Assign a Rule Set to an Agency

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. Navigate 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. Standard Reporting Rule Sets 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

To enable the FDA reporting rule:

  1. Navigate 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

To enable the EMA reporting rule:

  1. Navigate 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

To assign the PMDA reporting rule set:

  1. Navigate 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.