Build Research Protocols Automatically from Your Evidence
Turn your hypotheses and analyzed papers into a complete research protocol in minutes. Study design, population criteria, outcome measures, timeline, and budget, all grounded in published evidence.
Writing protocols manually takes weeks and misses critical details
A well-written research protocol is the foundation of any clinical study, but building one from scratch is a slow and error-prone process. Researchers spend weeks compiling study objectives, defining populations, calculating sample sizes, and writing inclusion and exclusion criteria, all while cross-referencing dozens of published papers for justification.
Missing a single exclusion criterion or underestimating the required sample size can delay a study by months. And when you factor in regulatory requirements from different ethics committees, the complexity multiplies.
NousLab's protocol builder reads all the evidence from your analyzed papers and generates a complete, structured protocol in minutes. Every criterion, every endpoint, and every design decision is traceable to published research in your project.
Manual writing vs NousLab
How automated protocol building works
From hypothesis to submission-ready protocol in four steps. Every section grounded in published evidence from your project.
Hypothesis generated
Start from a hypothesis generated by NousLab or define your own research question. The hypothesis serves as the foundation that drives the entire protocol structure.
AI builds the protocol
The AI reads the evidence from your analyzed papers and generates a complete protocol: objectives, design, population, sample size, criteria, intervention, outcomes, timeline, and budget.
Review and refine
Review each section individually. Inclusion criteria appear in green, exclusion criteria in red. Provide custom instructions to refine any part of the protocol until it meets your exact requirements.
Export and submit
Export the final protocol to PDF or DOCX. Translate to Spanish or Portuguese for multi-site studies. Submit directly to your ethics committee, IRB, or funding agency.
What the generated protocol includes
Every section a complete research protocol needs, generated from the evidence in your analyzed papers.
Objectives and Study Design
Clear primary and secondary objectives derived from your hypothesis. Recommended study design (RCT, cohort, case-control) based on precedents in your analyzed literature, with justification for the chosen approach.
Population and Sample Size
Target population definition with demographic parameters. Sample size estimation based on effect sizes observed in your analyzed papers, with power calculations and dropout rate assumptions grounded in the literature.
Inclusion and Exclusion Criteria
Comprehensive eligibility criteria derived from what previous studies used. Inclusion criteria displayed in green and exclusion criteria in red for quick visual distinction and review.
Intervention and Outcomes
Detailed intervention description including dosage, duration, and comparators. Primary and secondary outcome measures with measurement methods and assessment timepoints, all informed by endpoints used in similar published studies.
Timeline
Realistic study timeline with phases for recruitment, intervention, follow-up, and data analysis. Duration estimates based on comparable studies in the literature, including screening periods and interim analysis points.
Budget
Estimated budget breakdown covering personnel, equipment, consumables, participant compensation, and overhead costs. Budget categories are aligned with common funding agency requirements to streamline grant applications.
Built-in regulatory and ethics compliance
Your protocol is generated with regulatory requirements in mind, reducing back-and-forth with ethics committees and speeding up approval.
32 regulatory frameworks
Supports ICH-GCP, Declaration of Helsinki, FDA CFR Title 21, EU Clinical Trials Regulation, and 28 additional national and institutional frameworks.
Ethics committee integration
Protocols are structured to align with ethics committee requirements. NousLab's ethics profiles flag sections that need specific committee review based on your study type.
Multilingual export
Translate your protocol to Spanish and Portuguese for multi-site international studies or local ethics committee submissions that require documentation in the national language.
How a clinical researcher uses protocol building
A clinical researcher at a teaching hospital is preparing an IRB submission for a Phase III trial evaluating a novel GLP-1 receptor agonist in patients with type 2 diabetes and established cardiovascular disease. She has already analyzed 40 papers in NousLab covering prior GLP-1 RA trials, cardiovascular outcome studies, and relevant meta-analyses.
From her hypothesis on cardiovascular risk reduction, she triggers the protocol builder. Within minutes, the AI generates a complete protocol with a parallel-group RCT design, a target population of adults over 40 with HbA1c above 7% and prior MACE events, a sample size of 1,200 justified by effect sizes from the analyzed literature, and detailed inclusion criteria (in green) and exclusion criteria (in red) drawn from similar trials.
She reviews the outcome measures section and uses custom instructions to add a secondary endpoint for renal function. The AI regenerates that section while keeping the rest of the protocol intact. She then exports the protocol as a DOCX file formatted for her institution's IRB template.
What would normally take three to four weeks of writing and cross-referencing literature is completed in a single session. Her protocol is evidence-based, regulatory-aligned, and ready for committee review.
Frequently asked questions
What sections does the AI-generated protocol include?
NousLab generates a complete research protocol covering study objectives, study design, target population, sample size justification, inclusion and exclusion criteria, intervention details, primary and secondary outcome measures, data collection timeline, and estimated budget. Each section is grounded in the evidence from your analyzed papers.
How does the protocol builder use my analyzed papers?
The AI reads the structured data extracted from your analyzed papers, including methodology, population characteristics, endpoints, and statistical results, to inform every section of the protocol. Inclusion and exclusion criteria are derived from what previous studies used, and sample size estimates are based on effect sizes observed in the literature.
Can I export the protocol to PDF or Word?
Yes. Every generated protocol can be exported to PDF and DOCX formats, ready for submission to ethics committees, IRBs, or funding agencies. The exported documents maintain professional formatting and include all protocol sections with proper numbering and references.
What regulatory frameworks does NousLab support?
NousLab supports 32 regulatory and ethics frameworks including ICH-GCP, the Declaration of Helsinki, FDA CFR Title 21, EU Clinical Trials Regulation, and many national and institutional frameworks. The protocol builder considers the applicable requirements and flags sections that need ethics committee review.
Can I customize or refine the generated protocol?
Yes. After the AI generates the initial protocol, you can provide custom instructions to refine any section. You can ask the AI to adjust the study design, modify criteria, change the timeline, or adapt the protocol to specific institutional requirements. The AI will regenerate the relevant sections while keeping the rest intact.
Is the protocol available in languages other than English?
Yes. NousLab can translate the generated protocol into Spanish and Portuguese, which is useful for multi-site studies or submissions to ethics committees that require documentation in the local language. The translation preserves all technical terminology and formatting.
Ready to build your next research protocol?
See how NousLab can turn your evidence into a submission-ready protocol in minutes instead of weeks.
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