In this manual, you will learn how to add clinical trials to the system, what data is required to add one.

 

Needed data to add a trial:

 

Before starting to add a new trial, a personel must be added to the system as the principal investigator in the newly created trial. Learn more about this in the guides: Creating a new user and Adding medical staff and associating the profile with the user account.

 

Additionally, the following data, which are required when creating a trial, should be prepared. After saving, all entered data can be edited later.

Name: the name of the trial.

PI: a person who will be the principal investigator,

Type of research team: One of the values: All, Team blinded, Team unblinded. Here you decide which of these teams the principal investigator will belong to. Selecting one of the three options means that the Principal Investigator will have access to view and/or edit only those parts of the documentation in the EDM that are intended for his team. You can read more about research teams in the guide: Adding a member of the research team.

Status: One of the values: Start-up, Pre-activation, Screening, Closed, Visit ended, Trial ended, Canceled.

Monitor data: First name, Surname, Email, Phone number are the additional data. 




Menu -> Clinical trials -> Add trial

 

Every data entered during creating a trial can be edited later. To add a new trial:

From the menu on the left, select the Clinical trial tab (pills icon), then click the Add trial button.


In the add trial window fill in the required data such as: Name, PI, Type of research team, Status

In the add trial window fill in the optional data such as: 

Sponsor: this value is needed to conduct a visit that has a price list with defined value in the sponsor field. More about the price list you can learn more in the guide about the financial module.

CRO: Contract Research Organizations.

Phase: e.g phase I, phase II.

Clinical trial tags: are used to search for a trial by relevant tags. 

Protocol number: the protocol identifier for the clinical trial

Site number: the number of the site where the trial will be performed.

Indication: what is the rationale behind creating a new trial.

Click the Save button at the bottom of the page.

The add trial window is closed. We have been redirected to the trial list, in the upper-right corner a message appears: Trial successfully added.