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Clinical Study Agreement

Clinical Study Agreement Template for New Zealand

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase II drug trial between our pharmaceutical company and Auckland City Hospital, with specific provisions for handling biological samples and Māori cultural considerations, to commence in March 2025."

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Document background
The Clinical Study Agreement serves as the primary legal instrument for establishing and governing clinical research activities in New Zealand. This document is essential when organizations or individuals plan to conduct clinical trials or research studies involving human subjects within New Zealand's jurisdiction. It ensures compliance with local regulations including the Medicines Act 1981, Health and Disability Commissioner Act 1994, and Privacy Act 2020. The agreement comprehensively addresses key aspects such as study protocol implementation, participant protection, data handling, financial arrangements, and risk allocation between parties. This document is particularly crucial in New Zealand's healthcare landscape, where clinical research must align with specific cultural considerations and regulatory frameworks, including consultation with Māori health authorities where appropriate.
Suggested Sections

1. Parties: Identification of all contracting parties including the sponsor, research institution, and principal investigator

2. Background: Context of the clinical study, purpose, and general intentions of the parties

3. Definitions: Detailed definitions of technical terms, roles, and other key concepts used throughout the agreement

4. Study Conduct: Core obligations regarding study execution, compliance with protocol, and regulatory requirements

5. Regulatory Compliance: Obligations regarding ethics committee approval, regulatory submissions, and compliance with New Zealand laws

6. Personnel and Resources: Requirements for study staff, facilities, and resource allocation

7. Payment Terms: Financial arrangements, payment schedule, and budget details

8. Confidentiality: Provisions for protecting confidential information and study data

9. Intellectual Property: Rights and obligations regarding study-related IP, including results and discoveries

10. Publication Rights: Terms for publishing study results and academic publications

11. Data Management: Requirements for data collection, storage, protection, and sharing

12. Subject Safety and Informed Consent: Provisions for participant safety, informed consent process, and adverse event reporting

13. Insurance and Indemnity: Insurance requirements and indemnification provisions

14. Term and Termination: Duration of agreement, renewal terms, and termination conditions

15. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices

Optional Sections

1. Multi-Center Provisions: Additional terms for studies conducted across multiple research sites

2. Equipment and Materials: Specific provisions for specialized equipment or materials provided for the study

3. Third Party Agreements: Terms relating to subcontractors or other third party service providers

4. Biological Samples: Specific provisions for collection, storage, and use of biological samples

5. Post-Study Obligations: Specific requirements after study completion, including continued access to treatment

6. Technology Transfer: Terms for any technology or know-how transfer required for the study

7. Academic Rights: Additional provisions for academic institutions regarding research rights

8. Export Control: Provisions for international transfer of study materials or data

9. Force Majeure: Specific provisions for handling unforeseen circumstances or emergencies

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed protocol outlining the clinical study methodology and procedures

2. Schedule 2 - Budget and Payment Schedule: Detailed breakdown of costs and payment timeline

3. Schedule 3 - Timeline and Milestones: Key dates, deliverables, and project milestones

4. Schedule 4 - Personnel and Responsibilities: List of key personnel and their roles in the study

5. Schedule 5 - Required Reports: Details of all required study reports and their submission schedules

6. Schedule 6 - Insurance Certificates: Copies of required insurance documentation

7. Schedule 7 - Form of Informed Consent: Template for participant informed consent documentation

8. Schedule 8 - Data Management Plan: Detailed procedures for data handling and management

9. Schedule 9 - Quality Assurance Requirements: Specific quality control and assurance procedures

10. Appendix A - Regulatory Approvals: Copies of ethics committee and other regulatory approvals

11. Appendix B - Safety Reporting Procedures: Detailed procedures for adverse event reporting and safety monitoring

Authors

Alex Denne

Head of Growth (Open Source Law) @ Genie AI | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

