What this is, and who it is for
Creating a study makes three things at once: the study, its first version (1.0, in Build) and its first Project Manager. They are made together or not at all, so a study never exists without someone to run it. Creating a study does not build anything and does not open it to any site.
| You need | To |
|---|---|
study.create | See New study and create a study |
Held by: Organization Admin (study.create).
Because an Organization Admin holds no study role, the Project Manager is someone else: a member of your organization who is not an Organization Admin.
Where to find it
Studies (the home of every role except a site's own) → New study. An organization with no study yet shows Welcome and a card, Create your first study ("An Organization Admin can do this"), with a Setup progress list of what is left (roles, team, study). If the organization's roles are not set up or it has nobody who could run a study, the card says what is missing first (Set up your organization).
What you can do
- Choose New study. The dialog says: Creates the study, Version 1.0 in Build and its first Project Manager in one step.
- Fill in the details (below) and choose the Project Manager and their role.
- Choose Create study. You are taken to the new study.
- Opens the dialog that creates a study.
Every option
The study
| Field | Required | Notes |
|---|---|---|
| Code | Yes | Up to 64 characters, unique in your organization (case ignored). Example ONC-2026-001. It is the study's identity and cannot be changed. A duplicate is refused on the form and by the server (is already used by another study in your organization. Nothing was created.) |
| Phase | Yes | Phase I, II, III, IV or Observational. Starts as Phase III |
| Title | Yes | Up to 255 characters |
| Sponsor | Yes | Up to 255 characters |
| Therapeutic area | No | Oncology, Cardiovascular, Neurology, Immunology, Endocrinology, Respiratory, Gastroenterology, Vaccines, Rare Disease, Infectious Disease, Hematology, Dermatology, or Not specified |
| Planned enrolment | No | A whole number of at least 1: Subjects across all sites |
| Countries | No | Country codes separated by commas or spaces, such as IN. Starts as IN |
| Protocol summary | No | Up to 4,000 characters |
The other details of a study (protocol number, CRO, dates, ethics reference, endpoints and the rest) are completed later in Study Settings, which are kept in the version being built (Settings).
- Creates the study in Setup, with version 1.0 in Build.
Who runs the study
| Field | Notes |
|---|---|
| Project Manager | A member of your organization, listed by name and address. People you have invited who have not signed in yet are included: naming them gives them their first access. An Organization Admin cannot be named. If the list is empty, the dialog says to invite your team first and links to Organization Team |
| Their role on the study | Only study roles that can build a study team (those holding team.assign) are offered, the standard Project Manager first. Shown only to an administrator who can read roles; for anyone else the standard Project Manager role applies |
Under the choice the dialog says what it does: "{name} is added to this study's UAT and Live teams as soon as it is created, and gets an email." If you name yourself it says you are added at once.
What happens
- The study is created in state Setup with Version 1.0 in Build.
- The Project Manager is given the role in both workspaces, UAT and Live.
- The Project Manager is sent You've been added to {study} as {role}, and receives an in-app notification; you are sent Study {code} is created and ready to set up, which lists the next steps, and an in-app notification (Notifications).
If it is refused
Nothing is saved when the server refuses: there is no study, no version and no team to clean up.
| Message | Cause |
|---|---|
| {code} is already used by another study in your organization | The code is taken |
| {name} cannot be Project Manager with this role | The role cannot build a team ("Choose a role that holds 'Assign / provision a study team role'") |
| {name} cannot be Project Manager | A separation rule: an Organization Admin, or a person who is site staff |
| That person is not a member of your organization | Site personnel and people from other organizations cannot be Project Manager |
| You cannot create a study | You lack study.create |
What the system records
study.created in the study's audit trail, with the code, the person and the time, and the first version (study.version.created) and the team assignment (team.role_assigned) in the same transaction.
What you cannot do, and why
- Create a study without a Project Manager. An unowned study could not be staffed.
- Name an Organization Admin as Project Manager. An Organization Admin holds no study role, so that governance of the organization and conduct of a study are never in one person's hands.
- Change the code later. Choose it with care; the code is on every export and record.
Compliance Q&A
Yes. The study, its first version and its Project Manager are written in one transaction with an audit entry naming who created it, so there is no moment when a study exists without an accountable manager.
Evidence: server/src/modules/study/studies/application/commands/create-study.ts (study, Version 1.0 and the Project Manager in one transaction)audit events study.created, team.role_assigned
Related
Build a study · Staff a study team · Set up your organization · Settings · Statuses