Study Protocol
A concise description of research questions, hypotheses, causal identification strategy, primary and secondary outcomes, and planned robustness checks for reviewer evaluation.
A consistent Studio reduces rework, clarifies data provenance, and supports reproducibility required by journals and funders. It centralizes approvals and preserves a tamper-evident record of analytic choices.
Research offices and faculty use the Studio to organize study inputs, approvals, and analytic code before data access or preregistration.
Administrative staff, IRB reviewers, and funders consult the Studio record to verify compliance, timelines, and authorized signatories.
A concise description of research questions, hypotheses, causal identification strategy, primary and secondary outcomes, and planned robustness checks for reviewer evaluation.
Field-level metadata listing variable names, labels, units, missing value rules, derivations, and source files to ensure consistent interpretation across analysts.
Explicit equation(s), functional forms, fixed effects, clustering choices, and pre-specified estimation and inference procedures to limit post-hoc researcher degrees of freedom.
Annotated scripts (R, Python, Stata) with environment specifications and seed settings so others can re-run analyses and validate reported results.
Signed records of IRB approvals, data access agreements, and institutional sign-offs capturing who approved what and when for auditability.
Change log, version tags, and a snapshot of datasets and outputs associated with each release to preserve analytical provenance.
| Field | Configuration |
|---|---|
| Read-Only Metadata | Lock PI, IRB ID after approval |
| Conditional Fields | Show data access terms only if PHI selected |
| Signer Order | Enforce IRB approval before department head |
| Audit Trail | Enable full action logging and timestamps |
Use a platform that supports secure eSignatures, preserves audit trails, and accepts common research file types.
Allow 4–8 weeks for review and revision
Submit 2–6 weeks before analysis start
File before data access or first analysis
Match funder schedule; some require quarterly reports
Reserve time for replication and peer review
Document completes peer and PI review
Ethics approval and conditions recorded
Custodian confirms permitted use
Final materials deposited in repository
| 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 and Envelope Cap | 7-day free trial; no envelope cap | Trial varies; 100 envelopes/user/year cap | Trial varies; varies by plan | Trial varies; varies by plan | Trial varies; varies by plan |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes (BAA available) | Yes | Yes | No | No |