3
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.
Regulatory Compliance
Negotiation strategy
Ensure that all compliance requirements are clearly outlined and that responsibilities are assignable. Regularly review and update compliance protocols to align with current regulations.
Negotiate for reasonable compliance obligations that reflect the company's operational capabilities. Seek to include language that allows for updates as regulations evolve.
Essential elements
1
FDA Compliance
Adherence to FDA regulations.
2
HIPAA Compliance
Protection of patient data.
3
GMP Standards
Good Manufacturing Practices adherence.
Action framework
ACCEPT
Propose edits if specific regulatory references are missing or outdated.
EDIT
Reject if the clause lacks essential compliance obligations.
ADD
Add language for new or emerging regulations.
PRO TIP
Regularly consult with regulatory experts to ensure compliance clauses remain current and comprehensive.
Real-world examples
FAVORABLE
Comprehensive Compliance Clause
"The parties agree to comply with all applicable healthcare and life sciences laws, regulations, and industry standards, including but not limited to FDA regulations, HIPAA requirements, and GMP standards."
NEUTRAL
General Compliance Clause
"The parties shall use reasonable efforts to comply with applicable healthcare regulations."
UNFAVORABLE
Vague Compliance Obligations
"The parties will comply with relevant laws as necessary."
Alternative scenarios & positions
High-Risk Projects
In high-risk projects, ensure that compliance clauses are detailed and include specific risk mitigation strategies.
Cross-Border Transactions
Consider additional compliance requirements for international regulations and standards.
Data-Intensive Operations
Emphasize data protection and privacy compliance, particularly under HIPAA and similar regulations.
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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.
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