Establishing secure connection…Loading editor…Preparing document…

Clinical Research ICH GCP Statement

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

Clinical Research ICH GCP Statement

WHEREAS

WHEREAS, Sponsor Name: is responsible for initiating and managing the clinical trial identified above and for ensuring compliance with applicable regulatory requirements; and

WHEREAS, Investigator/Institution Name: shall conduct the clinical activities in accordance with the International Council for Harmonisation Good Clinical Practice (ICH GCP) guidelines, applicable law, and the protocol;

NOW, THEREFORE, the parties agree as follows.

Scope of Work

Clinical Commitments and Compliance

The Investigator affirms responsibility to conduct the clinical trial in strict conformity with ICH GCP principles, the approved protocol, the Investigator Brochure, the informed consent documents, and all applicable laws and regulations. The Investigator will ensure that all study staff are qualified by education, training, and experience to perform their assigned tasks.

The Sponsor affirms responsibility for trial design, safety monitoring, reporting obligations to regulators and ethics committees, provision of investigational product and essential documentation, and oversight necessary to ensure the integrity of trial data and subject safety.

The parties agree to permit authorized monitors, auditors, and regulatory inspectors reasonable access to study records, facilities, and personnel as necessary to verify compliance with this Statement and applicable requirements.

Investigator and Sponsor each acknowledge responsibility to adhere to ICH GCP and confirm adequate staffing and training to meet those obligations.

Investigator will obtain and document voluntary, informed consent from each subject prior to any protocol-specific procedures.

The parties will fulfill safety reporting obligations, including timely notification of serious adverse events as required by the protocol and applicable regulations.

Payment Terms

Term and Termination

This Statement commences on Start Date: and shall continue until End Date: unless earlier terminated in accordance with this section.

Either party may terminate this Statement for material breach by the other party if the breach remains uncured thirty (30) days after written notice specifying the breach. Sponsor may suspend or terminate activities immediately for safety concerns or regulatory noncompliance.

Confidentiality

Each party shall hold in confidence all proprietary information and clinical data exchanged in connection with the study, and shall not disclose such information except as required for performance under this Statement, for regulatory submissions, or as otherwise required by law. Confidential materials provided to third parties must be subject to confidentiality obligations at least as protective as those in this Statement.

Both parties acknowledge and accept the confidentiality obligations described above.

Data, Records and Retention

The Investigator shall maintain complete, accurate, and current records of all study activities and source data in accordance with ICH GCP and applicable law. Records shall be retained for the period required by applicable law and by Sponsor's reasonable document retention policy. The parties will cooperate to ensure secure transfer of required records upon termination.

Governing Law

This Statement shall be governed by and construed in accordance with the laws of the jurisdiction specified by the parties. The parties agree that disputes arising under this Statement shall be resolved by the mutually agreed dispute resolution mechanism or, absent agreement, by the competent courts of the agreed jurisdiction.

Entire Agreement

This Statement, together with any referenced protocol and appendices expressly incorporated herein, constitutes the entire agreement between the parties with respect to the subject matter herein and supersedes all prior proposals, communications, and agreements, whether written or oral. No amendment shall be effective unless made in writing and signed by authorized representatives of both parties.

Regulatory Inspection and Audit

The parties will cooperate to facilitate inspections and audits by regulatory authorities and by Sponsor-appointed auditors. Investigator will promptly notify Sponsor of any inspection request and will not unreasonably withhold access to records or staff necessary for inspection.

Sponsor Printed Name:

By:

Date:

Title:

Investigator / Institution Printed Name:

By:

Date:

Title:

Enter text✕
Prepare your document for signing right on this page
  • 01 Edit the text and complete the fields
  • 02 Click Sign Now and on the next screen add recipients and signature fields in SignNow
  • 03 Start your free trial to sign and send your doc
Sign Now

What a Clinical Research ICH GCP Statement Is and when it applies

A Clinical Research ICH GCP Statement is a formal declaration by an investigator, sponsor, or clinical site that a study and its personnel will adhere to ICH Good Clinical Practice (GCP) principles, applicable FDA requirements, and institutional policies. The statement typically accompanies study initiation documents, regulatory submissions, or investigator attestations and documents commitments on protocol conduct, informed consent, data integrity, and participant safety, creating a clear traceable record of responsibilities for audits, IRB review, and sponsor oversight.

Why the ICH GCP Statement matters for compliant trials

A clear ICH GCP Statement documents compliance commitments, aligns investigators with regulatory expectations, and supports IRB and sponsor oversight. It reduces ambiguity about roles, improves audit readiness, and helps demonstrate adherence to data integrity and participant protection standards under ICH E6.

Why the ICH GCP Statement matters for compliant trials

Who completes and relies on a Clinical Research ICH GCP Statement

Typical users include principal investigators, study coordinators, sponsors, contract research organizations, and institutional review boards.

  • Principal Investigator — Signs to confirm oversight responsibilities and that delegated staff meet training requirements.
  • Sponsor or CRA — Uses the statement to document site qualification and monitoring commitments.
  • IRB Administrator — Retains the statement as part of the approved study file and local assurance of compliance.

The statement creates a formal accountability record that multiple parties reference during enrollment, monitoring, and inspections.

Primary components to include in a professional GCP statement

A complete statement is concise but specific, naming parties, commitments, applicable standards, and effective dates to ensure enforceability and clarity for audits and regulatory review.

Parties

Name the investigator, sponsor, institution, and any CROs with role definitions and contact information for accountability and routing.

GCP Reference

Cite applicable guidance such as ICH E6(R2) and relevant FDA regulations to anchor expectations for conduct and documentation.

