💡 Plain English Explanation

Clinical trial and research data require specialized confidentiality protections that go beyond standard healthcare NDAs. This data includes study protocols, investigational drug information, patient outcomes, safety data, and regulatory submissions that can represent billions of dollars in R&D investment and determine the commercial viability of new treatments.

Research data confidentiality is governed by multiple overlapping frameworks: HIPAA for patient information, FDA regulations for clinical data (21 C.F.R. Parts 11, 50, 56, and 312), ICH-GCP guidelines for international trials, and the Common Rule (45 C.F.R. Part 46) for federally funded research. Your NDA must address these varied requirements while protecting valuable intellectual property.

Key categories of research data requiring protection:

⚠ Why This Clause Matters

For Research Sponsors: Clinical trial data represents enormous investment and competitive value. Premature disclosure of trial results, study design failures, or safety signals can tank stock prices, enable competitors to adjust their development strategies, and jeopardize regulatory approval. You need ironclad protection for this data.

For Research Partners: Academic institutions, contract research organizations (CROs), and clinical sites need clear guidelines on what data they can use for their own purposes, such as publications and follow-on research. Overly restrictive clauses can impede legitimate scientific activities, while unclear provisions create legal risk.

For Research Subjects: Research participants have consented to specific uses of their data. Confidentiality clauses help ensure that their sensitive health information and participation in experimental treatments remains protected, maintaining trust in the research enterprise.

📄 Clause Versions

Balanced Version: Protects sponsor interests while preserving academic freedom and reasonable publication rights. Appropriate for most sponsor-investigator and collaboration agreements. 
CLINICAL TRIAL AND RESEARCH DATA PROTECTION

1. Definition of Research Data.

"Research Data" means all data, information, and materials generated, collected, or obtained in connection with the Study, including:

(a) Study protocols, investigator brochures, case report forms, and statistical analysis plans;
(b) Individual patient data, including demographics, medical history, laboratory results, and adverse events;
(c) Aggregated study results, interim analyses, and final study reports;
(d) Regulatory submissions and correspondence with regulatory authorities;
(e) Investigational product information, including formulation, manufacturing, and stability data; and
(f) Data safety monitoring board reports and recommendations.

2. Confidentiality Obligations.

(a) The Receiving Party shall treat all Research Data as Confidential Information and shall not disclose Research Data to any third party without prior written consent of the Sponsor, except:
    (i) As required by applicable law or regulation;
    (ii) To regulatory authorities in connection with the Study;
    (iii) To the Receiving Party's Institutional Review Board (IRB) or Ethics Committee; or
    (iv) As permitted for publication under Section 4 below.

(b) Research Data may be used solely for conducting the Study and activities directly related thereto, and shall not be used for any commercial purpose without written agreement.

(c) The Receiving Party shall implement appropriate administrative, technical, and physical safeguards to protect Research Data, consistent with:
    (i) HIPAA Security Rule requirements for any PHI;
    (ii) FDA regulations at 21 C.F.R. Part 11 for electronic records; and
    (iii) ICH-GCP guidelines for clinical trial data.

3. Regulatory Compliance.

(a) Nothing in this Agreement shall prevent either party from making disclosures required by:
    (i) The FDA, EMA, or other regulatory authorities;
    (ii) Applicable laws regarding safety reporting;
    (iii) ClinicalTrials.gov registration and results reporting requirements; or
    (iv) Court orders or legal process.

(b) The parties shall cooperate in responding to regulatory inquiries and audits related to the Study.

4. Publication Rights.

(a) The Receiving Party may publish or present Study results, subject to the following:
    (i) The Receiving Party shall provide the Sponsor with a copy of any proposed publication at least forty-five (45) days before submission;
    (ii) The Sponsor may request removal of its Confidential Information and delay of publication for up to ninety (90) days to protect patent rights;
    (iii) Publications shall acknowledge the Sponsor's support and comply with ICMJE guidelines.

