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Working with studies

Create a study, open one, add sites, and start or import a protocol.

A study is the top-level container in Trelice. Everything else — the protocol, 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  • Suspended, Terminated, Withdrawn — the study was paused, stopped early, or withdrawn.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. 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.

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, 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, 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 and then through review. After a protocol is approved, changes go through amendments, and every approved version stays downloadable — see Amendment history and versions.

On the product site: Collaboration · Protocol authoring