Can this agreement be signed electronically?

Yes. Electronic signatures are generally valid under the federal ESIGN Act and applicable state UETA statutes, provided the parties demonstrate intent, consent, attribution, and retention capabilities.

Do I need a HIPAA addendum?

If the agreement involves protected health information, include a HIPAA Business Associate Agreement or addendum specifying permitted uses, safeguards, and breach reporting as required under HIPAA rules.

Who must sign on behalf of an institution?

An authorized institutional representative such as an authorized official, department chair, or delegated contracting officer should sign; confirm signature authority and delegation internally before execution.

How are amendments handled?

Amendments should be in writing, reference the original agreement, describe changes, and be signed by the same authorized parties to ensure enforceability and auditability.

What happens if a party withdraws consent?

Withdrawal procedures should be defined in the agreement; note that withdrawing consent may limit future data use but does not retroactively alter already lawfully processed data.

How long should I keep signed copies?

Retain executed agreements for the active study period plus applicable post-termination intervals; follow federal standards such as IRS three years and HIPAA six years as minimums.

Electronic Signature
Templates
Miscellaneous
Research Study Agreement

Research Study Agreement

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RESEARCH STUDY AGREEMENT

Parties

Party A (Sponsor or Funding Entity):

Party A - Entity Type

Corporation Research Institution Individual/Other

Party A - Address

Party B (Research Institution / Principal Investigator):

Party B - Entity Type

University Hospital Other

Party B - Address

Recitals

WHEREAS, Party A desires to sponsor and fund a research study concerning the subject matter described below; and

WHEREAS, Party B has the necessary personnel, facilities, and expertise to conduct the research study in accordance with applicable law, institutional policies, and ethical standards; and

WHEREAS, the parties wish to set forth the terms under which Party B will perform the research and Party A will provide funding and oversight.

Scope of Work

Description of Study: Party B will perform the research study described below in substantial conformity with the study protocol, milestone schedule, and deliverables set forth in this Agreement. Party B shall ensure that all work meets professional and scientific standards.

Detailed Scope of Work and Deliverables Primary Study Location(s)

Payment Terms

Compensation: In consideration for the Services described in the Scope of Work, Party A shall pay Party B the total amount of $ (the "Total Compensation"), subject to the schedule and conditions below.

Payment Schedule and Milestones

Invoicing: Party B shall submit itemized invoices to Party A in accordance with the Payment Schedule. Party A shall pay undisputed portions of properly submitted invoices within days of receipt.

Late Payment: Any undisputed amount not paid by Party A when due shall accrue interest at the lesser of (i) percent per month or (ii) the maximum rate permitted by applicable law.

Term and Termination

Term: This Agreement commences on and continues until unless earlier terminated in accordance with this Agreement.

Termination for Convenience: Either party may terminate this Agreement, without cause, upon written notice to the other party given at least days prior to the effective date of termination. Upon termination, Party A shall pay Party B for all Services satisfactorily performed through the effective date of termination.

Termination for Cause: Either party may terminate immediately upon written notice if the other party materially breaches this Agreement and fails to cure such breach within thirty (30) days after receipt of written notice specifying the breach.

Confidentiality

Definition: "Confidential Information" means non-public proprietary information disclosed by one party ("Disclosing Party") to the other ("Receiving Party") that is designated as confidential or that reasonably should be understood to be confidential given the nature of the information and the circumstances of disclosure.

Obligations: The Receiving Party shall (a) not disclose Confidential Information to any third party except as expressly permitted in this Agreement; (b) use Confidential Information solely for the performance of obligations under this Agreement; and (c) exercise at least the same degree of care to protect Confidential Information as it uses to protect its own confidential information, but in no event less than reasonable care.

Exclusions: Confidential Information does not include information that (i) is or becomes publicly available other than by breach of this Agreement; (ii) was rightfully known to the Receiving Party prior to disclosure; (iii) is independently developed without use of Confidential Information; or (iv) is required to be disclosed by law, provided the Receiving Party gives prompt notice and cooperates to seek protective measures.

Survival: The confidentiality obligations set forth herein shall survive termination or expiration of this Agreement for a period of from the date of disclosure.

