4
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.

Data Privacy & Security

Why This Matters: Weak data safeguards can lead to regulatory penalties, litigation, and loss of stakeholder trust.

Negotiation strategy

If you're the Sponsor:

Ensure that the contract includes specific references to GDPR and HIPAA compliance. Demand detailed breach notification procedures and insist on encryption and access controls.

If you're the Institution:

Propose reasonable efforts to comply with data protection laws. Offer to implement industry-standard security protocols and timely breach notifications.

Essential elements

1

Data Protection Compliance

Adherence to GDPR and HIPAA.
2

Breach Notification

Timely notification of data breaches.
3

Security Protocols

Encryption and access controls.

Action framework

ACCEPT

Propose edits to include jurisdiction-specific compliance requirements.

EDIT

Reject clauses lacking clear compliance with GDPR and HIPAA.

ADD

Add language for jurisdiction-specific data privacy laws.

PRO TIP

Always verify that data protection clauses reflect the latest regulatory updates.

Example clauses

FAVORABLE

Preferred GDPR and HIPAA Compliance

"The parties agree to comply with GDPR and HIPAA regulations, implementing industry-standard security protocols and breach notification procedures."
NEUTRAL

Fallback Reasonable Efforts

"The parties will use reasonable efforts to protect personal health information and notify each other of any data breaches in a timely manner."
UNFAVORABLE

Lack of Specific Compliance

"The parties will attempt to comply with applicable data protection laws."

Fallbacks

High-Risk Projects

In high-risk projects, ensure additional security measures are in place, such as regular audits and third-party assessments.

Cross-Border Data Transfers

For cross-border data transfers, include clauses that address data localization and international data transfer agreements.

Emerging Technologies

With emerging technologies, ensure that the contract addresses potential new data privacy challenges and incorporates adaptive security measures.
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