The Clinical Trial Confidentiality Agreement is essential for protecting sensitive information exchanged during clinical trials in Australia. It is typically used before and during clinical trials when confidential information needs to be shared between trial sponsors, research institutions, investigators, and other stakeholders. The agreement ensures compliance with Australian regulations including the Privacy Act 1988, Therapeutic Goods Act 1989, and state-specific health records legislation. It covers various types of confidential information including trial protocols, patient data, research methodologies, and proprietary information. This document is crucial for establishing clear obligations regarding information handling, security measures, and permitted uses while maintaining the integrity of clinical research and protecting intellectual property rights.
Your data doesn't train Genie's AI
You keep IP ownership of your information
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
OR
Let Ƶ's market-leading legal AI identify missing terms, unusual language, compliance issues and more - in just seconds.
1. Parties: Identification of the disclosing party (usually the sponsor/research organization) and receiving party (usually the investigator/institution)
2. Background: Context of the clinical trial, purpose of information sharing, and general framework of the confidentiality arrangement
3. Definitions: Detailed definitions including 'Confidential Information', 'Clinical Trial', 'Study Data', 'Trial Materials', and other key terms
4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the context of the clinical trial
5. Confidentiality Obligations: Core obligations regarding the use, protection, and non-disclosure of confidential information
6. Permitted Disclosures: Circumstances under which confidential information may be disclosed, including to regulatory authorities and ethics committees
7. Security Measures: Required security protocols and measures for protecting confidential information
8. Term and Survival: Duration of confidentiality obligations and provisions that survive termination
9. Return or Destruction of Confidential Information: Requirements for handling confidential information after the agreement ends
10. Breach and Remedies: Consequences of breach and available remedies
11. General Provisions: Standard contractual provisions including governing law, jurisdiction, and entire agreement
1. Third Party Contractors: Additional provisions for when third party contractors or consultants need access to confidential information
2. Multi-Site Trial Provisions: Special provisions for trials conducted across multiple sites or institutions
3. International Transfer of Data: Specific requirements for when confidential information needs to be transferred internationally
4. Publication Rights: Provisions regarding the right to publish trial results while maintaining confidentiality
5. Intellectual Property Rights: Specific provisions regarding IP rights in trial data and materials
6. Privacy Compliance: Detailed privacy compliance requirements when handling personal health information
7. Insurance and Indemnity: Additional protections regarding liability for information breaches
1. Schedule 1 - Description of Clinical Trial: Detailed description of the trial including protocol number and basic design
2. Schedule 2 - Specific Categories of Confidential Information: Detailed list of types of confidential information covered
3. Schedule 3 - Authorized Recipients: List of authorized personnel who may access confidential information
4. Schedule 4 - Security Protocols: Detailed security requirements and procedures
5. Appendix A - Form of Confidentiality Undertaking: Template confidentiality undertaking for individual staff members
6. Appendix B - Data Handling Procedures: Specific procedures for handling, storing, and transmitting confidential information
Relevant legal definitions
Clauses
Relevant Industries
Healthcare
Pharmaceuticals
Biotechnology
Medical Devices
Clinical Research
Healthcare Technology
Life Sciences
Academic Research
Medical Education
Relevant Teams
Legal
Clinical Operations
Research & Development
Regulatory Affairs
Compliance
Medical Affairs
Data Protection
Clinical Research
Ethics & Governance
Quality Assurance
Relevant Roles
Clinical Trial Manager
Principal Investigator
Research Coordinator
Legal Counsel
Privacy Officer
Chief Medical Officer
Research Director
Regulatory Affairs Manager
Clinical Operations Director
Data Protection Officer
Ethics Committee Member
Research Scientist
Clinical Research Associate
Medical Director
Compliance Manager
Find the exact document you need
Contract Disclosure Agreement
An Australian law-governed agreement establishing terms for sharing and protecting confidential information between parties.
find out more
Confidentiality Non Disclosure And Non Compete Agreement
An Australian law-governed agreement combining confidentiality obligations and competitive restrictions to protect business interests and sensitive information.
find out more
Mutual Non Circumvention Agreement
An Australian law-governed agreement protecting business relationships and preventing circumvention between parties in commercial dealings.
find out more
NDA Between Company And Consultant
An Australian-law governed NDA for protecting confidential information shared between companies and their external consultants.
find out more
Employee Privacy Agreement
An Australian-compliant agreement governing the collection, use, and protection of employee personal information under the Privacy Act 1988 and APPs.
find out more
Confidentiality Agreement Between Two Individuals
An Australian-law governed confidentiality agreement for protecting sensitive information shared between two individuals.
find out more
Business Non Disclosure Agreement Form
Australian-law compliant Business Non-Disclosure Agreement for protecting confidential information in business relationships.
find out more
Employee Secrecy Agreement
An Australian-law governed agreement establishing confidentiality obligations between employer and employee to protect sensitive business information and trade secrets.
find out more
NDA Settlement Agreement
An Australian law-governed agreement combining settlement terms with confidentiality obligations to resolve disputes while maintaining privacy of sensitive information.
