tiktok³ÉÈË°æ

All Countries
Research & Development
Confidential Disclosure Agreement In Clinical Research

Confidential Disclosure Agreement In Clinical Research Template for India

Create a bespoke document in minutes,  or upload and review your own.

4.6 / 5
4.8 / 5

Let's create your Confidential Disclosure Agreement In Clinical Research

Thank you! Your submission has been received!
Oops! Something went wrong while submitting the form.

Get your first 2 documents free

Your data doesn't train Genie's AI

You keep IP ownership of your information

Key Requirements PROMPT example:

Confidential Disclosure Agreement In Clinical Research

"I need a Confidential Disclosure Agreement in Clinical Research for a Phase III vaccine trial starting in March 2025, between our pharmaceutical company in Mumbai and three research hospitals across India, with special provisions for handling patient data and trial results."

Celebrated by
Collaborations with
Investors
Document background
The Confidential Disclosure Agreement In Clinical Research is a critical legal instrument used when parties need to share sensitive information during clinical research activities in India. This document is essential when research organizations, pharmaceutical companies, or healthcare institutions engage in clinical trials, research collaborations, or data sharing activities. It ensures compliance with Indian regulations, particularly the Drugs and Clinical Trials Rules, 2019, while protecting proprietary information, research methodologies, trial data, and patient confidentiality. The agreement is structured to address specific requirements of Indian healthcare laws and international clinical research standards, making it suitable for both domestic and international research collaborations within the Indian jurisdiction.
Suggested Sections

1. Parties: Identification of the disclosing and receiving parties, including full legal names, addresses, and registration details

2. Background: Context of the clinical research project and purpose of sharing confidential information

3. Definitions: Detailed definitions including 'Confidential Information', 'Clinical Trial Data', 'Research Project', 'Authorized Personnel', and other key terms

4. Scope of Confidential Information: Specific description of what constitutes confidential information in the clinical research context

5. Obligations of Receiving Party: Detailed responsibilities for handling and protecting confidential information

6. Permitted Disclosures: Circumstances under which confidential information may be shared with third parties

7. Data Protection Measures: Specific security measures required for protecting clinical research data

8. Term and Termination: Duration of the agreement and conditions for termination

9. Return or Destruction of Confidential Information: Procedures for handling confidential information after agreement termination

10. Governing Law and Jurisdiction: Specification of Indian law as governing law and jurisdiction for disputes

11. General Provisions: Standard contractual provisions including severability, amendments, and notices

Optional Sections

1. Regulatory Compliance: Additional section when specific regulatory requirements need to be addressed, such as DCGI guidelines or ICH-GCP compliance

2. Third Party Rights: Required when other parties (such as CROs or sponsors) may have rights to the confidential information

3. Publication Rights: Needed when parties want to reserve rights to publish research results

4. Intellectual Property Rights: Required when the confidential information includes patentable inventions or proprietary methods

5. Insurance and Indemnification: Needed for high-risk clinical research or when required by institutional policies

6. Export Control: Required when confidential information may be subject to export control regulations

7. Data Privacy Compliance: Additional section when handling personal health information of trial subjects

Suggested Schedules

1. Schedule A - Description of Clinical Research Project: Detailed description of the research project and its objectives

2. Schedule B - Types of Confidential Information: Comprehensive list of specific types of confidential information covered

3. Schedule C - Authorized Personnel: List of individuals authorized to access confidential information

4. Schedule D - Security Protocols: Detailed security measures and protocols for handling confidential information

5. Schedule E - Data Handling Procedures: Specific procedures for managing clinical trial data and other confidential information

Authors

Alex Denne

Head of Growth (Open Source Law) @ tiktok³ÉÈË°æ | 3 x UCL-Certified in Contract Law & Drafting | 4+ Years Managing 1M+ Legal Documents | Serial Founder & Legal AI Author

alex.den.21@genieai.co
Relevant legal definitions








































Clauses






























Relevant Industries

Healthcare

Pharmaceuticals

Biotechnology

Medical Devices

Clinical Research

Healthcare Technology

Life Sciences

Medical Education

Healthcare Consulting

Medical Diagnostics

Relevant Teams

Legal

Clinical Operations

Research & Development

Regulatory Affairs

Medical Affairs

Compliance

Data Management

Quality Assurance

Clinical Research

Scientific Affairs

Ethics Committee

Information Security

Document Control

Business Development

Project Management

Relevant Roles

Clinical Research Director

Medical Affairs Manager

Research & Development Head

Legal Counsel

Compliance Officer

Clinical Trial Manager

Principal Investigator

Research Project Manager

Data Protection Officer

Regulatory Affairs Manager

Ethics Committee Coordinator

Clinical Operations Director

Research Scientist

Medical Director

Quality Assurance Manager

Industries








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

Find the exact document you need

Subaward Agreement

An Indian law-governed agreement between a primary grant recipient and a subrecipient for delegating portion of granted work or research activities.

