Investigator Initiated Study Agreement Form

Use a Investigator Initiated Study Agreement Template template to make your document workflow more streamlined.

What an investigator study agreement does

An Investigator Initiated Study Agreement Form records the terms between an investigator, sponsoring organization, and participating institution for a study proposed and led by the investigator. It typically identifies the protocol, responsibilities, funding or material support, intellectual property, publication rights, confidentiality, data handling, insurance, and termination terms. The authorized parties review the completed form, sign it electronically, and receive a final copy. Under the federal ESIGN Act and applicable state UETA or New York ESRA rules, an electronic record and signature can generally carry the same legal effect as paper when intent, consent, attribution, and reliable retention are established.

Research teams

Principal investigators and research coordinators use the form to document sponsor support, protocol responsibilities, publication rights, confidentiality, and data obligations before an investigator-led study begins.

Institutions and sponsors

Universities, hospitals, and sponsor legal teams use signNow to route approvals, collect authorized signatures, and preserve the executed agreement with its audit trail for institutional records.

Who uses investigator study agreements

A principal investigator or research coordinator uses the agreement to document study responsibilities, funding terms, publication expectations, data handling, and required institutional approvals before work begins. signNow lets the coordinator route the same controlled document to the investigator, sponsor, and authorized institution representative without email attachments changing the signed record.
A university technology-transfer or clinical-research office manages repeat agreements through templates, role-based access, and delegated sending. The office can collect signatures from external sponsors while preserving the protocol reference, completion certificate, and audit trail needed for institutional review and later document retrieval.

Field detection

Upload the institution’s approved Investigator Initiated Study Agreement Form and use signNow’s field detection to identify signature, date, initials, and text fields before routing the document.

Role assignment

Assign each signature and approval field to the investigator, sponsor representative, or institutional official so every required party signs in the intended order.

Audit trail

Capture signer actions, timestamps, and completion evidence with the executed study agreement, giving research administrators a retrievable record of the signing process.

Reusable templates

Use reusable templates for recurring study agreements while preserving protocol-specific fields, funding terms, publication conditions, and institutional approval requirements.

Flexible delivery

Send the agreement through email or a signing link so external sponsors can review and sign without exchanging editable attachments.

Controlled storage

Maintain an encrypted electronic record that can be downloaded with its completion certificate and stored according to the institution’s research-record policy.

How the study agreement workflow works

The signNow workflow moves the Investigator Initiated Study Agreement Form from an approved draft to an executed, retrievable record.

Upload: Upload the approved study agreement PDF.
Prepare fields: Review detected fields and add missing signature, date, and initials fields.
Assign roles: Assign fields to the investigator, sponsor, and institution.
Complete: Send the completed agreement and preserve its audit trail.

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Complete the agreement in signNow

Prepare the approved Investigator Initiated Study Agreement Form in five controlled steps, from upload through evidence-preserving storage.

Upload the form:
Upload the institution-approved agreement PDF.
Review fields:
Check detected fields and add required fields.
Set recipients:
Assign signers and set the signing order.
Send for signature:
Send invitations or a signing link.
Store evidence:
Download the signed PDF and audit trail.

Use the signNow web app when a research coordinator prepares the approved Investigator Initiated Study Agreement Form, checks fields, and routes it from a managed desktop environment.
Use the signNow mobile app when an authorized investigator or sponsor representative needs to review and sign the agreement away from the office.
Use kiosk mode when an institution needs a controlled, shared device for an authorized signer to complete the agreement at a supervised research or administrative location.
Use a shareable signing link when an external sponsor or investigator needs direct access without receiving another editable document attachment.

Setting	Recommendation
Authentication method	Email verification with SMS OTP
Signature type	Legally binding electronic signature
Audit trail	Export completion certificate with signed PDF
Document retention	6 years for HIPAA records under 45 CFR 164.530(j)
Encryption	TLS 1.2/1.3 and AES-256 at rest

Integrations for study agreement administration

Connect study agreement routing with the institution’s CRM, ERP, collaboration, storage, or project systems to reduce duplicate entry and preserve the document’s operational context.

