Resources for independent research sites.
Primary-source guides, practical record templates, planning calculators and fair software comparisons for the people running the study.
Guides
Start with a guide when you need to understand the requirement or the reasoning behind a workflow. These articles use primary sources for regulatory topics and identify the limits of examples. Regulations, guidance and contractual templates are different kinds of evidence; the article explains which one supports a statement. Read the cited source and the study’s protocol before adopting a procedure. The publication date records the content date, not a promise that every linked source will stay unchanged.
- 21 CFR Part 11 for research sites: what the software does and what you own
A practical separation of electronic-record controls, investigator responsibilities and the evidence your site needs to review.
Updated
- Out-of-window visits: how to document deviations
Preserve actual visit dates, assess the protocol issue and record the review without disguising a late visit or inventing a universal reporting rule.
Updated
- Getting paid for every procedure: reconciling a clinical trial agreement fee schedule
An editorial reconciliation workflow for completed activity, contractual triggers, invoices and remittances, without assuming every procedure is payable.
Updated
- How to calculate visit windows (with examples)
A practical guide for coordinators: anchors, Day 0 versus Day 1, early and late limits, and the mistakes that turn a visit into a deviation.
Updated
- ICH E6(R3): what changes for research sites
The revised Good Clinical Practice guideline is written to be risk-proportionate and technology-neutral. Here is what it means for investigators and site staff.
Updated
- How much does CTMS software cost in 2026?
Most site software vendors do not publish prices. Here is what is public, what we could verify, and the cost lines to ask every vendor about.
Updated
Templates
Use a template when your team needs a record format to review. The delegation, screening and note-to-file downloads include field explanations, sample entries and practical review checks. They are free CSV and printable aids, not universally mandated forms. Adapt the format with your investigator and sponsor, and retain the supporting evidence. An empty downloaded log does not demonstrate that the underlying task was authorized or that the record is ready for inspection.
- Delegation log template
Free delegation log template (CSV and printable).
Updated
- Screening log template
Free screening and enrollment log template.
Updated
- Note to file template
Free note to file template.
Updated
Tools
Use a calculator to reproduce a planning calculation, then keep its inputs with the result. Visit windows depend on the protocol’s anchor and day convention; budgets depend on negotiated amounts and assumptions about visits. The tools do not approve exceptions, establish invoice eligibility or predict sponsor payment. CSV export and print support a review discussion without moving real participant records into a public page. Read the assumptions before copying a number into a study plan.
- Visit window calculator
Free calculator for protocol visit target dates and windows.
Updated
- Site budget calculator
Free calculator for a per-study site budget with CSV export.
Updated
Comparisons
Use comparisons to prepare questions for a vendor demonstration and a scoped quote. Public product pages establish that a vendor lists a workflow, not that it is included in every contract or suitable for every intended use. Unknown facts are marked Not published, not interpreted as missing features. Review the source links and verification month, then ask each provider for current products, terms, support and export arrangements. A fair selection considers both vendor strengths and your site’s actual handoffs.
- Compare site software
Side-by-side modules and published-price comparison with sources.
Updated
- CRIO alternative
Fair comparison with CRIO.
Updated
- RealTime-CTMS alternative
Fair comparison with RealTime-CTMS.
Updated
- Clinical Conductor alternative
Fair comparison with Advarra Clinical Conductor.
Updated
- Florence eBinders alternative
Fair comparison with Florence eBinders.
Updated
Use the right record for the question
A guide explains a requirement, a template helps structure evidence and a calculator produces arithmetic from your assumptions. None replaces your protocol, investigator oversight or executed clinical trial agreement. Use de-identified examples for a demonstration and keep names, health answers and source documents out of public forms. If your question needs sensitive material, agree on an appropriate transfer method with the team before sending it.
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