Before importing data into a study, the source file must be set up in a way that can be read logically by the system.
The file formats that can be imported are CSV and SAS7bdat.
All rows/records in a source file must have data that correspond to the form in Clinical Studio where it will be imported.
Importing must be done one form at a time. However, its okay if there are extra columns of data that don't apply. These columns simply won't be mapped in the configuration.
Every data file must have a minimum of four columns: Site, Subject, Visit, and Date.
Each of these columns is described below. Note, using these exact column header names is not required.
Use the site name that corresponds to each record. The site name must match what is found in the Site Manager
Each record must have a subject ID that matches the current subjects registered in the study.
Important Note: If the subject IDs in this column do not already exist in the study, they must be imported before subsequent data can be imported. Read here on importing new subjects.
Each record must have a visit name identified. The visit interval map is where these visit names are defined. Its important to use the same names that are mapped.
If the records being imported are log forms or the subject registration form, the visit can be left blank
This column is required because every record in Clinical Studio must have a date. This will be the column that corresponds to the visit transaction date that was set when the form was built.
Lastly, review all other columns in the file to ensure the formats are consistent within each column. These data formats will need to match up with the data field they are being imported into.
Here is an example of a file being used to import Adverse Event records into a study across multiple sites and subjects. The columns described above are highlighted.
Important Note: If subjects BPA-020 and BPA-02, from the image above, are new subjects that do not already exist in the database, they will need to first be imported before importing this file. Otherwise select the configuration option to only import existing subjects.