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Guides and tours, on your own time

How-to guides for the work your team does every day. Each one ends with how it runs in Datacapt, and some come with a product tour.

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Guides and tours

One guide per clinical task

Pick the task you need to do. Each guide gives you the steps, the mistakes to avoid and how Datacapt handles it. None of them ask for your email.

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Build an eCRF
3 min
How to design a case report form (CRF)
Turn your protocol into a case report form your sites fill in right the first time. Eight steps, the traps to avoid, and a 3-minute tour of the build in Datacapt.
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Data Collection
how-to-design-a-case-report-form
Guide
Write edit checks
How to write edit checks for an eCRF
Edit checks catch a wrong value while the site still has the source open. Specify, word and test them with the six steps below.
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Data Collection
how-to-write-edit-checks
Guide
Randomize a patient
How to randomize patients in a clinical trial
Pick the method, set the strata, keep the blind and plan the unblinding before the first patient. Six steps from protocol to allocation.
Read the guide
Data Collection
how-to-randomize-patients-in-a-clinical-trial
Guide
Collect an eConsent
How to collect informed consent with eConsent
Move informed consent to a screen and keep what makes it valid: understanding, identity, signatures and version control. Seven steps.
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Data Collection
how-to-collect-electronic-informed-consent
Guide
Send an ePRO questionnaire
How to collect patient-reported outcomes with ePRO
Get patients to answer the right questionnaire at the right time on their own phone, with data you can defend. Seven steps from instrument to dashboard.
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Data Collection
how-to-collect-patient-reported-outcomes-epro
Guide
Code an adverse event
How to code adverse events and medications (MedDRA, WHODrug)
Turn the free text sites type into MedDRA and WHODrug codes you can analyse. Dictionary versions, coding rules and review in six steps.
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Data Collection
how-to-code-adverse-events-meddra-whodrug
Guide
Manage queries
How to manage queries in an EDC
A query is a question about a data point. Word it well, route it to the right person and close it fast, and your database lock gets shorter.
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Data Collection
how-to-manage-queries-in-an-edc
Guide
Export the annotated eCRF
How to write a data management plan (DMP)
The data management plan says who does what with the data, from CRF design to archiving. Write it before the build and keep it current until lock.
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Data Collection
how-to-write-a-data-management-plan
Guide
Lock the database
How to lock a clinical trial database
Database lock freezes the data your statistician analyses. Plan it weeks ahead with a checklist, and the lock itself takes a day.
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Data Collection
how-to-lock-a-clinical-trial-database
Guide
Check the audit trail
How to validate an EDC system for 21 CFR Part 11
You stay responsible for the systems your study runs on. Validate your EDC with a risk-based plan, reuse the vendor's evidence and test what your study adds.
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Data Collection
how-to-validate-an-edc-system
Guide
Move from Excel to an EDC
How to move a study from Excel or paper to an EDC
Spreadsheets have no audit trail and no edit checks. Move your study to an EDC in six steps, mid-study if needed, and keep the data you already hold.
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Data Collection
how-to-move-a-study-from-excel-to-an-edc
Guide
Allocate a kit
How to manage clinical trial supply and site resupply
Too much stock expires, too little stops randomization. Set forecasts, triggers and expiry rules so each site holds what its next patients need.
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Data Collection
how-to-manage-clinical-trial-supply
Guide
Export your data
How to export clinical trial data for analysis
Your statistician needs clean, labelled datasets on a schedule. Plan formats, names and transfers at the build, and exports stop being a project.
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Data Collection
how-to-export-clinical-trial-data
Guide
Recruit online
How to recruit patients for a clinical trial online
Most trials fall behind their enrolment plan. Publish a landing page, pre-screen applicants against your criteria and hand sites a qualified list.
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Clinical Operations
how-to-recruit-patients-for-a-clinical-trial
Guide
Validate a payment order
How to pay clinical trial participants
Late payments cost you participants. Set the amounts with the ethics committee, tie each payment to a completed visit and pay in local currency.
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Clinical Operations
how-to-pay-clinical-trial-participants
Guide