When should exclusions be updated?

Update exclusion criteria when new safety data, protocol amendments, or IRB requests indicate a material change; record version history and effective dates to ensure consistent application at screening.

Can an excluded candidate be re‑evaluated?

Yes, if the exclusion is time‑bound or conditionally reversible. Document the new assessment, supporting data, and the reviewer who approved re‑screening to maintain auditability.

Is a signature required on the exclusion form?

Screening outcomes should be signed or electronically authenticated by the authorized screener; if PHI is involved, use a platform with audit trails and, when necessary, a BAA to meet HIPAA obligations.

Are exclusions subject to HIPAA rules?

When exclusions rely on protected health information, HIPAA applies. Ensure storage, access control, and retention meet HIPAA and institutional requirements (45 CFR §164.530(j)).

How should rationale be recorded?

Record concise, objective rationale tied to source data (labs, imaging, medications). Avoid ambiguous phrases and include enough detail for monitoring and IRB review.

What if criteria differ across sites?

Harmonize exclusion language during protocol finalization. If site‑specific modifications are necessary, document IRB approvals and maintain cross‑reference tables to explain differences.

Electronic Signature
Templates
Miscellaneous
Research Exclusion Criteria

Research Exclusion Criteria

This template is fully customizable. Edit the text, fill out the fields, and send it for signature. Give it a try!

RESEARCH EXCLUSION CRITERIA

Client Name: Research Provider Name:

Recitals

WHEREAS, Client engages Research Provider to perform research activities described in this Agreement and requires a formal statement of exclusion criteria to govern subject selection, data inclusion, and analysis boundaries; and

WHEREAS, Research Provider possesses the expertise and capacity to identify and implement objective exclusion criteria to protect participant safety, ensure data integrity, and comply with applicable ethical standards; and

WHEREAS, the parties agree that the exclusion criteria set forth herein form an essential element of the scope of work and the parties' obligations under the accompanying research services agreement.

Scope of Work

Project Description

The Research Provider shall apply the exclusion criteria below to all participant recruitment, enrollment, data acceptance, and analysis. Any deviation from these criteria must be documented in writing and approved by Client prior to inclusion.

Exclusion Criteria (select all that apply)

Participant-Based Criteria Currently pregnant or breastfeeding
History of condition or diagnosis that materially interferes with study outcomes (specify)
Concurrent participation in another investigational study affecting endpoints
Inability to provide informed consent or follow study procedures
Other exclusion criteria specific to protocol

Operational Implementation

Screening instruments, data sources, and personnel responsible for applying the exclusion criteria must be identified below.

Screening Instruments and Data Sources Personnel Responsible

Payment Terms

Client shall compensate Research Provider for the work necessary to define, implement, and document the exclusion criteria as follows.

Total Amount Payment Schedule Late Payment Fee

Term and Termination

This Exclusion Criteria Statement is effective as of the Start Date and shall remain in effect until the End Date or until earlier termination as provided below.

Start Date End Date Termination Notice Period

Either party may terminate for material breach if the breaching party fails to cure within the notice period above. Termination shall not relieve Client of payment obligations for work performed prior to termination.

Confidentiality

Each party shall hold in confidence all nonpublic information obtained from the other party in connection with the exclusion criteria and research project, including participant-level data, screening results, and analytic code (collectively, Confidential Information). Confidential Information shall not be disclosed except to employees, contractors, or consultants with a need to know who are bound by confidentiality obligations at least as protective as those herein. Confidentiality obligations shall survive termination of this document for a period of three (3) years, except that personally identifiable information and protected health information shall be retained and protected in accordance with applicable law and for the periods required by law.

Governing Law

This document shall be governed by and construed in accordance with the laws of the State of , without regard to choice-of-law principles that would result in the application of the laws of another jurisdiction.

Entire Agreement

This document constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, understandings, negotiations, and discussions, whether oral or written. Any amendment or modification must be in writing signed by both parties.

Representations and Certification

The undersigned certify that the exclusion criteria selected and the operational implementation plan are accurate and complete to the best of their knowledge, and that deviations will be reported and documented in accordance with the Termination and Operational Implementation provisions.

