FDA 3500A Generation Data Mapping

Learn how Vault Safety generates the FDA MedWatch 3500A form from a Case.

Sections in This Article

The following list describes how the system handles certain data while generating an FDA MedWatch 3500A form:

  • For events, diagnoses, indications, test names, and medical conditions, Vault Safety always populates the MedDRA lower-level term (LLT) when there is a coded value available. If there is no MedDRA term available, the reported term is used.

    Note You can opt to populate the MedDRA preferred term (PT) for adverse events instead of the LLT. This feature is available by request only. Contact Veeva Support to request this feature.

  • Dates are populated using the format dd-mmm-yyyy.
    Blank dates are populated as dashes (---).
  • Certain fields may be masked, depending on the blinding settings on the Case or masking settings on the Distribution. Generate Masked Distributions describes the fields that may be masked.
FDA 3500A Header Section
FDA MedWatch 3500A Field Populated Value
Mfr. Report # The value from the UID field on the Case.

A. Patient Information

A. Patient Information Section
FDA MedWatch 3500A Field Populated Value
1. Patient Identifier The value entered in the Patient Initials / ID field on the Case. If this field is blank, the system populates the value entered in the Investigation MRN field.
2. Age The value is mapped from one of the following Case fields, ordered by priority:
  1. Age (value and unit)
  2. Age (normalized)
2. Date of Birth The date entered in the Date of Birth field on the Case.
3. Sex The value from the Gender field on the Case.
4. Weight The value is mapped from one of the following Case fields, ordered by priority:
  1. Weight (value and unit)
  2. Weight (normalized)
5.a. Ethnicity The value from the Ethnicity field on the Case.
5.b. Race The value from the Race field on the Case.

B. Adverse Event or Product Problem

B. Adverse Event or Product Problem Section
FDA MedWatch 3500A Field Populated Value
1. Type of Report The appropriate box is selected, based on the report type.
  • For non-device Cases, the Adverse Event box is selected.
  • For device or combination product Cases, one or both boxes may be selected, based on the value of the Case Device Report Type field and the Malfunction Only field.
2. Outcome Attributed to Adverse Event The appropriate checkbox is selected, based on the criteria entered in the Case-level Seriousness field.

If the adverse event resulted in death, the date of death is populated from the Date of Death field on the Case.

3. Date of Event The earliest Onset Date for any Case Adverse Event associated with the Case version.
4. Date of this Report The date when the report was generated, according to the Timezone in your user settings.
5. Describe Event or Problem

This field is populated with any text in the Narrative Text field on the Case. After the narrative text, any text entered in the Company Comments field on the Case is populated.

Note that if the narrative text overflows onto additional pages, the copmany comments will also appear on the overflow pages.

6. Relevant Tests/Laboratory Data, Including Dates

This field is populated with any text in the Narrative Text field on the Case.

Also, the following information is repeated for each Case Test Result record, sorted alphabetically and from oldest to latest:

  • [Test Name (MedDRA) and Test Name (Reported)],
  • Test Date,
  • [Result (Code) or Test Result Qualifier + Result Value + Result (Unit) or Result (Unit) Text],
  • Result (Text),
  • (Normal Low Value - Normal High Value) Result (Unit) or Result (Unit) Text,
  • Result (Text),
  • Comments

In addition, if the adverse event resulted in death, the following information is populated from each Case Cause of Death record:

  • Reported Causes of Death: [Cause (MedDRA) or Cause (Reported)]
  • Autopsy-Determined Cause of Death: [Cause (MedDRA) or Cause (Reported)]
7. Other Relevant History, Including Preexisting Medical Conditions

The following information is repeated for each Case Medical History record, populated from the following fields:

  • Disease / Surgical Procedure (MedDRA),
  • [Start Date or ---] to [End Date or --- or Continuing],
  • Comments

Any text entered in the Medical History Text field on the Case is populated after listing each medical history line item.

C. Suspect Products

C. Suspect Product(s) Section
FDA MedWatch 3500A Field Populated Value
1. Name and Strength, Manufacturer/Compounder

The following information is populated for Case Products assigned a Drug Role of Suspect or Interacting:

  • Name and Strength: If the Product (Reported) (product_reported__v) field is populated on the Case Product, that value is mapped. Otherwise, the value is mapped from the Product (Coded) (product_name__v) field.
  • NDC # or Unique ID: The value entered in the National Drug Code field on the associated Product Registration record.
  • Manufacturer/Compounder: The sponsor selected in the Organization field in the associated Product Family.
  • Lot #: The value entered in the Batch/Lot Number field on the associated Product Dosage record.
2. Concomitant Medical Products and Therapy Dates

