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Clinical Study Agreement

Clinical Study Agreement Template for Saudi Arabia

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase III oncology trial to be conducted at three hospitals in Riyadh, Saudi Arabia, starting March 2025, where we (a US pharmaceutical company) are the sponsor and will be working through a local CRO."

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Document background
The Clinical Study Agreement serves as the primary legal instrument for establishing and governing clinical research relationships in Saudi Arabia. This document is essential when any organization plans to conduct clinical trials or research studies involving human subjects within Saudi Arabian jurisdiction. It must comply with the Saudi Food and Drug Authority (SFDA) regulations, Islamic law principles, and international research standards while addressing local regulatory and cultural requirements. The agreement typically covers comprehensive aspects of study conduct, including protocol implementation, safety monitoring, data protection, financial arrangements, and compliance requirements. It is particularly important for ensuring clear delineation of responsibilities between sponsors, research institutions, and investigators while protecting study subjects' rights and safety. The document must be structured to accommodate both international research standards and local Saudi Arabian legal requirements, making it suitable for both local and multinational clinical trials.
Suggested Sections

1. Parties: Identification of all contracting parties including Sponsor, Institution, Principal Investigator, and any CRO if applicable

2. Background: Context of the clinical study, purpose of the agreement, and brief description of the research project

3. Definitions: Detailed definitions of terms used throughout the agreement, including technical and legal terminology

4. Scope of Work: Detailed description of the clinical study, including objectives, protocol compliance requirements, and parties' responsibilities

5. Compliance with Laws and Regulations: Obligations to comply with Saudi laws, SFDA regulations, GCP, and Islamic law principles