Scope

Describe the protocol or study identifiers, investigational product, and the specific activities the statement covers, such as recruitment or data handling.

Commitments

List concrete commitments—consent processes, safety reporting timelines, monitoring frequency, and source data verification practices.

Effective Date

State when obligations begin and, if applicable, expiration or review date to manage version control and responsibility windows.

Signatures

Include printed name, title, signature, and date for each authorized signer; note any witness or notary requirements if used.

Required information typically captured on the statement

Investigator Name: Full legal name
Institution: Official site/legal entity
Protocol ID: Sponsor protocol identifier
Effective Date: MM/DD/YYYY format
Signature: Printed name, title, date
Scope Description: Activities or arms covered

Step-by-step completion process for the statement

Follow these sequential steps to prepare, verify, and finalize a GCP statement for a study site.

  • 01
    Prepare: Gather protocol, IRB approval, and site contact details.
  • 02
    Draft: Populate parties, scope, commitments, and dates in the template.
  • 03
    Verify: Confirm names, protocol ID, and required signatures before routing.
  • 04
    Sign & Store: Apply authorized signatures and retain per retention rules.

Configuring an online workflow for the ICH GCP Statement

Use a structured digital workflow to ensure correct participants, sequencing, and audit trails when completing statements electronically.

Field Configuration
Signer Order Set role-based order (PI → Site Admin → Sponsor)
Authentication Require email plus SMS or organization SSO for higher assurance
Conditional Fields Display witness or notary fields only when required
Retention Policy Auto-archive signed copy to secure repository

Where to send the completed ICH GCP Statement

The final statement should be routed to all stakeholders who enforce or retain compliance records.

  • IRB Office: Submit signed copy for site file and IRB records
  • Sponsor/CRO: Provide to sponsor for monitoring and inspection readiness
  • Site Regulatory File: Store locally in regulatory binder or secure electronic system
  • Quality Assurance: Share with QA for periodic audits

Digital signing and technical considerations

Choose a platform that supports secure authentication, audit trails, and required compliance frameworks for clinical records.

  • Authentication: Email, SMS, SSO
  • Formats: PDF, DOCX supported
  • Integrations: EHR, CTMS, cloud storage

Ensure the chosen system provides tamper-evident storage, reproducible audit logs, and a HIPAA-capable BAA if protected health information is present.

Timing considerations and common deadlines

Key time points ensure the statement is available when required for ethical review, site initiation, and regulatory oversight.

Before Site Initiation:

Statement should be signed prior to enrolling the first subject

IRB Submission:

Include signed statement with IRB or rely on site assurance as instructed

Protocol Amendments:

Update statement when amendments change scope or responsibilities

Sponsor Monitoring:

Provide copy during initial monitoring visit

Inspection Readiness:

Make available for FDA or sponsor audits without delay

Key milestones from draft to archived record

A typical lifecycle includes preparation, approval, active use, periodic review, and long-term retention.

01

Draft Approval

Finalize language and obtain institutional sign-off

02

Signature Collection

Gather all required signatures and authentications

03

Distribution

Share signed copies with sponsor, IRB, and site regulatory file

04

Archive

Store in controlled repository with audit trail

Common preparation mistakes to avoid

  • Using institutional acronyms instead of full legal names causes mismatches in contracting and billing records.
  • Omitting the protocol identifier or using an outdated protocol version breaks traceability during monitoring and audits.
  • Allowing unsigned or partially signed copies to circulate creates noncompliance risks during inspections.
  • Failing to retain an auditable, time-stamped copy of an electronic signature can undermine legal enforceability.

Consequences of incorrect or missing statements

IRB Action: Hold or suspension possible
Regulatory Findings: FDA observations or warning letters
Study Delay: Enrollment stoppage or remediation
Data Exclusion: Findings may be invalidated
HIPAA Violations: Potential penalties and breach notification
Contractual Liability: Sponsor indemnities or claims

Electronic signature versus digital (cryptographic) signature

Understand which signature type meets your study's regulatory and sponsor requirements before selecting a signing method.

Criteria Electronic Signature Digital Signature
Definition any electronic mark pki cryptographic signature
Authentication email/sms or account certificate authority based
Non-repudiation audit trail evidence strong cryptographic proof
Typical Use routine approvals high-assurance regulatory filings

eSignature vendor pricing and feature snapshot for clinical documents

Compare starting prices and core features across vendors relevant to clinical document signing. No data date is included here; verify plans with each vendor before purchase.

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 Varies Varies Varies Varies
Bulk Send Yes Yes Yes Yes No
Audit Trail Yes Yes Yes Yes Yes
HIPAA Compliant Yes Yes Yes No No
Envelope Cap No cap 100 envelopes/user/year Varies by plan Varies by plan Varies by plan

Practical examples of when a GCP statement is used

Two common scenarios illustrate practical use and benefits of a clear, signed statement in clinical operations.

Site Initiation Example

A PI signs a site-level GCP statement before enrolling subjects

  • The sponsor receives assurance to proceed with monitoring
  • The signed statement is filed in the regulatory binder and produced in audits to show site-level commitments and oversight.

Protocol Amendment Example

When a major amendment changes safety monitoring, the investigator signs an updated statement

  • The site re-certifies staffing and training
  • Updated statements are distributed to IRB, sponsor, and QA to document acceptance of new responsibilities.

Frequently asked questions about the Clinical Research ICH GCP Statement

Answers to common questions about validity, e-signatures, retention, and signer authority in the U.S. research context.


Need help? Contact support

be ready to get more
Join over 28 million airSlate SignNow users
Sign Now
Company
Forms
Pricing
Resources
Knowledge base
Other Products
© 2026 airSlate Inc. All rights reserved.