The Confidential Disclosure Agreement In Clinical Research is essential for protecting sensitive information exchanged during clinical research activities in Australia. This document is typically used when research organizations, pharmaceutical companies, healthcare providers, or other relevant parties need to share confidential information for clinical trials, medical research, or related activities. It covers various types of sensitive information including but not limited to patient data, research protocols, trial methodologies, and preliminary results. The agreement ensures compliance with Australian legislation including the Privacy Act 1988, Therapeutic Goods Act 1989, and state-specific health records laws. It is particularly important given Australia's strict regulatory environment regarding healthcare data protection and clinical research standards. The document provides a framework for secure information sharing while maintaining confidentiality and protecting intellectual property rights in clinical research contexts.
Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.
Your data doesn't train Genie's AI
You keep IP ownership of your docs
1. Parties: Identification of the disclosing and receiving parties, including any relevant research institutions, sponsors, or clinical trial organizations
2. Background: Context of the clinical research project and purpose of information sharing
3. Definitions: Detailed definitions including Confidential Information, Clinical Trial Data, Research Protocol, and other key terms specific to clinical research
4. Scope of Confidential Information: Detailed description of what constitutes confidential information in the clinical research context, including patient data, trial protocols, and research findings
5. Obligations of Confidentiality: Core confidentiality obligations, including handling of sensitive clinical data and research information
6. Permitted Use and Disclosure: Specified purposes for which the confidential information may be used, including research objectives and regulatory compliance
7. Security Measures: Required security protocols for protecting confidential information, especially for sensitive clinical data
8. Return or Destruction of Confidential Information: Procedures for handling confidential information after the agreement ends or upon request
9. Term and Termination: Duration of the agreement and circumstances for termination
10. Regulatory Compliance: Compliance requirements with relevant healthcare and research regulations
11. Breach and Remedies: Consequences of breach and available remedies
12. General Provisions: Standard contract terms including governing law, jurisdiction, and entire agreement
1. Third Party Disclosure: Rules for sharing information with authorized third parties such as ethics committees or regulatory bodies
2. Publication Rights: Terms regarding the publication of research results while maintaining confidentiality
3. Intellectual Property Rights: Specific provisions regarding IP arising from the use of confidential information
4. International Data Transfer: Requirements for transferring clinical data across international borders
5. Insurance and Indemnification: Additional protection for high-risk clinical research scenarios
6. Data Privacy Officer: Designation of responsible persons for data privacy compliance
7. Emergency Disclosure Provisions: Procedures for disclosing information in medical emergencies
1. Schedule 1 - Description of Clinical Research Project: Detailed description of the specific clinical research project or trial
2. Schedule 2 - Specific Confidential Information: Detailed list of confidential information types covered by the agreement
3. Schedule 3 - Security Protocols: Specific security measures and protocols for handling confidential information
4. Schedule 4 - Authorized Personnel: List of authorized personnel who may access the confidential information
5. Appendix A - Data Handling Procedures: Detailed procedures for handling, storing, and transferring clinical data
6. Appendix B - Regulatory Requirements: Specific regulatory requirements and compliance procedures
Find the exact document you need
Material Transfer Agreement
An Australian-law governed agreement for the transfer of research materials between organizations, addressing usage rights, safety, and compliance requirements.
Download
Research Contract
An Australian-law governed agreement establishing terms and conditions for research activities, including IP rights, funding, and compliance requirements.
Download
Standard Research Agreement
An Australian-law governed agreement establishing terms and conditions for conducting research activities between participating organizations.
Download
Sponsored Research Agreement
An Australian agreement governing sponsored research activities between research institutions and funding entities, outlining research terms, funding, and IP rights.
Download
Research License
An Australian-law governed agreement granting rights to use specified research materials or intellectual property for defined research purposes.
Download
Data Use Agreement
An Australian-compliant agreement governing the terms and conditions for data sharing and usage between parties, incorporating federal and state privacy law requirements.
Download
Studentship Agreement
An Australian-law governed agreement establishing terms and conditions for student research/study programs with financial support, including academic requirements and mutual obligations.
Download
Investigator Agreement
An Australian-compliant agreement establishing terms and conditions for conducting clinical trials between sponsors and investigators, meeting local regulatory requirements.
Download
Indirect Cost Rate Agreement
An Australian jurisdiction agreement establishing approved indirect cost rates and methodologies for recovering overhead costs in funded activities.
Download
Biobank Agreement
An Australian agreement governing the operation and management of biobank facilities, including collection, storage, and distribution of biological materials under Australian law.
Download
Confidential Disclosure Agreement In Clinical Research
An Australian-law governed agreement protecting confidential information in clinical research, ensuring compliance with local healthcare and privacy regulations.
Download
Market Research Agreement
An Australian market research services agreement governing the provision of research services, deliverables, and associated terms between client and research provider.
Download
Indirect Cost Agreement
An Australian law-governed agreement establishing the framework for calculating and managing indirect costs between parties, including methodology and compliance requirements.
Download
Research Grant Agreement
An Australian legal agreement establishing terms and conditions for research funding, including project scope, financial arrangements, and compliance requirements.
Download
Biological Material Transfer Agreement
An Australian-compliant agreement governing the transfer and use of biological materials between organizations, following national biosafety and research regulations.
Download
Clinical Study Agreement
An Australian-law governed agreement establishing terms and conditions for conducting clinical trials, defining relationships between sponsors, institutions, and investigators.
Download
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)