The Columbia Suicide Severity Rating Scale is the standard way to assess suicidal ideation and behaviour prospectively in clinical trials. This page shows how to build it as a clinician-rated eCRF that follows the scale's own branching.
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Suicidal ideation
1. Wish to be dead
2. Non-specific active suicidal thoughts
Items 3 to 5 skipped: item 2 answered No
Suicidal behavior
Actual attempt since last visit
C-SSRS at a glance
The instrument
The scale is a semi-structured interview. A trained clinician or rater asks a fixed sequence of questions and records yes or no answers, with probes where the participant says yes. Its strength is that the definitions are explicit: "active suicidal ideation with some intent to act" means the same thing at every site, which is exactly what a multi-site safety assessment needs.
Five questions of increasing severity: wish to be dead; non-specific active suicidal thoughts; active ideation with any methods but without intent; active ideation with some intent to act but no specific plan; and active ideation with a specific plan and intent. Questions 1 and 2 are always asked. If question 2 is answered yes, questions 3, 4 and 5 follow; if it is no, the interview moves on.
If any ideation is present, the rater identifies the most severe type and rates its frequency, duration, controllability, deterrents and reasons for ideation. These ratings describe how serious the ideation is beyond its type.
Actual attempt, interrupted attempt, aborted or self-interrupted attempt, preparatory acts or behaviour, and non-suicidal self-injurious behaviour, each with yes or no and counts where applicable. Actual attempts also record actual and potential lethality.
Q1 Wish to be dead
Always asked
Q2 Non-specific active suicidal thoughts
Always asked. If No, skip Q3 to Q5
Q3 to Q5 Methods, intent, plan
Only when Q2 is Yes
Intensity of most severe ideation
When any ideation is Yes
Suicidal behaviour section
Always completed
Versions
| Version | Look-back | Typical use in a trial |
|---|---|---|
| Baseline / Screening | Lifetime plus a recent period set by the protocol | Screening visit: history and eligibility. |
| Since Last Visit | Since the previous assessment | Every visit after baseline. |
| Screener | Short triage version | Settings where a brief screen is needed; less common as a trial endpoint. |
| Paediatric and cognitively impaired versions | As above, adapted wording | Studies in children or populations with cognitive impairment. |
Obtain the exact version, wording and any training requirements from the Columbia Lighthouse Project. This page describes the structure only and does not reproduce the scale.
Build it in Capture
The C-SSRS is completed by site staff during the visit, so it is set up as a site form (a ClinRO) rather than a participant questionnaire. Yes/no questions use single choice, counts use numeric fields, and skip logic reproduces the scale's branching so raters only see the questions that apply.
| Analyte | Result | Unit | Ref. range |
|---|---|---|---|
| Haemoglobin | 13.8 | g/dL | 13.0 to 17.0 |
| White blood cells | 6.2 | 10^9/L | 4.0 to 10.0 |
| Platelets | 412 | 10^9/L | 150 to 400 |
Positive findings
Custom-value edit checks on the higher-severity ideation questions and on every behaviour question raise a high-priority auto-query the moment a positive answer is saved. The investigator sees it in the action list and follows the risk management steps your protocol defines.
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.
Set up the skip logic, test every path with sample answers and export the blank form for your ethics package.
Regulatory context
Before prospective assessment became standard, suicidality signals in trials were usually identified retrospectively from adverse event narratives, which made them hard to classify consistently. FDA's draft guidance on the prospective assessment of suicidal ideation and behaviour asks sponsors of trials involving many drugs with central nervous system activity, and some others, to assess it at baseline and at each visit using a structured instrument whose results map to standard categories. The C-SSRS was built for exactly that purpose and is the instrument most sponsors use.
Whatever your study population, write the assessment into the protocol with the version, the visits, who administers it, and the actions that follow a positive finding. Those actions are part of your safety plan and should be consistent with how you record adverse events.
The Columbia Suicide Severity Rating Scale, a semi-structured clinician interview that classifies suicidal ideation and behaviour. It is the most widely used instrument for prospective suicidality assessment in clinical trials.
No. Results are categorical: which types of ideation and behaviour occurred. Intensity items describe the most severe ideation.
Usually the Baseline/Screening version at screening and the Since Last Visit version at every later visit. Confirm the version with the Columbia Lighthouse Project.
Trained clinicians or raters. Many sponsors require rater training before site staff can administer it.
Capture's skip logic shows questions 3 to 5 only when question 2 is yes, and the intensity section only when ideation is present, matching the scale.
Custom-value edit checks raise a high-priority auto-query to the site so the investigator can act according to the protocol's safety plan.
No. It explains the structure and how to build the form. Obtain the scale and permission from the Columbia Lighthouse Project.
Keep exploring
PHQ-9 eCRF template
Item 9 often triggers a C-SSRS.
EDC for psychiatry trials
Rating scales and raters across sites.
EDC for CNS and neurology trials
Where prospective suicidality assessment is common.
Adverse event reporting
Recording and escalating safety events.
Edit checks software
How custom-value checks raise queries.
eCOA software
Clinician-rated outcomes alongside PROs.
Build the C-SSRS form with its branching and test it free. No credit card.