Migrating Safety Cases
New Studies that are migrating from a third party EDC system and have an automated solution for the transfer of safety data can now enable E2BLink after the migration to Vault CDMS. Vault administrators can use Vault Loader to load Safety Cases from the originating system into Vault CDMS, which Vault uses to also create Safety Messages. After the CDMS vault and safety system are connected, Vault automates all new and existing Safety Cases for the life of the Study.
Creating the Loader File
You will use two loader files (CSV) to create records in the Safety Case and Safety Case - Form objects.
Safety Case File
Include the following columns in your Vault Loader file:
| Column Header | Expected Value |
|---|---|
| cdms_safety_case_unique_id__v | Enter a unique identifier for the Safety Case. |
| first_reporter_first_name__v | Enter the first name of the first reporter. |
| first_reporter_last_name__v | Enter the last name of the first reporter. |
| first_reporter_country__v | Enter the 2-letter abbreviation of the country for the first reporter. |
| safety_definition__v | Enter the ID of the Safety Definition (safety_definition__v.id). This can be obtained from Admin > Business Admin > Safety Definitions. |
| study__v.name__v | Enter the Name of the Study that (study__v.name__v). |
| date_report_first_received_from_source__v | Enter the date and time when the SAE was first captured by EDC. |
| site__v.name__v | Enter the Site Number (site__v.name__v) of the Site for this Safety Case. |
| study_country__v.name__v | Enter the Study Country (study_country__v.name__v) of the Study Country for this Safety Case. |
| subject__v | Enter the ID (subject__v.id) of the Subject for this Safety Case. This can be obtained from Admin > Business Admin > Subjects. |
| subject_name__v | Enter the Subject ID (subject__v.name__v) of the Subject for this Safety Case. |
| case_status__v | Enter one of the following statuses: case_accepted__v, closed__v, rejected__v. |
| message_starting_number__v | Enter a number for EDC to use as the next Message Number if the originating EDC system creates a new follow up, For the first message in the case created by CDMS (when the starting number is null), use 0. If not null, use message_starting_number + 1. This value is null if the case was created by CDMS. If the case was migrated, this value is not null. |
Safety Case - Form File
Include the following columns in your Vault Loader file:
| Column Header | Expected Value |
|---|---|
| ae_form_def_name__v | Enter the Name of the Form Definition (form_def__v.name__v) for your Serious Adverse Event form. |
| ae_form_id__v | Enter the ID for your Serious Adverse Event form (form__v.id). This can be obtained from Admin > Business Admin > Forms. |
| ae_form_seq_num__v | Enter the Sequence Number (Reference #) for the Serious Adverse Event form (form__v.form_seq__v). |
| safety_case__v | Enter the ID for the Safety Case (safety_case__v.id). This can be obtained from Admin > Business Admin > Safety Cases. |
Load the Files
First load the Safety Case loader file, then load Safety Case - Form.
To load a file:
- In the left panel of the Loader tab, click Load.
- For the CSV File, click Choose and select the CSV input file.
- In the Object Type drop-down, select the object on which to perform bulk actions.
- In the Action Type drop-down, select Create.
- Click Start Load.
Before processing the request, Vault validates the selected CSV file. If the file is valid, Vault begins processing the request. When finished, you’ll receive a Vault email with request details and CSV output files.
File Validation
Before beginning the Vault Loader job to create object records, Vault checks that the selected CSV file meets certain criteria:
- If creating object records, the total number of records in the vault, plus new records created by the CSV, would not exceed your vault’s limits
- If creating object records, includes at least one record
- Is not empty
- Does not contain empty columns
- Includes a valid header row (Invalid header rows are those with no columns that match to metadata for the records you’re loading.)
If your file is not valid, Vault displays a notification, stops the process, and allows you to select a new CSV file. If some of the column headers do not match metadata for your vault, the notification will allow you to stop the load or ignore those columns and proceed.
Message Creation
After you load the files, Vault creates the necessary object records. Vault uses the number you entered for message_starting_number__v when creating a Safety Message for the case. Vault then treats this as a follow-up, instead of the first send. If you used the Closed case status, Vault doesn’t create a Safety Message for the case.