Client Name:

By:

Date:

Research Provider Name:

By:

Date:

What the Research Exclusion Criteria Is and when it applies

A Research Exclusion Criteria document lists conditions, characteristics, or circumstances that disqualify prospective participants from enrollment in a study. It complements inclusion criteria by defining safety, scientific validity, and regulatory boundaries used during screening. Typical reasons include medical comorbidities, conflicting medications, age limits, previous participation in related trials, or inability to provide informed consent. Well‑written exclusion criteria reduce risk to participants, protect data quality, and help ensure consistent screening decisions across study staff and sites while documenting rationale for regulatory review.

Why clear exclusion criteria matter for study integrity

Clear exclusion criteria protect participants, preserve scientific validity, and simplify IRB review by reducing subjective screening decisions and preventing avoidable protocol deviations.

Which roles commonly complete or rely on this document

The Research Exclusion Criteria is used by study teams during protocol development and by operational staff during screening.

Principal investigator and study leadership: Set high‑level scientific and safety boundaries used in the protocol and sponsor documentation.
IRB coordinators and regulatory specialists: Review and approve exclusion language for compliance with human subjects protections and institutional policy.
Study coordinators and screeners: Apply criteria at point of contact and record screening outcomes for audits and reporting.

Consistent use across these roles reduces errors, streamlines enrollment, and creates an auditable trail for regulatory review.

Essential elements to include in a professional exclusion list

A comprehensive document combines precise criteria with screening logic, a justification for each exclusion, and references to protocol sections and consent.

Eligibility clause

A short summary that links the exclusion list to the protocol inclusion criteria and identifies the study population and objectives.

Individual exclusions

Each exclusion stated as an actionable item with measurable thresholds (for example, lab value cutoffs, age ranges, or medication lists) to minimize interpretive ambiguity.

Rationale

A concise explanation for each exclusion referencing safety concerns, scientific validity, or regulatory reasons so reviewers understand the purpose.

Screening procedure

Stepwise checks and tests required to determine whether a candidate meets the exclusion, including timing and acceptable sources of information.

Cross‑references

Links to the informed consent, protocol sections, and case report forms so staff can verify related obligations and documentation requirements.

Approval and versioning

Fields for IRB approval, effective date, and version number so the team can enforce the correct criteria set during enrollment.

Data and security items to note on the form

PHI handling: Mark whether PHI is required and apply HIPAA protections.

Audit logging: Capture who screened and when for traceability.

Access controls: Limit edit privileges to authorized staff only.

Encryption: Use encryption in transit and at rest.

BAA required: Attach BAA when a vendor handles PHI.

Retention policy: Indicate retention timeframe and storage location.

Step-by-step: completing the Research Exclusion Criteria

Follow a short, repeatable workflow to draft, approve, and use exclusion criteria consistently across study sites.

01

Draft criteria: List exclusions as discrete, measurable items linked to protocol rationale.
02

Define tests: Specify required labs, assessments, or history checks with acceptable sources.
03

Review and approve: Submit to IRB/regulatory for review, capture approval and effective date.
04

Apply and record: Use during screening and log decisions in source documents and CRFs.

How the exclusion criteria integrates into the screening workflow

A standard flow keeps screening decisions consistent and auditable across staff and locations.

Draft and link: Attach criteria to the protocol and consent documents.
Screen candidates: Apply tests and history checks per stepwise procedure.
Record outcome: Log exclusion reason and source documents.
Report and review: Include exclusion data in monitoring and IRB reports.

Configuring an online workflow for consistent screening

Key configuration options reduce manual errors and ensure consistent routing of screening decisions.

Field mapping	Map form fields to your EDC or EMR for automatic population.
Conditional logic	Show or hide follow‑up questions based on prior answers to reduce noise.
Authentication	Require role-based login or 2FA for users making screening decisions.
Retention policy	Set automated retention flags consistent with institutional rules.
Notifications	Notify PI and regulatory staff on exclusions or protocol deviations.

Technical considerations for electronic completion and submission

Use a platform that supports secure forms, role-based access, and an auditable signing workflow.

