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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) @ 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
Adverse Event
Applicable Laws
Approval
Background IP
Biological Materials
Case Report Form
Clinical Trial
Confidential Information
Contract Research Organization
Data Protection Laws
Effective Date
Ethics Committee
Foreground IP
GCP (Good Clinical Practice)
ICH Guidelines
Informed Consent Form
Institution
Intellectual Property Rights
Investigation Site
Investigational Product
Ministry of Public Health
Monitor
Patient Data
Personal Data
Principal Investigator
Protocol
Qatar Research Ethics Committee
Quality Assurance
Research Records
Research Results
Research Staff
Serious Adverse Event
Sponsor
Study
Study Completion
Study Data
Study Drug
Study Participant
Study Period
Study Protocol
Study Site
Study Subject
Study Team
Sub-Investigator
Territory
Third Party
Trial Master File
Clauses
Definitions
Scope of Services
Duration
Protocol Compliance
Regulatory Compliance
Study Conduct
Patient Safety
Informed Consent
Data Protection
Confidentiality
Intellectual Property
Publication Rights
Payment Terms
Record Keeping
Quality Assurance
Insurance
Indemnification
Liability
Force Majeure
Termination
Governing Law
Dispute Resolution
Assignment
Amendments
Notices
Ethics Committee Approval
Personnel Requirements
Site Management
Material Transfer
Monitoring Rights
Audit Rights
Safety Reporting
Subject Recruitment
Documentation Requirements
Representations and Warranties
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
Law No. 2 of 1983 Regarding the Practice of Medicine and Dental Medicine and Surgery: Establishes the fundamental framework for medical practice in Qatar, including provisions relevant to clinical research
Law No. 9 of 2020 Regulating Medical Products and Healthcare Products: Governs pharmaceutical products, medical devices, and their use in clinical research
Qatar Supreme Council of Health Guidelines for Clinical Research: Provides specific requirements for conducting clinical research in Qatar, including approval processes and ethical standards
Law No. 13 of 2016 Concerning Personal Data Protection: Regulates the collection, processing, and protection of personal data, including sensitive medical information
Qatar Civil Code (Law No. 22 of 2004): Provides the general framework for contracts and obligations under Qatar law
Ministry of Public Health (MoPH) Guidelines for Clinical Trials: Outlines specific requirements for clinical trial conduct, including safety reporting and monitoring
Qatar Research Ethics Committee Guidelines: Sets ethical standards and requirements for research involving human subjects
GCC Guidelines for Good Clinical Practice: Regional guidelines that Qatar follows for ensuring quality standards in clinical research
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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