--- title: "Working with studies | Trelice User Guide" description: "Create a study, open one, add sites, and start or import a protocol." canonical_url: "https://www.trelice.com/docs/working-with-studies" --- # Working with studies A study is the top-level container in Trelice. Everything else, the [protocol](/docs/glossary), consent forms, sites, and reports, lives inside a study. This guide shows you how to find your studies, create a new one, add participating sites, and start (or import) a protocol. ## The Studies page Click **Studies** in the menu on the left. The page has a toolbar at the top and a table below it. From left to right, the toolbar contains: - A search box with the hint **Search studies...**. Type part of a study's title or study number to narrow the list. - A dropdown that starts as **All statuses**. Choose a status (for example **Active** or **Completed**) to show only studies in that stage. - A blue **New Study** button in the top-right corner. The table has six columns: **Study Number**, **Title**, **Phase**, **Status**, **Protocols**, and **Created**. Click any column heading to sort by that column; click it again to reverse the order. Click a study's title to open it. > **Note:** If the table shows **No studies found.**, clear the search box and set the status dropdown back to **All statuses**, a filter is probably hiding your studies. If you have many studies, **Previous** and **Next** buttons appear at the bottom of the table, with a count like "24 studies total". ## What a study's status means Each study carries one status. It describes where the study is in its life: - **Concept**: an idea; nothing formal yet. - **Protocol Dev**: the protocol is being written. - **Reg. Review**: the protocol is with regulators or an ethics committee. - **Active**: the study is running and enrolling. - **Enrol. Complete**: enrollment has finished; participants are still on study. - **Follow-up**: treatment is done; participants are being followed. - **Completed**: the study finished normally. - **Suspended**, **Terminated**, **Withdrawn**: the study was paused, stopped early, or withdrawn. ## Creating a study 1. On the Studies page, click the blue **New Study** button in the top-right corner. 2. A window titled **New Study** opens. Fields marked with a red star are required. 3. Fill in **Study Number** (for example, LA-2024-001). This is your organization's identifier for the study. 4. Choose a **Phase** from the dropdown: **First in Human**, **Phase 1**, **Phase 1/2**, **Phase 2**, **Phase 2/3**, **Phase 3**, **Phase 4**, **Bioequivalence**, or **Not Applicable**. 5. Type the full study **Title**. 6. If you like, add a **Short Title**, an abbreviated name. 7. The remaining fields are optional and can be filled in later: **Sponsor** (choose from your organization list), **Therapeutic Area** (for example, Oncology), **Indication** (the disease being studied), **Investigational Product** (the drug or device name), **IND Number**, **Planned Start Date**, and **Planned End Date**. 8. Click **Create Study**. The button briefly reads **Creating…**. **What you'll see:** the window closes and your new study appears in the table. > **Troubleshooting:** If a red message such as "Study number is required." appears, one of the three required fields (Study Number, Title, Phase) is still empty. Fill it in and click **Create Study** again. ## Inside a study Click a study's title to open its detail page. From top to bottom you will see: - A breadcrumb trail (**Studies** › the study number) so you always know where you are. - A header card with the study's title, its number, phase and indication, and a status badge on the right. Below a divider, four facts: **Sponsor**, **Therapeutic Area**, **IND Number**, and **Investigational Product**. A dash means the field was left blank. - The **Sites & IRBs** card. - The **Protocols** list. ## Adding sites and IRBs The **Sites & IRBs** card lists the clinics and hospitals taking part in the study. Each site has its own Principal Investigator and reviewing [IRB](/docs/glossary). Trelice uses this information to generate site-specific consent forms and IRB packets. 1. Click the blue **Add Site** button on the right side of the card. 2. In the **Site** dropdown, pick an existing site, or choose **➕ New site…** to add one. For a new site, type the site name (required); city and country are optional. 3. In the **Reviewing IRB / Ethics Committee** dropdown, pick an IRB, choose **➕ New IRB…**, or leave it as **None / not yet assigned**. 4. Fill in the contact boxes as far as you know them: Principal Investigator, PI email, PI phone, 24-hour emergency phone, site number, and IRB protocol number. All of these are optional. 5. Click **Save Site**. **What you'll see:** the form closes and the site appears in the list with its PI and IRB. Use the small pencil icon to edit a site or the trash icon to remove it. > **Note:** If you do not see the **Add Site** button, your role does not include site management. Administrators, Regulatory Affairs, and Clinical Operations staff can edit sites, see [Roles and permissions](/docs/roles-and-permissions). ## Starting a protocol Below the sites card is the **Protocols** heading. If your organization's contract includes the Protocol Authoring product, two buttons appear on the right: **Import Protocol** and **New Protocol**. If they are missing, your organization does not have that product, this is not an error on your part. ### Creating a blank or template-based protocol 1. Click the blue **New Protocol** button. 2. A window titled **New Protocol** opens. Type a **Title** and a **Version Number** (for example, 1.0). 3. If your organization has [protocol templates](/docs/protocol-templates), a **Start from Template** list appears. **Blank protocol (all ICH E6 sections)** is selected by default; click a template instead to start from your organization's preferred outline. 4. Click **Create Protocol**. **What you'll see:** a protocol card appears in the list, showing its version, a status badge, and a "Section completion" bar. Click **Edit** on the card to open [the protocol editor](/docs/protocol-editor-overview), or **Documents** to reach the document generation page. ### Importing an existing protocol document If your protocol already exists as a PDF or Word file, Trelice can read it for you. 1. Click **Import Protocol**. 2. In the window titled **Import Protocol**, click the dashed box that says **Choose a PDF or Word (.docx) file, max 50 MB** and pick your file. 3. Check the **Title** (Trelice suggests one from the file name) and the **Version Number**. Optionally record the document's own version in **Original Version** (for example, "Amendment 3"). 4. Click **Import Protocol**. **What you'll see:** a spinner with **Uploading and extracting text…**, then **AI is parsing the protocol…**. Parsing a full protocol can take a few minutes. You may close the dialog, the import keeps running, and the protocol appears on the study page when it finishes. When the import completes, a green message reads **Protocol imported** with a count of populated sections. Below it, a list shows what happened in each section: **Fields + text**, **Fields only**, **Text only**, or **Empty**. Click **Open Protocol** to review the result. > **Note:** If some source content did not match a standard section, a yellow notice explains it was preserved under Appendices as "Unmapped imported content", nothing is thrown away. If the document was in another language, the content is translated to English and the original file stays attached for verification. > **Troubleshooting:** "Only PDF and Word (.docx) documents are accepted." or "The file is larger than 50 MB." means the file type or size is not supported, export a smaller PDF or .docx and try again. If the import fails partway, click **Try Again**. ## What happens next Once the protocol exists, work moves to [the protocol editor](/docs/protocol-editor-overview) and then through [review](/docs/submitting-for-review). After a protocol is approved, changes go through [amendments](/docs/creating-and-editing-amendments), and every approved version stays downloadable, see [Amendment history and versions](/docs/amendment-history).