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Clinical Study Agreement

Clinical Study Agreement Template for Indonesia

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Key Requirements PROMPT example:

Clinical Study Agreement

"I need a Clinical Study Agreement for a Phase III diabetes drug trial to be conducted at three hospital sites in Jakarta, Indonesia, starting March 2025, with a CRO managing the study on behalf of our US-based pharmaceutical company."

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Document background
The Clinical Study Agreement serves as the primary contractual framework for conducting clinical trials in Indonesia, binding sponsors, research institutions, and investigators. This document is essential when implementing pharmaceutical, biotechnology, or medical device studies in Indonesian healthcare facilities. It must comply with Indonesian regulations, including BPOM guidelines, Health Law No. 36/2009, and Ministry of Health regulations regarding clinical trials. The agreement covers crucial elements such as study protocol implementation, regulatory compliance, patient safety measures, data protection, financial arrangements, and intellectual property rights. It's specifically adapted to meet Indonesian legal requirements while maintaining international clinical research standards and good clinical practice guidelines.
Suggested Sections

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

2. Background: Context of the clinical study, including the drug/device being studied and general purpose

3. Definitions: Detailed definitions of terms used throughout the agreement

4. Scope of Study: Detailed description of the clinical study, objectives, and protocol requirements

5. Regulatory Compliance: Compliance with Indonesian laws, regulations, and ethical requirements including BPOM regulations

6. Study Conduct: Requirements for study conduct, including GCP compliance and protocol adherence

7. Personnel and Resources: Responsibilities regarding study personnel, facilities, and resource allocation

8. Payment Terms: Financial terms, payment schedule, and budget details

9. Confidentiality: Confidentiality obligations and protection of study-related information

10. Data Protection: Compliance with Indonesian PDP Law and data protection requirements

11. Intellectual Property: IP rights, ownership of study data, and innovations

12. Publication Rights: Terms for publication of study results and review procedures

13. Liability and Indemnification: Risk allocation, insurance requirements, and indemnification provisions

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

15. General Provisions: Standard legal provisions including governing law, dispute resolution, and notices

Optional Sections

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

2. Sub-study Provisions: Include when additional sub-studies are contemplated

3. Equipment Provision: Include when sponsor is providing specific equipment for the study

4. Material Transfer: Include when biological materials or compounds need to be transferred

5. Multi-center Provisions: Include for multi-center studies with multiple participating institutions

6. Pharmacovigilance: Include detailed safety reporting requirements for drug studies

7. Translation Requirements: Include when documents require Indonesian translation

8. Local Ethics Committee: Include specific local ethics committee requirements when applicable

Suggested Schedules

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

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

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

4. Schedule 4 - Personnel: Key study personnel and their responsibilities

5. Schedule 5 - Material Transfer Terms: Details of any material transfer requirements

6. Schedule 6 - Insurance Certificates: Copies of required insurance documentation

7. Schedule 7 - Form of Informed Consent: Template informed consent form in Indonesian and English

8. Schedule 8 - Data Processing Agreement: Detailed data processing and protection requirements

9. Appendix A - Regulatory Approvals: Copies of BPOM and ethics committee approvals

10. Appendix B - Safety Reporting Procedures: Detailed safety and adverse event reporting 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
Applicable Law
BPOM
Case Report Form
Clinical Trial
Confidential Information
Contract Research Organization
Data Protection Laws
Effective Date
Ethics Committee
Good Clinical Practice
Institution
Intellectual Property Rights
Investigational Product
Investigator Brochure
Ministry of Health
Monitor
Patient
Personal Data
Principal Investigator
Protocol
Protocol Deviation
Quality Assurance
Regulatory Authority
Research Staff
Serious Adverse Event
Site
Sponsor
Study
Study Data
Study Document
Study Materials
Study Results
Study Subject
Study Team
Sub-Investigator
Subject Information Sheet
Trial Master File
Informed Consent Form
Study Completion
Study Drug
Background IP
Foreground IP
Study Budget
Completion Date
Confidentiality Period
Material Transfer Agreement
Quality Control
Safety Report
Study Timeline
Territory
Third Party
Research Ethics Committee
Clauses
Parties
Recitals
Definitions
Study Conduct
Regulatory Compliance
Protocol Adherence
Ethics Committee Approval
Patient Recruitment
Informed Consent
Study Materials
Personnel Requirements
Site Management
Quality Control
Record Keeping
Data Protection
Safety Reporting
Pharmacovigilance
Confidentiality
Intellectual Property
Publication Rights
Payment Terms
Budget
Insurance
Indemnification
Liability
Force Majeure
Term
Termination
Material Transfer
Monitoring Rights
Audit Rights
Dispute Resolution
Governing Law
Assignment
Amendments
Notices
Entire Agreement
Severability
Counterparts
Language Requirements
Anti-Corruption
Representatives
Survival
Relevant Industries

Pharmaceuticals

Healthcare

Biotechnology

Medical Devices

Clinical Research

Healthcare Services

Research & Development

Life Sciences

Medical Education

Relevant Teams

Legal

Clinical Operations

Regulatory Affairs

Research & Development

Medical Affairs

Clinical Research

Compliance

Quality Assurance

Data Management

Contract Management

Ethics & Safety

Site Management

Business Development

Finance

Pharmacovigilance

Relevant Roles

Clinical Research Director

Principal Investigator

Medical Director

Legal Counsel

Regulatory Affairs Manager

Clinical Operations Manager

Research Coordinator

Ethics Committee Chair

Data Protection Officer

Contract Manager

Chief Medical Officer

Research Compliance Officer

Site Director

Clinical Trial Manager

Quality Assurance Manager

Industries
Minister of Health Regulation No. 657/MENKES/PER/VIII/2009: Regulates the conduct of clinical trials for pharmaceutical products in Indonesia, including requirements for approval, monitoring, and safety reporting
Health Law No. 36/2009: Foundation law governing healthcare services and medical research in Indonesia, including provisions for patient rights and safety
National Agency of Drug and Food Control Regulation No. 21/2015: Guidelines for clinical trials, including requirements for trial protocols, informed consent, and adverse event reporting
Law No. 11/2019 on National System of Science and Technology: Governs research activities including medical research, material transfer, and research collaboration with foreign entities
Government Regulation No. 39/1995: Regulations on health research and development, including requirements for research ethics
Law No. 29/2004 on Medical Practice: Regulates medical practice and healthcare professionals' responsibilities in clinical research
Personal Data Protection Law (PDP Law): Governs the collection, processing, and protection of personal data, including sensitive medical information in clinical trials
BPOM Regulation No. 8/2017: Guidelines for clinical trial inspections and good clinical practice implementation
Law No. 13/2016 on Patents: Protects intellectual property rights related to clinical research findings and innovations
Minister of Health Regulation No. 66/2013: Regulates the establishment and operation of research ethics committees for 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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