The Accelerated Clinical Trial Agreement is utilized when parties need to conduct clinical trials on an expedited basis, typically in response to urgent medical needs or public health emergencies. This agreement type, governed by English and Welsh law, includes provisions for accelerated patient recruitment, streamlined data collection, and expedited review processes while maintaining compliance with regulatory requirements. It establishes clear responsibilities, timelines, and obligations for all parties involved, incorporating necessary safeguards for patient safety and data protection.
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1. Parties: Identification and details of all parties involved in the trial, including sponsor, investigator, and institution
2. Background: Context of the trial, purpose of the agreement, and basic framework of the accelerated clinical trial
3. Definitions: Key terms used throughout the agreement including technical, medical, and legal definitions
4. Trial Protocol: Detailed description of the trial methodology, procedures, and compliance with regulatory requirements
5. Obligations of Parties: Specific responsibilities of each party including sponsor obligations, investigator duties, and institution commitments
6. Timeline and Milestones: Accelerated schedule, key deliverables, and expedited timelines for trial completion
7. Safety Reporting: Procedures for adverse event reporting, SUSAR reporting, and safety monitoring
8. Data Management: Handling and protection of trial data, compliance with GDPR and data protection laws
9. Confidentiality: Protection of confidential information, trade secrets, and trial-related data
10. Term and Termination: Duration of the agreement, termination rights, and post-termination obligations
1. Publication Rights: Terms for publishing trial results and academic publications, typically included when academic institutions are involved
2. Specimen Management: Handling of biological specimens and associated procedures, included when trial involves collection of biological samples
3. Third Party Contractors: Management of external service providers and their obligations, included when external contractors are involved
4. Intellectual Property Rights: Allocation of IP rights and inventions, included when new IP is likely to be generated
5. Equipment Provision: Terms for providing and maintaining trial equipment, included when specific equipment is provided for the trial
1. Schedule 1 - Trial Protocol: Detailed protocol document including trial design, methodology, and procedures
2. Schedule 2 - Budget and Payment Schedule: Financial terms, payment milestones, and breakdown of costs
3. Schedule 3 - Insurance Certificates: Proof of required insurance coverage and liability protection
4. Schedule 4 - Data Processing Agreement: Detailed data protection terms and GDPR compliance requirements
5. Schedule 5 - Form of Safety Report: Template for safety reporting and adverse event documentation
6. Schedule 6 - Key Personnel: List of key team members and their responsibilities
7. Schedule 7 - Material Transfer Terms: Terms for transfer and handling of trial materials and supplies
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