Study Summary
A short abstract (2–4 sentences) that states purpose, population, and primary activities so reviewers quickly understand the study's intent.
A concise memo clarifies responsibilities, timelines, and data handling expectations for both researchers and the site, reducing review friction and administrative delay.
Final approval may require signatures from multiple offices; identify required signers up front to avoid repeated routing.
A short abstract (2–4 sentences) that states purpose, population, and primary activities so reviewers quickly understand the study's intent.
List measurable objectives and intended outcomes; tie each objective to specific activities to make approval conditions clear.
Describe recruitment, data collection methods, instruments, and any interactions with site staff or participants that could affect operations.
Provide proposed start and end dates, major milestones, and contingency windows so sites can evaluate scheduling impact.
Specify space, equipment, staff assistance, and data access required from the site, including contact points and hours of operation.
Include signature block(s) with printed name, title, organization, date, and any witness or notary lines required by the site.
| Field | Configuration |
|---|---|
| PI Signature | Required; date stamp auto-filled |
| IRB Approval | Upload IRB letter; attachment required |
| Site Manager | Order after IRB; visible comments field |
| Notary / Witness | Conditional field shown if required |
Verify the platform can produce a signed copy with an auditable certificate for retention and possible future audits.
Date when site access is needed; clearly state backup dates.
Record the IRB approval effective date for compliance.
Define permitted days and hours for on-site work.
When permission lapses and access must end.
When changes require re-authorization or addendums.
Memo and attachments finalized by PI before routing.
Ethical approval documented and linked to memo.
Facility confirms schedule and resources.
Signed memo saved to institutional records with retention metadata.
A PI provided an attached IRB letter and a one‑page access schedule to the registrar
Clinical team included a data handling appendix and BAA in the original submission
| 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 vendor | Varies by vendor | Varies by vendor | Varies by vendor |
| Bulk Send | Yes | Yes | Yes | Yes | Limited |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |