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Entering and Reviewing Data for 3500A Reports (End User)

When you populate a regulatory report, many fields are copied from the product issue record. When you edit these fields in the regulatory report record, the edits are not copied back to the product issue record.

NOTE:  The process described here is to enter data in the Manufacturer, Investigation, and Importer views of the Regulatory Reports screen. However, an alternate way is to enter the data in these views in the Product Issues screen before the regulatory report is populated. If you use the Product Issues screen, you have copies of the data in both the product issue record and in the regulatory report record.

This task is a step in Process of Regulatory Reporting.

To review and enter data for the 3500A report

1. Navigate to Regulatory Reports screen > Regulatory Report List view.
2. Drill down on a 3500A regulatory report record.
3. Review and edit if necessary the information in the More Info and Patient views.
4. If you are a manufacturer:
   1. Make sure that the Facility Type field in the Importer view is blank. (By default, this field is set to blank.)
   2. Complete the fields in the Manufacturer view.

      These fields populate section G of the 3500A form. Some fields are described in the following table. (The letter and number combination in the last column indicates how this field maps to the 3500A form.)

      Field	Comments	Mapping to 3500A Form
      (A)NDA #	The abbreviated new drug application or the new drug application number. This field is automatically populated if there is an (A)NDA number associated with the protocol site.	G5
      STN #	Product Submission Tracking Number (STN). If this number does not exist, then use the U.S. License Number.	G5
      PMA/510(K) #	Premarket application (PMA) or premarket notification (510(k)) submission number for the approved or cleared medical device, or combination product. If a product has several applicable submission numbers, and you cannot determine the specific number to use, then use the first approved PMA or 510(k) number.	G5
      Combo Product	Define whether a suspect product comprises a drug-device, device-biological, drug-biological, or a drug-device-biological product.	G5
      10-day	Select the check box to indicate that the report is a 10-day report.	G7
      15-day	For reports of serious and unexpected adverse events.	G7
      5-day	For events requiring remedial action to prevent unreasonable risk to public health, or where written notice is required.	G7
      7-day	Select the check box to indicate that the report is a 7-day report.	G7
      30-day	Select the check box to indicate that the report is a 30-day report.	G7
      Address	Manufacturer contact office address - Street.	G1
      AE Terms	List of adverse event terms that most accurately characterize the adverse event described in Event Detail section.	G8
      City	Manufacturer contact office address - City.	G1
      Consumer	Report Source is the consumer or treating health care provider.	G3
      Contact Name	Manufacturer contact's last name.	G1
      Contact Office	Manufacturer's contact office.	G1
      Country	Manufacturer contact office address - Country.	G1
      Distributor	Check this if report was received from the distributor (importer) of the suspect product.	G3
      First Name	Manufacturer contact's first name.	G1
      Follow-up	Check if the report is a follow-up to a previously submitted report.	G7
      Follow-Up #	Follow-up sequence number.	G7
      Foreign	Report Source is a foreign source (for example, foreign medical facility, affiliate, or government).	G3
      IND #	The investigational new drug (IND) application number. This field is automatically populated if there is an IND number associated with the protocol site.	G5
      Initial	Check if the report is the first submission of a manufacturer report (30 day report for device).	G7
      Literature	Report Source is the scientific literature or an unpublished manuscript.	G3
      Mfg Report #	Regulatory report number.	G9
      OTC Product	Check if the suspect medication can be purchased over-the-counter (without a prescription).	G5
      Other	Report Source is any source not covered by the previous categories.	G3
      Periodic	For reports of serious labeled and non-serious (labeled and unlabeled) adverse events.	G7
      Phone #	Manufacturer contact's work phone number.	G2
      PI Received	The date when a company representative became aware of the event.	G4
      Postal Code	Manufacturer contact office address - Postal Code.	G1
      Pre-1938	Check the box if the suspect medication was marketed prior to 1938 and does not have an NDA #.	G5
      Products	Product(s) involved in the event.
      Professional	Report Source is a physician, pharmacist, nurse, and so on.	G3
      Protocol #	Protocol number identifies the clinical trial at a site. If regulatory report is an IND safety report, enter the protocol number.	G6
      Received Report #	Report number for the MedWatch form received from a Importer or a User Facility.	MedWatch Header
      Representative	Check this if a company representative reported the event based on information from a health professional.	G3
      State	Manufacturer contact office address - State.	G1
      Study	Report Source is a postmarketing, clinical trial, surveillance, or other study.	G3
      User Facility	Check this if the manufacturer received the report from the MDR contact in a user facility as identified in section F.	G3

5. If you are a device manufacturer, complete the fields in the Investigation view.

   These fields populate section H of the 3500A form. Some fields are described in the following table. (The letter and number combination in the last column indicates how this field maps to the 3500A form.)

