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Overview of Study Invitations
Study invitations are used to allow the flow of information between your SiteVault and a sponsor or CRO’s vault. Study invitations are always sent from the sponsor or CRO to you.
During acceptance of the study invitation, you can determine whether the incoming study already exists in your SiteVault. If the study doesn’t exist, SiteVault automatically creates the study and populates the Study Identifier, Sponsor Site ID, and Sponsor Study ID fields. You can update these fields as needed. In some cases, accepting a study invitation will also create Study Product records. You can view the created study in the Studies tab.
Once accepted, the following Current-state Person Profile or Organization Profile documents for study team members or organizations that are in an Active state on your study are automatically transferred to the sponsor or CRO’s vault:
- IRB/IEC Compliance
- IRB/IEC Composition
- Lab Certification
- Lab Normal Ranges
- Medical License
- Training Evidence (non study-specific)
Note Profile documents for organizations with the role of either Central Lab or Central IRB are not transferred automatically.
In addition, any documents sent from or requested by the sponsor or CRO are displayed in the Documents > Regulatory Document Requests tab.
Approving a Study Invitation
You can approve a study invitation only after you’ve reviewed and confirmed that all study information is accurate. Complete the following steps to review and approve a study invitation:
- In the All Tasks view of the Home tab, select Accept then Complete on the Approve Study Invitation task. SiteVault displays the Review Details section of the study invitation.
- Review the study invitation details, then select Next.
- Select one of the options below in the Resolve Study section depending on whether a record for the study already exists in your SiteVault.
- If the study exists, select Yes then search for and select the study.
- Select No if the study doesn’t exist. SiteVault creates the incoming study as a new record.
- If the incoming study includes a product, select Next to move to the Resolve Product section. Select one of the options below depending on whether a record for the product already exists in your SiteVault. If the incoming study includes more than one product, you can select Next to move to the next section.
- If the product exists, select Yes then search for and select the product.
- Select No if the product doesn’t exist. SiteVault creates the product as a new record and associates it with the study.
- When you’re finished resolving the study and any associated products, select Complete.
- In the Approve Study Invitation dialog box, select Approve then Complete.
Rejecting a Study Invitation
You should only reject a study invitation if you find errors while completing the approval process. We recommended that you reach out to the sponsor or CRO point of contact before rejecting any invitations.
To reject a study invitation, complete the steps in the Approving a Study Invitation section but select Reject in Step 6.