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How are sequence IDs created and used to group multiple adverse events?

If your study has one or more Adverse Event forms and a Safety Case form, the sequence number assigned is used to show InForm site users which adverse events are related to the safety case. In InForm, the site user copies the sequence number from the Adverse Event form onto the Safety Case form to identify all adverse events that are part of the same Argus case.

What the study designer does in Central Designer:

  1. Creates an AE form.
  2. Adds a read-only field to the AE form and uses calculation rule to calculate AE sequence ID.

    This is done because rules will be written off this number, and that cannot be done with the actual sequence ID that InForm populates.

    For more information, see Step 1a: Create one or more Adverse Event forms.

  3. Creates a Safety Case form.
  4. Adds a field for sequence ID (not read only) to Safety Case form. For more information, see Step 1b: Create a Safety Case form (if needed).
  5. Creates rules to copy over selected information from the AE form to the Safety Case form when the sequence ID is entered.

    The purpose of this information is to confirm to the site user that they have entered the right information into the sequence ID field.

    For more information, see Step 2b: (Optional) Map the safety case-related sequence number control.

What the site user does in InForm:

  1. Enters adverse event data into an Adverse Event form (InForm calculates the sequence ID upon submission).
  2. Writes down/remembers the specific sequence IDs on the Adverse Event form that need to be grouped into a safety case.
  3. Adds an entry on the Safety Case form with the first adverse event that needs to be part of the case.
  4. Submits the added entry.
  5. Adds additional adverse events as necessary.
  6. Checks the submitted adverse events to make sure they did not enter the wrong sequence ID.
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