A protocol is created in Slope to model the inventory requirements for your clinical trial. For every physical asset your clinical trial requires, you can define a standard set of inventory templates that sites will use to manage inventory.
When a protocol is deployed to a study site, a new workspace is created at that site. The workspace is populated with inventories that link back to one of the inventory templates that you defined in the protocol. In doing so, Slope can allow the Sponsor to establish a shared nomenclature for every item in their protocol and remotely monitor these inventory levels at every site subscribed to the protocol.
Adding a new protocol
Let's say that we have a trial that is launching soon and we want to set it up within Slope. To create a new protocol, you would first need to be assigned a Sponsor admin role by your team's Slope account administrator. You can now click the Actions button in either the Sponsor dashboard or the main protocols list and choose New protocol from the dropdown list of options. You'll see a form that looks like this:
Here's some detail about each of these form fields:
- Type - You can choose either "Clinical Trial" (the default) or "Supply Group." Use the later to track inventory for a non-clinical trial related project. When you select "Supply Group", the CRO Name and Therapeutic Area fields will disappear.
- Protocol Name - Provide the name that everyone connected to the protocol will see. If you change this value and sites have already subscribed to the protocol, the name will be updated on their end automatically. Please be careful with changing the name often, as it can result in confusion at the sites.
- Sponsor Name - This field will be pre-populated with the current Sponsor name. Whatever you put here will be visible to everyone connected to the protocol.
- CRO Name - Provide the CRO name if applicable. Whatever you put here will be visible to everyone connected to the protocol.
- Therapeutic Area - Choose one of the provided therapeutic areas from the list.
- Sites can add custom inventories - Check this box if you want sites to be able to add their own inventories in addition to the ones you have defined through inventory templates within the protocol. The caveat is that a Sponsor will not have visibility for these additional inventories because they are not connected to an inventory template that has been previously defined.
Once you click the Create Protocol button, the protocol will be built and you'll be forwarded to the protocol details view.
By default, new protocols will be created in the active state. This allows it to be deployed to sites and show up in dashboards. As your clinical trial ends and your protocol is no longer active, Slope provides a set of status management tools to hide these protocols from primary dashboards.
From the protocols list or a protocol details view, you can click the Actions button to get a dropdown list of state transitions. Here's details about each:
- Disable - Shown if the protocol is active. Clicking this transitions the protocol to disabled, which will remove it from primary dashboards. You can still navigate the protocol and its inventory templates, but you cannot make changes.
- Close - Shown if the protocol is active or disabled. Clicking this will bring up a modal window that you must type in the exact name of the protocol in order to close it. Once the protocol is closed it will remain in a read-only state indefinitely.
- Activate - Shown if the protocol is disabled. Allows you to take the protocol out of the disabled state and transition it to an active state again.