Study identification
Unique study title and reference number that aligns with IRB and sponsor records, plus version history to track amendments and avoid mismatches during review.
A complete form reduces administrative delays, ensures alignment with funder requirements, and documents consent and data-protection measures required for healthcare research.
Typical users who prepare, review, or sign this form include both operational and compliance roles across the sponsor and the healthcare organization.
Multiple signers and reviewers may be required; identify roles early to reduce routing delays and ensure proper authorizations.
| Field | Configuration |
|---|---|
| Routing order | Sequential signers: PI → Department Head → Grants Office |
| Authentication | Email link or SMS code for guest signers |
| Notifications | Automatic reminders at configurable intervals |
| Audit settings | Enable full audit trail and document versioning |
Confirm that your chosen platform supports secure e-signing, audit trails, and any regulatory controls needed for protected health information.
For healthcare workflows, ensure the platform can support a Business Associate Agreement (BAA), encryption in transit and at rest, and audit logs to meet HIPAA and institutional requirements.
Unique study title and reference number that aligns with IRB and sponsor records, plus version history to track amendments and avoid mismatches during review.
Full names, institutional roles, contact emails, and ORCID or other researcher identifiers so responsibility and correspondence routing are explicit and auditable.
Concise study objectives, endpoints, participant criteria, and data collection methods to ensure reviewers understand scope and risk level before approving.
Detailed budget by category, funding source, indirect costs, and any required matching funds to support financial review and sponsor compliance checks.
Description of PHI handling, de-identification, storage location, access controls, and retention schedules that align with HIPAA and institutional policy requirements.
Designated signature blocks for PI, departmental approver, grants officer, and IRB sign-off with dates and capacity to attach electronic certificates of completion.
Provide upon payer request; no fixed federal deadline
To recipient and IRS by January 31
April 15 (extension to October 15 with Form 4868)
Keep 3 years after hire or 1 year after termination, whichever later (8 CFR §274a.2)
Submit prior to participant enrollment per institutional policy
| 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 plan | Varies by plan | Varies by plan | Varies by plan |
| Bulk Send | Yes | Yes | Yes | Yes | Yes |
| 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 |