Title Page
Project title, short abstract, principal investigator name, institutional affiliation, contact information, and sponsor or funding source information.
A well-structured Research Study Proposal clarifies scientific rationale, demonstrates regulatory compliance, and documents protections for participants. It supports timely IRB review, helps sponsors assess risk and cost, and creates an auditable record for institutional oversight and grant administration.
Each role requires different sections and documentation; shared clarity speeds review and reduces revision cycles.
The PI attests to scientific accuracy, responsible conduct, and compliance with protocol and institutional policies; signature establishes accountability for study execution and reporting.
An institutional signing official (department chair, grants officer, or institutional official) certifies institutional commitments for resources, IRB oversight, and financial management.
Project title, short abstract, principal investigator name, institutional affiliation, contact information, and sponsor or funding source information.
Concise literature review and rationale showing the knowledge gap the study addresses and how the study design will address it.
Primary and secondary objectives with measurable endpoints, hypotheses, and predefined success criteria for statistical analysis.
Study design, population, inclusion/exclusion criteria, recruitment plan, interventions, data collection instruments, and analysis plan.
Informed consent process, risk/benefit assessment, data privacy measures, adverse event reporting, and plan for IRB submission.
Itemized budget, personnel effort, milestone schedule, deliverables, and any subcontractor or vendor arrangements.
| Field | Configuration |
|---|---|
| Upload Document | PDF or DOCX accepted; include all attachments as a single package. |
| Signer Order | Set sequential routing: PI → Department Head → Grants Office → IRB liaison. |
| Authentication | Use email-based links or stronger MFA for institutional signers. |
| Audit Trail | Enable detailed timestamps, signer IPs, and completion certificates. |
Use tools that create an auditable record and support secure storage to meet institutional and regulatory needs.
Allow 1–4 weeks for departmental and grants office checks before formal submission.
Expedited reviews may take 1–2 weeks; full-board reviews commonly require 4–8 weeks.
Funding decisions vary widely — expect 2–6 months for competitive grants.
Institutional contract and budget finalization commonly add 2–8 weeks.
Plan ahead for continuing review submissions per IRB schedule to avoid lapses.
Finalize methods, endpoints, and safety monitoring before administrative review.
Grants and departmental approvals must be in place for institutional submission.
Obtain written IRB approval for the protocol and informed consent forms.
Complete site setup, training, and any sponsor requirements before recruiting participants.
| 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 trial | Varies by plan | Varies by plan | Varies by plan | Varies by plan |
| Bulk Send | Yes (plan-dependent) | Varies by plan | Varies by plan | Varies by plan | Varies by plan |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | Varies | Varies |
A university team developed a randomized pilot study protocol to test an intervention.
A public agency solicited proposals for a program evaluation with strict reporting timelines.