Scope of Work
Describe participant enrollment targets, study procedures, and deliverables in measurable terms, including key milestones and acceptance criteria to avoid disputes about performance.
A well-drafted Healthcare Phase 1 Agreement reduces regulatory risk, clarifies budgets and data flows, protects patient privacy, and documents responsibilities for safety reporting and IRB interactions. Clear terms expedite study start and minimize disputes.
The agreement is used by sponsors, clinical research organizations (CROs), investigational sites, and institutional compliance teams during early-stage studies.
Each organization usually routes the agreement through clinical, legal, and finance stakeholders to ensure IRB, budget, and compliance alignment before execution.
A contracting officer or clinical operations manager authorized to accept budget, indemnity, and publication terms on behalf of the sponsor; typically reviews clinical and regulatory clauses with legal counsel before signing.
A licensed investigator at the site who confirms the site can meet protocol requirements, ensure informed consent, and accept monitoring and reporting obligations; signature indicates readiness to begin enrollment.
| Field | Configuration |
|---|---|
| Signer Authentication | Email verification with optional SMS two-factor authentication |
| Field Types | Signature, initials, date, checkboxes, and text fields |
| Conditional Logic | Show payment fields only after budget acceptance |
| Audit Trail | Capture IP, timestamp, and action log for each signer |
Choose a platform that supports secure signing, audit trails, and integrations to your clinical or finance systems.
Proper integration reduces manual entry and ensures executed agreements flow into trial tracking, billing, and document retention systems.
Describe participant enrollment targets, study procedures, and deliverables in measurable terms, including key milestones and acceptance criteria to avoid disputes about performance.
Specify how protected health information (PHI) will be collected, stored, transmitted and de-identified, and whether a separate Data Use Agreement (DUA) applies.
List per-subject compensation, milestone payments, invoicing procedures, expense categories, and timing to ensure predictable cash flow and auditability.
Require adherence to IRB approvals, applicable statutes, and facility policies; include obligations for safety reporting and regulatory inspections.
Define ownership of study data, inventions, and any commercialization rights; clarify publication and confidentiality restrictions for both parties.
Spell out termination for convenience, breach remedies, limitation of liability, and insurance requirements to manage financial and operational risk.
Drafting and internal review of scope, budget, and regulatory language.
Confirm IRB application and local approvals before final execution.
Obtain authorized signatures from sponsor and site; distribute fully executed copies.
Begin screening and enrollment once all prerequisites are satisfied.
Obtain prior to first subject enrollment; delays block study initiation.
Finalize budget and payment milestones before invoicing begins.
Report serious adverse events per protocol and regulatory requirements promptly.
Process amendments quickly to reflect protocol or budget changes.
Adhere to predefined timelines for data transfers and monitoring reviews.
| 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 by vendor | Varies by vendor | Varies by vendor | Varies by vendor |
| Bulk Send | Yes | Yes | Yes | Yes | Varies |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |
A clinical site streamlined patient consent and contract routing for a Phase 1 protocol using e-signatures.
A sponsor used electronic agreements to centralize contract versions across multiple investigational sites.