Can this agreement be e‑signed?

Yes. Electronic signatures are legally valid under the federal ESIGN Act (15 U.S.C. ch. 96, 2000) and UETA where adopted; confirm exceptions such as wills or court orders do not apply to your transaction.

Is a BAA required if PHI is shared?

If the agreement permits access to protected health information, a HIPAA Business Associate Agreement should be in place and executed prior to data exchange to meet HIPAA obligations.

Do I need a notary or witnesses?

Notarization or witness requirements depend on state law and agreement terms. Some states or institutional policies may require notarization for specific delegations—confirm per‑state rules and institutional counsel.

How do I correct an error after signing?

Minor clerical errors usually require an amendment or an agreed written correction executed by authorized signers; do not alter the executed PDF without mutual written consent.

How long should records be kept?

Retain executed agreements for the full term plus statutory minimums: IRS records 3 years (IRC §6501(a)), HIPAA records 6 years (45 CFR §164.530(j)); adjust for state requirements.

What if a signer lacks authority?

If a signer lacked authority, the agreement may be unenforceable against the organization; confirm corporate authority before execution or obtain ratification from appropriate executives or governing body.

Electronic Signature
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Clinical Evaluation Agreement

Clinical Evaluation Agreement

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CLINICAL EVALUATION AGREEMENT

This Clinical Evaluation Agreement ("Agreement") is made effective as of by and between:

Evaluator (Service Provider) Evaluator Organization / Practice Evaluator License / Credentials Evaluator Address Client (Recipient of Services) Client Identifier / DOB Client Address

WHEREAS

WHEREAS, Evaluator represents that Evaluator is licensed, qualified, and equipped to perform clinical assessments and evaluations in the area of practice identified above and will perform evaluations in accordance with applicable professional standards and laws; and

WHEREAS, Client requests that Evaluator perform a clinical evaluation for the purpose of determining diagnostic, treatment, placement, or accommodation recommendations as described in this Agreement; and

WHEREAS, the parties desire to set forth the terms and conditions under which the evaluation will be performed and the manner of payment for such services.

SCOPE OF WORK

Evaluator will perform the clinical evaluation described below. This evaluation may include record review, standardized testing, clinical interviews, observation, scoring, formulation of findings, and preparation of a written report and recommendations.

Type and Purpose of Evaluation Detailed Scope of Work Deliverables and Timeline

PAYMENT TERMS

Client shall pay Evaluator for services rendered in accordance with the following terms.

Total Fee for Evaluation Payment Schedule Invoices and Due Date

Invoices will be issued by Evaluator and are due within days of invoice date.

Late Payment Fee

Client is responsible for reasonable collection costs, including attorney fees, for delinquent amounts.

TERM AND TERMINATION

This Agreement shall commence on and shall continue until unless earlier terminated in accordance with this section.

Termination for Convenience

Either party may terminate this Agreement for any reason upon providing days' written notice to the other party. In the event of termination, Evaluator shall be paid for services performed and reasonable preparatory time up to the effective date of termination.

Termination for Cause

CONFIDENTIALITY

Evaluator shall maintain as confidential all protected health information and other confidential information disclosed by Client in connection with the evaluation, in accordance with applicable law. Evaluator shall not disclose such information except (a) as necessary to perform the evaluation, (b) pursuant to a valid authorization signed by Client, (c) as required by law, or (d) to comply with professional reporting obligations.

Duration of Confidentiality

Confidential obligations shall survive termination of this Agreement for years, or for the period required by applicable law, whichever is longer.

INSURANCE, COMPLIANCE, AND RELATIONSHIP

Evaluator shall maintain professional liability insurance in amounts consistent with professional standards and shall perform services as an independent contractor. Nothing in this Agreement shall create an employer-employee relationship, joint venture, or partnership.

Independent Contractor Acknowledgment

Evaluator is retained as an independent contractor and is responsible for all taxes and employment charges applicable to Evaluator.

GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to conflict of law principles.

LIMITATION OF LIABILITY

Except for liability arising from willful misconduct or gross negligence, Evaluator's total liability to Client for any claim arising out of or relating to this Agreement shall be limited to the total fees paid to Evaluator for the specific evaluation giving rise to the claim.

ENTIRE AGREEMENT

This Agreement constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, representations, and understandings. Any amendment to this Agreement must be in writing and signed by both parties.

NOTICES

All notices required or permitted under this Agreement shall be in writing and sent to the addresses set forth above or to such other address as either party may designate in writing.

