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Clinical Trial Agreement

Clinical Trial Agreement Template for Singapore

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Key Requirements PROMPT example:

Clinical Trial Agreement

"I need a Clinical Trial Agreement for a Phase II oncology study between our Singapore-based pharmaceutical company and National University Hospital, with specific provisions for biological sample collection and storage, scheduled to commence in March 2025."

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Document background
Clinical Trial Agreements are essential documents used when conducting medical research involving human subjects in Singapore. These agreements establish the framework for collaboration between sponsors, institutions, and investigators while ensuring compliance with Singapore's stringent regulatory requirements. The Clinical Trial Agreement defines roles, responsibilities, and obligations of all parties, covering crucial aspects such as regulatory approvals, patient safety, data protection, and financial terms. It must align with Singapore's Health Sciences Authority (HSA) guidelines, Good Clinical Practice standards, and relevant healthcare legislation.
Suggested Sections

1. Parties: Identification of all contracting parties including Sponsor, Institution, Principal Investigator

2. Background: Context of the clinical trial, purpose of the agreement, and reference to the study protocol

3. Definitions: Key terms used tHRoughout the agreement including Study, Protocol, Study Drug, Study Data, etc.

4. Study Conduct: Requirements for conducting the clinical trial in accordance with Protocol, GCP, and applicable laws

5. Regulatory Compliance: Obligations regarding HSA approvals, ethics committee approvals, and regulatory reporting

6. Data Protection and Confidentiality: PDPA compliance, data handling, and confidentiality obligations

7. Intellectual Property: Ownership and rights to study data, inventions, and publications

8. Payment Terms: Financial arrangements, payment schedule, and costs coverage

9. Term and Termination: Duration of agreement and termination provisions

Optional Sections

1. Equipment Provision: Terms for equipment supplied by sponsor when specific equipment is provided for the trial

2. Biological Samples: Handling and rights regarding biological samples when trial involves collection of biological materials

3. Sub-contractor Terms: Requirements for third-party service providers when parts of the trial are outsourced

Suggested Schedules

1. Protocol: Detailed clinical trial protocol

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

3. Insurance Certificates: Clinical trial insurance documentation

4. Form of Ethics Committee Approval: Template or actual ethics committee approval

5. Data Protection Requirements: Specific data handling and protection procedures

6. Safety Reporting Procedures: Procedures for reporting adverse events

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
Study/Clinical Trial
Protocol
Study Drug/Investigational Product
Study Data
Study Site
Principal Investigator
Study Team
Sponsor
Institution
Ethics Committee/IRB
Confidential Information
Intellectual Property
Serious Adverse Event
Applicable Laws
Good Clinical Practice
Health Sciences Authority
Case Report Form
Study Subject/Trial Participant
Informed Consent Form
Background IP
Study Results
Study Completion
Essential Documents
Monitor
Quality Assurance
Regulatory Authority
Source Documents
Study Budget
Study Timeline
Trial Master File
Personal Data
Research Materials
Study Completion Date
Effective Date
Force Majeure
Sub-Investigator
Territory
Third Party
Clauses
Conduct of Study
Regulatory Compliance
Ethics Committee Approval
Patient Recruitment
Informed Consent
Study Drug Management
Data Collection and Reporting
Safety Reporting
Confidentiality
Data Protection
Intellectual Property
Publication Rights
Payment Terms
Budget
Record Retention
Monitoring and Auditing
Quality Assurance
Insurance and Indemnification
Term and Termination
Force Majeure
Dispute Resolution
Governing Law
Assignment
Amendment
Notices
Warranties
Liability
Study Equipment
Document Retention
Personnel Obligations
Sub-contracting
Publicity
Entire Agreement
Survival
Severability
Industries

Medicines Act (Chapter 176): Primary legislation governing the regulation of medicinal products, clinical trials, and pharmaceutical matters in Singapore

Health Products Act (Chapter 122D): Legislation controlling the manufacture, import, supply, presentation and advertisement of health products in Singapore

Human Biomedical Research Act (HBRA): Regulatory framework for human biomedical research, ensuring research is conducted ethically and with appropriate safeguards

Personal Data Protection Act 2012 (PDPA): Law governing the collection, use, disclosure and care of personal data, including patient information in clinical trials

Singapore Guideline for Good Clinical Practice (SG-GCP): National guidelines ensuring clinical trials are conducted according to highest scientific and ethical standards

HSA Clinical Trials Guidance: Regulatory guidance documents from Health Sciences Authority for conducting clinical trials in Singapore

MOH Clinical Trials Regulations: Ministry of Health guidelines and requirements for clinical trial conduct and oversight

NMEC Guidelines: National Medical Ethics Committee guidelines for ethical conduct of clinical research

Clinical Trial Certificate Requirements: Regulatory requirements for obtaining and maintaining Clinical Trial Certificates from HSA

Safety Reporting Framework: Requirements for reporting adverse events and safety information during clinical trials

Data Protection Requirements: Specific requirements for handling, storing, and transferring clinical trial data and personal information

IP Rights Framework: Intellectual property considerations and requirements in clinical trial agreements

Insurance Requirements: mandatory insurance and liability coverage requirements for clinical trials in Singapore

Publication Guidelines: Requirements and restrictions regarding the publication of clinical trial results

Financial Compliance Framework: Guidelines for financial arrangements, payments, and research grants 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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Clinical Trial Agreement

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