Reporting Rule Sets

Vault Safety includes standard Safety Rule Sets, which you can assign to create reporting obligations.

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About Standard Safety Rule Sets

Vault Safety comes with Safety Rule Sets for certain standard agencies. Safety Rule Sets are comprised of one or more Safety Rules, which contain rule parameters that define conditions for which a Transmission is generated.

For more information on how the rules engine is triggered to automatically generate Submissions and Distributions, see Understand Reporting Rules.

The standard Safety Rule Sets are automatically available for customers who have enabled the Evaluate Reporting Obligations action.

When new reporting rules are added, you can configure when to adopt the new rules using the Reporting Rule Version. See Manage Reporting Rule Versions for instructions.

Note Vault Safety does not currently support adding custom Safety Rule Sets. If you require custom rule sets, we recommend getting help from Veeva Services.

You can assign a Safety Rule Set to an Agency or distribution rule.

The following sections list the Safety Rules and their parameters for each of the standard Safety Rule Sets.

Tip In the Excel file, the Regulation is the agency's regulation associated with the reporting rule.

FDA ICSR Reporting Rule Set

Click the following button to download an Excel file with the FDA Reporting Rules, including version 2.0 and 3.0 of the Rule Set:

Download FDA Reporting Rules

For version 1.0 of the FDA Rule Set, used before the 21R1 release (April 2021), see Reporting Rule Sets (20R3 and Earlier).

Version 3.0 of the FDA ICSR Reporting Rule Set contains the following rules:

  • Public Health Risk
  • Malfunction-Only
  • Downgrade to Serious Expected
  • Downgrade to Non-Serious
  • Downgrade to SAE
  • Serious Unexpected
  • SUSAR (Death)
  • SUSAR (Life Threatening)
  • SUSAR
  • Serious Expected
  • Non-Serious
  • One Last Time
FDA Reporting Rules
FDA Reporting Rules

EMA ICSR Reporting Rule Set

Click the following button to download an Excel file with the EMA Reporting Rules, including version 2.0 and 3.0 of the Rule Set:

Download EMA Reporting Rules

For version 1.0 of the EMA Rule Set, used before the 21R1 release (April 2021), see Reporting Rule Sets (20R3 and Earlier).

Version 3.0 of the EMA ICSR Reporting Rule Set contains the following rules:

  • Downgrade to Non-Serious
  • Downgrade to SAE
  • Serious
  • SUSAR (Death)
  • SUSAR (Life Threatening)
  • SUSAR
  • Non-Serious
  • One Last Time
EMA Reporting Rules
EMA Reporting Rules

MHRA Rule Set

The MHRA Rule Set inherits the EMA ICSR Reporting Rule Set.

PMDA ICSR Reporting Rule Set

Click the following button to download an Excel file with the PMDA Reporting Rules:

Download PMDA Reporting Rules

The PMDA ICSR Reporting Rule Set contains the following rules:

  • INV - 7day - Death - Unexpected
  • INV - 7day - LT - Unexpected
  • INV - 15day - Serious - Unexpected
  • INV - 15day - Serious -Death - Expected
  • INV - 15day - Serious - LT - Expected
  • PMK - 15day - ADR - Death - Unexpected
  • PMK - 15day - ADR - Death - Expected
  • PMK - 15day - ADR - Serious - Unexpected
  • PMK - 15day - ADR - Serious - Expected - Domestic - Recently Approved
  • PMK - 30day - ADR - Serious - Expected - Domestic
  • PMK - 15day - Serious - Infection
  • PMK - 15day - NonSerious - Infection - Domestic
  • INV - 15day - Research/Safety Measure
  • PMK - 30day - Research
  • PMK - 15day - Safety Measure
  • Downgrade
PMDA Reporting Rules

Template Rule Sets

Vault Safety comes with two template rule sets: the General Distribution Rule Set and the Placeholder (Empty) Rule Set.

You can use these template rule sets as a starting point to set up general distribution rules for a reporting destination such as a partner or other safety system.

Warning You must perform testing and validation during implementation to use the General Distribution or Placeholder (Empty) rule set. Contact Veeva Services for assistance.

General Distribution Rule Set

You can assign the General Distribution Rule Set to an Agency or Partner Distribution List when you need more flexibility than the standard rule sets provide.

The General Distribution Rule Set is assigned the EMA ICSR Rule Set as it’s Base Rule Set, along with additional rules. This means that the General Distribution Rule Set inherits all of the EMA reporting rules.

The rules in the General Distribution rule set exist as a starting point and an example of rules you can configure (such as initial case submission rules). This is not an exhaustive list, nor does it cover every scenario.

Placeholder (Empty) Rule Set

To ensure the system does not automatically generate Transmissions (Submissions or Distributions) for a reporting destination, you can assign the Placeholder (Empty) Rule Set to an Agency or Partner Distribution List.

The Placeholder (Empty) Rule Set is another configuration example of a rule set without any reporting rules associated with it. Thus, no Transmissions are generated when a Product or Study Registration matches this rule set.

Override Study Reporting Rules

By default, Case due dates follow the FDA or EMA reporting rules, depending on the case criteria. To override Case due date calculations, add a Submission Rule Override.

  1. Go to the Study record page.
    Find Study records on the Business Admin > Studies page.
  2. Select Edit.
  3. Expand Submission Rules.
  4. Beside Due Date Override, select Yes.
  5. To override the submission rule for adverse events that are life-threatening or result in death, edit the 7 Day Override field.
  6. To override the submission rule for other serious adverse events, edit the 15 Day Override field.
  7. Select Save.

Result

When the system calculated due dates for Cases linked to this Study Registration, the due dates follow the Submission Rule Override settings configured on the Study Registration.


Understand the Reporting Rules Engine
Reporting Rule Parameter Reference
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