Select a project
Click the "My Projects" tab and select your . All projects that you have access to will appear in the list. Click the appropriate project.
Creating a record
Subjects / participants have a single record, identified by the first variable on the first form (record or study ID). A record may be associated with multiple events (data collection time points), and each event may be can contain multiple forms (instruments). For longitudinal studies, a single form (instrument) may be used across multiple events. Ad hoc forms (instruments) can also be used multiple times within the same event and are linked to the participant record.
For patient screening, click "Add/Edit Records" from the left-hand "Data Collection" menu, then click "add new record". A screening ID will be created automatically. If data access groups (DAG) are being used, and you have access to more than one DAG, ensure to select the correct DAG with the DAG switcher.
In the trial database, click "import" on the Project Home tab. This will import all patients who have been randomised and automatically create new records with study ID (randomisation number).
Enter a new study ID to create a new record (e.g., randomisation number). The record will be created when the first form is saved (even if blank). If you enter the study ID incorrectly, contact the project manager to get the ID changed.
Data forms (instruments) can be access in two ways:
2) Click "Add/Edit Records" from the left-hand "Data Collection" menu. Select the correct record from the "Choose an existing Study ID" drop-down menu.
Remember to click the "Save Record" button in the top left-hand corner of the page after entering data. save the page after entering data by clicking one of the buttons below. "Save & Stay" saves data and allows you stay on the current page.
Consult your study data management SOP management SOPs for use of the record form status and locking process functions for you your trial.