Linkedin in social icon imageX social icon image
alex.den.21@genieai.co
Relevant legal definitions
Agreement
Applicable Laws
Adverse Event
Background IP
Clinical Trial
Confidential Information
Contract Research Organisation (CRO)
Data
Effective Date
Ethics Committee
Facility
Good Clinical Practice (GCP)
Health and Disability Ethics Committee
Human Research Ethics Committee
Intellectual Property Rights
Investigator
Investigator's Brochure
Medical Records
Medicines Act
MEDSAFE
Monitor
Monitoring
Multi-Center Study
New Zealand Regulatory Authority
Patient
Personal Information
Principal Investigator
Privacy Act
Protocol
Research Institution
Research Staff
Serious Adverse Event
Site
Sponsor
Study
Study Completion
Study Data
Study Drug
Study Materials
Study Personnel
Study Product
Study Protocol
Study Records
Study Results
Study Subject
Sub-Investigator
Term
Territory
Trial
Trial Site
Clauses
Regulatory Compliance
Study Conduct
Patient Safety
Informed Consent
Data Protection
Confidentiality
Intellectual Property
Payment Terms
Insurance
Indemnification
Publication Rights
Record Keeping
Monitoring and Auditing
Personnel Obligations
Equipment and Materials
Term and Termination
Force Majeure
Dispute Resolution
Governing Law
Assignment
Ethics Committee Compliance
Adverse Event Reporting
Quality Assurance
Site Management
Protocol Compliance
Budget and Finance
Documentation Requirements
Privacy Protection
Liability
Amendment
Notice
Severability
Entire Agreement
Subcontracting
Research Standards
Sample Management
Data Ownership
Publication Review
Study Timelines
Recruitment
Reporting Requirements
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Life Sciences

Healthcare Technology

Academic Research

Contract Research

Medical Education

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Medical Affairs

Compliance

Contract Management

Data Management

Quality Assurance

Clinical Research

Business Development

Ethics

Finance

Research Administration

Relevant Roles

Clinical Research Director

Principal Investigator

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Medical Director

Contract Manager

Ethics Committee Coordinator

Chief Medical Officer

Research Administrator

Data Protection Officer

Clinical Trial Manager

Compliance Officer

Research Scientist

Business Development Manager

Healthcare Facility Administrator

Quality Assurance Manager

Industries
Medicines Act 1981: Regulates the manufacture, sale, and supply of medicines, medical devices, and related products. Critical for clinical trials as it governs the use and testing of medicines in New Zealand.
Health and Disability Commissioner Act 1994: Promotes and protects the rights of health consumers and disability services consumers. Includes the Code of Health and Disability Services Consumers' Rights, which is crucial for clinical trials involving human participants.
Privacy Act 2020: Governs the collection, use, and disclosure of personal information. Particularly relevant for handling patient data and maintaining confidentiality in clinical studies.
Health Information Privacy Code 2020: Specific rules for handling health information, including requirements for collection, storage, and sharing of health-related data in research contexts.
Health Research Council Act 1990: Establishes the framework for health research funding and ethical oversight in New Zealand, including requirements for research approval and monitoring.
Contract and Commercial Law Act 2017: Provides the general framework for contract formation and enforcement in New Zealand, essential for the basic contractual elements of the agreement.
Health and Safety at Work Act 2015: Ensures the health and safety of workers and others affected by work activities, including those involved in clinical trials.
New Zealand Bill of Rights Act 1990: Protects fundamental rights including the right to refuse to undergo medical treatment, relevant for informed consent in clinical trials.
Accident Compensation Act 2001: Relevant for handling compensation claims that might arise from adverse events during clinical trials.
Teams

Employer, Employee, Start Date, Job Title, Department, Location, Probationary Period, Notice Period, Salary, Overtime, Vacation Pay, Statutory Holidays, Benefits, Bonus, Expenses, Working Hours, Rest Breaks,  Leaves of Absence, Confidentiality, Intellectual Property, Non-Solicitation, Non-Competition, Code of Conduct, Termination,  Severance Pay, Governing Law, Entire Agreemen

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