RTSM / IRTUpdated September 26, 2026

Randomization and trial supply, built into your EDC

Capture randomizes the subject, proposes the right kits, records the dispensing under an e-signature and keeps every role correctly blinded. No separate IRT vendor, no integration to maintain.

  • Randomization with enrolment caps
  • Blinded and unblinded roles
  • Kit dispensing under e-signature
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Free sandbox · No credit card · 21 CFR Part 11 aligned

Study coordinator

Subject 01-004

Randomized · R-0012

Treatment assignment blinded

KitK-10418

Arm columnNot sent

Unblinded administrator

Subject 01-004

Randomized · R-0012

Treatment: Active (A)

KitK-10418

Arm columnA

Same subject, same screen. The arm never reaches blinded roles.

1

system for EDC, randomization and supply

3

cap levels: study, country, site

1

e-signature commits allocation and dispensing

0

integrations to maintain

How it works

From consented subject to dispensed kit

  1. 1

    Load the list

    Generate a randomization list with block size and seed, or upload your own.

  2. 2

    Randomize

    The site confirms consent and randomizes. Caps and prerequisites are checked on the server.

  3. 3

    Dispense

    Capture proposes kits, the site confirms each one and signs once to commit.

  4. 4

    Account

    Shipments, returns and destruction feed the drug accountability report.

Randomization

Randomize with the checks built in

Randomization only happens when the subject is ready. Capture checks the prerequisites and the caps before assigning the next number, inside one database transaction.

  • Treatment arms with ratios, product names and import aliases.
  • Randomization lists generated with block size and seed, or uploaded.
  • Configurable randomization number format and trigger: after enrolment, after screening or manual.
  • Consent confirmation on the randomization step.
  • Enrolment caps by study, country and site, with an early warning at 80% and a hard block at the cap.
More on randomization software
Randomize subject 01-007
Site 01: 3 randomization slots remaining17 / 20

Study status Live

Site activated Yes

Randomization list 42 allocations left

Has the subject signed the current informed consent?

YesNo
Next numberR-0013

Blinding

Blinding enforced by the data, not by hiding a column

Blinded roles never receive the treatment arm, not even in the response behind the screen. An Unblinded Administrator handles the unblinded work, and emergency unblinding stays one step away for investigators.

  • Blinded roles see "Treatment assignment blinded" everywhere: casebook, AE form, inventory and exports.
  • An Unblinded Administrator role owns the medication list and randomization list.
  • Emergency unblinding for the PI and sub-investigator.
  • The study owner can approve an unblinding request without seeing the answer.
  • SO

    Study owner

    Builds and configures the study

  • PI

    Principal investigator

    Oversees the site, signs off the casebook

  • SI

    Sub-investigator

    Enters and signs clinical data

  • SC

    Study coordinator

    Screens subjects, enters visit data

  • CRA

    Monitor (CRA)

    Verifies data, raises queries

  • DM

    Data manager

    Reviews, freezes and locks data

  • PT

    Participant

    Completes their own questionnaires

Dispensing

One signed transaction per dispensing

Capture proposes kits by earliest expiry and holds them while the site confirms. Nothing is written to inventory until the password is entered, so a closed dialog never strands a kit.

  • Kits proposed earliest-expiry-first and held for the user, not allocated.
  • Scan or tap each kit to confirm you are holding it.
  • A physical verification checklist before signing.
  • Allocation and dispensing committed together under an e-signature.
  • Holds released automatically after inactivity.
Dispense IMP · Week 4
Occasion
Kits
Verify
Sign

1 of 2 kits confirmed

K-10418B-2207 · exp 03-2027
K-10419B-2207 · exp 03-2027
Sign stays disabled: confirm all 2 kits before signing.

See blinding from both sides

Open the same subject as a blinded and an unblinded user in a free sandbox.

Try RTSM free

Supply

Supply and accountability in the same place

Depots ship kits to sites, sites receive them against a checklist, and every kit keeps a custody history through to destruction.

  • Shipments uploaded against a destination site, received kit by kit.
  • Missing or damaged kits quarantined with a reason.
  • Returns recorded as used or unused, reconciled by the monitor.
  • Drug accountability report and CSV export, blinded for blinded roles.
IMP inventory and accountability

Kit K-10418 · custody history

  1. At depotAvailable
  2. In transitAvailable
  3. At siteAssigned
  4. With patientDispensed
  5. ReturnedReturned (used)
  6. DestroyedDestroyed

Only physically possible combinations can be saved.

The difference

A standalone IRT vs RTSM inside Capture

Systems
EDC and IRT from different vendors
One system for data, randomization and supply
Integration
Subject and visit data synced between systems
Nothing to sync, it is the same record
Set-up
Separate specification, build and testing
Configured in study settings by your team
Site experience
Two logins and two workflows
Randomize and dispense from the subject page

FAQ

Questions teams ask before they switch

Something not covered here? Ask us directly.

What is RTSM software?

RTSM (randomization and trial supply management), also called IRT or IWRS, assigns participants to treatment arms and manages the investigational product that goes with them: shipments, dispensing, returns and accountability.

Is RTSM included in the EDC?

Yes. Randomization, dispensing and inventory are part of Capture, so there is no separate IRT system or integration.

How is blinding protected?

Blinded roles never receive the treatment arm from the server. An Unblinded Administrator handles unblinded tasks, and investigators keep access to emergency unblinding.

Can I upload my own randomization list?

Yes. You can generate a list with block size and seed, or upload one prepared by your statistician.

How do enrolment caps work?

Set caps for the study, each country and each site. Sites see a warning at 80% by default, and randomization is blocked at the cap. Every cap change needs a reason.

How are kits dispensed?

Capture proposes kits earliest-expiry-first and holds them. The site confirms each kit, completes a verification checklist and signs once to commit allocation and dispensing together.

Is stratified randomization supported?

Randomization currently runs from a single list per study. Talk to us about your stratification needs before you start.

Can I try it before buying?

Yes. The free sandbox includes randomization and inventory with sample data. No credit card is needed.

Keep exploring

Related pages

Randomization software

Randomization on its own.

IMP inventory and accountability

Shipments, custody and destruction.

Block randomization software

Block sizes, seeds and lists.

Adverse event reporting

Safety with blinded IP panels.

Clinical trial workflow software

The whole trial workflow.

Part 11 compliant EDC

E-signatures and audit trail.

Run randomization and supply in one system

Free sandbox with every feature. No credit card, no sales call.

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