Pancreatic studies move participants through restaging, surgery decisions and fast-changing performance status, often within a short survival window. Capture holds the staging, treatment, operative and pathology data, marker results and adverse events together, with one audit trail. Build it free in the sandbox, no credit card.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Enrolled
34
Restaging forms open
5
Open queries
11
SAEs awaiting sign-off
1
79 percent
What a pancreatic cancer trial needs from its EDC
The study data
Pancreatic cancer protocols split by disease extent, and the extent decides the data model. Resectable and borderline resectable studies add neoadjuvant therapy before surgery and then adjuvant treatment after it, so they behave like perioperative trials. Locally advanced and metastatic studies are treatment trials with imaging-based response and progression. Registered neoadjuvant protocols list endpoints such as overall survival from treatment start, recurrence-free survival, the proportion with R0 or R1 resection, pathological response, perioperative morbidity and mortality, and CA 19-9 response. Which of these is primary varies, but each needs its own place in the schedule.
The operative and pathology block is the part generic oncology forms handle worst. For participants who reach surgery, capture the date, whether the procedure was completed as planned or abandoned, the resection margin status, lymph node findings and the pathology response grade if the protocol uses one. Make the form dependent on a surgery decision field so participants who do not go to surgery never see it, and keep the reason for not operating (progression, performance status, patient choice) as a coded answer. That reason is often analysed on its own.
CA 19-9 is commonly collected because registered protocols use it as a response measure, for example a fall of more than 50 percent from baseline, and published analyses describe normalization before surgery as linked to longer survival in some cohorts. Findings differ between cohorts and thresholds, so the safe approach is to store the raw value, unit, sample date and the laboratory’s upper limit, and leave the definition to the analysis plan. Keep in mind that bile duct blockage can distort the marker, so a protocol may want a field recording whether biliary drainage was in place at the sample date.
Performance status often decides whether a participant continues, goes to surgery or leaves treatment. Record the status at every visit using the ECOG performance status form structure, and add an edit check so that a drop below the protocol’s continuation threshold prompts a query asking for the treatment decision. Weight and nutritional status can sit on the vital signs form.
Staging and eligibility
Resectability class recorded
Neoadjuvant therapy
Cycles, doses, grades
Restaging
Scan, CA 19-9, ECOG
Surgery decision
Operate or reason not
Pathology
Margin status, response
Adjuvant and survival follow-up
Recurrence, death, last contact
Protocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and resectability | Stage, resectability class, performance status, baseline labs | Screening eCRF with edit checks; ECOG form |
| Restaging | Scan date, response, new lesions, surgery decision and reason | Visit eCRF form with skip logic to the surgery form |
| CA 19-9 | Value, unit, date, reference limit, biliary drainage in place | Laboratory form with range-based edit checks |
| Surgery and pathology | Procedure, completion, margin status, nodes, response grade | Conditional eCRF forms that appear only after a surgery decision |
| Treatment exposure | Cycle date, dose, reductions, delays and reasons | Repeating cycle form; BSA calculated from height and weight |
| Adverse events | Term, CTCAE grade, seriousness, relationship, action | Adverse event form and SAE report form |
| Survival and follow-up | Recurrence, death, date last known alive, later therapy | Follow-up form with date-logic checks |
Resectability classification and response rules are applied by the investigators under your protocol. Capture records the inputs and the decision.
Upload the protocol, let the AI draft the visits and forms for review, then test the surgery decision branch with practice participants. Free sandbox.
Safety reporting
Pancreatic regimens commonly combine several cytotoxic drugs, and the events that come with them are familiar: neutropenia, diarrhea, fatigue, peripheral neuropathy and thromboembolic events. Participants also carry disease complications such as pain, weight loss and biliary problems, which makes attribution harder. The adverse event form therefore needs fields for onset, CTCAE grade, seriousness, relationship to each study drug and action taken, and the protocol should say whether disease-related symptoms are recorded as adverse events or as baseline conditions.
Serious events carry deadlines, and in a population where hospital admissions are frequent, a fast and unambiguous path matters. Use the SAE report form for the content and the SAE reporting deadline calculator to plan the clock. The AE seriousness decision tree helps teams agree what is serious before the first event arrives, and the adverse event reporting software page describes the workflow end to end.
Pain and appetite change quickly, so some teams add a short phone check-in between visits. The Brief Pain Inventory form structure and the oncology side-effect diary are starting points; licences for any instrument remain with your study documents. Treat patient-reported data as support for the investigator’s assessment.
Cannot submit yet
Causality is required because the event is serious.
Try it
The same lookup that sits on its own page, here for terms such as neutrophil count decreased, diarrhea or peripheral sensory neuropathy.
| 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.
Monitoring and exports
When survival is the endpoint and time is short, late data entry is costly. Edit checks and auto-queries catch problems at entry rather than at monitoring visits; see the edit checks page and query management. Source data verification can be set per field, so monitors focus on eligibility, restaging and pathology rather than every entry; the approach is described under risk-based monitoring and SDV.
Multi-site pancreatic trials usually involve specialist surgical centers. Capture offers QR-code enrollment, site-level participant numbering, a site coordinator portal and by-site exports; see multi-site clinical trial management. Exports include CSV or Excel with a data dictionary and CDISC SDTM datasets as SAS XPT files with Define-XML (the SDTM export page). For general oncology building blocks see EDC for oncology clinical trials, and the Capture EDC overview covers the platform.
Before first participant
The classification used, who assigns it and when it is recorded.
Operated and not-operated paths both produce clean exports.
Reference limit, units, biliary drainage field and response definition location.
Start date, event date and last known alive for each survival endpoint.
Who enters, who signs off and how the clock is monitored.
Wide CSV with data dictionary opened in the statistics package.
Yes. Surgery and pathology forms can be conditional on a surgery decision field, so participants who do not operate never see them, and the reason is captured as a coded answer.
Store the raw value, unit, date and reference limit on a laboratory form. The response definition belongs in your analysis plan, and the stored values let the statistician apply it.
Yes. Margin status, nodal findings and pathological response are fields on a pathology form that follows the surgery.
Through the SAE report form with a sign-off path, and the investigator assigns seriousness and relationship. Reporting clocks follow your protocol and regulations.
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
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.