What is an eRegulatory binder?

An eRegulatory binder is the electronic investigator site file, sometimes called an eISF or eBinder. It organizes the essential records a site retains for a study, such as approvals, protocol versions, delegation and training evidence. It is more than an unstructured shared folder.

Which documents should our site include?

Use the protocol, sponsor requirements, your site procedures and ICH E6(R3) to define the checklist. Common categories include IRB approvals, consent documents, investigator qualifications, delegation, training and correspondence. The software organizes records; it does not decide that your file contains every required document.

Does a new upload replace the old version?

Version history is important because reviewers may need to understand what was in force at an earlier date. Inspect how your document revisions and metadata are retained during the demo. Staff should review whether a revision changes the document’s approval or use status.

How are expiring documents handled?

Document validity information supports review of upcoming expirations. A reminder is not a renewal or a finding that the document is acceptable. Assign responsibility for checking the replacement, updating the record and confirming its effect on staff activities or study conduct.

Can an outside monitor review the binder?

Authorized staff can provide named, study-scoped monitor access for a defined period. Review the exact records available to that account before inviting a reviewer. Access should fit the monitoring purpose and the site’s confidentiality procedures, rather than expose the entire organization.

Does the binder determine retention periods?

No. The site must establish retention under applicable regulations, the protocol, sponsor agreements and its procedures. Preserving electronic history is part of the record workflow, but staff still own retention decisions, review arrangements and the handling of original records during a switch.

eRegulatory binder for independent research sites.

Keep essential documents, staff delegation and expiry information within the study record.

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Kyros Trials / Sample workspace

CARD-204 / Essential records

01Expiry identified
02Replacement reviewed
03Delegation updated

Staff license: Validity reviewed
Document version: Version 2 metadata
Delegation record: Staff task recorded
Responsible person: Investigator review

Delegation is a separate reviewed record

Sample record. Not real participant data.

What breaks today

The question on monitoring day is rarely whether a file exists somewhere. It is whether the site can identify the right version, explain its status and show the supporting staff records. A digital investigator site file should preserve that context without turning every review into another binder assembly exercise. Kyros Trials brings study documents, version history, expiry information, delegation and training into connected site workflows. Your team still defines its essential-record checklist and reviews the content of each document before treating it as ready for use.

01I found three approval letters. Which one is current?
A filename cannot establish which protocol or consent version an approval supports. Documents need a study context and retained history. Staff should be able to review the approval letter itself, not infer readiness from a folder called current or a coordinator’s memory.
02The license expires next month, and the reminder is on one person’s calendar.
Validity dates need to survive staff handoffs. A binder workflow can bring upcoming expirations into view, but it cannot renew a credential or decide whether a document remains acceptable. The next action still belongs to a named person at the site.
03The monitor is coming, so we’re rebuilding the binder.
Staging copies can create yet another version to reconcile. Scoped review access lets authorized monitors inspect study records without granting broad site access. The site remains responsible for deciding what can be shared, setting the access period and following sponsor confidentiality requirements.

Laboratory bench with equipment — Illustrative workspace. Photo by Adam Bezer on Unsplash.

Essential records

The right document, with its history.

A digital binder should do more than hold files. Your team needs to identify the current version, follow expiry dates and give monitors appropriate access.

CARD-204 / Regulatory binder

Sample workflow

Document: IRB approval
Study: CARD-204
Version: Approval supporting protocol version 2

Illustrative workflow. Not live records or customer results.

What’s included

These are core site workflows, available with Advanced off. Access still follows your staff roles and study permissions. Optional AI depends on the plan and service configuration.

Study binders: Organize essential documents against the study they support.
Document classification: Classify document types in the study’s essential-record register.
Version metadata: Record revision identifiers and document version information.
IRB records: File approvals and amendments in study context.
Validity dates: Record effective and expiry information for review.
Expiry worklist: Bring upcoming regulatory expirations into the site’s work.
Delegation log: Record staff responsibilities within the study.
Training records: Keep staff training information available for review.
Electronic signatures: Use the shared authorized signing workflow.
Scoped monitor access: Define the study and period an outside reviewer can access.

Controls and site responsibilities

Use this mapping to structure your review, not as a regulatory determination. Regulations and guidance describe expectations; your intended use, procedures, training and evidence determine how the workflow supports your study.

Regulation, software support and site responsibility
Regulation or requirement	What Kyros Trials does	What your site still owns
ICH E6(R3) essential records	Organizes study documents, versions, delegation and training records.	Determine essential records, check their content and maintain the investigator site file.
21 CFR 312.62	Keeps relevant study records and their history available for review.	Meet applicable investigator recordkeeping and retention duties; drug accountability is not this binder demonstration.

Compliance depends on how each site validates and uses the system.

How it connects

The an eregulatory binder for your research site workflow feeds the next site record while preserving the distinction between captured information, staff review and an authorized action.

01
Approval
02
Binder version
03
Delegation
04
Monitor review

A connected record is not an automatic approval. Staff check the underlying evidence, confirm permissions and decide when the next step is appropriate. The sample demonstrates a handoff; it does not access clinical records or imply a measured customer result.

Before and after, at the site

Paper or spreadsheets compared with Kyros Trials workflows
Site task	Paper or spreadsheets	Kyros Trials
Identify a document	Several similarly named files in shared folders.	Study document context and retained versions.
Track validity	Expiry dates copied onto a personal calendar.	Expiry information visible in the document workflow.
Maintain delegation	A paper log reconciled after staffing changes.	Study-linked delegation records for staff review.
Find training evidence	Certificates scattered across email attachments.	Staff training records alongside site workflows.
Prepare a monitor review	Another set of copied files and printed tabs.	Named, scoped review access for the relevant study.

Workflow comparison, not a claim of time saved or improved clinical outcomes. Review the steps against your own protocol and operating procedures.

Bring your data from CRIO, RealTime-CTMS or spreadsheets

Start with a de-identified export and agree on the field mapping before moving records. Staff review identifiers, dates, statuses and the destination structure. Keep the original records available under your retention policy; a CSV import does not reconstruct another system’s audit trail. Document and historical-record migration require a separate review of available exports and file structure.

Review switching Open the related site resource

Published pricing, before the demo

Included in every plan. Published price: $599 per site per month.

That is the Site plan price. Starter is $299 per month with its study limits; Network is $499 per location per month for two or more locations. Core modules are included across plans. AI drafting and prescreen chat are Site and Network options and require configuration. Review current terms and limits before selecting a plan.

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Questions before you choose

Answers to the questions research sites ask most.

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Related site workflows and resources

See your own protocol in Kyros Trials.

Walk through your visit schedule, source records and sponsor billing with our team.

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