Assigning partner organizations to a study is important for organization profile documents, for example, IRB/IEC composition, IRB/IEC compliance, lab director qualifications, lab certification, and lab normal ranges. Once an organization is added to a study and made Active, their corresponding profile documents are filed to that study. This also enables the study team to quickly identify all of the vendors being used on the study.
Other than the standard organization profile documents, other documents such as IRB/IEC response and IRB/IEC submission require that you select an organization when creating the document. Therefore, even if the organization isn’t added to the study, the organization still needs to be in the system so that you can file the document.