language for missing deliverables or timelines.

PRO TIP

Ensure acceptance criteria are measurable and agreed upon to avoid future disputes.

Example clauses

FAVORABLE

Preferred Scope of Services

"The Provider shall deliver the following services: [list services]. Each deliverable shall be completed by [date] and meet the following acceptance criteria: [criteria]."
NEUTRAL

Fallback Scope of Services

"The Provider shall use best efforts to deliver the services outlined in Exhibit A, subject to mutual agreement on timelines and acceptance criteria."
UNFAVORABLE

Ambiguous Scope

"The Provider will provide services as needed, with timelines to be determined."

Fallbacks

Complex Service Arrangements

If the scope involves multiple phases or complex service arrangements, further analysis is required to ensure clarity and mutual understanding.

High-Risk Projects

For high-risk projects, ensure the scope includes detailed risk management and mitigation strategies.

International Contracts

In international contracts, consider jurisdictional differences in defining scope and responsibilities.
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