find out more
Non Disclosure Agreement For Board Members
Australian-law governed Non-Disclosure Agreement for board members, ensuring protection of confidential information while complying with directors' duties under Australian law.
find out more
Disclosure Agreement Form
An Australian-law governed agreement that establishes terms for sharing and protecting confidential information between parties, ensuring compliance with local privacy laws and regulations.
find out more
Individual Confidentiality Agreement
An Australian-law governed agreement establishing confidentiality obligations between an individual and an organization, protecting sensitive information with locally enforceable provisions.
find out more
Two Sided NDA
An Australian law-governed mutual non-disclosure agreement protecting confidential information exchanged between two parties.
find out more
Confidential Meeting Agreement
An Australian legal agreement protecting confidential information shared during business meetings, ensuring compliance with federal and state privacy laws.
find out more
Non Disclosure Agreement For Resigned Employee
An Australian-compliant Non-Disclosure Agreement for resigned employees, protecting company confidential information and intellectual property post-employment.
find out more
Candidate Confidentiality Agreement
An Australian-law governed confidentiality agreement for job candidates to protect company information during the recruitment process.
find out more
Confidentiality Agreement Between Two Companies
An Australian-law governed confidentiality agreement between two companies for protecting sensitive information shared during business dealings.
find out more
Non Disclosure Agreement For Restaurant Employees
An Australian-compliant Non-Disclosure Agreement protecting confidential information in restaurant operations, including recipes, procedures, and business information.
find out more
Confidentiality Agreement Financial Information
Australian-law confidentiality agreement template for protecting sensitive financial information shared during business transactions and professional engagements.
find out more
Confidentiality Letter
An Australian-law Confidentiality Letter establishing legally binding confidentiality obligations between parties sharing sensitive information.
find out more
Salary Non Disclosure Agreement
An Australian-compliant agreement establishing employee obligations to maintain the confidentiality of salary and compensation information.
find out more
Real Estate Confidentiality Agreement
An Australian-compliant confidentiality agreement for protecting sensitive information in real estate transactions and property-related dealings.
find out more
Real Estate Agent Confidentiality Agreement
An Australian-compliant confidentiality agreement for real estate professionals handling sensitive property and client information.
find out more
Limited Disclosure Agreement
An Australian law-governed agreement that specifically defines and controls permitted disclosures of confidential information while prohibiting others.
find out more
Intern Non Disclosure Agreement
Australian-compliant Non-Disclosure Agreement for interns, protecting company confidential information while acknowledging the educational nature of internships.
find out more
Employee Innovation And Proprietary Information Agreement
An Australian agreement protecting employer IP rights and confidential information in employment relationships, ensuring compliance with federal IP and employment laws.
find out more
Employee Exit NDA
An Australian-compliant Non-Disclosure Agreement for departing employees, protecting company confidential information while adhering to Australian employment law requirements.
find out more
Confidentiality And Restraint Of Trade Agreement
An Australian law-governed agreement combining confidentiality obligations and restraint of trade provisions to protect business interests and confidential information.
find out more
Confidentiality Agreement In Clinical Trials
Australian-jurisdiction Confidentiality Agreement for clinical trials, ensuring protection of sensitive trial data and compliance with local regulations.
find out more
Three Way NDA
An Australian law-governed three-way confidentiality agreement protecting information shared between multiple parties in business transactions.
find out more
Reciprocal Non Disclosure Agreement
An Australian-law governed mutual confidentiality agreement establishing reciprocal obligations between parties to protect shared confidential information.
find out more
Privacy And Confidentiality Agreement
Australian Privacy and Confidentiality Agreement ensuring protection of confidential information and personal data under Australian privacy laws and regulations.
find out more
Privacy Agreement Form
An Australian-compliant Privacy Agreement Form that governs the collection, use, and protection of personal information under the Privacy Act 1988 and APPs.
find out more
Non Disclosure Non Solicitation Agreement
An Australian-law governed agreement protecting confidential information and preventing solicitation of employees, clients, and business partners.
find out more
Non Disclosure Agreement Property
An Australian-jurisdiction Non-Disclosure Agreement for protecting confidential information in property-related transactions and dealings.
find out more
Non Competition Non Solicitation And Confidentiality Agreement
An Australian law-governed agreement combining non-compete, non-solicitation, and confidentiality provisions to protect business interests while ensuring compliance with local restraint of trade principles.
find out more
Non Circumvention Agreement
An Australian law agreement preventing parties from bypassing each other in business dealings and protecting shared business relationships and opportunities.
find out more
Indefinite Confidentiality Agreement
An Australian law-governed Indefinite Confidentiality Agreement establishing permanent obligations to protect confidential business information and trade secrets.
find out more
Employee Proprietary Information Agreement
An Australian law-governed agreement protecting employer's confidential information and intellectual property rights in employment relationships.
find out more
Confidentiality Agreement In Business Plan
An Australian law-governed agreement protecting confidential business plan information shared between parties, ensuring its secure handling and limited use.
find out more
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
We are ISO27001 certified, so your data is secure
Organizational security:
You retain IP ownership of your documents and their information
You have full control over your data and who gets to see it
.png)