Subject data can be stored in BSI on databases that have Study Level Security enabled and data can only be defined and stored for studies that require authorization. Only users that have been authorized for a study can enter, view, or print labels on subject data.
There are two types of Subject data fields: common and study-specific fields. Common subject data is stored in fields that are available across studies. This information does not change depending on the study and can include items such as First Name, Last Name, and Date of Birth. Study-specific data is stored in fields which only pertain to a given study.
Subject Attributes for a specific Study ID are defined in the Subject Attributes submanager. Once these fields have been defined, they can be entered by users in the Subject Manager and Editor or via Data Entry.
The Subject Editor is used to add new subject data and to edit existing subject data and can be opened from the Subject Manager or through a data entry add batch. A new subject record is created based on the Subject ID and Study ID.
Example: Study A needs to record human subject data relating to a measles vaccination, while Study B tests kittens and needs to record information such as fur length and color. Since neither study is using the other’s fields, the study coordinator created a study-specific field called “Measles Vaccination” for Study A and study-specific fields called “Fur length” and “Fur Color” for Study B.
Since all studies on the database want to see a Blood Type field, the study coordinator included a field called “Blood Type” to the common subject fields so users can enter data for that field across all studies. She adds items to the corresponding code list to allow kittens to be assigned a blood type of “A”, “B”, and “AB”, instead of the human equivalents, which are specified as positive or negative.
Users must have permission to access the Subjects manager. Users who can access the Subjects manager but have not been authorized for a study, can view default subject fields for any database subject, including: Study ID, Subject ID, Date Created, Created By, Date Last , and any common subject level fields.