Instrument template · OncologyUpdated September 28, 2026

ECOG performance status eCRF with the definitions on screen

A single question with six answers, and one of the most common oncology eligibility criteria. Showing the full grade definitions on the form keeps ratings consistent across sites and visits.

  • Grades 0 to 5 with definitions
  • Eligibility range check
  • Clinician-rated

Free sandbox · No credit card · 21 CFR Part 11 aligned

ECOG performance status · Screening
Subject 004-0019 · Rated by investigatorQuery open

ECOG performance status

0 Fully active1 Restricted in strenuous activity2 Ambulatory, capable of self-care, up >50% of waking hours3 Limited self-care, in bed or chair >50%4 Completely disabled5 Dead

Protocol requires ECOG 0 or 1

Eligibility flagged at entry

At a glance

  • The ECOG scale, from the Eastern Cooperative Oncology Group (now ECOG-ACRIN), grades a patient's level of functioning from 0 (fully active) to 5 (dead).
  • Many oncology trials require ECOG 0 or 1 (sometimes 0 to 2) for eligibility, and record it at later visits to track decline.
  • It is clinician-rated and quick, but subjective; showing the full grade definitions improves consistency.
  • The Karnofsky Performance Status (0 to 100) is an alternative with finer steps; approximate conversions exist but the scales are not identical.
  • The ECOG scale is widely published and free to use.

The scale

ECOG grades and definitions

GradeDefinition
0Fully active, able to carry on all pre-disease performance without restriction.
1Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature.
2Ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than 50% of waking hours.
3Capable of only limited self-care; confined to bed or chair more than 50% of waking hours.
4Completely disabled; cannot carry on any self-care; totally confined to bed or chair.
5Dead.

Source: ECOG-ACRIN Cancer Research Group performance status scale.

In practice

Making a subjective grade consistent

Studies comparing raters have found that ECOG scores assigned by different clinicians, or by clinicians and patients, often disagree by a grade, especially between 1 and 2. Because the difference between 1 and 2 can decide eligibility, that matters. Showing the full definition next to each option, rather than just the number, is the simplest way to reduce disagreement, and it costs nothing.

For eligibility, add a custom-value edit check that raises a query when the grade is outside the protocol range, and link the result to the eligibility screening form. During treatment, record ECOG at each cycle or assessment visit; a decline is clinically meaningful and may accompany adverse events.

ECOG and approximate Karnofsky
ECOGKarnofsky (approx.)
Fully active090 to 100
Light work only170 to 80
Self-care, no work250 to 60
Limited self-care330 to 40
Disabled410 to 20
Approximate; the scales are not identical

Add ECOG with an eligibility check

Copy the template and set your protocol range in the free sandbox.

Use the ECOG template free

In trial design

How ECOG shapes a study beyond eligibility

Performance status is one of the strongest prognostic factors in oncology, so it appears in several places in a protocol: as an inclusion criterion, often as a stratification factor for randomisation, and as a baseline characteristic in every results table. A trial that stratifies by ECOG 0 versus 1 needs the value recorded before randomisation and made available to the allocation.

During treatment, a decline in performance status can signal toxicity or progression and may prompt dose modifications. Recording ECOG at each assessment visit on the same form, by an investigator, gives a consistent series. Some studies also collect patient-reported function, for example the physical functioning scale of the EORTC QLQ-C30, which complements the clinician's grade.

Conversions

ECOG and Karnofsky: approximate equivalents

ECOG gradeApproximate Karnofsky scoreIn short
090 to 100Fully active
170 to 80Restricted in strenuous activity, ambulatory
250 to 60Ambulatory, capable of self-care, unable to work
330 to 40Limited self-care, in bed or chair more than half of waking hours
410 to 20Completely disabled
50Dead

The scales were developed separately and do not map exactly. Record the scale your protocol specifies rather than converting at entry; if both are needed, collect both.

Before go-live

ECOG setup checklist

Definitions shown

Full grade definitions next to each option.

Eligibility check

Custom-value check for grades outside the protocol range.

Stratification

Recorded before randomisation if used as a factor.

Rater

Investigator or delegated medically qualified staff.

Schedule

Screening, each cycle or assessment visit, end of treatment.

FAQ

Questions about this template

Something not covered here? Ask us directly.

What is the difference between ECOG 1 and ECOG 2?

ECOG 1 means restricted in strenuous activity but ambulatory and able to do light work. ECOG 2 means ambulatory and capable of self-care but unable to work, and up and about more than half of waking hours. The distinction often decides eligibility.

Can ECOG be patient-reported?

ECOG is designed as a clinician rating. Some studies also collect patient-reported performance status, but record it separately and do not substitute it for the investigator's grade.

What is ECOG performance status?

A clinician-rated scale from 0 (fully active) to 5 (dead) describing how a disease affects a patient's daily functioning.

What ECOG score is required for most trials?

Many oncology trials require ECOG 0 or 1, some allow 2. The protocol defines the range.

How does ECOG compare with Karnofsky?

Karnofsky uses a 0 to 100 scale in steps of 10. Approximate conversions exist, but the scales are not identical.

Is the ECOG scale free to use?

Yes, it is widely published by ECOG-ACRIN and free to use.

Can the eCRF flag ineligible scores?

Yes. A custom-value edit check raises a query when the grade is outside the protocol range.

Consistent performance status at every site

Definitions on screen, eligibility checked. Free sandbox.

Use the ECOG template free