Printable clinical checklist

Complete Section D only for systems already in use.

System name: Date: Assessor:

Phase 1Before use: three sources of assurance

Section A: Clinical evidence

Source: the published evaluation or product documentation.Does it work safely for the oncology task and the patients we intend to use it for?

1.8100%

Does the published evaluation report accuracy separately for each task the system will be used for?

YesNoNot assessable

1.1496.6%

Does it report performance on real clinical records, or only on standardised clinical vignettes?

YesNoNot assessable

2.1100%

Does it report a hallucination rate?

YesNoNot assessable

2.286.2%

Does it grade potentially harmful outputs on a defined harm classification scale, rather than describing them narratively?

YesNoNot assessable

3.192.6%

Does it report performance broken down by patient subgroup, at minimum age and sex, and declare any missing demographic data?

YesNoNot assessable

4.1100%

Does it identify exactly which system was tested — model name, version, date of access, and how it was prompted?

YesNoNot assessable

4.496.6%

Does it report whether repeated identical queries produce consistent answers?

YesNoNot assessable

8.693.1%

Does it assess the risk that the system had already seen the evaluation cases during training?

YesNoNot assessable

5.179.3%

Does it include validation at an institution other than the one that developed the system?

YesNoNot assessable

5.282.8%

Does the evidence go beyond retrospective cases into a controlled prospective setting?

YesNoNot assessable

8.1082.8%

Is the supporting evidence drawn from oncology, rather than from other specialties alone?

YesNoNot assessable

Section B: Institutional readiness

Source: local policy and governance.Can we use it responsibly and safely in our own department or institution?

7.6100%

Does this system transmit patient data outside the institution, and are the categories of data it requires permitted under our institutional rules?

YesNoNot assessable

7.189.7%

Is this system covered by a documented institutional governance decision, rather than being used informally?

YesNoNot assessable

4.882.8%

Is it documented whether this system is locally hosted or cloud-based, and is that choice recorded as a governance decision with its reasoning?

YesNoNot assessable

7.586.2%

Is the regulatory status of this system in our jurisdiction documented ?

YesNoNot assessable

7.489.7%

Does the documentation for this system state that it functions as decision support, with final responsibility for the clinical decision remaining with the treating clinician?

YesNoNot assessable

7.381.5%

Is there a documented arrangement for informing patients when this system contributes to decisions about their care?

YesNoNot assessable

2.1189.7%

Is there a documented fallback procedure for when this system is unavailable or produces unreliable output?

YesNoNot assessable

Section C: Vendor assurance

Source: supplier documentation or contract.Will the deployed version be supported and monitored responsibly?

5.996.6%

Does the vendor provide evidence of a post-deployment safety monitoring arrangement, including structured feedback collection from clinical users?

YesNoNot assessable

5.882.8%

Does the vendor provide a written division of responsibility between supplier and institution for continuous quality and safety monitoring?

YesNoNot assessable

5.1092.6%

Does the vendor provide a reporting channel through which a clinician can report an error or unexpected output to both the institution and the developer?

YesNoNot assessable

5.693.1%

Does the vendor provide evidence that the validation shown applies to the version we will actually be running?

YesNoNot assessable

Deployment gate

Section A: Clinical evidence

Yes
No
Not assessable

Section B: Institutional readiness

Yes
No
Not assessable

Section C: Vendor assurance

Yes
No
Not assessable

If all critical safeguards are adequately addressed, the system can proceed to controlled clinical deployment. If not, resolve the gap, restrict the intended use, or do not deploy.

Decision

Proceed to controlled clinical deploymentResolve the gapRestrict the intended useDo not deploy

Note

Phase 2Once in use: monitor and evaluate

Section D: Monitor and evaluate

1. Monitor routinely
2. Trigger a review
3. Re-evaluate locally
4. Make a decision

1. Monitor routinely

Performance drift, clinician over-reliance, unexpected or unsafe outputs

5.3100%

Is there documented monitoring in place to detect performance falling off as guidelines change and new drugs are approved?

YesNoNot assessable

6.989.7%

Is there evidence that over-reliance (i.e. clinicians accept incorrect outputs without independent review) is being watched for?

YesNoNot assessable

2. Trigger a review

Scheduled review date; new guideline, drug or standard of care; model, API or interface update

5.496.6%

Is there a documented date, or trigger, at which this system will be formally re-evaluated?

YesNoNot assessable

5.596.6%

Are there documented rules for what happens when the vendor releases a new version, and a named person managing that?

YesNoNot assessable

3. Re-evaluate locally

Clinical accuracy and safety, patient outcomes, technical stability

5.789.7%

Is there a documented arrangement linking AI-supported decisions to what actually happened to those patients?

YesNoNot assessable

5.1186.2%

Is there evidence that output remains stable across our hardware, software versions and interface updates?

YesNoNot assessable

4. Make a decision

Continue / Modify and revalidate / Pause / Retire

Close the loop

Decision

ContinueModify and revalidatePauseRetire

Accountable owner

Next review date