(b) Multi-center trial results shall be published first as a joint publication reflecting data from all sites, with individual site publications permitted thereafter.

5. Data Ownership and Return.

(a) The Sponsor shall own all Research Data and regulatory submissions.
(b) The Receiving Party may retain copies of Research Data as required by applicable law, IRB requirements, or institutional policies, subject to ongoing confidentiality obligations.
(c) Upon Study completion or termination, the Receiving Party shall return or certify destruction of all Research Data not required to be retained.
Disclosing Party Favor (Sponsor): Maximum protection for research data with strict publication controls and broad ownership rights. Use for high-value trials where data leakage could cause significant competitive harm. 
CLINICAL TRIAL AND RESEARCH DATA PROTECTION

1. Comprehensive Definition of Research Data.

"Research Data" means, without limitation, all data, information, materials, inventions, discoveries, and know-how of any kind, whether or not patentable, that are generated, collected, obtained, conceived, or developed in connection with, or arising from, the Study, including:

(a) All study documents: protocols, amendments, investigator brochures, informed consent forms, case report forms, monitoring reports, audit reports, and correspondence;
(b) All patient-level data: screening data, baseline assessments, efficacy endpoints, safety data, laboratory values, biomarker data, pharmacokinetic data, and imaging data;
(c) All analytical outputs: statistical analyses, interim analyses, data cuts, final study reports, and any interpretations or conclusions;
(d) All regulatory materials: IND/NDA submissions, regulatory correspondence, meeting minutes, and approval documents;
(e) All investigational product data: formulation, synthesis, manufacturing, quality control, stability, pharmacology, and toxicology data;
(f) All biological materials: samples, specimens, cell lines, and derivatives collected from study subjects; and
(g) All inventions, discoveries, methods, and know-how arising from analysis of Research Data.

2. Absolute Confidentiality.

(a) Research Data constitutes the Sponsor's most valuable trade secrets. The Receiving Party shall:
    (i) Maintain Research Data in strict confidence using the highest degree of care;
    (ii) Limit access to Research Data to individuals with a direct need-to-know who have signed confidentiality agreements at least as protective as this Agreement;
    (iii) Not discuss Research Data in any public forum, conference, or setting where unauthorized persons may be present;
    (iv) Not disclose the existence of the Study or the Receiving Party's participation therein without prior written consent;
    (v) Immediately notify Sponsor of any suspected unauthorized access or disclosure.

(b) The Receiving Party shall not, directly or indirectly:
    (i) Use Research Data for any purpose other than performance of the Study;
    (ii) Develop or assist in developing any competing product or treatment;
    (iii) Provide Research Data to any competitor of Sponsor;
    (iv) Trade securities of Sponsor or any other company based on knowledge of Research Data; or
    (v) File any patent application or claim any intellectual property rights in Research Data.

3. Strict Publication Controls.

(a) The Receiving Party shall not publish, present, or disclose any Research Data without prior written consent of Sponsor, which Sponsor may withhold in its sole discretion.

(b) If Sponsor consents to publication:
    (i) The Receiving Party shall submit proposed publications at least ninety (90) days before intended submission;
    (ii) Sponsor may require modifications to protect Confidential Information;
    (iii) Sponsor may delay publication for up to twelve (12) months to file patent applications;
    (iv) Sponsor shall have the right to be listed as co-author on any publication;
    (v) All publications shall acknowledge Sponsor's exclusive ownership of Research Data.

(c) Multi-center publications shall be controlled exclusively by Sponsor. Individual investigators may not publish site-specific results.

4. Ownership and Assignment.

(a) Sponsor exclusively owns all Research Data, regardless of which party generated it.
(b) The Receiving Party hereby assigns to Sponsor all rights in and to any inventions, discoveries, or intellectual property arising from the Study.
(c) The Receiving Party shall execute any documents necessary to perfect Sponsor's ownership rights.
(d) The Receiving Party shall have no rights to use Research Data following Study completion.