find out more

Clinical Trial Research Agreement

A regulatory-compliant agreement for conducting clinical trials in India, governing relationships between sponsors, research institutions, and investigators under Indian law.

find out more

Research Cooperation Agreement

An Indian law-governed agreement establishing terms for collaborative research activities between multiple parties, including IP rights, confidentiality, and operational framework.

find out more

Research Contract

An Indian law-governed agreement establishing terms and conditions for research collaboration, including IP rights, funding, and compliance requirements.

find out more

Standard Research Agreement

An Indian law-governed agreement template for establishing research collaboration terms, intellectual property rights, and compliance requirements.

find out more

Sponsored Research Agreement

An Indian law-governed agreement establishing terms for sponsored research activities between research institutions and funding sponsors.

find out more

Research License Agreement

An Indian law-governed agreement enabling the licensed use of intellectual property for research purposes, with comprehensive protection for both licensor and licensee.

find out more

Research License

An Indian law-governed agreement enabling the licensed use of intellectual property or materials for research purposes, with defined terms for usage and result management.

find out more

Data Use Agreement

A legal agreement governing data sharing and processing arrangements between parties under Indian law, ensuring compliance with local data protection regulations.

find out more

Studentship Agreement

An Indian law-governed agreement between an educational institution and student establishing the terms and conditions of studentship.

find out more

Research Data Sharing Agreement

An Indian law-governed agreement for sharing research data between organizations, ensuring legal compliance and data protection.

find out more

Investigator Agreement

An India-governed agreement between sponsors/CROs and medical investigators for conducting clinical trials, ensuring compliance with Indian healthcare regulations and ethical guidelines.

find out more

Technology Transfer License Agreement

An Indian law-governed agreement for structured technology transfer between parties, covering licensing terms, implementation procedures, and regulatory compliance.

find out more

Confidential Disclosure Agreement In Clinical Research

An India-compliant Confidential Disclosure Agreement for protecting sensitive information in clinical research, aligned with DCGI guidelines and Indian healthcare regulations.

find out more

Accelerated Clinical Trial Agreement

An agreement governing accelerated clinical trials in India, establishing expedited research protocols while ensuring compliance with Indian regulations and safety standards.

find out more

Market Research Agreement

An Indian law-governed agreement establishing terms for market research services, including research scope, methodology, deliverables, and data protection requirements.

find out more

Indirect Cost Agreement

An Indian law-governed agreement establishing the framework and methodology for allocating indirect costs among multiple entities while ensuring regulatory compliance.

find out more

Technology Development Agreement

An Indian law-governed agreement setting out terms for technology development projects, including scope, IP rights, and delivery milestones.

find out more

Biological Material Transfer Agreement

An agreement governing the transfer of biological materials between organizations, compliant with Indian biodiversity and research regulations.

find out more

Clinical Study Agreement

A legally binding agreement governing clinical trials in India, ensuring compliance with Indian regulations while establishing rights and responsibilities of all parties involved in clinical research.

find out more

Contract Research Agreement

An Indian law-governed agreement establishing terms and conditions for contracted research services, including research scope, IP rights, and deliverables.

find out more

Download our whitepaper on the future of AI in Legal

By providing your email address you are consenting to our Privacy Notice.
Thank you for downloading our whitepaper. This should arrive in your inbox shortly. In the meantime, why not jump straight to a section that interests you here: /our-research
Oops! Something went wrong while submitting the form.

³Ò±ð²Ô¾±±ð’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; ³Ò±ð²Ô¾±±ð’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

Our bank-grade security infrastructure undergoes regular external audits

We are ISO27001 certified, so your data is secure

Organizational security

You retain IP ownership of your documents

You have full control over your data and who gets to see it

Innovation in privacy:

Genie partnered with the Computational Privacy Department at Imperial College London

Together, we ran a £1 million research project on privacy and anonymity in legal contracts

Want to know more?

Visit our for more details and real-time security updates.

Read our Privacy Policy.