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?

  SiteVault does not have a specific feature designed to blind information to certain users, we recommend the following solution to manage blinded and unblinded study documents:

  • Create the Study and assign the Study Team, External Users, Products, Partner Organizations, and Participants, as needed.
  • Upload only BLINDED (unrestricted) documents to SiteVault.
  • Maintain UNBLINDED (restricted) documents outside of SiteVault according to internal business processes.
• 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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Creating and Managing Studies

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Related Help

• Documents FAQs
• Study eBinder
• Exporting Study Documents
• Document Library