PRO-CTCAE lets patients report the symptomatic side effects clinicians grade with CTCAE. Pick the items your treatment needs, schedule them weekly and let participants answer from their own phone.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Symptom check · Week 3
In the last 7 days:
How OFTEN did you have NAUSEA?
What was the SEVERITY of your NAUSEA at its WORST?
PRO-CTCAE at a glance
Why it exists
Research comparing clinician-graded adverse events with patient reports has consistently found that clinicians miss or under-grade many symptomatic toxicities: fatigue, nausea, neuropathy, pain and others that patients feel between visits. NCI developed PRO-CTCAE so those symptoms could be reported directly by the people experiencing them, using terms aligned with CTCAE so the two sources can be compared.
Regulators have increasingly encouraged patient-reported tolerability data in cancer trials, and PRO-CTCAE is the most widely used tool for it. It sits alongside the clinician-graded adverse event form, not in place of it: the investigator still grades and reports AEs with CTCAE, while PRO-CTCAE gives the patient's side of the same story.
Select items from the expected toxicity profile of your treatment (for example nausea, vomiting, diarrhoea, mouth sores and fatigue for many chemotherapies, or rash and itching for some targeted therapies), plus a few for symptoms you want to rule out. Keep the list short enough to complete in a few minutes every week; long weekly questionnaires are the fastest way to lose compliance.
A published algorithm combines a symptom's frequency, severity and interference answers into a composite grade from 0 to 3. Apply it in analysis from the exported coded answers; keep the raw attribute responses as the source.
Completed
41 / 44
Severe or worse
6
Overdue
3
Response scales
| Attribute | Question pattern | Response options |
|---|---|---|
| Frequency | How OFTEN did you have [symptom]? | Never, Rarely, Occasionally, Frequently, Almost constantly |
| Severity | What was the SEVERITY of your [symptom] at its WORST? | None, Mild, Moderate, Severe, Very severe |
| Interference | How much did [symptom] INTERFERE with your usual or daily activities? | Not at all, A little bit, Somewhat, Quite a bit, Very much |
| Presence / absence | Did you have any [symptom]? | Yes, No |
| Amount | Used for a few symptoms such as hair loss | Item-specific |
PRO-CTCAE is maintained by the US National Cancer Institute and available from NCI under its terms of use, with official translations. Use the published wording.
Weekly schedule
PRO-CTCAE earns its value between clinic visits, when symptoms happen. In Capture it runs as a recurring questionnaire every seven days, with a completion window and a reminder ladder so participants answer on time without anyone phoning them.
Clinical follow-up
A participant reporting "very severe" diarrhoea on a Tuesday should not wait for the next cycle. Custom-value edit checks on the severity items raise an auto-query for the site, which can then contact the participant and, where the investigator judges it an adverse event, record it on the AE form.
Edit checks / auto-queries
2Type
Range High
Operator
Greater than
Value
180
Priority: High
Type
Range Low
Operator
Less than
Value
80
Priority: Normal
Query raised automatically
Value 192 violates limit (180). Please verify.
Pick your symptoms, schedule weekly and preview on your phone in the free sandbox.
Practical setup
Because PRO-CTCAE is a library, the build starts with a decision rather than a template: which symptoms, which attributes, how often. Getting that decision right keeps the questionnaire short enough to complete weekly for months, which is the whole point of collecting it.
Studies with several arms or treatment phases may need different item sets. Build a form per item set and place each on the schedule for the arms or epochs where it applies, rather than one long form with everything in it. Every item keeps the attributes NCI defines for it; do not add attributes the library does not include.
Participants may experience symptoms not on your list. A free-text question asking about any other symptoms, followed by a severity rating, catches them without adding dozens of items. Site staff review these entries and decide whether they represent adverse events.
A paediatric version (Ped-PRO-CTCAE) exists for children and adolescents, with caregiver-report options. Use only NCI's official translations for non-English speaking participants; each language has been linguistically validated.
Before go-live
Based on the expected toxicity profile, plus a few to rule out.
Each item keeps exactly the attributes NCI defines.
Recurring every 7 days with reminders and a completion window.
Which answers raise a query, and who reviews them how quickly.
Algorithm and missing-data handling in the analysis plan.
NCI-provided languages only.
The patient-reported outcome version of the Common Terminology Criteria for Adverse Events: an NCI item library that lets patients report symptomatic side effects of cancer treatment.
The library contains 124 items representing 78 symptomatic adverse events. Trials select only the items relevant to their treatment.
The past 7 days, which suits a weekly schedule.
No. It complements it. Investigators still grade and report adverse events with CTCAE.
It is available from the National Cancer Institute under its terms of use, with official translations.
A published algorithm combines frequency, severity and interference answers into a composite grade per symptom. Apply it in analysis from the exported coded responses.
Yes. The questionnaire opens in the phone browser from a secure link, with no app to install.
Keep exploring
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Cancer quality of life alongside symptoms.
Adverse event eCRF template
Clinician CTCAE grading.
EDC for oncology trials
Oncology trials end to end.
Patient diary software
Recurring questionnaires between visits.
GI symptoms template
Daily GI diary.
BYOD ePRO, no app
Why browser-based ePRO lifts completion.
Weekly PRO-CTCAE on participant phones. Free sandbox, no credit card.