Intellectual Property and Publication

Ownership: Unless otherwise agreed in writing, Party B shall retain ownership of pre-existing intellectual property. Intellectual property and data first created or generated in the course of performing the Study ("Study IP") shall be owned as follows: Party B retains ownership of raw study data and analysis; Party A shall have a paid-up, non-exclusive license to use Study IP for internal research, regulatory, and commercial evaluation purposes as necessary to exploit rights granted hereunder.

Publication: Party B may publish study results provided that Party B provides Party A with a copy of any proposed publication at least days prior to submission. Party A may request deletion of confidential technical information or filing for intellectual property protection; such requests shall not be unreasonably withheld.

Representations and Warranties

Each party represents and warrants that it has full power and authority to enter into this Agreement and perform its obligations, and that performance will comply with applicable laws, regulations, and institutional policies, including requirements for human subjects research and data protection where applicable.

Indemnification and Insurance

Indemnification: Each party shall indemnify, defend, and hold harmless the other party from and against third-party claims arising out of its negligence, willful misconduct, or material breach of this Agreement. Liability for indirect, incidental, or consequential damages is excluded to the extent permitted by law.

Insurance: Each party shall maintain insurance coverage appropriate to its activities under this Agreement, including professional liability and general commercial liability insurance in amounts customary for similar entities and activities.

Governing Law

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to its conflicts of law principles. Exclusive venue for any dispute arising under this Agreement shall be the state or federal courts located in that state, unless the parties agree otherwise in writing.

Entire Agreement; Amendments

Entire Agreement: This Agreement, together with any attachments, appendices, and the Scope of Work incorporated herein, constitutes the entire agreement between the parties with respect to the subject matter and supersedes all prior and contemporaneous understandings and agreements, whether written or oral.

Amendments: Any amendment or modification of this Agreement must be in writing and signed by authorized representatives of both parties.

Notices

Notices to Party A Notices to Party B

Miscellaneous

Severability: If any provision of this Agreement is held invalid or unenforceable, the remainder of the Agreement shall remain in full force and effect.

Assignment: Neither party may assign or delegate this Agreement or any of its rights or obligations without the prior written consent of the other party, except that Party A may assign this Agreement to an affiliate or successor in interest provided that such assignee assumes Party A's obligations hereunder.

Party A (Sponsor):

By:

Date:

Party B (Institution):

By:

Date:

What a Research Study Agreement Is and when it applies

A Research Study Agreement is a written contract that defines the responsibilities, deliverables, data handling, funding, intellectual property, and compliance obligations between parties conducting or sponsoring a research study. It commonly governs timelines, subject recruitment, data access, confidentiality, indemnity, publication rights, and regulatory compliance such as HIPAA or FDA requirements when relevant. The agreement formalizes who owns study data, who may use it, how identifiers are protected, how adverse events are reported, and the conditions for termination and post-study obligations.

Why documenting research responsibilities matters

A clear Research Study Agreement minimizes disputes, clarifies regulatory duties, and protects participant privacy by assigning operational roles, data safeguards, and reporting responsibilities required under HIPAA, FDA rules, and institutional policies.

Who typically prepares and signs a Research Study Agreement

Agreements should also list delegated contacts, billing contacts, and legal representatives to ensure smooth execution and compliance tracking.

Principal investigator at the study site responsible for protocol adherence, subject safety, and local regulatory reporting.
Sponsor or funding organization that provides resources, retains certain data rights, and manages overall study oversight.
Institutional review board (IRB) or compliance office involved in approval and ensuring consent and privacy protections.

Essential clauses to include in a professional agreement

A robust Research Study Agreement groups obligations into operational, legal, and technical sections so parties can locate duties and compliance requirements quickly.

Scope of Work

Define study objectives, protocol number, tasks each party performs, enrollment targets, and specific deliverables with measurable acceptance criteria.

Data Use and Access

Specify data ownership, de-identification steps, permitted secondary uses, data sharing permissions, and retention responsibilities between parties.

Compliance and Approvals

State obligations for IRB approvals, informed consent forms, adverse event reporting, HIPAA safeguards, and any FDA submissions if applicable.

Payments and Budget

List payment schedule, invoicing procedures, allowable costs, travel reimbursements, and conditions for withholding or adjusting payments.

Intellectual Property

Allocate rights to inventions, patents, and publications, and include processes for disclosure, prosecution, and revenue sharing when relevant.

Termination and Liability

Describe termination rights, notice periods, transition obligations, indemnification limits, insurance requirements, and liability caps if negotiated.

