What special provisions do clinical trial NDAs need?

Clinical trial NDAs require provisions for: IRB (Institutional Review Board) oversight compliance, patient data de-identification per HIPAA Safe Harbor or Expert Determination methods, publication rights and timing restrictions, adverse event reporting obligations, FDA submission rights, and sponsor vs. investigator data ownership.

How do publication rights work in medical research NDAs?

Publication rights typically include: a review period (30-90 days) before submission, the right to delay publication to file patents, restrictions on publishing proprietary methods or trade secrets, and acknowledgment requirements. Academic institutions often negotiate for guaranteed publication rights.

What is the minimum data de-identification requirement for research NDAs?

HIPAA provides two de-identification methods: Safe Harbor (removing 18 specific identifiers) and Expert Determination (statistical certification that re-identification risk is very small). Research NDAs should specify which method applies and who bears de-identification responsibility.

Who owns clinical trial data under a research NDA?

Data ownership varies by arrangement: Sponsors typically own raw trial data and results. Investigators may retain rights to publish and use aggregated findings. Academic institutions often negotiate joint ownership or perpetual license rights. The NDA should clearly define ownership, usage rights, and regulatory submission authority.

Medical Research NDA | Clinical Trials & Research Partnerships

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Clinical Trials

Phase I-IV trials, investigator-sponsored studies, and multi-site research protocols.

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Academic Collaborations

University partnerships, sponsored research, and joint research agreements.

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Data Sharing

Registry access, biobank partnerships, and secondary research use agreements.

📋 IRB Considerations

Research NDAs involving human subjects must address Institutional Review Board requirements and protections.

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Protocol Alignment

NDA scope must align with IRB-approved protocol and consent forms.

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Subject Protections

Confidentiality provisions must meet or exceed consent form promises.

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Modification Procedures

Changes to data sharing may require IRB amendment approval.

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Retention Requirements

Data retention must comply with IRB and regulatory requirements.

The Receiving Party acknowledges that the research data disclosed hereunder was collected pursuant to research protocols approved by [Institution]'s Institutional Review Board (IRB). Receiving Party agrees to use such data solely in accordance with the approved protocol and to immediately notify Disclosing Party of any proposed use that may require additional IRB approval.

🔒 Data De-identification Requirements

HIPAA provides two methods for de-identifying patient data for research purposes.

Safe Harbor Method

Preferred for Research

Remove all 18 HIPAA-specified identifiers. Clear, objective standard.

Names, addresses, dates (except year)
Phone, fax, email, SSN, MRN
Health plan numbers, account numbers
Vehicle identifiers, device IDs
URLs, IP addresses, biometrics
Full-face photos, unique codes

Expert Determination

Alternative

Statistical expert certifies re-identification risk is very small.

More flexible than Safe Harbor
Allows retention of some identifiers
Requires qualified statistical expert
Must document methods used
Annual re-certification recommended

Prior to disclosure, Disclosing Party shall de-identify all research data in accordance with 45 CFR 164.514(b)(2) (Safe Harbor method) by removing all eighteen (18) categories of identifiers specified therein. Receiving Party shall not attempt to re-identify any individual from the de-identified data or link such data with other data sources.

📚 Publication Rights & Timing

Balancing open science with intellectual property protection and sponsor interests.

Manuscript submitted for review

30d

Sponsor review period

60d

Patent filing delay (if needed)

90d

Maximum delay typical

Key negotiation points:

Right to publish vs. discretionary approval
Removal of confidential information only vs. substantive edits
Patent filing delay rights and duration
Multi-site coordination requirements
Acknowledgment and authorship requirements

Investigator shall have the right to publish research results, subject to a thirty (30) day review period during which Sponsor may identify Confidential Information for removal. Publication may be delayed an additional sixty (60) days if necessary to file patent applications. In no event shall total delay exceed ninety (90) days from manuscript submission.

🚨 Adverse Event Reporting Obligations

Research NDAs must address safety reporting requirements that may supersede confidentiality.

24h

Fatal/Life-threatening events to sponsor

IND Safety Reports to FDA

15d

Serious unexpected events

Annual

Safety summary reports

Notwithstanding any confidentiality obligations herein, Investigator shall immediately report to Sponsor any serious adverse event (as defined in 21 CFR 312.32) occurring during the study, and Sponsor shall have the right to report such events to FDA and other regulatory authorities as required by law. Such safety reporting shall not constitute a breach of this Agreement.

🏭 FDA Submission Rights

Clinical research data is often destined for regulatory submissions. NDAs should address who has submission rights.

Sponsor Right to Reference

Sponsor may reference and submit all trial data in regulatory filings worldwide.

Data Exclusivity

Address whether data can be used to support generic or biosimilar applications.

Cross-Reference Letters

Right to provide cross-reference authorization to other parties.

21 CFR Part 11 Compliance

Electronic records and signatures must meet FDA requirements.

Investigator hereby grants to Sponsor the irrevocable right to reference, use, and submit all study data, including raw data and source documents, in any regulatory filing worldwide. This includes the right to authorize third parties to cross-reference such data. Sponsor shall own all regulatory rights in the study data.

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⚖️ Consult a Research Attorney

Clinical research agreements involve complex regulatory requirements including FDA, OHRP, and institutional policies. We strongly recommend having experienced research counsel review any agreement involving human subjects research. Request a consultation.