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Roadmap: Study set up and user management
Setting up a study requires actions from different IRT users:
- The Drug Supply Manager reviews and approves the drug schedule.
- A Statistician reviews and approves the randomization schedule.
- A Study Manager, CRA, or Field Monitor adds and manages countries, regions, and users.
Step #
Action
Menu to select
What happens?
1
Study (
)Study Set-Up
Drug Schedule
Randomization Schedule
Approving the drug and randomization schedules are the critical first steps in preparing the study.
After the drug schedule is approved, drug units can be associated with depots, assigned lot numbers, added to label groups, and shipped to sites.
After the randomization schedule is approved, subjects can be randomized into the study. Subjects must be randomized before they can participate in a study.
2
Study (
)Study Set-Up
Study Limits
The screening limit sets the maximum number of people who can be screened for a study, region, or country.
The randomization limit sets the maximum number of subjects who can be randomized into a study, region, or country.
Screening status determines whether studies, regions, or countries can screen potential subjects. If screening is open, potential subjects can be screened.
Randomization status determines whether studies, regions, and countries can randomize subjects. If randomization is open, subjects can be randomized.
3
Study (
)Study Set-Up
Manage Regions
Manage Countries
After countries and regions are added to a study:
- You can add sites to those regions and countries.
- Depots and sites become active in the study.
4
Study (
)Users
User Upload
Edit User
Link to Site/Depot
Pending Users
After you upload a user, the user receives a User Authentication Code (UAC) by email or fax. Users are considered to be pending users until they activate their accounts.
You can edit users' details and associate them with sites or depots.
