Melanoma studies combine pathology details, molecular status, long adjuvant courses and immune-related events that can appear months after a dose. Capture holds the staging, recurrence dates, treatment exposure and adverse events together with one audit trail. Build it free in the sandbox, no credit card.
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Primary tumor and nodes
Date of definitive surgery
SGDTCBreslow thickness
BRSLWUlceration
ULCERSentinel nodes positive
SNPOSBRAF V600 status
BRAFRESAssay and sample date on the next row
What a melanoma trial needs from its EDC
The study data
Melanoma trials fall into recognisable families. Adjuvant studies treat resected stage III disease and are commonly judged on recurrence-free survival, the time from randomization to recurrence or death; landmark adjuvant anti-PD-1 trials such as KEYNOTE-054 and CheckMate 238 used this endpoint. Neoadjuvant designs add a pathological response read at surgery. Advanced disease studies measure tumor response and progression on imaging, and often compare treatment sequences or combinations. Each family needs a different case report form set, but all share pathology, treatment exposure, safety and survival.
The pathology block is where eligibility is decided, so design it with care. Thickness, ulceration, number of positive nodes and the nodal burden are the sort of variables stratification factors are built from. Add the staging edition named in the protocol as its own field. If you collapse these into a stage group at entry, you lose the ability to re-stage later, and a monitor cannot see which input drove an eligibility call.
Molecular status deserves its own repeating structure. BRAF V600 status is commonly collected because it can determine which therapies are relevant, and some protocols also ask for other markers. Capture the result, the assay, the sample date and the laboratory as typed fields and add an edit check that stops randomization before the result date when the protocol requires a result. For the general idea, see the biomarker glossary entry.
A recurrence date is only as good as its definition. Record the date of the scan or biopsy that documented recurrence, the site of first recurrence, and who made the call, and keep a separate field for the date it was entered. Add date logic so a recurrence cannot precede surgery and a death cannot precede the last recorded visit. Censoring depends on the date last known alive, which is often the least maintained field in the study; schedule a short follow-up form with a visit window so lapses show up early.
weeks
Pathology and staging
Cycles with safety labs
Recurrence follow-up
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and staging | Surgery date, thickness, ulceration, nodes, staging edition | Screening eCRF with edit checks and skip logic |
| Molecular status | Marker result, assay, sample date, laboratory | Typed fields beside the eligibility form; repeating rows for re-tests |
| Randomization | Allocation, stratification (for example by stage group) | Randomization in the same platform; blinded roles never receive arm values |
| Treatment exposure | Infusion date, dose, hold, discontinuation and reason | Repeating treatment form; dose logic in the protocol |
| Recurrence and survival | Recurrence date and site, death, date last known alive | Follow-up form with date edit checks |
| Adverse events | Term, CTCAE grade, seriousness, relationship, steroids, outcome | Adverse event form and SAE report form |
| Skin and physical exam | Skin and nodal exam findings, new lesions, photographs held at site | Physical exam form |
Capture records the data your protocol defines. Staging rules and response criteria are applied by the investigator.
Upload the protocol, let the AI draft the visits and forms for review, then run a practice participant from surgery to recurrence. Free sandbox.
Safety reporting
Immunotherapy changes the shape of safety data. Immune-related adverse events commonly affect the skin, gut, liver and endocrine glands, and they can start weeks or months into treatment, sometimes after the last dose. A basic adverse event form is not enough: you also want the onset date, the CTCAE grade, whether steroids or other immunosuppression were given, whether the study drug was held, and the outcome with a resolution date. Build these as fields next to the term so reviewers do not have to open free text.
Keep severity, seriousness and causality as separate answers, because a grade 2 event that causes hospitalization is serious while a grade 3 lab abnormality may not be. Use the CTCAE grade lookup to check a term against published criteria; the grade itself stays with the investigator. For causality, the AE causality assessment page shows how relationship fields are structured, and the AE seriousness decision tree helps with the serious/non-serious split.
Published analyses have linked immune-related events and longer recurrence-free survival in adjuvant melanoma, but these are post hoc and observational, so the right response for a study team is simply to capture onset and treatment timing cleanly. If someone later wants to model events as time-varying, the data is there.
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Causality is required because the event is serious.
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The same lookup that sits on its own page, here for checking terms such as colitis, rash or ALT increased.
| Grade 1 | <LLN - 1500/mm3; <LLN - 1.5 x 10e9 /L |
|---|---|
| Grade 2 | <1500 - 1000/mm3; <1.5 - 1.0 x 10e9 /L |
| Grade 3 | <1000 - 500/mm3; <1.0 - 0.5 x 10e9 /L |
| Grade 4 | <500/mm3; <0.5 x 10e9 /L |
| Grade 5 | – (grade not available) |
Source: NCI CTCAE v5.0, published 27 November 2017 (ctcae-v5.0.xlsx, dctd.cancer.gov).
*Instrumental ADL: preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL: bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. A semicolon means “or” within a grade; a dash means the grade is not available for that term. LLN and ULN are the lower and upper limits of normal.
Reference only: 34 common terms, not the full CTCAE, and not validated software. Use the version your protocol names. Grading, seriousness and causality are the investigator's clinical judgement; always check the official NCI document.
Follow-up and scale
Surveillance is the long part of an adjuvant melanoma study. Plan imaging and skin examination visits with windows, and use the compliance view to see by study, country and site which participants are overdue. Where participants report symptoms between visits, a short questionnaire opens from a secure link on the phone with no app install, and the oncology side-effect diary template shows a structure to adapt; the ePRO module is described on the ePRO page.
Multi-site work uses QR-code enrollment, site-level participant numbering, a site coordinator portal and by-site exports; see multi-site clinical trial management. CSV and Excel exports include an automatic data dictionary, and CDISC SDTM export gives SAS XPT datasets with Define-XML, covered on the SDTM export page. Teams sizing a recurrence-free survival endpoint can start with the survival sample size calculator. For tumor types beyond melanoma, see EDC for oncology clinical trials.
Before first participant
The edition and stratifiers written into the protocol and the form.
What counts as documented recurrence, who confirms it and which date is used.
Marker, assay, sample date and laboratory for every stratification factor.
Onset, grade, steroid use, drug hold and outcome on the safety form.
Imaging and skin exam visits with windows and reminders.
Wide CSV with data dictionary opened in the statistics package.
Yes. Surgery, randomization, first dose, documented recurrence, death and last contact are separate date fields, with edit checks for impossible sequences. The survival analysis itself runs in your statistics package.
Yes. Result, assay, sample date and laboratory are typed fields, and re-tests can be added as repeating rows so earlier results stay in the audit trail.
As adverse event terms with CTCAE grade, onset, seriousness, relationship, treatment given, study drug action and outcome. The investigator assigns the grade and relationship.
Yes. A short questionnaire opens from a secure link in the phone browser, with reminders and a completion window you control. The content is yours to supply.
Yes. Forms and schedule are built from your protocol, so recurrence-based and progression-based endpoints use the same building blocks with different visit patterns.
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
Oncology building blocks across tumor types.
CTCAE grade lookup
Grade criteria for common adverse event terms.
Survival sample size calculator
Size a recurrence-free or overall survival endpoint.
Physical exam eCRF template
Skin and nodal exam form structure.
Capture EDC overview
The data capture platform.
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