> For the complete documentation index, see [llms.txt](https://help.connected.illumina.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://help.connected.illumina.com/connected-insights/interpret-and-report/inter-interp-a-variant/inter-clinical-trial.md).

# Create Clinical Trials

* Users can create clinical trial records when they need to add a clinical trial or edit information about a clinical trial present in an external knowledge base.
* Two ways to create clinical trials: from scratch or by editing external knowledge base assertions.

## Creating Clinical Trials

From scratch:

* Navigate to the Biomarker Details page.
* Select **Create New Assertion** in the top-right corner or under the list of variant assertions to be included in the report.
* In the **Clinical Trial** tab, add information to the fields described below.

From an external knowledge base:

* Navigate to the Biomarker Details page.
* Select a clinical trial from an external knowledge base (e.g., CKB).
* Select **Copy to new assertion** in the menu next to "Report".
* Add and edit information in the fields described below.

## Clinical Trial Fields

### Level

For more information, refer to [Interpret a Variant](/connected-insights/interpret-and-report/inter-interp-a-variant.md#level).

### Consequences

For more information, refer to [Interpret a Variant](/connected-insights/interpret-and-report/inter-interp-a-variant.md#consequences).

### Status

The Status field describes the status of TMB, MSI, and GIS that the assertion is applicable to.

The following categories are available:

* TMB-High
* TMB-Low
* MSI-High
* MS-Stable
* GIS-High
* GIS-Low

### HRD

The HRD field indicates if the assertion is related to HRD for GIS and BRCA1 and BRCA2 variants.

The following categories are available:

* Undetermined
* Positive
* Negative

### Title

The Title field indicates the clinical trial title.

### Registry

The Registry field indicates the clinical trial registry (e.g., <https://clinicaltrials.gov/>).

### Registry ID

The Registry ID field indicates the clinical trial registry identifier (e.g., NCT1234).

### Phase

The Phase field indicates the phase of the clinical trial (e.g., Phase III).

### External Link

The External Link indicates the URL for the clinical trial record online.

### Disease

For more information, refer to [Interpret a Variant](/connected-insights/interpret-and-report/inter-interp-a-variant.md#disease).

### Location

The Location field indicates the city, state, and country of the clinical trial.

* Multiple locations can be added.
* Country is required.

### Approval Status

The Approval Status field indicates the assertion approval status. See [Manage Assertions](/connected-insights/interpret-and-report/inter-interp-a-variant/inter-manage-assertions.md) for more details.


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