Who can complete this task?
- Clinical Basics: CTMS Vault Admin, Clinical Basics: Study Manager, Clinical Basics: Monitor
You may identify safety, protocol implementation, or other issues during a monitoring visit or between visits. When this happens, you need to document those issues, either as Protocol Deviations or Observations.
- Protocol Deviation - something that breaks the protocol standards.
- Observation - something that should be checked, but is not a direct violation of protocol.
When you create a protocol deviation or observation, you will specify a category and sub category for the issue. This table shows the categories and sub categories available in Veeva Clinical Basics: CTMS.
| Category | Sub Category |
|---|---|
| Safety | AE/SAE not reported to IRB |
| Safety | Laboratory tests not done |
| Safety | SAE not reported within 24 hours |
| Informed Consent | Consent form missing |
| Informed Consent | Consent form not current approved version |
| Informed Consent | Consent form not signed and dated |
| Informed Consent | Failure to obtain informed consent |
| Eligibility Criteria | Participant does not meet eligibility criteria |
| Eligibility Criteria | Randomization of an ineligible participant |
| Protocol Implementation | Missed assessment |
| Protocol Implementation | Missed visit |
| Protocol Implementation | Participant received wrong treatment |
| Protocol Implementation | Participant seen outside of visit window |
| Protocol Implementation | Randomization prior to IRB approval of protocol |
| Protocol Implementation | Use of disallowed concomitant medication |