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Clinical Research Agreement

Clinical Research Agreement Template for Qatar

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Key Requirements PROMPT example:

Clinical Research Agreement

"I need a Clinical Research Agreement governed by Qatar law for a Phase III oncology trial between our hospital and a US pharmaceutical company, with specific provisions for biological sample handling and multi-center study coordination across three sites in Qatar."

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Document background
The Clinical Research Agreement is a crucial document used when establishing a formal relationship between parties conducting clinical research in Qatar. It's essential for any clinical trial or research study involving human subjects, particularly when pharmaceutical companies or research organizations collaborate with local healthcare institutions. The agreement must comply with Qatar's Ministry of Public Health regulations, Law No. 2 of 1983 regarding medical practice, and Law No. 9 of 2020 regulating medical products. It covers critical aspects such as protocol adherence, participant protection, data management, financial arrangements, and regulatory compliance. This agreement type is fundamental for ensuring proper governance of clinical research activities while protecting all parties' interests and maintaining compliance with Qatar's healthcare regulatory framework.
Suggested Sections

1. Parties: Identification of the contracting parties including the research institution, sponsor, and principal investigator

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

3. Definitions: Detailed definitions of technical terms, key concepts, and abbreviated terms used throughout the agreement

4. Scope of Work: Detailed description of the clinical research to be conducted, including study objectives and design

5. Regulatory Compliance: Obligations regarding compliance with Qatar laws, MoPH regulations, and international guidelines

6. Study Protocol: Requirements for protocol adherence, amendments, and deviations

7. Responsibilities of Parties: Specific duties of each party including sponsor, institution, and principal investigator

8. Financial Provisions: Payment terms, budget details, and financial responsibilities

9. Participant Protection: Requirements for informed consent, participant safety, and adverse event reporting

10. Data Management: Data collection, protection, storage, and transfer requirements

11. Confidentiality: Protection of confidential information and trade secrets

12. Intellectual Property: Ownership and rights to research results, innovations, and publications

13. Term and Termination: Duration of agreement and conditions for termination

14. Insurance and Indemnification: Insurance requirements and allocation of liability

15. General Provisions: Standard contractual clauses including governing law, dispute resolution, and amendments

Optional Sections

1. Multi-Center Study Provisions: Additional provisions for studies conducted across multiple research sites

2. Biological Materials Handling: Specific requirements for collection, storage, and transfer of biological samples

3. Equipment Provision: Terms regarding supply and maintenance of specialized research equipment

4. Publication Rights: Detailed procedures for academic publication of study results

5. Sub-contractor Arrangements: Terms governing the involvement of third-party service providers

6. Post-Study Obligations: Continuing obligations after study completion including data retention and participant follow-up

7. Technology Transfer: Provisions for transfer of technical knowledge or methodologies

8. Translation Requirements: Provisions for Arabic translation of study documents when required

Suggested Schedules

1. Schedule 1 - Study Protocol: Detailed research protocol including methodology and procedures

2. Schedule 2 - Budget and Payment Schedule: Detailed financial terms, payment milestones, and budget breakdown

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

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

5. Schedule 5 - Insurance Certificates: Copies of required insurance policies and certificates

6. Schedule 6 - Data Management Plan: Detailed procedures for data collection, storage, and handling

7. Schedule 7 - Safety Reporting Procedures: Procedures for adverse event reporting and safety monitoring

8. Schedule 8 - Form of Informed Consent: Template informed consent forms in English and Arabic

9. Appendix A - Key Personnel: List of key study personnel and their responsibilities

10. Appendix B - Quality Assurance Requirements: Detailed quality control and monitoring procedures

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

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Academic Medical Centers

Contract Research Services

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research Administration

Medical Affairs

Compliance

Quality Assurance

Data Management

Business Development

Research Ethics

Finance

Contracts Administration

Relevant Roles

Clinical Research Director

Legal Counsel

Principal Investigator

Research Coordinator

Regulatory Affairs Manager

Contract Manager

Medical Director

Chief Medical Officer

Research Ethics Officer

Clinical Operations Manager

Business Development Manager

Quality Assurance Manager

Data Protection Officer

Clinical Trial Manager

Research Administration 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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