   Field	Comments	Mapping to 3500A Form
   Evaluation	If an evaluation was conducted, note summary here and choose Evaluation Summary Attached in Evaluated by Mfg Field.	H3
   Death	Check only if the death was an outcome of the adverse event.	H1
   Correction	Do not check when creating an initial report. Follow-up with changes to previously submitted information.	H2
   Serious Injury	Event is life-threatening, results in permanent impairment, requires intervention to prevent permanent impairment.	H1
   Additional Information	Do not check when creating an initial report. Information concerning the event that was not provided in the initial report.	H2
   Malfunction	Device malfunctions.	H1
   Response to FDA Request	Do not check when creating an initial report. Additional information requested by FDA concerning the device/event.	H2
   Other	Event not covered by death, serious injury, or malfunction. This type of category should be rarely used.	H1
   Device Evaluation	Do not check when creating an initial report. Evaluation/analysis of device.	H2
   Mfg Narrative	Any additional information, evaluation, or clarification of data presented in previous sections.	H10
   Recall	Remedial Action - Recall.	H7
   Method Codes	Method codes capture two items — the source of the device that was evaluated and the type of evaluation performed. Do not enter more than four codes.	H6
   Repair	Remedial Action - Repair.	H7
   Result Codes	Describes the results of evaluation and analyses of the reported device problem(s). Do not enter more than four codes.	H6
   Replace	Remedial Action - Replace.	H7
   Conclusion Codes	Describes the evaluation conclusions. Do not enter more than four codes.	H6
   Relabeling	Remedial Action - Relabeling.	H7
   Evaluated by Mfg	If you do not check this box, then you should complete the Non-Evaluation Codes field. Identify if the device was evaluated.	H3
   Notification	Remedial Action - Notification.	H7
   Non-Evaluation Codes	If an evaluation of a returned medical device was NOT conducted, provide the appropriate code.	H3
   Corrected Data	Additional, corrected, or missing information, identifying each data item by the applicable section and block number.	H11
   Inspection	Remedial Action - Inspection.	H7
   Usage of Device	Indicates whether the use of the suspect medical device was the initial use, reuse, or unknown.	H8
   Patient Monitoring	Remedial Action - Patient monitoring.	H7
   Mfg Date	Month and year of manufacture of the suspect medical device. This field may be based on asset number (asset manufacture date) or lot number (effective start date).	H4
   Modification	Remedial Action - Modification.	H7
   Labeled Single Use	Indicates whether the device was labeled for single use.	H5
   Other	Remedial Action - Other - Specify the type of action in this field.	H7
   Correction #	If action reported to FDA under 21 USC 360i(f), list correction or removal reporting number.	H9

6. If you are a user facility or importer, complete the fields in the Importer view.

   These fields populate section F of the form. Some fields are described in the following table. (The letter and number combination in the last column indicates how this field maps to the 3500A form.)

   Field	Comments	Mapping to 3500A Form
   Facility Type	Indicate whether the report is from a user facility, importer, or others.	F1
   Importer	Name of the distributor or importer.	F3
   Contact Name	Last name of the distributor's or importer's representative to contact regarding the event.	F4
   Device Age	The approximate age of the device.	F9
   Report #	Regulatory report # for this report, which is being submitted by an importer. This number is auto-populated when the report is generated.	F2
   Address	Distributor's or Importer's address - Street Address line #1. This field is auto-populated based on the distributor's or importer's name.	F3
   First Name	First name of the distributor's or importer's representative to contact regarding the event.	F4
   Age UoM	Unit of measurement for device age.	F9
   Report Type	Indicates if the report to the regulatory agency will be an initial or follow-up report.	F7
   City	Distributor's or importer's address - City.	F3
   Phone #	Contact's work phone number.	F5
   Patient Codes	Patient codes describe what happened to the patient as a result of the event. Do not enter more than three codes.	F10
   Follow-up #	Sequence number of the follow-up report.	F7
   Postal Code	Distributor's or importer's address - Postal Code.	F3
   Reported FDA	Indicates if the distributor or importer has already sent a report to the regulatory agency.	F11
   Device Codes	Device codes describe device failures or problems encountered during the event. Do not enter more than four codes.	F10
   Reported Mfg	Indicates if the distributor or importer has sent a report to the manufacturer.	F13
   State	Distributor's or importer's address - State.	F3
   FDA Report Date	Date the report was sent to the regulator agency.	F11
   Event Location	Location of the actual occurrence of the event.	F12
   Mfg Report Date	Date the report was sent to the manufacturer.	F13
   Country	Distributor's or importer's address - Country.	F3
   PI Received	The date when a company representative became aware of the event.	F6