Randomization & supplies
Set up randomization and blinding, randomize participants and track kits.
- Set up randomizationSwitch on the Randomization module, then open Settings > Randomization. Choose the method, add the treatment arms with their ratios, set stratification and when randomization happens, and click Save Configuration. Then generate or load the randomization list.For Study owners & admins, Data managers
- Randomize a participantOn the participant page, click Randomize Subject (or Enroll & randomize). In Randomization Review, check the participant and eligibility details, tick the confirmations, enter your password and click Authorize & Randomize. The randomization number is assigned and can never be changed.For Site coordinators & staff, Investigators
- What blinding hides, and from whomIn blinded studies, only unblinded roles see treatment arms, block sizes, the randomization list and the unblinded kit list. Everyone else sees "Treatment assignment blinded", kit numbers without arms, and totals instead of per-arm counts.For Study owners & admins, Data managers, Investigators, Site coordinators & staff, Monitors (CRAs), Sponsors & CROs
- Unblind a participant in an emergencyOn the participant's Randomization card, click Emergency Unblind. Give the medical reason, tick the attestation, type UNBLIND to confirm and click Reveal Treatment. The arm is shown to you and the action is recorded permanently.For Investigators
- Load the unblinded kit listAn unblinded administrator or statistician opens Inventory > Import Unblinded List, chooses the CSV or Excel file with kit numbers and treatment codes, and clicks Load medication list. The kits go into the depot pool, ready to ship.For Study owners & admins, Data managers
- Create a kit shipment to a siteSet the supply levels once in Settings > Inventory, then click Create Shipment on the Inventory page, choose the site and quantity, check the preview and click Create shipment. The kits are in transit until the site receives them.For Study owners & admins
- Receive a kit shipment at your siteOpen Inventory > Shipments, find the shipment under In Transit, click Receive, tick every kit you physically received and click Submit. Kits you did not tick are quarantined with a reason.For Site coordinators & staff, Investigators
- Dispense kits to a participantOpen the participant, click Dispense IMP on the IMP Dispensing card, scan or type the kit numbers, tick the quality checks, enter your password and click Sign & Dispense.For Investigators, Site coordinators & staff
- Record kit returns, accountability and reconciliationSite staff record returned kits and count used, unused and lost units in Inventory > Accountability & Reconciliation; the CRA or depot then reconciles them. Each step is signed with your password.For Site coordinators & staff, Investigators, Monitors (CRAs)
- Destroy kits with a destruction basketOpen Inventory > Destruction, create a basket, add reconciled or unusable kits, then Finalize and later Confirm destruction with the certificate number. Both steps are signed with your password.For Site coordinators & staff, Investigators, Monitors (CRAs)
- Give participants app access codesThe unblinded administrator opens App codes, saves the app settings, pastes the codes in Add codes, then clicks Assign code for each participant and Show in portal or records how the code was handed over.For Study owners & admins
Still need help?
Email support@capture.study or use the contact form. Tell us the study name, what you were trying to do and the exact message on screen; a screenshot helps.
Please never send participant names, contact details or health information to support.