FDA 3500A Generation Data Mapping

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

Last Updated Dec 6, 2023

Sections in This Article

• Optional Configuration
• Header
• A. Patient Information
• B. Adverse Event or Product Problem
• C. Suspect Products
• D. Suspect Medical Device
• E. Initial Reporter
• F. For Use by User Facility/Importer (Devices Only)
• G. All Manufacturers
• H. Device Manufacturers Only
• Additional (Overflow) Pages

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

• 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.
• Open-label Products within blinded Studies may be unmasked, depending on your Admin’s configuration of Show Unmasked Open-Label Products on Blinded Forms.
• Case Products with a Drug Role of Suspect, Interacting, or Drug Not Administered are mapped to form sections as shown in the following table:

  CASE PRODUCT TYPE	PRODUCT TYPE	SECTIONS
  Company Product	Device OTC Device	D. Suspect Medical Device H. Device Manufacturers Only
  Company Product	Drug Biologic Vaccine Combination Product Cosmetic OTC Drug Nutritional	C. Suspect Products
  External Product	Device	D. Suspect Medical Device H. Device Manufacturers Only
  External Product	Any type other than Device	C. Suspect Products
  Study Product	Device	D. Suspect Medical Device H. Device Manufacturers Only
  Study Product	Any type other than Device	C. Suspect Products

Optional Configuration

To evaluate Case Products with the Drug Role of Drug Not Administered as suspect, your Admin must have enabled Extend Definition of Suspect to Drug Not Administered. Otherwise, the system evaluates only Case Products with the Suspect or Interacting Drug Role as suspect.

Header

FDA MedWatch 3500A Field	Populated Value
Mfr. Report #	The value from the UID field on the Case.

A. Patient Information

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: Age (value and unit) 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: Weight (value and unit) 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

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 Vault's Timezone.
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 company 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

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, Interacting, or Drug Not Administered: Name and Strength: By default, 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. Note Your Admin can configure your Vault to export the Product (Coded) field by default. 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 Note For Device-only Cases, this information is located in Section D.11 below.
3. Dose, Frequency, Route Used	The following fields are populated for Case Products assigned a Drug Role of Suspect, Interacting, or Drug Not Administered: 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?	For each Case Product section, if any part of the Product has an FDA registration with the Registered As field set to a Transmission Product Type of OTC Drug, the Yes checkbox is selected. Otherwise, the field is left blank.
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 yes – yes (rechallenge was done, reaction recurred), then the Yes checkbox is selected. If the Reaction Recurrence field is set to yes - no (rechallenge was done, reaction did not recur), then the No checkbox is selected. If the Reaction Recurrence field is set to any of the following options, then the Doesn't apply checkbox is selected: yes - unk (rechallenge was done, outcome unknown) no - n/a (no rechallenge was done, recurrance is not applicable) The field is left blank

D. Suspect Medical Device

FDA MedWatch 3500A Field	Populated Value
1. Brand Name	The value entered in the Product (Reported) field on the Device-type Case Product. Note Your Admin can configure your Vault to export the Product (Coded) field by default.
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	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

E. Initial Reporter

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.

