EDC for First-in-Human (FIH) Studies

Electronic data capture for first-in-human studies: safety, consent, and PK in one platform with 21 CFR Part 11–aligned controls and audit trails.

21 CFR Part 11–aligned · HIPAA-aligned security · No credit card required

Using Capture.Study from protocol readiness to first dose

FIH teams typically start working in Capture as soon as the protocol and informed consent form are stable enough to draft the build. In a sandbox or non-production environment, they define cohorts, visits, sampling schedules, and safety assessments; once the configuration is reviewed and validated according to sponsor procedures, the same design is promoted to production for live use. This mirrors how other Capture.Study customers work with early-phase and academic trials described elsewhere on the site, but with added emphasis on traceability and documentation for FIH.

  • Configure the FIH study in a sandbox, including cohorts, visits, and consent flows, before validation
  • Run internal UAT according to your validation plan, using the same web interface that sites will see
  • Promote the validated configuration to production and restrict changes to controlled processes
  • Keep consent, dosing, safety and PK data aligned in one application as the study proceeds

Aligning FIH oversight with Capture.Study features

Oversight bodies for FIH programs want assurance that the technology stack supports data integrity and participant protection. Capture’s focus on 21 CFR Part 11–aligned controls, HIPAA-aligned security, audit trails, and role-based access is intended to align with those expectations, while still giving lean teams a practical environment to run first-in-human studies without enterprise overhead.

  • Role-based access so investigators, monitors, data managers and QA have appropriate, auditable permissions
  • Comprehensive audit trails for consent events, CRF changes, and AE updates
  • Configurable exports so pharmacokinetics, safety, and governance teams can obtain the slices of data they need
  • Documentation to support your validation and oversight processes for Enterprise implementations

Overview

EDC for First-in-Human (FIH) Studies

First-in-human (FIH) studies are the first administration of an investigational product to humans. They require rigorous consent, safety monitoring, and precise data capture—and are closely scrutinized by regulators and ethics committees. Stakeholders expect transparent documentation of every consent version, safety assessment, and protocol change, and they need to be able to reconstruct what happened at each step of the study from a single, trustworthy system of record. Your EDC must support versioned consent with electronic signature, dense PK and safety sampling, adverse event capture with full follow-up, and complete audit trails and access controls, while enabling rapid deployment so you don’t delay first dose. Capture provides integrated eConsent, EDC, and safety in one platform with 21 CFR Part 11–aligned controls and HIPAA-aligned infrastructure, so you can run FIH and Phase 1a studies without the long implementation cycles of enterprise systems or fragmented data across multiple tools.

Why FIH studies are different

FIH trials are closely scrutinized by regulators and ethics committees. Consent must be clear, versioned, and electronically signed with a full audit trail; safety data must be complete and auditable. You need one system that links consent, CRFs, and adverse events so inspectors and monitors can trace the full data flow. Your EDC should be built for this level of control without the long implementation cycles of enterprise systems—and without per-seat or per-module pricing that doesn’t fit small volunteer cohorts.

Common FIH workflow

  • Final protocol and consent documents; ethics and regulatory approvals
  • Site readiness, training, and activation (typically one or few sites)
  • Screening and eligibility checks
  • Informed consent (electronic) with version control and e-signature
  • Dose administration and close safety monitoring
  • PK/PD and safety sampling at defined time points
  • Adverse event reporting, severity, causality, and follow-up with full audit trail
  • Concomitant medication and protocol deviation capture
  • Data review, query resolution, database lock, and export for analysis

Traditional tool pain points

  • Months of implementation before first dose, extending time to FIH
  • Heavy validation and change control for small studies that could move faster
  • High cost for small volunteer cohorts and enterprise licensing that doesn’t scale
  • Disconnected consent, EDC, and safety tools with no single audit trail
  • Slow vendor support for study build and consent/CRF updates when timelines are critical
  • Overbuilt features and training burden for lean FIH teams

How Capture supports FIH studies

  • Integrated eConsent with versioning and electronic signature; every consent event in the audit trail
  • EDC and safety workflows in one platform so consent, CRFs, and AEs are linked and traceable
  • Rapid study build and deployment to avoid delaying first dose
  • Flexible visit and form design for dose escalation and PK/safety sampling
  • 21 CFR Part 11–aligned controls: e-signatures, comprehensive audit trails, access control
  • HIPAA-aligned security and data handling for participant data and PHI
  • Documentation and support for sponsor validation and UAT (Enterprise) for regulated studies

Related

Clinical trial softwareAffordable EDC for clinical trials

FAQ

Questions we hear a lot

Is Capture suitable for first-in-human trials?
Yes. Capture is designed for early-phase and FIH-style studies. You get eConsent, EDC, and safety in one system with audit trails and controls aligned with 21 CFR Part 11. Many teams use Capture for FIH and Phase 1a trials. For regulated studies we provide documentation and support for qualification and UAT as part of Enterprise offerings.
How is consent handled?
Capture includes electronic consent with version control and electronic signature. Each consent event is recorded in the audit trail so you have full traceability for regulators and ethics. You can support multiple consent versions if the protocol or ICF is amended.
What documentation do you provide for validation?
For Enterprise customers we provide documentation and support for qualification and user acceptance testing. Capture is designed with 21 CFR Part 11–aligned controls; we help sponsors document fit for their validation approach. For regulated studies, onboarding may include validation, documentation, and sponsor-led UAT prior to go-live.
How quickly can we deploy for FIH?
Study build can start as soon as you have protocol and consent finalization. Many teams build and deploy FIH studies in weeks. For regulated studies, timeline depends on your validation and UAT process; we supply the documentation and support you need to run that efficiently.
Can we keep configuration and production environments separate?
Yes. Sponsors typically use separate environments for configuration/validation and for live FIH data collection. Each environment has its own audit trail so you can document qualification and operational use separately.
How do we handle protocol or consent amendments mid-study?
You can update forms and consent configurations in the study build according to your change-control procedures. Capture tracks these changes in the audit trail so you can show when updates were made and which participants were affected.
Does Capture support safety signal review for FIH?
Yes. You can configure exports and dashboards that highlight key safety parameters (AEs, labs, ECGs, vitals) for review by medical monitors and governance bodies, using the same underlying dataset captured by sites.
Can we restrict who sees potentially unblinded FIH data?
Yes. Role-based access allows you to restrict access to unblinded or sensitive data to specific users while giving others blinded views, aligned with your governance model.
Is Capture suitable for both healthy volunteer and patient FIH studies?
Yes. You can configure the same platform for healthy volunteer or patient-based FIH studies by tailoring visits, forms, and roles to your protocol while keeping consent and safety capture consistent.
How does Capture support inspection readiness for FIH?
Because consent, safety data, and audit trails all live in one system, it is easier to respond to regulator or ethics committee questions. You can show how consent versions evolved, which participants were dosed when, and how safety events were captured and followed up.

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