The following information is repeated for each associated Case Product record, populated from the following fields:

  • [Product or Product (Reported)],
  • [First Admin Date or --- or unk] to [Last Admin Date or --- or unk] (Duration) Action(s) Taken,
  • [Dose or Dose Text] + Frequency,
  • Indication

If the Therapy dates are unknown, this field will be populated with the value from the Duration field. The system updates the Duration field value to “Ongoing” if any of the following values are in the Action(s) Taken field:

  • Dose Reduced
  • Dose Increased
  • Dose Not Changed
3. Dose, Frequency, Route Used

The following fields are populated for suspect and interacting products:

  • Dose: The value and unit entered in the Dose or Dose Text field on the associated Case Product.
  • Frequency: The value and unit entered in the Frequency field on the associated Case Product.
  • Route Used: The value entered in either the Patient RoA or Patient RoA (Reported) field on the associated Case Product Dosage.
4. Therapy Dates

This field is populated with the following fields from the associated Case Product Dosage record:

[First Admin Date or --- or unk] to [Last Admin Date or --- or unk] (Duration)

If the Therapy dates are unknown, this field will be populated with the value from the Duration field. The system updates the Duration field value to “Ongoing” if any of the following values are in the Action(s) Taken field:

  • Dose Reduced
  • Dose Increased
  • Dose Not Changed
5. Diagnosis for Use The value entered in either the Name (MedDRA) or Indication (Reported) field on the associated Case Product Indication record.
6. Is the Product Compounded? If any value is selected in the Compounding Type field on the Case Product Registration, then the Compounded checkbox is selected.
7. Is the Product Over-the-Counter? This field is not automatically populated.
8. Expiration Date The date entered in the Expiration Date field on the associated Case Product.
9. Event Abated After Use Stopped or Dose Reduced? The system uses the following fields to calculate whether a dechallenge test occurred and populates the appropriate checkbox:
  • Action Taken on the primary Case Product
  • Outcome on the primary Case Adverse Event

The following table outlines how different values in these fields populate this field on the FDA 3500A form:

Action Taken (G.k.8) E2B Code* Outcome (E.i.7) FDA 3500A C.9 Box
Drug Withdrawn
Dose Reduced
1
2
Recovered/Resolved
Recovering/Resolving
Recovered/Resolved with Sequalea
Yes
Drug Withdrawn
Dose Reduced
1
2
Not Recovered
Not Resolved
Ongoing
Fatal
No
Drug Withdrawn
Dose Reduced
1
2
Unknown (blank) (blank)
Dose Increased
Dose Not Changed
Not Applicable
3
4
9
Any N/A
Unknown 0 Any (blank)
Any other condition (blank)
*Includes custom Action Taken Controlled Vocabulary records
10. Event Reappeared After Reintroduction?

The system uses the Reaction Recurrence field on the primary Case Assessment to determine whether a rechallenge test occurred and populate the appropriate checkbox.

If the Reaction Recurrence field is set to no - n/a, then the Not Applicable checkbox is selected.

D. Suspect Medical Device

D. Suspect Medical Device Section
FDA MedWatch 3500A Field Populated Value
1. Brand Name The value entered in the Product (Reported) field on the Device-type Case Product.
2. Common Device Name The value entered in the Generic Name field on the Device-type Case Product.
2b. Procode The value entered in the Product Code field on the associated Product Registration.
3. Manufacturer Name, City and State If an organization is selected in the Manufacturer field on the associated Product Family record, the name, city, and state are populated from that organization.

Otherwise, this field is populated using the sponsor selected in the Organization field in the associated Product Family.

4. Model # The value entered in the Model Number field on the Device-type Case Product.
4. Lot # The value entered in the Lot Number field on the Device-type Case Product.
4. Catalog # The value entered in the Catalog Number field on the Device-type Case Product.
4. Expiration Date The value entered in the Expiration Date field on the Device-type Case Product.
4. Serial # The value entered in the Serial Number field on the Device-type Case Product.
4. Unique Identifier (UDI) # The value entered in the Unique Identifier field on the Device-type Case Product.
5. Operator of Device The value entered in the Operator of Device field on the Device-type Case Product.
6. If Implanted, Give Date The value entered in the Date Implanted field on the Device-type Case Product.
7. If Explanted, Give Date The date entered in the Date Explanted field on the Device-type Case Product.
8. Is this a single-use device that was reprocessed and reused on a patient? The appropriate checkbox is selected based on the Reprocessed/Reused field on the Device-type Case Product.
9. If Yes to Item 8, Enter Name and Address of Reprocessor The value entered in the Reprocessor field on the Device-type Case Product.
10. Device Available for Evaluation?