6. Study Duration: Timeline of the study, including start date, end date, and any potential extensions

7. Financial Arrangements: Payment terms, schedule, currency, and payment conditions

8. Confidentiality: Provisions for protecting confidential information, including study data and trade secrets

9. Intellectual Property Rights: Ownership and rights to study results, data, inventions, and publications

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

11. Subject Injury and Indemnification: Responsibility for subject injuries and mutual indemnification provisions

12. Insurance: Required insurance coverage for the study and parties involved

13. Data Protection and Privacy: Compliance with data protection laws and handling of personal/medical data

14. Study Materials and Equipment: Provisions regarding study drug, equipment, and materials management

15. Termination: Grounds for termination, notice requirements, and post-termination obligations

16. Governing Law and Dispute Resolution: Specification of Saudi law as governing law and dispute resolution mechanisms

17. General Provisions: Standard contract clauses including notices, amendments, and assignment

Optional Sections

1. CRO Obligations: Specific section when a Contract Research Organization is involved in study management

2. Sub-investigator Obligations: Required when multiple investigators are involved in the study

3. Multi-center Study Provisions: Needed for studies conducted across multiple sites

4. Biological Samples Handling: Required when the study involves collection and storage of biological samples

5. Translation Requirements: Needed when study documents require Arabic translation

6. Electronic Systems Usage: Required when specific electronic data capture or management systems are used

7. Quality Assurance Requirements: Detailed QA provisions for complex studies

8. Special Safety Reporting: Additional safety reporting requirements for high-risk studies

9. Future Use of Data: Terms for data use in future research or analysis

10. Equipment Transfer: Required when significant equipment is provided for the study

Suggested Schedules

1. Schedule 1 - Protocol: Full clinical trial protocol or protocol summary

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

3. Schedule 3 - Study Timeline: Detailed timeline of study activities and milestones

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

5. Schedule 5 - Required Documentation: List of essential documents required for study conduct

6. Schedule 6 - Safety Reporting Procedures: Detailed procedures for adverse event reporting

7. Schedule 7 - Data Management Plan: Specifications for data collection, management, and transfer

8. Schedule 8 - Quality Management Plan: Details of quality assurance and monitoring procedures

9. Schedule 9 - Form of Informed Consent: Template of patient informed consent form in English and Arabic

10. Schedule 10 - Equipment List: Detailed list of equipment provided for the study

11. Appendix A - SFDA Requirements: Specific regulatory requirements and compliance procedures

12. Appendix B - Insurance Certificates: Copies of required insurance documentation

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
Approved Protocol
Background Intellectual Property
Case Report Form (CRF)
Clinical Trial
Confidential Information
Contract Research Organization (CRO)
Data Protection Laws
Effective Date
Ethics Committee
Foreground Intellectual Property
Good Clinical Practice (GCP)
Human Biological Materials
Informed Consent Form
Institution
Intellectual Property Rights
Investigational Product
Investigator Brochure
Islamic Law (Sharia)
Medical Records
Monitor
Monitoring Visit
Patient
Personal Data
Principal Investigator
Protocol
Protocol Deviation
Quality Assurance
Regulatory Authority
Research Staff
Serious Adverse Event
SFDA
Site
Source Documents
Sponsor
Study
Study Completion
Study Data
Study Drug
Study Materials
Study Subject
Study Team
Sub-investigator
Subject Information
Term
Third Party
Trial Master File
Clauses
Parties
Recitals
Definitions
Scope of Work
Study Conduct
Regulatory Compliance
Protocol Adherence
Patient Safety
Subject Recruitment
Informed Consent
Financial Terms
Payment
Confidentiality
Data Protection
Intellectual Property
Publication Rights
Study Materials
Documentation
Record Keeping
Quality Assurance
Monitoring
Audit Rights
Insurance
Indemnification
Liability
Force Majeure
Term
Termination
Study Completion
Material Transfer
Equipment Usage
Staff Obligations
Reporting Requirements
Safety Reporting
Regulatory Inspections
Amendment
Assignment
Notices
Dispute Resolution
Governing Law
Entire Agreement
Severability
Counterparts
Language
Cultural Compliance
Islamic Law Compliance
Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Academic Medical Centers

Contract Research Services

Life Sciences

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research and Development

Medical Affairs

Compliance

Quality Assurance

Clinical Research

Contracts Administration

Data Management

Ethics Committee

Site Management

Medical Writing

Clinical Development

Relevant Roles

Clinical Research Director

Legal Counsel

Medical Director

Principal Investigator

Research Coordinator

Regulatory Affairs Manager

Contract Manager

Chief Medical Officer

Clinical Operations Manager

Research Compliance Officer

Study Site Manager

Medical Science Liaison

Clinical Trial Manager

Research Ethics Committee Member

Quality Assurance Manager

Data Protection Officer

Industries
Clinical Trials Regulation (CTR): The main regulation governing clinical trials in Saudi Arabia, issued by the Saudi Food and Drug Authority (SFDA), outlining requirements for conducting clinical research, approval processes, and safety monitoring
Good Clinical Practice (GCP) Guidelines: SFDA's guidelines ensuring ethical standards and scientific quality in clinical trials, based on international ICH-GCP guidelines but adapted for Saudi Arabia
Law of Practicing Healthcare Professions: Regulates healthcare professionals' conduct and responsibilities in clinical studies, including liability and professional standards
Saudi Law of Ethics of Research on Living Creatures: Establishes ethical principles for research involving human subjects, including informed consent requirements and protection of vulnerable populations
Personal Data Protection Law: Governs the collection, processing, and protection of personal data, including sensitive medical information in clinical trials
Islamic Law (Sharia): Fundamental legal framework in Saudi Arabia affecting contract formation, ethical considerations, and general principles of agreements
National Committee of Bioethics (NCBE) Guidelines: Provides ethical guidelines for medical research and clinical trials in Saudi Arabia
Saudi Law of Pharmaceutical Establishments and Products: Regulates pharmaceutical products, including those used in clinical trials, their handling, and related responsibilities
Civil Transactions Law: Governs general contractual relationships and obligations between parties in Saudi Arabia
Medical Research Centers Regulations: Specific regulations for research centers conducting clinical trials, including operational requirements and standards
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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