Studies FAQs

Answers to some of the most frequently asked questions (FAQs) about managing studies.

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• Can I manage blinded and unblinded documents and data in SiteVault?

  While SiteVault currently doesn’t have a specific feature designed to blind information to certain users, we recommend the following solution to manage blinded and unblinded study documents:

  1. Identify study team members who can be unrestricted by study and fulfill the responsibilities as a Research Organization Administrator or Site Administrator SiteVault user. Grant these unrestricted users either the Research Organization Administrator or Site Administrator system role.
  2. Grant the restricted users who require to be blinded the Research Organization Staff and Site Staff system roles. If needed, you can update the users’ system roles after the study is archived or blinded staff are unblinded.
  3. Create two different Study records in SiteVault for the study, and name the studies in such a way that they can be clearly identified as either blinded or unblinded, for example, [Study Name] - Blinded and [Study Name] - Unblinded.
  4. Assign the restricted users to the appropriate study. Add blinded site staff users to the blinded study; add unblinded site staff users to the unblinded study. The users are only able to view study documents for the study they’re assigned to, and each can then manage their respective documents as needed. The Research Organization Administrator or Site Administrator users have access to both studies.

  Tip To see how these permissions work, compare your current users who have the Site Staff system role with users who have an administrator system role. You’ll see that the Site Staff system role limits the study information that the user can view to the studies they’re currently assigned to. By contrast, users with an administrator system role can view study information for all studies regardless of whether they’re assigned to the study.

• Why should I create a user for everyone on my team and assign them to studies?
  Among other benefits, creating user accounts for team members and assigning them to studies enables you to send them documents for electronic signature and training, upload their profile documents, and add them to the digital delegation log.
• How do I create a study?
  See the help for creating studies to learn how to create a study in SiteVault.
• Why should I use the Participants (Subjects) section of a study?

  Assigning participants to the study is important for uploading source documents. When you add a participant, SiteVault creates a record for the participant. Any documents that you upload and associate with that participant are displayed in the Documents section of the participant’s record. You can also use the record to track enrollment status, and you can create patient records to associate with study participants to use SiteVault as a mini CTMS.

  See the Managing Study Participants page for more information.

• Why should I create organizations and add them to my studies?

  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.

• Why should I create products and add them to my studies?

  Assigning products is important for documents to be associated with the IP or device under investigation. Some documents require that you complete the Product field when creating the document. Once documents are associated with the product, you can filter the document library by that product to quickly find the documents you’re looking for.

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Overview of Studies

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Managing Studies

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Related Help

• Documents FAQs
• Study eBinder & Document Library
• Exporting Study Documents
• Remote Monitoring FAQs