5. Enhanced Remedies.

(a) The Receiving Party acknowledges that breach of this section would cause irreparable harm for which monetary damages are inadequate.
(b) Sponsor shall be entitled to injunctive relief without bond.
(c) The Receiving Party shall indemnify Sponsor for all damages arising from unauthorized disclosure, including lost profits, diminished market exclusivity, and reputational harm.
Receiving Party Favor (Research Institution): Protects sponsor data while preserving academic freedom, publication rights, and researcher autonomy. Appropriate for academic medical centers and universities. 
CLINICAL TRIAL AND RESEARCH DATA PROTECTION

1. Definition of Research Data.

"Research Data" means confidential data and information that:
(a) Is disclosed by Sponsor specifically for conduct of the Study;
(b) Is marked as confidential at the time of disclosure; and
(c) Would reasonably be understood to be confidential given its nature.

Research Data includes study protocols, investigator brochures, and investigational product information provided by Sponsor. Research Data does not include:
(i) Data or information independently developed by Institution or its investigators;
(ii) General medical or scientific knowledge;
(iii) Information that becomes publicly available through no fault of Institution; or
(iv) Patient records maintained by Institution in its ordinary course of clinical care.

2. Reasonable Confidentiality.

(a) Institution shall maintain the confidentiality of Research Data using reasonable measures consistent with its standard practices for research data and applicable regulations.

(b) Institution may disclose Research Data:
    (i) To its employees, faculty, and staff with a need to know;
    (ii) To its IRB/Ethics Committee as required for study oversight;
    (iii) As required by applicable law, regulation, or court order;
    (iv) To regulatory authorities with jurisdiction over the Study;
    (v) In connection with publications pursuant to Section 4 below; and
    (vi) To successor institutions in connection with faculty departures.

(c) Institution's standard information security measures shall be deemed adequate to satisfy the confidentiality requirements of this Agreement.

3. Regulatory Compliance and Data Integrity.

(a) Both parties shall comply with applicable regulatory requirements, including FDA regulations, HIPAA, and ICH-GCP guidelines.
(b) Institution shall maintain research records as required by applicable regulations and institutional policies.
(c) Institution shall cooperate with regulatory inspections and audits, provided that Sponsor provides reasonable notice and reimburses Institution's costs.

4. Publication Rights.

(a) Institution and its investigators shall have the right to publish Study results. Academic freedom and the free exchange of scientific information are paramount.

(b) Prior to submission for publication, Institution shall provide Sponsor with a copy of the proposed publication and a thirty (30) day review period. Sponsor may:
    (i) Request removal of Sponsor's Confidential Information improperly included;
    (ii) Request a delay of up to sixty (60) days to file patent applications; and
    (iii) Provide comments for Institution's consideration (which Institution is not obligated to accept).

(c) Institution shall not be required to:
    (i) Delete accurate scientific findings;
    (ii) Include conclusions not supported by the data;
    (iii) Delay publication beyond sixty (60) days; or
    (iv) Suppress negative or inconclusive results.

(d) All publications shall disclose Sponsor's funding and any relevant conflicts of interest, consistent with ICMJE guidelines.

5. Data Rights and Ownership.

(a) Sponsor shall own Sponsor-provided Research Data and aggregated Study results for regulatory purposes.
(b) Institution shall own patient records, institutional data, and data independently developed by Institution.
(c) Institution and its investigators may use de-identified Study data for:
    (i) Future research and academic purposes;
    (ii) Educational activities;
    (iii) Quality improvement initiatives; and
    (iv) Applications for future research funding.

(d) Inventions shall be owned in accordance with applicable law (including Bayh-Dole for federally funded research) and institutional policy.

6. Limitation of Liability.

Institution's liability under this section shall be limited to direct damages and shall not exceed the Study funding received, except for claims arising from gross negligence or willful misconduct. Institution shall not be liable for the actions of individual investigators beyond its reasonable control.

💬 Key Considerations