Assign a Rule Set to an Agency

To automatically generate regulatory Submissions, assign a reporting ruleset to an Agency Organization.

About Agency Submission Rules

Assign a Safety Rule Set to an Agency to automatically generate Submissions to that Agency when a Case matches a reporting rule.

For more information on how the rules engine automatically generates Submissions for agencies, see Understand Reporting Rules.

To reduce chances of errors in regulatory reporting, we recommend that you create validation rules to ensure the appropriate regulatory rule set is assigned to each regulatory agency. Configuring Record Validation Rules provides more information about configuring validation rules on Vault objects.

Add Reporting Rules to a Custom Agency

Manage Organizations provides information on configuring new Agency Organizations.

  1. Go to Business Admin > Objects > Organizations.
  2. Open the Agency to which you want to add a reporting rule, and then select Edit.
  3. In the Submission Rules field, select the reporting ruleset to use. Reporting Rulesets provides more information on the available rulesets.
  4. Select Save.

After You Finish

For electronic submissions, configure a Custom AS2 Connection.

For manual submissions, configure a Manual Transmission Profile.

Add Reporting Rules to the FDA

If your Vault is upgraded from Vault Safety 19R2, you must perform the following steps to enable the FDA reporting rule:

  1. Go to Business Admin > Objects > Organizations.
  2. On the Organizations page, open the FDA record.
  3. Select Edit.
  4. In the Submission Rules field, select FDA ICSR Reporting Rule Set.
  5. Select Save.

After You Finish

For post-market submissions to the FDA ESG, configure the FDA AS2 Connection.

For manual study submissions to the FDA, configure the FDA Manual Transmission Profile.

Add Reporting Rules to the EMA

If your Vault is upgraded from version 19R2, you must perform the following steps to enable the EMA reporting rule:

  1. Go to Business Admin > Objects > Organizations.
  2. On the Organizations page, open the EMA record.
  3. Select Edit.
  4. In the Submission Rules field, select EMA ICSR Reporting Rule Set.
  5. Select Save.

After You Finish

Configure the EMA AS2 Connection.

Add Reporting Rules to the PMDA

If your Vault was originally deployed before 21R3 (December 2021), you must perform the following steps to assign the PMDA reporting rule set:

  1. Go to Business Admin > Objects > Organizations.
  2. On the Organizations page, open the PMDA record.
  3. Select Edit.
  4. In the Submission Rules field, select PMDA ICSR Reporting Rule Set.
  5. Select Save.

After You Finish

Configure the PMDA AS2 Connection.