Platform requirements for study agreements

SignNow supports completing the Investigator Initiated Study Agreement Form through Chrome, Firefox, Safari, or Edge on Windows and macOS. Signers can also use the signNow mobile apps on iOS and Android, with encrypted connections using TLS 1.2 or TLS 1.3.

Browser support Chrome, Firefox, Safari, and Edge
Operating systems Windows, macOS, iOS, and Android
Mobile access Desktop and mobile signNow apps

Research offices should use managed devices when agreements contain confidential protocol, financial, or participant-related information. Confirm browser updates, institutional identity controls, and storage permissions before deployment. API, SSO, certificate, or long-term validation requirements should be reviewed against the selected signNow plan and institutional policy.

Security for investigator agreements

Data in transit:

TLS 1.2 and TLS 1.3

Data at rest:

AES-256 encryption

Security reporting:

SOC 2 Type II certified

Information security:

ISO 27001 certified

Health information:

HIPAA compliant with BAA

Electronic signatures:

ESIGN and UETA compliant

Challenges when preparing study agreements

Protocol identifiers, funding terms, publication rights, or data-use provisions may be copied incorrectly when an agreement is rebuilt from an older study template.
Multiple institutional and sponsor reviewers can create conflicting revisions unless one approved PDF is designated before signature fields are assigned.
External sponsors may delay execution when invitations use incorrect email addresses, unclear signing order, or authentication requirements they were not told to expect.
Research offices can lose evidentiary context when the signed PDF is archived without its completion certificate, audit trail, protocol number, or approval record.

Risks of incomplete study agreements

Weak consent record

Missing consent evidence

Incomplete execution

Unassigned signature fields

Version dispute

Uncontrolled revisions

Poor admissibility

Lost completion certificate

Best practices for retaining study agreements

Preserve the executed agreement, completion evidence, and protocol context together so research and compliance teams can retrieve one authoritative record.

Set the retention period before signing

Keep the signed agreement and its completion certificate together for the period required by your institution, sponsor, protocol, and applicable records policy. For HIPAA-covered records, retain documentation for 6 years from creation or the last effective date under 45 CFR 164.530(j).

Export the audit trail with the agreement

Export the signNow audit trail after every completed agreement and preserve it with the final PDF. The record should show signer actions, timestamps, and completion details so the institution can demonstrate intent, attribution, and document integrity under ESIGN and UETA.

Archive executed agreements securely

Use controlled access for investigator, sponsor, and institutional records staff, and prevent local downloads from unmanaged devices. Restrict editing after signature and maintain a documented archive location with version history for the executed study agreement.

Index protocol and signer information

Record the agreement’s protocol identifier, investigator name, sponsor contact, signature dates, and superseded-version status in the archive index. This makes the exact signed study document retrievable without relying on an email thread or an individual employee’s mailbox.

Troubleshooting investigator study agreements

Use these answers to resolve field, authentication, compliance, plan, and archival questions before the Investigator Initiated Study Agreement Form is finalized.

Upload the final approved PDF again and confirm that every required signature, date, initials, and text field is assigned to the correct participant. The Business plan includes templates and audit trails; field assignments should be reviewed before sending because a completed agreement cannot substitute for a missing institutional approval.

A signer can open the agreement through the email invitation or signing link without creating an account in many workflows. If the institution requires stronger attribution, enable SMS authentication or another available signer-authentication control and retain the resulting activity in the audit trail.

SignNow’s Business plan is listed at $8 per user per month with annual billing and includes audit trails, templates, and mobile apps. Confirm the plan’s current limits and any invitation usage before routing a high-volume series of investigator agreements.

For agreements containing protected health information, signNow identifies HIPAA compliance as requiring a business associate agreement. The research institution should determine whether the document contains PHI, execute the BAA when required, and apply its own HIPAA record-retention policy.

The ESIGN Act, 15 U.S.C. chapter 96, generally recognizes electronic signatures in interstate commerce when intent, consent, attribution, and record accessibility are established. UETA generally governs participating states, while New York uses ESRA; confirm institutional and state requirements.

Export the signed PDF and completion certificate from signNow, then place both in the institution’s approved research archive with the protocol identifier. Keep access limited to authorized staff and apply the retention period required by the sponsor, institution, and applicable law.

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