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Clinical Study Agreement

Clinical Study Agreement Template for United Arab Emirates

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase III diabetes drug trial to be conducted at three hospitals in Dubai and Abu Dhabi, starting March 2025, with our CRO managing the study and involving potential subject recruitment of 500 patients."

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Document background
The Clinical Study Agreement serves as the primary contractual document for establishing and managing clinical trials in the United Arab Emirates. This agreement is essential whenever a pharmaceutical company, research organization, or medical device manufacturer wishes to conduct clinical research at UAE healthcare facilities. The document must comply with UAE federal laws, including Federal Law No. 4 of 2016 and various healthcare regulations, while addressing specific requirements from relevant health authorities such as MOHAP, DHA, or DOH. The agreement covers crucial aspects such as study protocol implementation, patient safety measures, data protection, financial arrangements, and regulatory compliance. It defines the roles and responsibilities of all parties involved, including the sponsor, healthcare institution, principal investigator, and any contract research organizations. The document also includes specific provisions for subject protection, adverse event reporting, and insurance requirements as mandated by UAE healthcare regulations.
Suggested Sections

1. Parties: Identification of all contracting parties including the Sponsor, Institution, Principal Investigator, and any Contract Research Organization (CRO) if applicable

2. Background: Context of the agreement, brief description of the study, and the parties' interests and capabilities

3. Definitions: Detailed definitions of terms used throughout the agreement, including UAE-specific regulatory terms

4. Study Conduct: Requirements for conducting the study in accordance with the protocol, UAE regulations, and international standards

5. Regulatory Compliance: Obligations regarding MOHAP approvals, ethics committee requirements, and other UAE regulatory requirements

6. Personnel and Resources: Responsibilities regarding study staff, facilities, and resource allocation

7. Payment Terms: Financial arrangements, payment schedule, and currency considerations

8. Confidentiality: Provisions for protecting confidential information and trade secrets

9. Intellectual Property: Rights and obligations regarding study data, inventions, and publications

10. Data Protection: Compliance with UAE data protection laws and handling of patient information

11. Documentation and Records: Requirements for maintaining study records and ensuring accessibility for monitoring/auditing

