Industry Sponsored Clinical Trial Agreement Template
Create a legally compliant clinical trial agreement that protects your interests, ensures regulatory compliance, and streamlines collaboration between sponsors and research institutions.
Industry Sponsored Clinical Trial Agreement
An industry sponsored clinical trial agreement (CTA) is a legally binding document that governs the relationship between a commercial sponsor and a research institution conducting clinical trials. This comprehensive agreement establishes the terms, conditions, and responsibilities for all parties involved in the clinical research process.
What This Template Is For
This template is designed for pharmaceutical companies, biotechnology firms, and medical device manufacturers sponsoring clinical trials at research institutions, hospitals, or academic medical centers. It provides a structured framework for defining study protocols, payment terms, data rights, and regulatory compliance requirements.
When To Use This Template
Use this agreement template when:
- Initiating a new industry-sponsored clinical trial
- Establishing a formal research relationship between sponsor and institution
- Defining roles and responsibilities for multi-site clinical studies
- Setting up Phase I-IV clinical trials
How To Customize It
Follow these steps to customize the agreement:
- Insert specific study protocol details and trial phase information
- Define payment schedule and budget details
- Specify data management and reporting requirements
- Add institution-specific compliance requirements
- Include relevant regulatory requirements based on jurisdiction
- Customize intellectual property and publication rights
Common Use Cases
This template is commonly used for:
- Pharmaceutical drug trials
- Medical device testing
- Biotech product evaluation
- Multi-center clinical studies
- Academic medical center research
Best Practices
Follow these guidelines:
- Ensure alignment with ICH-GCP guidelines
- Include clear subject injury and compensation provisions
- Define precise confidentiality terms
- Specify clear publication rights
- Include detailed budget and payment terms
Template Variations
Consider these variations based on your needs:
- Master Clinical Trial Agreements for multiple studies
- Phase-specific agreement templates
- Device trial variations
- International trial agreements
Success Stories
Research institutions report faster trial initiation and fewer legal delays using standardized CTAs. Major pharmaceutical companies have reduced negotiation time by 60% using well-structured agreement templates.
Frequently Asked Questions
What are the essential components of a clinical trial agreement?
Key components include study protocol, budget, payment terms, regulatory compliance, subject safety, data rights, and publication terms.
How long does the agreement negotiation typically take?
Negotiation typically takes 6-12 weeks, but can be expedited with standardized templates.
Who needs to review and approve the agreement?
Legal counsel, institutional review board, research administration office, and principal investigators typically review CTAs.
What regulatory requirements must be addressed?
The agreement must comply with ICH-GCP, FDA regulations, and local regulatory requirements.
How are intellectual property rights typically handled?
IP rights usually distinguish between sponsor's background IP, study data, and new inventions.
Adapt this agreement template to your specific clinical trial needs