View and manage safety reports in a binder.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Safety Report Binders
After generating a document collection from a Case Collection, Vault exports all forms to a binder and updates are version-controlled. This makes downloading and sharing collections quick and easy. For more information, see Binders Overview.
Prerequisite
Your Admin must enable Create and Export Case and Safety Report Collections.
Working with Safety Report Binders
You can view a binder by selecting the link on the associated Case Collection. You can also find binders generated from Case Collections in the Library. For more information, see Searching Vault.
Vault includes the following safety report binder document types, subtypes, and classifications:
- Case Binder > Case Collection Binder > CIOMS Masked Case Collection
- Case Binder > Case Collection Binder > CIOMS Unmasked Case Collection
- Case Binder > Case Collection Binder > E2B Case Collection
Safety Report Versions
When generating safety reports for a Case Collection, Vault creates or updates document versions based on the Case version’s state and whether safety reports already exist in that format. Vault generates a report for the Case version if one (1) does not already exist. The report is added to the binder and the Case.
CIOMS I Masked Form Generation Considerations
Vault completes the following configuration when generating CIOMS I Masked forms:
- The Redacted field is set to Yes.
- If the Study Case version’s Blind Protection field is set to On, the expected study content is blinded.
E2B(R3) Generation Report Considerations
Consider the following when generating E2B(R3) reports:
- The format for E2B(R3) reports is always ICH E2B(R3). Localized E2B(R3) reports cannot be generated from Case Collections.
- When generating ICH E2B(R3) reports for Case Collections, Vault populates some required data elements as outlined in the following table:
| E2B Data Element Name | Populated Value |
|---|---|
| N.1.2 Batch Number | Vault generates a batch number. |
| N.1.3 Batch Sender Identifier | SENDERID |
| N.1.4 Batch Receiver Identifier | RECEIVERID |
| N.2.r.2 Message Sender Identifier | SENDERID |
| N.2.r.3 Message Receiver Identifier | RECEIVERID |