Study Title
Full protocol title, version number, and a one-line summary. Include protocol ID and sponsor reference to avoid mismatched records during review and reporting.
A Research Field Trials Template reduces administrative error, speeds IRB and sponsor review, and ensures consistent data collection across locations. Standardizing fields clarifies roles, documents informed-consent protections, and helps satisfy regulatory and funding requirements while supporting reproducible methods for publication and audits.
Typical users include principal investigators, study coordinators, institutional compliance staff, and sponsor project managers preparing multi-site field studies.
Teams use the template to coordinate approvals, manage logistics, and maintain a consistent record for monitoring, reporting, and publication.
Full protocol title, version number, and a one-line summary. Include protocol ID and sponsor reference to avoid mismatched records during review and reporting.
Precise primary and secondary objectives, measurable endpoints, and success criteria. Clear objectives reduce ambiguity during data analysis and IRB assessment.
Site locations, sampling plan, inclusion/exclusion criteria, and standard operating procedures. Specify equipment, calibration, and field measurement protocols for reproducibility.
Risk assessments, participant protections, emergency contacts, and adverse-event reporting procedures. Document PPE, environmental hazards, and contingency plans for field settings.
Data capture methods, storage locations, backup frequency, de-identification steps, and who controls access. Tie procedures to regulatory and sponsor retention requirements.
IRB/ethics approvals, sponsor signoff, local site permissions, and required permits. Include signature blocks and dates for each approval authority.
| Field | Configuration | Type | Value |
|---|---|
| Conditional sections | Show site-specific fields only when a site is selected. |
| Reviewer routing | Route to IRB admin then sponsor compliance automatically. |
| Signer authentication | Use email or SMS code; escalate to KBA for sensitive records. |
| Audit trail | Enable full event logging and PDF certificate on completion. |
Choose distribution methods that preserve document integrity and capture a tamper‑evident audit trail before sharing with signers.
Submit complete package before any participant contact or field activity.
Do not begin enrollment until IRB and sponsor approvals are documented.
Provide scheduled safety and progress reports per sponsor or IRB schedule.
Submit study closeout and final data summary as required by sponsor.
Ensure record retention timelines are set before project closeout.
| 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 | Yes, 7-day trial | No | No | Yes, limited | Yes, limited |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
The PI signs to attest to study conduct and oversight. The PI’s signature confirms responsibility for protocol adherence, reporting obligations, and safety monitoring; institutions often require an authorized institutional official to countersign for contractual or financial commitments.
An institutional official or sponsor representative with delegated authority must sign for contractual acceptance, funding commitments, or regulatory attestations; their signature carries institutional accountability for compliance and resource allocation.