The appropriate checkbox is selected based on the Device Available field on the Device-type Case Product.

If there is a date specified in the Returned Date field, the date is populated and the Returned to Manufacturer checkbox is selected.

11. Concomitant Medical Products and Therapy Dates This field is not automatically populated.

E. Initial Reporter

E. Initial Reporter Section
FDA MedWatch 3500A Field Populated Value
1. Name and Address The contact information fields are populated using the name and address on the primary Case Reporter record.
2. Health Professional? This field is populated using the Qualification field on the primary Case Reporter record. If the occupation selected is a qualified healthcare professional, the Yes checkbox is selected.
3. Occupation This field is populated using the occupation selected in the Qualification field on the primary Case Reporter record.
4. Initial Reporter Also Sent Report to FDA This field is populated using the Sent to FDA? field on the primary Case Reporter record.

F. For Use by User Facility/Importer (Devices Only)

Note While Vault Safety does not currently support automatically populating section F fields, this section is available on the form for manual data entry.

F. For Use by User Facility/Importer (Devices Only)

G. All Manufacturers

G. All Manufacturers Section
FDA MedWatch 3500A Field Populated Value
1. Contact Office (and Manufacturing Site for Devices) or Compounding Outsourcing Facility

When generating a form for submission or distribution, the contact information is populated with the contact details for the user selected in the Sender User field on the associated Transmission (Submission or Distribution) record.

When generating a form preview from the Case, the contact information is populated with the contact details for the Case Organization.

2. Phone Number

When generating a form for submission or distribution, this field is populated with the phone number for the user selected in the Sender User field on the associated Transmission (Submission or Distribution) record.

When generating a form preview from the Case page, this field is populated with the phone number for the organization selected in the Manufacturer on the Product record associated with the Case Product.

3. Report Source The appropriate Report Source checkbox is selected, depending on the following logic:
Checkbox Logic
Foreign Checked based on the Country field on the primary Reporter-type Case Contact.
Study

Checked when the option selected in the Case > Report Type field corresponds to a Report Type Controlled Vocabulary where E2B Code=2.

In the standard vault template, the following Report Types check this box:

  • Study
  • Literature (Study)
Literature

Checked when the option selected in the Case > Report Type field corresponds to a Report Type Controlled Vocabulary where Literature=Yes.

In the standard vault template, the following Report Types check this box:

  • Literature (Spontaneous)
  • Literature (Study)
Consumer

Checked when the option selected in the Reporter-type Case Contact > Qualification field corresponds to a Qualification Controlled Vocabulary where Qualified HCP=No.

In the standard vault template, the following Qualifications check this box:

  • Administrator / Supervisor
  • Biomedical Engineer
  • Consumer or other non health professional
  • Lawyer
  • Risk Manager
  • Unknown
Health Professional

Checked when the option selected in the Reporter-type Case Contact > Qualification field corresponds to a Qualification Controlled Vocabulary where Qualified HCP=Yes.

In the standard vault template, the following Qualifications check this box:

  • Dentist
  • Pharmacist
  • Physician
  • Physician Assistant
  • Nurse
  • Nurse Practitioner
  • Other health professional
User Facility Checked when FDA 3500A Report Source=User Facility on the primary Reporter-type Case Contact.
Company Representative Checked when FDA 3500A Report Source=Company Representative on the primary Reporter-type Case Contact.
Distributor Checked when FDA 3500A Report Source=Distributor on the primary Reporter-type Case Contact.
Other

Checked when FDA 3500A Report Source=Other on the primary Reporter-type Case Contact.

On the space following the checkbox, the system populates the value from the Case Identifier field from the associated Transmission (Submission or Distribution).

4. Date Received by Manufacturer

The system maps this field differently for initial and follow-up cases.

Initial: The value is mapped from one of the following Case fields, ordered by priority:

  1. New Info Date
  2. Initial Receipt Date

A Case is considered initial when it meets one of the following conditions:
  1. For a report generated from a Transmission, the Transmission Reason field value must map to E2B Code I (Initial)
  2. For a report preview generated from a Case, the Version must be less than or equal to 1.0
Follow-Up: The date is mapped from the Case New Info Date field, if populated.

A Case is considered follow-up when it meets one of the following conditions:
  1. For a report generated from a Transmission, the Transmission Reason field value must not map to E2B Code I
  2. For a report preview generated from a Case, the Version must be greater than 1.0
5. NDA # If the Registration Type field on the associated Product Registration is set to NDA, the system takes this value from the Registration Number field.
5. ANDA # If the Registration Type field on the associated Product Registration is set to ANDA, the system takes this value from the Registration Number field.
5. IND #

For Study Cases with a Study Type of Clinical Trial or blank, if there is a US Study Registration with a Registration Type of IND, the system populates the IND number from the Study Registration Number field from that Study Registration.

