Cell and gene therapy studies run on a different clock: collection, manufacturing, conditioning, a single infusion day, intensive early safety monitoring and years of follow-up. Capture structures each phase so the data holds together over the whole timeline.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Weeks from enrolment
Chain of identity recorded
CRS and ICANS assessments
What matters in cell and gene therapy trials
The timeline
In a conventional trial, visits follow enrolment or randomisation. In a cell therapy trial, the time from enrolment to infusion depends on manufacturing and on the participant's condition, and everything that matters for safety and efficacy is measured relative to the infusion. The study schedule has to reflect that: pre-infusion visits relative to enrolment, and post-infusion visits (day 1, 7, 14, 28 and so on) relative to the infusion date.
In Capture each visit is anchored to a date: screening, a milestone, an earlier visit, a fixed study day or a date recorded on a form. Post-infusion visits can therefore be anchored to the infusion date recorded on the infusion form, with their own windows, while pre-infusion visits follow enrolment. Epochs separate the phases, and the status overview shows every participant against every visit, whatever their individual timeline.
Manufacturing and logistics systems hold the chain of identity and custody for autologous products. The eCRF should record the identifiers needed to link the clinical record to the product (for example batch or lot numbers and collection and infusion dates) so the link can be verified during monitoring. The manufacturing system remains the source for chain of custody.
Anchor
Offset
Window
Epoch
TreatmentVisit location
Early safety
Record CRS and ICANS as adverse events with their grade, onset, maximum grade and management, using the grading system specified in the protocol. Serious events raise routed safety alerts, the SAE timeline tracks each event to sign-off, and adverse events of special interest get their own form linked to the SAE.
Cannot submit yet
Causality is required because the event is serious.
Long-term follow-up
Long-term follow-up studies ask participants to report new malignancies, neurological or autoimmune conditions and other delayed events for many years. Annual questionnaires completed at home, with reminders, reduce clinic burden and keep participants in contact, while site visits capture examinations and labs when needed.
When due
18:00
Your evening diary is open
Next day
18:00
Reminder: your diary is still open
Final notice
21:30
Last chance before the window closes
Quiet hours
22:00 to 08:00 in the participant's time zone
Stops
As soon as the task is completed
Build pre- and post-infusion epochs with visit windows in the free sandbox.
Study build
Pre-infusion relative to enrolment; post-infusion relative to day 0.
Batch or lot, collection and infusion dates recorded for chain-of-identity verification.
Grading system named in the protocol and help text.
Secondary malignancy, prolonged cytopenia and others as defined.
Duration by product type and remote options.
Participants understand the follow-up commitment.
Because time from enrolment to infusion varies with manufacturing and patient condition, while safety and efficacy are measured relative to the infusion.
FDA recommends up to 15 years for some products, such as integrating vectors and genome editing, and around 5 years for others, depending on risk.
As adverse events with grade, onset, maximum grade and management, using the grading system in the protocol.
The manufacturing system holds chain of custody. The eCRF records the identifiers needed to link the clinical record to the product.
Yes, in the free sandbox with every feature.
Keep exploring
EDC for rare disease trials
Many gene therapies target rare disease.
EDC for oncology trials
CAR-T and oncology.
Long-term follow-up consent
Consent for years of follow-up.
Adverse event eCRF template
CRS and ICANS on the log.
BLA
Licensing biological products.
Orphan and breakthrough designations
Expedited programmes.
Free sandbox with every feature.