Hematologic malignancy studies mix imaging, marrow and blood sampling, dense lab monitoring and graded cytopenias across repeated cycles. Capture keeps the response assessments, sample logistics, cycle dosing and adverse events in one study with one audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Screen | C1D1 | C1D8 | C2D1 | C4D1 | EoT | FU 3m |
|---|---|---|---|---|---|---|---|
| PET-CT response assessment | |||||||
| Bone marrow sample | |||||||
| CBC with differential | |||||||
| Treatment administration and dose | |||||||
| CTCAE adverse events |
x = done at this visit
What a lymphoma or leukemia trial needs from its EDC
The study data
Lymphoma and leukemia are several diseases that happen to share a clinic. Lymphoma trials are usually built around imaging: baseline and follow-up PET-CT or CT, a response category after a set number of cycles, and a complete-response rate at the end of treatment or progression-free survival over time. Leukemia trials lean on blood and marrow: counts, blast percentage, cytogenetic and molecular results, and, in many modern designs, minimal residual disease (MRD) measured on a schedule. The first modeling decision is therefore whether your protocol is image-led, sample-led, or both, because that decides how many forms carry the primary endpoint.
For lymphoma, the Lugano 2014 classification is commonly used for both Hodgkin and non-Hodgkin disease. It reads FDG PET with the five-point Deauville scale, where scores of 1 to 3 are generally considered negative and 4 to 5 positive, and it uses the categories complete response, partial response, no response or stable disease, and progressive disease, with new lesions counting toward progression. Registered protocols often make complete response at the end of therapy the primary endpoint. Capture the score, the scan date and the response category as separate variables and keep the site read and any central or independent review as separate forms, so the analysis can use the designated read and the disagreement is visible.
For leukemia, response is defined by the disease-specific guidelines your protocol cites, and those differ between chronic and acute disease. The EDC does not apply those rules; it holds the inputs. Store the count values, the marrow findings, the molecular result, the assay and its sample date, and the investigator’s response call, each in its own field. That keeps the dataset reconstructable when a reviewer asks how a remission was concluded.
In an MRD-driven design, a sample taken eight days late may change the analysis window. Record the planned timepoint, the actual collection date, the type of sample and the receiving laboratory on a repeating row, and add an edit check that raises a query when a collection date falls outside the visit window. The lab results eCRF template shows the repeating-row structure, and lab data and reference range management explains how local ranges are handled.
Imaging
PET-CT date
RSDTCDeauville score, reference lesion 1
DVSCORENew lesions
TUNEWOverall response, site read
RSORRESCentral read requested
RSCENProtocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and diagnosis | Histology, stage, prior lines, performance status, key baseline labs | Screening eCRF form with edit checks; ECOG form template |
| Response assessment | Scan date, Deauville score, new lesions, overall response, per timepoint | Visit eCRF form; separate form if a central read is planned |
| Marrow, blood and MRD samples | Planned and actual date, sample type, laboratory, result | Repeating-row sample form with visit-window checks |
| Treatment exposure | Cycle date, dose given, reductions, delays and reasons | Repeating cycle form; BSA calculated from height and weight |
| Hematology monitoring | Counts, units, local reference ranges, out-of-range flags | Laboratory form with range-based edit checks |
| Adverse events | Term, CTCAE grade, seriousness, relationship, action taken | Adverse event form and SAE report form |
| Survival follow-up | Progression, relapse, death, date last known alive, later therapy | Follow-up form with date-logic edit checks |
Response rules are applied by the investigator or the central reviewer. Capture records the inputs and the call, and does not decide response.
Upload the protocol, let the AI draft the visits and forms for review, then run a practice participant through two cycles with a late marrow and a grade 3 neutropenia. Free sandbox.
Safety reporting
Hematologic regimens often lower blood counts by design, so the safety form has to distinguish an expected cytopenia from one that needs action. Neutropenia, anemia and thrombocytopenia are graded on the CTCAE scale of 1 to 5, and the grade alone is not enough: record seriousness, relationship to each study drug, the action taken (dose held, reduced, or unchanged) and any supportive care such as growth factor or transfusion. Infusion-related reactions, infections and, depending on the agent class, immune-related or cytokine-mediated events add further terms that your protocol will name.
Keep severity, seriousness and causality as separate answers. The CTCAE grade lookup lets sites and data managers check a term against the published criteria; the investigator still assigns the grade. Serious events follow the SAE report form, and the SAE reporting deadline calculator helps plan reporting clocks. The adverse event reporting software page describes the wider workflow.
Dose modifications follow lab values, so link them. A range-based edit check can raise a query when a day-1 neutrophil count is below the protocol’s start threshold but a full dose is recorded, which gives a monitor a concrete question instead of a vague review comment. Treat such checks as prompts for people, not as automatic dosing decisions.
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Causality is required because the event is serious.
Build sequence
A realistic order of work for a sponsor or investigator-initiated team.
Upload the protocol (PDF, DOCX or DOC) and let the AI study builder propose the schedule and forms. Nothing is saved until a person reviews it.
Response fields for the imaging or marrow-based endpoint, plus repeating sample rows with planned and actual dates.
Lab range checks, date logic across scan, progression and death, and visit windows around each response assessment.
Cycle form with dose, delay and reduction reasons, and BSA calculated from height and weight.
Run practice participants through response, relapse and death, check the exports, approve the forms and start the paid live phase when real participants enroll.
Sites and exports
Hematology trials often run across specialist centers, and sample shipping makes site discipline matter. Capture supports QR-code enrollment, site-level participant numbering, a separate site coordinator portal and by-site filtering and exports; see multi-site clinical trial management. Source data verification can be set per field, so a monitor can concentrate on the response and eligibility fields, as described under risk-based monitoring and SDV.
Exports come as CSV or Excel with an automatic data dictionary, and CDISC SDTM export produces SAS XPT datasets with Define-XML; the CDISC SDTM export page explains the output. For survival endpoints, the survival sample size calculator gives a first estimate. For the wider oncology picture, see EDC for oncology clinical trials, and for late-phase designs, EDC for Phase 3 trials.
Before first participant
Which guideline and version, who reads the scan or marrow, and whether a central review applies.
Timepoints, windows, tubes, laboratory and what counts as a missed sample.
Which date is progression or relapse, which is censoring, which is last known alive.
Which events are graded each cycle and which trigger a dose rule.
Questionnaire terms confirmed with their rights holders and kept in the study documents.
Wide CSV with data dictionary opened in the statistics package.
Yes. Build the scan date, Deauville score, new-lesion flag and overall response as typed fields on a visit eCRF form. Response rules are applied by the investigator or central reviewer, not by Capture.
Yes. A repeating-row sample form can hold the planned timepoint, actual collection date, sample type, laboratory and result, with edit checks on the visit window.
As adverse event terms with a CTCAE grade, seriousness, relationship and action taken, alongside the laboratory values. Edit checks can prompt a query when a dose conflicts with a protocol threshold.
The building blocks are shared, but the response logic and sampling differ. Capture builds the forms and schedule from your protocol, so each disease uses the fields it needs.
Yes. Capture is used from Phase 1 through Phase 3, with site-level numbering, a site coordinator portal and by-site exports for multi-center work.
Capture provides 21 CFR Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for oncology clinical trials
Dose escalation and BSA dosing across tumor types.
CTCAE grade lookup
Grade criteria for common adverse event terms.
Laboratory eCRF template
Repeating-row lab structure.
Adverse event eCRF template
The AE form structure.
Capture eCRF builder
Design forms, edit checks and visits.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.