In all other scenarios, if the Registration Type field on the associated Case Product Registration is set to IND, the system takes this value from the Registration Number field.

5. BLA # If the Registration Type field on the associated Product Registration is set to BLA, the system takes this value from the Registration Number field.
5. PMA/510(k) # This field is not automatically populated.
5. Combination Product This box is selected when at least one Case Product is part of a Combination Product.

Note For Study Cases with Products that are part of a Combination Product, if Study Content Protection is enabled or a blinded regulatory report preview is generated, the box is not selected.

5. Pre-1938 If the International Birthdate is set to a date earlier than 1938 on the associated Product record, then this checkbox is selected.
5. OTC This box is not automatically populated.
6. If IND/PreANDA, Give Protocol # The value in the Sponsor Study Number field on the Case.
7. Type of Report If the FDA Report Type field is specified on the Submission record, the system selects the appropriate checkbox based on the selected value. Otherwise, the system automatically populates this box based on the following logic:
  • 5-day: This box is selected when the Case Device Report Type field contains Public Health Risk.
  • 7-day: This box is selected when the Case is tagged as a SUSAR and when the Case Seriousness field contains Fatal or Life-Threatening.
  • 15-day: This box is selected based on the following logic:
    1. For an Initial Study Case: The Case is tagged as a SUSAR and does not qualify for the 7-day option (the Case Seriousness is not Fatal or Life-Threatening).
    2. For an Initial Postmarket/Spontaneous Case: The Case Seriousness field is populated (serious) and the Case Expectedness field is set to No (unexpected).
    3. For a Follow-Up Postmarket/Spontaneous Case: The Case Seriousness field is populated (serious) and the Case Expectedness field is set to No (unexpected).
  • 30-day: This box is selected for device malfunction-only reports.
  • Periodic: This box is selected when one of the following conditions are met:
    • The Case Seriousness field is not populated (non-serious).
    • The Case Seriousness field is populated (serious) and the Case Expectedness field is set to Yes (expected).
    • The Case is a Follow-Up Study Case tagged as a SUSAR.
  • The Initial and Follow-up # checkboxes are selected based on the following logic:
    1. If a Transmission record exists for the Case and a value is populated in the Transmission Reason field:
      1. If the Transmission Reason is Initial, the Type of Report is set to Initial.
      2. If the Transmission Reason is populated with any other value, the Type of Report is set to Follow-Up.
    2. If there is no Transmission record associated with the Case:
      1. If the Case New Info Date is less than or equal to the Case Receipt Date, the Type of Report is set to Initial.
      2. If the Case New Info Date is greater than the Case Receipt Date, the Type of Report is set to Follow-Up.
The Follow-up # value is populated from the Follow-up Number field on the Submission record.
8. Adverse Event Term(s) The value in the Event (MedDRA) field or the Event (Reported) - English field on the primary Case Adverse Event record.
9. Manufacturer Report Number The value in the UID field on the Case.

H. Device Manufacturers Only

H. Device Manufacturers Only

Note Section H is only populated for Cases concerning a Combination Product with a device-type Product Constituent.

FDA MedWatch 3500A Field Populated Value
1. Type of Reportable Event The appropriate box is selected, based on the value in the Device Reportable Event field on the Case.
2. If Follow-up, What Type? The appropriate box is selected, based on the Follow-Up Type field on the Case.
3. Device Evaluated by Manufacturer Either Yes or No is selected, based on the Device Evaluated field on the associated Case Product.
The additional boxes in this field are not supported at this time.
4. Device Manufacture Date The value from the Manufacture Date field on the associated Case Product.
5. Labeled for Single Use? This field is not automatically populated.
6. Event Problem and Evaluation Codes This field is not automatically populated.
7. Remedial Action Initiated, Check Type The appropriate box is selected, based on the value selected in the Remedial Action field on the Case.
If Other, the value from the Remedial Action - Other field is populated.
8. Usage of Device The appropriate box is selected, based on the value in the Device Usage Type field on the associated Case Product.
9. If action reported to FDA under 21 USC 360i(f), list correction/removal reporting number This field is not automatically populated.
10. Additional Manufacturer Name This field is not automatically populated.
11. Corrected Data This field is not automatically populated.

Additional Pages

When Vault Safety generates the FDA MedWatch 3500A form, any text that exceeds field character limits is overflowed to additional pages. The indicator “(…)” and/or “(Continued)” is appended to any field or section that continues on additional pages. Any text on the additional pages is identified with the relevant section and field.


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