Sections in This Article
- 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 Pages
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.
Header

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

FDA MedWatch 3500A Field | Populated Value |
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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:
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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:
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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 |
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1. Type of Report | The appropriate box is selected, based on the report type.
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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:
In addition, if the adverse event resulted in death, the following information is populated from each Case Cause of Death record:
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7. Other Relevant History, Including Preexisting Medical Conditions | The following information is repeated for each Case Medical History record, populated from the following fields:
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 | ||||||||||||||||||||||||||||||||
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1. Name and Strength, Manufacturer/Compounder | The following information is populated for Case Products assigned a Drug Role of Suspect or Interacting:
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2. Concomitant Medical Products and Therapy Dates | The following information is repeated for each associated Case Product record, populated from the following fields:
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:
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3. Dose, Frequency, Route Used | The following fields are populated for suspect and interacting products:
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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:
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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:
The following table outlines how different values in these fields populate this field on the FDA 3500A form:
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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

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

FDA MedWatch 3500A Field | Populated Value |
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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 | ||||||||||||||||||||
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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. |
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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. |
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3. Report Source | The appropriate Report Source checkbox is selected, depending on the following logic:
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4. Date Received by Manufacturer | The system maps this field differently for initial and follow-up cases.
A Case is considered follow-up when it meets one of the following conditions:
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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. |
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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. |
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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 | 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 box based on the following logic:
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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 |
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1. Type of Reportable Event | The Death or Serious Injury box is selected based on the value in the Device Report Type field on the Case. The Malfunction box is selected based on the value in the Malfunction field on the primary Case Device Product.
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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 | Codes in this section are populated as follows:
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:
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7. Remedial Action Initiated, Check Type | The system uses the following priority order to select the appropriate boxes:
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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.