Ƶ

All Countries
Research & Development
Clinical Study Agreement

Clinical Study Agreement Template for Saudi Arabia

Create a bespoke document in minutes,  or upload and review your own.

4.6 / 5
4.8 / 5

Let's create your Clinical Study Agreement

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Get your first 2 documents free

Your data doesn't train Genie's AI

You keep IP ownership of your information

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."

Celebrated by
Collaborations with
Investors
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) @ Ƶ | 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

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










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

Find the exact document you need

Clinical Study Agreement

A legal agreement for conducting clinical research studies in Saudi Arabia, governed by Saudi law and SFDA regulations, establishing terms between sponsors, institutions, and investigators.

find out more

Contract Research Agreement

A Saudi Arabian law-governed agreement establishing terms and conditions for collaborative research activities, including IP rights, financial terms, and research obligations.

find out more

Collaboration Research Agreement

A Saudi Arabian law-governed agreement establishing terms and conditions for collaborative research activities between multiple parties.

find out more

Download our whitepaper on the future of AI in Legal

By providing your email address you are consenting to our Privacy Notice.
Thank you for downloading our whitepaper. This should arrive in your inbox shortly. In the meantime, why not jump straight to a section that interests you here: /our-research
Oops! Something went wrong while submitting the form.

ұԾ’s Security Promise

Genie is the safest place to draft. Here’s how we prioritise your privacy and security.

Your documents are private:

We do not train on your data; ұԾ’s AI improves independently

All data stored on Genie is private to your organisation

Your documents are protected:

Your documents are protected by ultra-secure 256-bit encryption

Our bank-grade security infrastructure undergoes regular external audits

We are ISO27001 certified, so your data is secure

Organizational security

You retain IP ownership of your documents

You have full control over your data and who gets to see it

Innovation in privacy:

Genie partnered with the Computational Privacy Department at Imperial College London

Together, we ran a £1 million research project on privacy and anonymity in legal contracts

Want to know more?

Visit our for more details and real-time security updates.

Read our Privacy Policy.