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 | Failure to withdraw participant meeting discontinuation criteria |
| Safety | Safety event not reported to IRB per policy |
| Safety | Safety event not reported within protocol-defined timelines |
| Informed Consent | Consent form or process has insufficient documentation |
| Informed Consent | Consent form signed by participant was not current approved version |
| Informed Consent | Failure to obtain informed consent prior to study-specific procedures |
| Informed Consent | Failure to obtain reconsent |
| Eligibility Criteria | Participant enrolled did not meet all inclusion criteria |
| Eligibility Criteria | Participant enrolled met one or more exclusion criteria |
| Protocol Implementation | Enrollment prior to IRB approval of protocol |
| Protocol Implementation | GCP violation |
| Protocol Implementation | Incorrect or incomplete IRT / enrollment process |
| Protocol Implementation | Missed assessment |
| Protocol Implementation | Missed visit |
| Protocol Implementation | Participant seen outside of visit window |
| Protocol Implementation | Regulatory or training documentation missing |
| Protocol Implementation | Use of prohibited medication or interventions |
| Protocol Implementation | Visit / Procedure / Assessment not performed as defined in the protocol or supporting study documents |
| Investigational Product | Dosing compliance issue noted |
| Investigational Product | Failure to return IP by participant |
| Investigational Product | Improper storage, handling, or dispensing of IP |
| Investigational Product | IP documentation insufficiency |
| Investigational Product | Participant received incorrect IP / dose |
| Investigational Product | Use / dispensing of damaged or expired IP |