R01, R21 and K-award teams are small, budget-bound and still answer to reviewers, IRBs and auditors. Capture gives you 21 CFR Part 11-aligned controls without an enterprise contract, and a free sandbox so you can show the study working before you submit.
Free sandbox · No credit card · 21 CFR Part 11 aligned
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Study
R01 pilot, demo
What NIH-funded investigators usually need
The funded-investigator problem
NIH-funded investigators sit in an awkward gap. On one side are enterprise EDC systems designed for large sponsors, with implementation projects, minimum contract values and vendor timelines that do not fit an R21 pilot or a K-award career-development study. On the other are survey tools, spreadsheets and institutional databases that are quick to start but may lack the controls a clinical trial is judged by: electronic signatures, a tamper-resistant audit trail, role-based access and a locked, approved form lifecycle. Teams often start in the second group and discover the gap when an IRB, an auditor or a reviewer asks how the data were controlled.
Capture is built for this gap. It is a self-serve platform: you sign up, build the study yourself or let the AI study builder draft visits and forms from your protocol for you to review, test everything in a free sandbox and go live when you are ready. There is no sales call needed to start. The controls are aligned with 21 CFR Part 11, but Part 11 compliance is a shared responsibility, so your own validated use and your institution's procedures matter too. The page on the 21 CFR Part 11 compliance checklist shows what to verify on your side.
Whether your award is an R01 with several sites, an R21 exploratory study or a K award where the investigator is also the study coordinator, the practical needs are the same: forms that match the protocol, data that can be audited and exported cleanly, and costs that fit a fixed budget. The rest of this page covers how those needs connect to NIH requirements.
NIH requirements
A short orientation, not legal or compliance advice. Your program officer, grants office and IRB decide what applies to your award.
| Requirement | What NIH expects | Where an EDC helps |
|---|---|---|
| Data Management and Sharing | A DMS Plan with competing applications from January 25, 2023, and a plan to manage and share scientific data | Structured data, an automatic data dictionary and consistent exports make the plan easier to describe and follow |
| Single IRB | A single IRB of record for non-exempt multi-site US research, for applications due from January 25, 2018 | Blank eCRF PDF and consent exports for the IRB package; one study shared across sites |
| ClinicalTrials.gov | Registration within 21 days of the first enrolment and results within one year of primary completion, with limited exceptions | A clean dataset with defined endpoints makes results reporting less painful |
| Human subjects protections | IRB-approved consent and data protection | eConsent with on-screen signature, role-based access, PII segregation |
| Rigor and reproducibility | Clear methods and traceable data | Field-level audit trail with reason for change; locked forms |
Policy details were checked against NIH pages on 2026-10-06 and can change. Confirm current requirements with NIH and your institution. This is not legal advice.
Build forms, consent and a visit schedule in the free sandbox, then export the blank eCRF PDF for your IRB. No credit card.
Budgeting
Reviewers like a data management line item that is specific, proportionate and explained. The cleanest approach is to separate three phases: build and testing, the live collection period, and close-out with export. In Capture the first phase is free in the sandbox, and charges begin when real participants are enrolled; the site does not publish prices, so ask for terms for your study design and enrolment before you commit a number to a proposal. Our EDC cost calculator and the explainer on what an EDC costs for a 100-patient trial help you structure the comparison, and hidden EDC fees lists the line items to ask any vendor about.
Use the same logic for comparison: in a budget justification, name what the software provides (EDC, ePRO, eConsent, audit trail, exports) rather than a brand, and note what it replaces, such as a custom database, a separate survey tool and a paper consent process. If your institution already provides an academic data capture tool, the REDCap comparison and REDCap true cost versus an EDC set out the trade-offs honestly, including the case where using the institutional tool is the right answer.
Remember that costs recur with scope. Extra sites, a longer follow-up or an amended protocol change the bill and the workload. Ask how amendments are handled, and read protocol amendments without change orders so you know what to expect from your own build.
Grant timeline
From application to close-out.
Build a draft of the study in the sandbox, export the blank eCRF PDF and describe the data flow, roles and controls in your data management section.
Finish the forms, add edit checks and consent, and attach the exports to your IRB package. Draft the data management plan from the template.
Approve and lock the forms, assign roles for the PI, coordinators and any blinded staff, and go live when the first participant is ready.
Collect data, resolve queries raised by edit checks, monitor completion and keep the audit trail as the record of changes.
Export CSV or Excel with the data dictionary for analysis, results reporting and sharing under your approved plan.
Fit and limits
Capture is a good fit when you run the study with a small team, need clinical-grade controls and want to control the build yourself. That covers most R21 pilots, K-award studies, investigator-initiated R01 trials and multi-site academic trials, including Phase 3 designs. For multi-site work, QR-code enrolment, site-level participant numbering, a separate site coordinator portal and by-site exports keep sites organised; see multi-site clinical trial management and EDC for academic clinical trials.
It is not the right choice if your funding mechanism or coordinating centre mandates a specific data system, or if the trial needs complex multi-depot drug supply or a specialist imaging pipeline as its main data flow. And if your institution requires its own database for institutional data governance, use it. Capture does not hold a validated CDISC SDTM export; templates carry SDTM domain labels, so plan your statistical programming accordingly.
Hosting is in the EU (Frankfurt) or the USA (N. Virginia), data are encrypted at rest and in transit, and roles keep names with site coordinators while researchers see coded IDs. Your institution's security office may ask for details; the security page and GDPR page describe the controls we publish.
Before you submit
Notice of award, program officer guidance and institutional data policy.
Variables, roles, quality control, export and retention.
How the dataset, dictionary and any documentation will be shared.
Blank eCRF PDF, consent and data protection description.
Build, live collection and close-out, with terms confirmed.
ClinicalTrials.gov registration and results timeline set for the PI.
Yes. Capture suits investigator-initiated R01 trials, including multi-site and Phase 3 designs, with Part 11-aligned controls, ePRO, eConsent and randomization in one platform.
Yes. A small team can build the study in the free sandbox and go live when ready, with no IT support or enterprise contract needed to start.
Capture provides Part 11-aligned controls such as a field-level audit trail, electronic signatures and role-based access. Compliance is shared with your own validated use. This is not legal advice.
The sandbox is free, so build and testing cost nothing; you pay when real participants are enrolled. Pricing is not published, so ask for terms before putting a number in your budget.
It gives you structured data, an automatic data dictionary and CSV or Excel exports. The plan itself, and what you share, is your decision with your institution and program officer.
The IRB process is outside the software, but you can export a blank eCRF PDF and the consent documents for the IRB package, and run all sites in one study.
Yes. The security page and GDPR guide describe hosting, encryption and access controls. Ask us for anything your office needs beyond that.
Use whichever fits your requirements. If you need electronic signatures, a stronger audit trail or integrated ePRO and eConsent, compare the options on the REDCap comparison page.
Keep exploring
EDC budget line item for grant proposals
Write the cost into your application.
EDC for academic clinical trials
The wider academic view.
Capture vs REDCap
Institution-hosted tool versus platform.
Data management plan template
Start your plan.
21 CFR Part 11 compliance checklist
What to verify on your side.
IRB submission checklist
Assemble the package.
Free sandbox with every feature. No credit card, and you pay only when you go live.