Step-by-step: completing the agreement

Follow these steps in order to ensure the agreement is complete, compliant, and ready for signing.

01

Gather documents: Collect protocol, budget, consent form, and IRB approval.
02

Populate core fields: Enter names, dates, payment terms, and study ID.
03

Confirm compliance: Verify HIPAA or FDA obligations are reflected.
04

Execute signatures: Have authorized reps sign and date the final page.

Configuring an electronic workflow for execution

Set up a clear signing order, authentication, and document routing to streamline execution and auditability.

Field	Configuration
Signing order	Sequential: Sponsor then site then PI
Authentication method	Email link plus SMS code for higher assurance
Document versioning	Lock final PDF and archive prior drafts
Notifications	Automated reminders at set intervals

Typical e-signing flow for a Research Study Agreement

An electronic workflow reduces turnaround time while capturing an audit trail of who signed and when.

Upload document: Sender uploads final PDF to the platform
Place fields: Add signature, date, and initial fields
Send to signers: Specify order or send parallel links
Capture audit: Platform logs IP, timestamp, and actions

Technical considerations for secure electronic execution

Confirm the platform can support BAAs for HIPAA, export signed PDFs with certificates, and offer retention controls aligned with your records policy.

Authentication: Email, SMS, or stronger methods
Encryption: TLS in transit; AES-256 at rest
Integrations: Connects to EHR, LMS, or cloud storage

Common timing and reporting deadlines to include

Specify milestone dates and reporting intervals so parties can track enrollment, reporting, and closeout tasks.

Effective date:

Date agreement obligations begin

Enrollment start:

Target date to begin participant recruitment

Interim reports:

Frequency and due dates for progress reports

Closeout date:

Deadline for final study activities

Data transfer:

Date and method for delivering final datasets

Potential legal and operational risks

HIPAA breach: Civil and criminal exposure

Regulatory noncompliance: FDA or IRB sanctions

Contract breach: Liability for missed obligations

Data integrity issues: Invalid or unusable study data

Funding delays: Payments withheld or deferred

Audit findings: Corrective action or penalties

Common mistakes to avoid when preparing the agreement

Using inconsistent party names across schedules and invoices, which can delay execution and payment processing.
Failing to specify data access levels and de-identification processes, leading to disputes over reuse or publication rights.
Omitting IRB or ethics committee responsibilities, which can stall study start or trigger regulatory noncompliance.
Leaving payment terms vague or lacking invoicing instructions, causing disputes and administrative hold-ups.

Comparing eSignature vendors for executing research agreements

Vendor pricing and features differ; below is a high-level comparison with signNow listed first to show starting costs and key compliance considerations.

	signNow	DocuSign	Adobe Sign	PandaDoc	HelloSign
Starting Price	$8/user/mo	$15/user/mo	$14/user/mo	$19/user/mo	$15/user/mo
Free Trial	Yes, 7-day free trial	Varies by plan	Varies by plan	Varies by plan	Varies by plan
Bulk Send	Yes	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No
Envelope Cap	No envelope cap	100 envelopes/user/year	Varies	Varies	Varies

Frequently asked questions about Research Study Agreements

Answers to common questions about signing, validity, amendments, and recordkeeping for research agreements executed electronically.

Need help? Contact support

Can this agreement be signed electronically?
Yes. Electronic signatures are generally valid under the federal ESIGN Act and applicable state UETA statutes, provided the parties demonstrate intent, consent, attribution, and retention capabilities.
Do I need a HIPAA addendum?
If the agreement involves protected health information, include a HIPAA Business Associate Agreement or addendum specifying permitted uses, safeguards, and breach reporting as required under HIPAA rules.
Who must sign on behalf of an institution?
An authorized institutional representative such as an authorized official, department chair, or delegated contracting officer should sign; confirm signature authority and delegation internally before execution.
How are amendments handled?
Amendments should be in writing, reference the original agreement, describe changes, and be signed by the same authorized parties to ensure enforceability and auditability.
What happens if a party withdraws consent?
Withdrawal procedures should be defined in the agreement; note that withdrawing consent may limit future data use but does not retroactively alter already lawfully processed data.
How long should I keep signed copies?
Retain executed agreements for the active study period plus applicable post-termination intervals; follow federal standards such as IRS three years and HIPAA six years as minimums.

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