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Accelerated Clinical Trial Agreement

Accelerated Clinical Trial Agreement Template for Ireland

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Key Requirements PROMPT example:

Accelerated Clinical Trial Agreement

"I need an Accelerated Clinical Trial Agreement for a Phase II oncology drug trial in Ireland, with specific provisions for remote monitoring and a 6-month accelerated timeline starting March 2025."

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Document background
The Accelerated Clinical Trial Agreement is designed for situations requiring expedited clinical research while maintaining rigorous safety and regulatory standards under Irish law. It is particularly relevant for urgent medical research, such as during public health emergencies, or for trials of breakthrough treatments for serious conditions. The agreement incorporates streamlined processes and condensed timelines while ensuring compliance with EU Clinical Trials Regulation 536/2014, Irish clinical trial regulations, and GDPR requirements. It details specific responsibilities, risk management protocols, and enhanced monitoring requirements necessary for accelerated trials. This document is essential for pharmaceutical companies, research institutions, and healthcare facilities conducting time-sensitive clinical research in Ireland, providing a comprehensive framework that balances speed with safety and regulatory compliance.
Suggested Sections

1. Parties: Identification of the contracting parties including Sponsor, Institution, and Principal Investigator

2. Background: Context of the accelerated clinical trial, including the need for expedition and regulatory basis

3. Definitions: Key terms used throughout the agreement, including specific definitions related to accelerated trial processes

4. Scope of Trial: Detailed description of the trial, including accelerated timeline justification and methodology

5. Regulatory Compliance: Compliance requirements with Irish and EU regulations, especially expedited review processes

6. Timeline and Milestones: Specific accelerated timeframes, key milestones, and delivery dates

7. Responsibilities of Parties: Detailed obligations of each party, including expedited review commitments

8. Patient Safety and Medical Care: Provisions for ensuring patient safety in an accelerated trial context

9. Data Protection and Confidentiality: GDPR compliance and data handling procedures

10. Trial Drug Supply and Management: Management and accountability of trial medication

11. Financial Arrangements: Payment terms, costs, and expedited processing fees

12. Insurance and Indemnification: Coverage requirements and liability provisions

13. Publication Rights: Terms for publishing trial results, including expedited publication provisions

14. Term and Termination: Duration, termination rights, and early completion provisions

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

Optional Sections

1. Emergency Procedures: Additional safety measures for high-risk trials, required when the trial involves critical or emergency treatments

2. Sub-contractor Provisions: Required when third-party service providers are involved in the trial

3. International Transfer Provisions: Required when data or materials will be transferred outside Ireland/EU

4. Specialized Equipment Provisions: Required when specific equipment or technology is provided for the trial

5. Intellectual Property Rights: Detailed IP provisions required when novel methods or technologies are being developed

6. Translation Requirements: Required when trial materials need to be provided in multiple languages

7. Post-Trial Access: Required when continued patient access to treatment post-trial is anticipated

Suggested Schedules

1. Schedule 1 - Trial Protocol: Detailed protocol including accelerated timeline justification and methodology

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms including expedited processing costs

3. Schedule 3 - Timeline and Milestone Schedule: Detailed timeline with specific deadlines and acceleration points

4. Schedule 4 - Required Documents and Approvals: List of regulatory and ethical approvals needed

5. Schedule 5 - Data Management Plan: Detailed procedures for data collection, storage, and processing

6. Schedule 6 - Safety Reporting Procedures: Expedited safety reporting requirements and procedures

7. Schedule 7 - Site Requirements: Specific requirements for trial site facilities and personnel

8. Appendix A - Form of Patient Informed Consent: Template for accelerated trial informed consent

9. Appendix B - Investigation Team Members: List of authorized personnel involved in the trial

10. Appendix C - Quality Assurance Requirements: Specific quality control measures for accelerated timeline

Authors

Alex Denne

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

alex.den.21@genieai.co
Relevant legal definitions
















































Clauses




































Relevant Industries

Pharmaceutical

Healthcare

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Contract Research Services

Life Sciences

Academic Medical Research

Public Health

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Quality Assurance

Clinical Development

Data Management

Medical Affairs

Compliance

Contract Management

Ethics Review

Risk Management

Research Administration

Relevant Roles

Clinical Research Director

Principal Investigator

Medical Director

Research Coordinator

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Data Protection Officer

Quality Assurance Manager

Clinical Trial Manager

Research Ethics Officer

Contract Manager

Compliance Officer

Medical Science Liaison

Study Monitor

Chief Medical Officer

Research Department Head

Clinical Development Director

Industries










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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