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: 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.
FEATURED SOLUTIONS
Contract Email Agent
Self-service Al for instant contract review and markups.
Never leave your inbox. Effortless contract markups and summaries—delivered straight to your inbox. No signups, no apps, no plugins, no playbooks, no delays.
Import PDF. Redline on DocJuris. Export to Word. Save a day of work.
Import locked PDFs or Word docs and get work done with our world-class contract editing platform. Track your changes and comments and export seamlessly to MS Word without the headaches of clunky add-ins.
Markup clauses in seconds. See the reasoning, stay in control.
Negotiate with confidence using DocJuris’s AI-powered suggestions. Pick a suggested action to balance or lean specific terms in favor of a party. Or, quickly make a clause mutual or simpler with a single click without the back-and-forth.
Uncover opportunities and risks in your signed contracts.
Turn your contracts into structured insights. With Repository AI, DocJuris analyzes every imported agreement—so you always know what’s expiring, auto-renewing, or exposing risk. Total visibility, zero guesswork.
Unlike complex CLMs with long implementations and steep learning curves, DocJuris is built for speed and simplicity. We integrate with your workflow—whether connecting to a CLM or uploading agreements manually—so you're up and running in days, not months.
WEEK 1
CLM Readiness and Design
Our CX team works with you to understand your contracting challenges, prioritize key workflows, and identify the biggest impact areas. We build a tailored implementation plan that fits your needs.
WEEK 2
Install Module
We connect DocJuris to your contract repositories, set up admin and user accounts, and ensure your environment is ready for success.
WEEK 3
Deliver & Test
Your team builds initial playbooks, reviews existing clause libraries, and trains the DocJuris agent to align with your internal standards and negotiation positions.
WEEK 4
Launch
We support you in rolling out DocJuris to a pilot group or your full organization—with launch materials, training, and hands-on support to drive adoption from day one.
Not another CLM
Tackle everything your team needs using existing IT without expensive consultants, outrageous user licensing fees, or complex coding. DocJuris takes on the heavy lift and delivers your requirements with its people, process, and technology.
See how DocJuris can automate your legal, procurement, and sales operations.
DocJuris is not a law firm or a substitute for an attorney or law firm. We cannot provide any kind of advice, explanation, opinion, or recommendation about possible legal rights, remedies, defenses, options,selection of forms or strategies.