Scope of Work
Detailed study tasks, enrollment targets, dosing schedules, and deliverables.
A well-drafted Phase I Contract reduces regulatory risk, clarifies sponsor and site obligations, secures patient data handling, and speeds enrollment by removing operational ambiguity.
The contract is created and reviewed by several internal and external stakeholders who each focus on different risk and operational areas.
Clear role separation—legal for terms, regulatory for compliance, clinical for execution—helps avoid delays and ensures enforceability.
| Field | Configuration |
|---|---|
| Template Library | Reusable templates for protocol, budget, and indemnity clauses |
| Conditional Fields | Show site- or sponsor-specific clauses only when applicable |
| Signer Authentication | Email, SMS code, or stronger KBA as required |
| Audit Trail | Enable full IP, timestamp, and action logs |
Ensure the chosen platform supports required formats, authentication, and compliance controls before relying on electronic execution.
Sponsor countersign within 14 calendar days typically
IRB approval must be obtained before enrollment
Provide proof of insurance within 30 days
Site reports SAEs to sponsor per protocol timelines
Retain executed contract per internal retention plan
All material terms agreed and redlines resolved.
Institution counsel signs off on indemnity and liability.
All authorized parties sign and receive copies.
IRB approval and site training completed; enrollment begins.
Detailed study tasks, enrollment targets, dosing schedules, and deliverables.
Milestone payments, invoicing cadence, and expense reimbursement rules.
Who may access raw data, timing, and permitted uses.
Adverse event notification procedures and timelines.
Liability allocation, insurance minimums, and claims handling.
Grounds for termination and post-termination obligations.
The institution adopted electronic execution for clinical agreements to streamline operations and improve compliance.
A small clinical sponsor moved to digital contracts to close site agreements faster and reduce paper handling.
| 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 | Varies by plan | Varies by plan | Varies by plan | Varies by plan |
| Bulk Send | Yes | 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 | Varies | Varies | Varies |