12. Liability and Indemnification: Allocation of risks and responsibilities for study-related injuries or claims

13. Insurance: Insurance requirements as per UAE regulations

14. Term and Termination: Duration of agreement and conditions for early termination

15. Governing Law and Jurisdiction: Specification of UAE law as governing law and jurisdiction for disputes

16. General Provisions: Standard contractual provisions including notices, amendments, and assignment

Optional Sections

1. Sub-contracting: Include when certain study activities will be delegated to third parties

2. Equipment Provision: Include when sponsor will provide specific equipment for the study

3. Translation Requirements: Include when study materials need translation into Arabic or other languages

4. Biological Samples: Include when study involves collection and handling of biological samples

5. Subject Injury Compensation: Include specific compensation mechanisms for study-related injuries

6. Publication Rights: Include detailed publication procedures when academic institutions are involved

7. Anti-bribery and Corruption: Include detailed provisions when required by sponsor's compliance policies

8. Force Majeure: Include specific provisions for pandemic or other extraordinary circumstances

9. Dispute Resolution: Include specific arbitration or mediation procedures if preferred over court proceedings

Suggested Schedules

1. Schedule 1 - Protocol: Full study protocol including all amendments

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

3. Schedule 3 - Timeline: Study timeline including key milestones and deliverables

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

5. Schedule 5 - Required Approvals: List of required regulatory and ethics committee approvals

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

7. Schedule 7 - Form of Informed Consent: Approved informed consent forms in required languages

8. Schedule 8 - Data Protection Requirements: Specific data handling and protection procedures

9. Schedule 9 - Quality Requirements: Quality assurance and control procedures

10. Schedule 10 - Safety Reporting Procedures: 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 Law
Approval
Case Report Form
Clinical Trial
Confidential Information
Contract Research Organization (CRO)
Data Protection Laws
Effective Date
Ethics Committee
Good Clinical Practice (GCP)
Health Authority
Institution
Intellectual Property Rights
Investigational Product
Investigator Brochure
Investigator's Site
Medical Records
MOHAP
Monitor
Patient
Personal Data
Principal Investigator
Protocol
Regulatory Authority
Research Subject
Serious Adverse Event
Site
Source Documents
Sponsor
Study
Study Data
Study Materials
Study Personnel
Study Team
Sub-Investigator
Subject Information
Trial Master File
UAE Healthcare Laws
Informed Consent Form
Study Completion
Study Drug
Study Timeline
Quality Requirements
Safety Reporting Procedures
Research Staff
Study Budget
Biological Samples
Background IP
Foreground IP
Publication Rights
Study Results
Adverse Event
Data Management System
Monitoring Procedures
Study Completion Report
Interim Analysis
Statistical Analysis Plan
Clauses
Parties and Recitals
Definitions
Study Conduct
Regulatory Compliance
Ethics Committee Approval
Patient Safety
Informed Consent
Protocol Adherence
Study Drug Management
Data Collection and Management
Quality Assurance
Monitoring and Auditing
Personnel Requirements
Facility Requirements
Documentation Requirements
Record Retention
Confidentiality
Data Protection
Intellectual Property
Publication Rights
Payment Terms
Financial Disclosure
Insurance Requirements
Indemnification
Liability
Term and Duration
Termination
Force Majeure
Assignment
Subcontracting
Dispute Resolution
Governing Law
Notices
Amendments
Entire Agreement
Severability
Waiver
Counterparts
Language Requirements
Anti-bribery and Corruption
Material Transfer
Subject Injury Compensation
Safety Reporting
Study Timeline
Publication Policy
Equipment Provision
Site Access
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Academic Medical Research

Contract Research Services

Healthcare Regulation

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Medical Affairs

Compliance

Quality Assurance

Clinical Research

Contract Management

Data Management

Ethics Committee

Site Management

Patient Safety

Clinical Documentation

Relevant Roles

Clinical Research Director

Legal Counsel

Principal Investigator

Clinical Trial Manager

Research Coordinator

Regulatory Affairs Manager

Medical Director

Compliance Officer

Contract Manager

Chief Medical Officer

Research Ethics Officer

Site Manager

Quality Assurance Manager

Clinical Operations Manager

Healthcare Facility Director

Research Administrator

Data Protection Officer

Clinical Research Associate

Industries
Federal Law No. 4 of 2016: The Medical Liability Law governing healthcare practices and medical responsibility in the UAE, including provisions for medical research and experimentation
Cabinet Resolution No. 28 of 2018: Regulations concerning clinical research, including requirements for conducting clinical trials and research studies in the UAE
Federal Law No. 8 of 2019: The Medical Products Law regulating medical products, including investigational medicinal products used in clinical trials
MOHAP Guidelines for Clinical Trials: Ministry of Health and Prevention guidelines specifying requirements for conducting clinical trials, including approval processes and safety monitoring
Federal Law No. 2 of 2019: Law concerning the use of ICT in healthcare, relevant for electronic data collection and management in clinical trials
DOH Clinical Research Law (Abu Dhabi): Department of Health Abu Dhabi specific regulations for clinical research conducted in Abu Dhabi
DHA Research Guidelines (Dubai): Dubai Health Authority specific guidelines for conducting clinical research in Dubai
Federal Law No. 27 of 1981: Law concerning medications and pharmaceuticals, relevant for drug trials and pharmaceutical research
UAE Data Protection Laws: Various federal and emirate-level regulations governing data protection and privacy, particularly relevant for handling patient data in clinical trials
Federal Law No. 7 of 1975: Law concerning the practice of human medicine, relevant for medical professionals involved in 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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