Fdp Fixed Price Clinical Trial Subaward Agreement Nih Form

Use a FDP Fixed Price Clinical Trial Subaward Agreement NIH template to make your document workflow more streamlined.

What this FDP subaward agreement does

The FDP Fixed Price Clinical Trial Subaward Agreement is a research-contract form used to document a fixed-price subaward for clinical trial work funded through an NIH-related award. It identifies the awarding and subaward organizations, principal investigators, project scope, fixed-price terms, responsibilities, compliance commitments, and authorized approvals. Upload the agreement to signNow, review detected fields, assign institutional and subrecipient signers, and send it for electronic execution. The completed PDF and audit trail can then be retained with the sponsored-research record under applicable award, institutional, and privacy policies.

Organizations that use this form

The form is designed for institutions and subrecipients coordinating fixed-price clinical trial obligations under NIH-funded research arrangements.

A university sponsored-research office can route fixed-price clinical trial subawards to principal investigators, institutional officials, and subrecipient representatives while preserving the executed agreement and audit trail for award administration.
A hospital research institute can use the form workflow to coordinate clinical trial subrecipient approvals, protect sensitive study information, and retain signature evidence alongside contracting and compliance records.
A nonprofit research organization receiving NIH-supported clinical trial funds can complete its subaward commitments, obtain authorized signatures remotely, and return a documented agreement without relying on paper circulation.

Reusable template

Upload the FDP agreement, detect fillable fields, and create a reusable template for repeated clinical trial subaward execution without rebuilding the document.

Role-based routing

Route the agreement to principal investigators, sponsored research officials, and authorized subrecipient representatives in a defined signing sequence.

Audit evidence

Preserve timestamps, signer actions, and document history with the completed agreement so administrators can demonstrate how execution occurred.

Mobile signing

Collect signatures from desktop or mobile devices when research teams, subrecipients, or institutional officials work away from the office.

Signer verification

Use SMS-based authentication or other available controls to strengthen identity assurance for external subrecipient personnel handling award documents.

Record connections

Connect signing activity with NetSuite, Microsoft 365, Google Drive, or Box to organize agreements alongside sponsored-research records.

Setting	Recommendation
Authentication method	Two-factor authentication for institutional signers
Signature type	Legally binding electronic signatures
Audit trail	Capture timestamps, IP addresses, and action history
Document retention	Retain records under NIH award policy
Encryption and provisioning	AES-256 protection with controlled user access

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How the subaward workflow works

Move the FDP agreement from document preparation to verified execution without losing its approval history.

Upload document: Upload the FDP agreement and let signNow detect fillable fields.
Prepare fields: Review award terms and place signatures, initials, dates, and approvals.
Route agreement: Assign institutional and subrecipient signers in the required order.
Archive evidence: Collect signatures and store the completed PDF with its audit trail.

Use signNow’s web app to upload the FDP agreement, review detected fields, and prepare a controlled signing workflow from an institutional workstation.
Use the signNow mobile app when a principal investigator or subrecipient official must review and sign the agreement away from the office.
Use kiosk mode for supervised, in-person completion when an authorized representative signs on an institution-managed device.
Generate a shareable signing link only when the institution’s access policy permits link-based delivery and signer identity remains adequately controlled.

Retain and review executed agreements

Use the signed FDP agreement, audit trail, award file, and applicable privacy rules together when establishing records procedures.

Validate award and subrecipient details

Confirm the awarding institution, subrecipient, principal investigator, project period, fixed-price amount, and clinical trial scope against the approved award before placing signature fields. Resolve discrepancies with sponsored research and contracting staff rather than correcting substantive terms after execution.

Preserve the audit trail

Export the completed agreement and signNow audit trail after final execution. Store both records together with the award file, access restrictions, and a documented naming convention so reviewers can connect the signed terms with the signing history.

Map retention to the record

Apply the retention rule that actually governs the record. IRS tax records generally use three years under IRC §6501(a), while HIPAA records require six years under 45 CFR §164.530(j) when protected health information is involved.

Control access to records

Limit access to sponsored-research administrators, authorized investigators, contracting personnel, and approved subrecipient contacts. Review shared links, downloaded PDFs, and storage permissions so sensitive protocol, budget, or participant information is not broadly exposed.

Set the agreement retention schedule

Retention depends on the agreement’s contents and related records; apply the specific federal, award, institutional, and state rule.

Award records: policy-defined period

Apply the governing award and institutional record policy; no universal FDP-specific period is established here.

Tax records: three years

Keep tax-related records three years from filing under IRC §6501(a), unless an exception applies.

HIPAA records: six years

Retain records containing protected health information six years under 45 CFR §164.530(j).

OSHA records: five years

Retain OSHA injury records five years following the relevant year under 29 CFR §1904.33, when applicable.

Exposure records: 30 years

Retain OSHA exposure records 30 years under 29 CFR §1910.1020, when applicable.

Authenticate signer:

Records the signer identity and selected authentication event.

Timestamp activity:

Captures the date and time for each action.

Hash document:

Associates the signing event with the agreement record.

Seal evidence:

Preserves document history after execution.

Track actions:

Logs invitations, views, signatures, and completion events.

Export trail:

Allows administrators to retrieve and export audit evidence.

Protect subaward records and signatures

Data at rest:

AES-256 encryption at rest

Data in transit:

TLS 1.2/1.3 encryption in transit

SOC 2 Type II:

SOC 2 Type II report available

ISO 27001:

ISO 27001 certification

HIPAA protection:

HIPAA compliance with BAA

21 CFR Part 11:

21 CFR Part 11 compliance

Connect subaward records to work systems

Connect the FDP agreement workflow with research administration, finance, storage, and collaboration tools used to manage subrecipient records.

Access the agreement across devices

Complete the FDP Fixed Price Clinical Trial Subaward Agreement through signNow using Chrome, Firefox, Safari, or Edge on Windows or macOS. signNow also provides iOS and Android apps for reviewing, signing, and tracking documents while research teams work away from institutional offices.

Browsers Chrome, Firefox, Safari, and Edge
Desktop systems Windows and macOS desktops
Mobile apps iOS and Android mobile apps

Institutions should manage devices, browser updates, identity controls, and storage permissions through their own information-security policies. Enterprise deployments can evaluate API access, SSO provisioning, and integrations with research or finance systems. Confirm certificate, retention, and protected-health-information requirements before enabling a regulated workflow.

Troubleshoot subaward signing issues

Resolve field, authentication, plan, privacy, and signer-access questions before executing an NIH clinical trial subaward agreement.

Upload the completed FDP Fixed Price Clinical Trial Subaward Agreement as a PDF, then use signNow’s field detection and editor to place signatures, dates, and initials. Confirm every required award, budget, and institutional approval field before sending.

The Business plan includes legally binding eSignatures, templates, audit trails, and mobile apps. Business Premium adds bulk send, while Enterprise adds advanced signer authentication. Select the plan based on signer volume and required controls.

Enable SMS OTP or another available authentication control for external investigators and institutional officials. signNow’s audit trail records signer activity, timestamps, and document history, supporting evidence under ESIGN and applicable state law.

HIPAA compliance requires a business associate agreement when the workflow handles protected health information. signNow identifies HIPAA compliance as requiring a BAA; confirm the clinical trial data scope and institutional privacy obligations before sending.

The 7-day free trial is a signNow product period, not a legal deadline for a federal award. Establish the subaward execution date and sponsor-required milestones separately, then preserve the completed agreement and audit trail.

If a signer cannot access the link, verify the email address, resend the invitation, or generate a signing link when appropriate. Review role order and permissions before resending so the agreement reaches the authorized institutional official.

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