Evaluator Name:

By:

Date:

Client Name:

By:

Date:

What a Clinical Evaluation Agreement Is and When it Applies

A Clinical Evaluation Agreement is a written contract that establishes terms for evaluating a product, device, therapy, or diagnostic procedure in a clinical setting. It defines responsibilities between the sponsor, investigator, clinical site, and any third‑party vendors; covers scope of work, timelines, data handling, confidentiality, compensation, and liability; and often incorporates regulatory and ethical requirements such as Institutional Review Board (IRB) oversight and data protection obligations when personal health information is involved. The agreement frames operational, legal, and compliance expectations before a clinical evaluation begins.

Why a Clear Clinical Evaluation Agreement Matters

A well‑drafted Clinical Evaluation Agreement reduces operational risk, clarifies oversight and payment terms, ensures compliance with HIPAA and research regulations, and protects intellectual property and study data during an evaluation.

Who Typically Prepares and Signs This Agreement

Multiple parties prepare and sign clinical evaluation agreements depending on the setting and product under study.

Clinical Sponsors and Manufacturers — Legal and regulatory teams prepare scope, device descriptions, and indemnities.
Clinical Sites and Investigators — Site administrators and principal investigators review clinical procedures, IRB obligations, and data handling.
Research Contracting Offices — Contracts or sponsored research offices negotiate payment schedules and liability provisions.

Parties should identify their internal signatories and any required institutional approvals before execution to avoid delays.

Stepwise Process to Complete and Execute the Agreement

Follow a sequential approach from preparation through signing and recordkeeping to keep stakeholders aligned and regulatory obligations met.

01

Gather Documents: Collect product specs, IRB approvals, insurer certificates, and relevant licenses.
02

Draft Terms: Define scope, timelines, payment, confidentiality, and IP allocation clearly.
03

Review & Negotiate: Legal, compliance, and clinical leads should review and mark any regulatory gaps.
04

Execute and Archive: Sign using authorized signers, capture audit trail, and store the final agreement securely.

Essential Elements to Include in a Professional Agreement

These six components are foundational: each clarifies obligations, mitigates risk, and supports regulatory compliance throughout the evaluation.

Scope

Detailed description of the product or procedure under evaluation, study objectives, inclusion/exclusion criteria, outcome measures, and deliverables tied to measurable milestones and reporting expectations.

Compensation

Payment rates, invoicing cadence, reimbursable expenses, retainers, and any milestone or performance‑based payments with clear invoicing instructions and tax withholding responsibilities.

Data and Records

Data ownership, retention, permitted uses, PHI protections, de‑identification standards, security measures, and obligations to provide data for audits or regulatory review.

Regulatory Duties

IRB review responsibilities, adverse event reporting timelines, device reporting obligations, and regulatory compliance clauses identifying applicable laws and standards.

Confidentiality

Non‑disclosure terms, permitted disclosures (e.g., to IRB or regulators), duration of confidentiality, and carve‑outs for publication or required reporting.

Liability & Indemnity

Limitation of liability, indemnification scope, insurance requirements (limits/types), and procedures for claims handling and notice.

Typical Security and Compliance Details to Verify

Data Encryption: TLS 1.2/1.3 and AES‑256 at rest

HIPAA Status: BAA required for PHI

Audit Trail: Timestamps, IP addresses, and action logs

Authentication: Email, SMS code, or stronger MFA

Retention Policy: Retention terms defined and enforced

Certifications: SOC 2 Type II, ISO 27001, PCI DSS

Common Risks and Consequences of an Incorrect Agreement

Noncompliance Exposure: HIPAA violations

Contract Voidability: Improper signatory may void obligations

Financial Loss: Unclear payment terms cause disputes

Regulatory Delay: Missing IRB or reporting obligations

Data Breach Liability: Insufficient protections trigger penalties

Intellectual Property Risk: Ambiguous IP terms cause litigation

Frequent Preparation Pitfalls to Avoid

Using informal or abbreviated party names leads to ambiguity and barriers for institutional sign‑off or payment processing.
Failing to attach required IRB approvals or protocol documents delays site initiation and may breach sponsor obligations.
Omitting explicit data handling and PHI clauses forces costly renegotiation when investigators need to share patient information.
Leaving indemnity and insurance limits undefined exposes smaller sites to unanticipated financial risk in a claim.

How the Digital Signing and Routing Workflow Typically Works

Digital signing streamlines execution by defining signers, authentication, and order, then capturing a verifiable audit trail at completion.

Upload Document: Add the final agreement PDF to the signing platform.
Place Fields: Insert signature, date, and initial fields for each signer.
Define Signers: Enter signer name, email, and signing order.
Execute: Send for signature and capture completion certificate.

