- Documentation
Trial
The central object of the application, which contains all information of ...
It is possible to deactivate a trial site, with the following implications:
Trial status
In RANDI2 a trial has different statuses with different effects:
- In Preparation
- It is possible to change the structure of the trial, but the randomization is not allowed.
- Active
- Users with the role investigator can randomize, and the principle Investigator/trial administrator can add new users to the trial or change the status to paused/finished.
- Paused
- The principle Investigators/trial administrators can add new users to the trial or change the status to active/finished, but it is not allowed to randomize patients.
- Finished
- No changes are allowed and users (principle investigator/trial administrator/monitor/statistician) can view and export (CSV format) the randomized patients.
Open or closed trial
In RANDI2 to it is also possible to define open or closed trials. Open means that it is possible to new participating trial sites during the course of the study.
Characteristics
A trial contains the following properties:
| Property | Description | Constraint |
|---|---|---|
| Name | The name of the trial.. | Alphanumeric string with maximal 256 chars. |
| Abbreviation | The abbreviation of the trial. | Alphanumeric string with maximal 256 chars. |
| Start date | The start date of the trial. | Date in the following ISO format: yyyy-MM-dd |
| Is Open? | An logical value to indicate the possibility to add trial sites during the trial course. | True, false |
| Participating Sites | A list of participating sites, only members of these sites can own one or more of the trial specific roles. | |
| Treatment arms | One or more treatments, the treatment definitions are used by the randomization methods. | Every treatment consists of the following mandatory information: name, description, and planned subject size. |
| Identification creation type | Specify the way of the creation of the patient identifiers. | (i) COUNTINUOUS_COUNTER - every new patients get a continuous number (ii) TRIAL_ARM_COUNTER - the identifier is generated in the following form TrialName_ArmName_ContinuousNumberInArm (e.g. testTrial_arm1_12 - this means that the patients is number 12 in the treatment arm1 in trial testTrial) (iii) EXTERNAL - the identifier have to be set during the randomization process by the investigator |
| Subject properties | One or more treatments, the treatment definitions are used by the randomization methods. | see Definition |
| Randomization method | The definition of the used randomization method. | see Definition |
| Status | Status of the Trial | IN_PREPARATION, ACTIVE, PAUSED, FINISHED |