G. All Manufacturers

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: New Info Date Initial Receipt Date A Case is considered initial when it meets one of the following conditions: For a report generated from a Transmission, the Transmission Reason field value must map to E2B Code I (Initial) 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: For a report generated from a Transmission, the Transmission Reason field value must not map to E2B Code I 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) #	If the Registration Type field on the associated Product Registration is set to either PMA or 510k, the system takes this value from the Registration Number field.
5. Combination Product	This checkbox 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	Across all Case Products in sections C and D, if any part of a Product has an FDA registration with the Registered As field set to a Transmission Product Type of OTC Drug or OTC Device, the Yes checkbox is selected.
6. If IND/PreANDA, Give Protocol #	The value in the Sponsor Study Number field on the Case.
7. Type of Report	The system selects the appropriate checkbox based on the value in the FDA Report Type field, which is set based on the Due in Days reporting rule parameter. Otherwise, the system populates this checkbox 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: 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). For an Initial Postmarket/Spontaneous Case: The Case Seriousness field is populated (serious) and the Case Expectedness field is set to No (unexpected). 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. Note When generating FDA MedWatch 3500A preview reports, the Periodic checkbox is selected when it shouldn't be. This is a known limitation that will be addressed in a future release. When generating Transmissions, the G.7 Report Type checkbox selections are accurate. The Initial and Follow-up # checkboxes are selected based on the following logic: If a Transmission record exists for the Case and a value is populated in the Transmission Reason field: If the Transmission Reason is Initial, the Type of Report is set to Initial. If the Transmission Reason is populated with any other value, the Type of Report is set to Follow-Up. If there is no Transmission record associated with the Case: If the Case New Info Date is less than or equal to the Case Receipt Date, the Type of Report is set to Initial. 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

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 Death or Serious Injury checkbox is selected based on the value in the Device Report Type field on the Case. The Malfunction checkbox is selected based on the value in the Malfunction field on the primary Case Device Product. If that field is blank, the system populates the checkbox based on the Device Report Type field on the Case.
2. If Follow-up, What Type?	The appropriate checkboxes are selected based on the Follow-Up Type field on the Case.
3. Device Evaluated by Manufacturer	Either the Yes, No, or Not Returned to Manufacturer checkbox is selected based on the Device Evaluated field on the associated Case Product. If Yes is selected, the Evaluation Summary Attached checkbox is also selected.
4. Device Manufacture Date	The value from the Manufacture Date field on the associated Case Product.
5. Labeled for Single Use?	For Device Products, the system takes the value from the Single Use field.
6. Event Problem and Evaluation Codes	Codes in this section are populated as follows: Patient Code: These fields are not populated. Device Code: Depending on your Admin’s configuration, this value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the device-type Case Product. The system exports up to three (3) Medical Device Problem codes. If no Medical Device Problem codes are found, the field is populated with “Unknown”. If there are more than three (3) Medical Device Problem codes, all appear on the overflow pages instead of in this section. Method: This value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the device-type Case Product. The system exports up to four (4) Type of Investigation codes. If no Type of Investigation codes are found, the field is populated with “Unknown”. If there are more than four (4) Type of Investigation codes, all appear on the overflow pages instead of in this section. Result: This value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the device-type Case Product. The system exports up to four (4) Investigation Findings codes. If no Investigation Findings codes are found, the field is populated with “Unknown”. If there are more than four (4) Investigation Findings codes, all appear on the overflow pages instead of in this section. Conclusions: This value is populated with the level 1, 2, or 3 FDA or IMDRF code that was entered on the device-type Case Product. The system exports up to four (4) Investigation Conclusion codes. If no Investigation Conclusion codes are found, the field is populated with “Unknown”. If there are more than four (4) Investigation Conclusion codes, all appear on the overflow pages instead of in this section. Note If your organization is not using Case Product-level device coding, the system exports FDA codes for one device. This is either the highest-ranked or earliest-entered device on the Case. The code entered on the Case is populated for each of the following: Device Problem Evaluation Method Evaluation Result Evaluation Conclusion .
7. Remedial Action Initiated, Check Type	The system uses the following priority order to select the appropriate boxes: Remedial Action field on the primary Case Device Product. When "Other" is selected, the text in the Remedial Action Other field on the Case Product is populated. Remedial Action field on the Case. When "Other" is selected, the text in the Remedial Action - Other field on the Case 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	The value from the Correction/Removal Reporting Number field on the associated Case Product.
10. Additional Manufacturer Narrative	The Additional Manufacturer Narrative checkbox is selected if the same field on the associated Case Product is populated. The text entered in the Additional Manufacturer Narrative field is also populated here. Text that exceeds the field character limit appears in the overflow pages under the heading "H.10 Additional Manufacturer Narrative”.
11. Corrected Data	This field is not automatically populated.

Additional (Overflow) 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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