Common Digital Workflow Settings for the Agreement

Recommended configuration options help ensure authorized execution and a complete compliance record.

Field	Configuration
Signature Order	Sequential or parallel, set per contracting requirements
Authentication	Email link plus optional SMS code or ID verification
Attachment Required	Require IRB or COI documents before signing
Audit Trail	Enable full event logging and certificate generation

Technical and Integration Considerations for eSubmission

Verify the digital platform supports necessary security, integrations, and compliance features for this agreement.

Integrations: Salesforce, NetSuite, Microsoft 365 supported
File Types: PDF, DOCX, and editable templates supported
Compliance: HIPAA, ESIGN, UETA support available

Confirm the chosen provider can produce tamper‑evident PDFs, retain audit logs, and (if handling PHI) sign a BAA before executing agreements.

Key Deadlines and Typical Processing Expectations

Timelines vary by sponsor and institution; build clearance steps into the schedule to accommodate IRB review, contracting, and site initiation.

IRB Review Window:

Allow 4–8 weeks for full board review in many institutions

Contract Negotiation Time:

Expect 2–6 weeks depending on complexity and redlines

Execution Deadline:

Set a firm date for signatures to align with project start

Data Submission Schedules:

Define reporting cadence for interim and final data

Insurance Certificate:

Require updated COI prior to site activation

Typical Milestones from Draft to Study Start

Use a milestone view to coordinate reviewers and avoid bottlenecks before enrollment begins.

01

Draft Finalization

Complete internal legal and clinical review of terms.

02

IRB Submission

Submit protocol and consent documents for ethics approval.

03

Execution

Obtain authorized signatures and verify audit trail.

04

Site Activation

Confirm training, data systems access, and study initiation.

Practical Examples of How Institutions Use These Agreements

Two short examples show how clinical sites and sponsors typically structure and use a Clinical Evaluation Agreement.

Hospital Research Agreement

A hospital research office sets standardized compensation and reporting schedules to simplify multiple device evaluations.

The agreement ties payments to milestone reports.
This reduces negotiation time between clinical teams and manufacturers, ensures IRB deliverables are honored, and clarifies data ownership for later publication or regulatory submissions.

Small Device Manufacturer

A device sponsor uses a template to engage multiple community clinics quickly.

Templates include HIPAA handling and liability limits.
Standardized templates let the sponsor scale evaluations across sites while ensuring sites receive consistent indemnity language and required insurance evidence before enrollment.

How a Clinical Evaluation Agreement Differs from Similar Contracts

Compare common contract types to identify the right template and key clause differences for a clinical evaluation.

Criteria	Clinical Evaluation Agreement	Research Collaboration Agreement
Purpose	device/clinical testing	joint research and ip creation
IP Ownership	sponsor retains primary rights	shared or negotiated
Data Handling	sponsor‑defined reporting	joint analysis often required
Publication Rights	sponsor review common	collaborative publication rules

Comparison of eSignature Pricing and Core Capabilities

Platform pricing and features vary; signNow appears first for direct comparison. Check plan specifics for bulk or enterprise features before selecting.

	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	7-day free trial	No	No	No	No
Bulk Send	Yes (Business Premium)	Yes	Yes	Yes	No
Audit Trail	Yes	Yes	Yes	Yes	Yes
HIPAA Compliant	Yes	Yes	Yes	No	No

Frequently Asked Questions and Troubleshooting

Answers to common legal, technical, and operational questions encountered when preparing or executing a Clinical Evaluation Agreement.

Need help? Contact support

Can this agreement be e‑signed?
Yes. Electronic signatures are legally valid under the federal ESIGN Act (15 U.S.C. ch. 96, 2000) and UETA where adopted; confirm exceptions such as wills or court orders do not apply to your transaction.
Is a BAA required if PHI is shared?
If the agreement permits access to protected health information, a HIPAA Business Associate Agreement should be in place and executed prior to data exchange to meet HIPAA obligations.
Do I need a notary or witnesses?
Notarization or witness requirements depend on state law and agreement terms. Some states or institutional policies may require notarization for specific delegations—confirm per‑state rules and institutional counsel.
How do I correct an error after signing?
Minor clerical errors usually require an amendment or an agreed written correction executed by authorized signers; do not alter the executed PDF without mutual written consent.
How long should records be kept?
Retain executed agreements for the full term plus statutory minimums: IRS records 3 years (IRC §6501(a)), HIPAA records 6 years (45 CFR §164.530(j)); adjust for state requirements.
What if a signer lacks authority?
If a signer lacked authority, the agreement may be unenforceable against the organization; confirm corporate authority before execution or obtain ratification from appropriate executives or governing body.

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