What this category's data looks like
In the research ethics review scenario, ethics review applications, informed consent form templates, and risk assessment forms constitute the core materials. An ethics review application records the research protocol, review comments, and approval date; an informed consent form template states the subject notification items, signature field, and version date; a risk assessment form registers the risk level, handling measures, and responsible person's signature. The material sources are the institutional ethics committee office, submissions by researchers, and routine archiving, and the update cadence is triggered by protocol revisions, regulatory adjustments, or annual re-review. Field characteristics center on four categories: name, quantity, date, and signature: the same subject quantity should be consistent across two materials, the review date and signature date should be correspondable, and the template version number and the version referenced by the application should be in sync. After the materials enter scheduled tasks and automation, the trigger configuration is responsible for invoking the process on a cycle, the tool node is responsible for reading and comparing material fields, and business processing executes or reruns by record, ultimately forming a version ledger and change records.
Configuration and implementation checks
This part is executed by the trigger configuration and the tool node (scheduling capability is not in the tool introduction), outputting trigger records and execution results. The trigger configuration invokes the process on a cycle; whether the tool call is executed is decided by the model based on the tool introduction; when the model does not need to summarize further, a tool call termination node can be attached at the end of the tool to end this call. The version ledger and change records are then completed by business processing executing or rerunning by record.
| Object | Check | Verification action |
|---|---|---|
| Ethics review application | The four field categories of name, quantity, date, and signature correspond item by item with the informed consent form template and the risk assessment form, and the referenced version number is consistent | Check the subject quantity, review date, signature field, and receipt in the application, and compare the same-named fields in the other two materials; check the trigger records and execution results, and confirm that the process wiring has been connected to the corresponding tool node |
| Informed consent form template | The template version number is in sync with the version referenced by the application, the signature field and date field have no missing items, and the old version is traceable | Check that the introduction field clearly states when it should be executed, and check which step the termination node is connected to; compare the template version number with the version referenced by the application version by version, and confirm that the old version is archived and retrievable |
| Risk assessment form | The risk level, handling measures, and responsible person's signature match the name, quantity, and date in the application and template | Check whether the risk item names and quantities are consistent with the application, and check whether the signature and receipt are complete; view the trigger records and execution results, and confirm that it executes on time and only once |
| Version ledger and change records | The current version is unique, old versions are traceable, and references are updated in sync | After changing one piece of content, check whether the version number and references are updated in sync; check the trigger records and execution time, and confirm that the same task has not been executed repeatedly |
Three common errors
- Phenomenon: the same subject quantity does not match between the ethics review application and the risk assessment form. Cause: the field sources are not in sync, and after the material was revised, it was not written back to the other material.
- Phenomenon: the informed consent form template version is not in sync, and the application still references the old version. Cause: the version change did not trigger a reference update, and the old version was not marked as invalid.
- Phenomenon: the risk assessment form is missing the responsible person's signature or receipt. Cause: the signature field was not included in the check, and missing items were not rerun after process execution.
How to verify the setup
This feature's acceptance: look at the trigger records and execution time, and confirm that it executes on time and only once; check that the process wiring has been connected to the corresponding tool node, that the introduction field clearly states when it should be executed, and that when no summary is needed the termination node has been connected at the end of the tool.
Business test: change one piece of content, and see whether the version number and references are updated in sync; check that in the version ledger and change records the current version is unique and old versions are traceable.
- Check whether the name, quantity, date, and signature fields of the ethics review application, informed consent form template, and risk assessment form correspond item by item, and check whether the referenced version numbers are consistent.
- View the trigger records and execution results, and confirm that it executes on time and only once; for records missing signatures or receipts, business processing executes or reruns by record.