File formats: PDF and DOCX support ensures compatibility with EDC and archival systems.
Authentication levels: Support for email, SMS, and stronger verification reduces identity risk.
Integration options: Integrations with EHR, EDC, and document storage simplify recordkeeping.

Ensure the chosen platform provides encryption in transit and at rest, audit trails, and the ability to attach approvals and supporting documentation.

Typical timelines and reporting expectations

Timelines vary by study and oversight body; use the protocol and IRB conditions as primary guidance.

Pre‑screening window:

Perform screening within the timeframe specified in the protocol before enrollment.

Adverse screening findings:

Report any safety‑relevant exclusions as required by the protocol and IRB promptly.

Version effective date:

Apply only the criteria version active on the candidate’s screening date.

Annual review:

Align exclusion list review with IRB continuing review schedules when applicable.

HIPAA retention reference:

Maintain PHI records per HIPAA for six years from creation or last effective date (45 CFR §164.530(j)).

Common mistakes to avoid when preparing exclusion criteria

Using vague language like 'clinically significant' without a measurable definition leads to inconsistent screening.
Failing to cite the evidence or rationale for exclusions can trigger IRB questions or requests for modification.
Not versioning the document or omitting approval metadata causes ambiguity during audits and monitoring visits.
Neglecting to map exclusion items to source data increases the chance of documentation gaps and query generation.

Regulatory and operational risks of poorly documented exclusions

HIPAA breach: Unauthorized PHI disclosure risk

IRB noncompliance: Protocol deviations and corrective action

Invalid enrollment: Data exclusion or unusable datasets

Enrollment bias: Threatens study validity

Financial penalties: Fines or sponsor remediation costs

Legal exposure: Potential contractual or liability claims

Realistic examples of exclusion criteria in practice

Two concise scenarios illustrate how exclusion language is used and documented during screening.

Phase II cardiology study

Intro: A cardiology protocol excludes participants with uncontrolled hypertension or recent myocardial infarction.

Point: Screening requires two blood pressure readings twenty minutes apart.
Outro: The exclusion reduces safety risk and standardizes enrollment across sites; screeners record readings, source documents, and the exclusion rationale in the monitoring log for verification.

Behavioral intervention trial

Intro: A behavioral study excludes candidates with active substance use disorders receiving concurrent therapy.

Point: Screening uses validated self‑report plus recent prescription history.
Outro: The combined criteria protect internal validity and ensure interventions target the intended population; all exclusion decisions are timestamped and stored with consent documentation.

Common eSignature platform options for executing exclusion forms

Platforms vary by price model, HIPAA support, and envelope or usage limits; signNow appears first for direct feature comparison.

	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 credit card required	Varies by vendor	Varies by vendor	Varies by vendor	Varies by vendor
Bulk Send	Yes (plan-dependent)	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 limit	Varies by plan	Varies by plan	Varies by plan

FAQs and troubleshooting for common screening and documentation issues

Answers to frequent questions about applying, documenting, and revising exclusion criteria in research settings.

Need help? Contact support

When should exclusions be updated?
Update exclusion criteria when new safety data, protocol amendments, or IRB requests indicate a material change; record version history and effective dates to ensure consistent application at screening.
Can an excluded candidate be re‑evaluated?
Yes, if the exclusion is time‑bound or conditionally reversible. Document the new assessment, supporting data, and the reviewer who approved re‑screening to maintain auditability.
Is a signature required on the exclusion form?
Screening outcomes should be signed or electronically authenticated by the authorized screener; if PHI is involved, use a platform with audit trails and, when necessary, a BAA to meet HIPAA obligations.
Are exclusions subject to HIPAA rules?
When exclusions rely on protected health information, HIPAA applies. Ensure storage, access control, and retention meet HIPAA and institutional requirements (45 CFR §164.530(j)).
How should rationale be recorded?
Record concise, objective rationale tied to source data (labs, imaging, medications). Avoid ambiguous phrases and include enough detail for monitoring and IRB review.
What if criteria differ across sites?
Harmonize exclusion language during protocol finalization. If site‑specific modifications are necessary, document IRB approvals and maintain cross‑reference tables to explain differences.

be ready to get more

Join over 28 million airSlate SignNow users

Sign Now