Siebel Life Sciences Guide > Regulatory Reporting > Process of Regulatory Reporting >
Entering and Reviewing Data for 3500A Reports
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
- Navigate to Regulatory Reports screen, then the Regulatory Report List view.
- In the Regulatory Report List, drill down on a 3500A regulatory report record.
- Review and if necessary modify the information in the More Info and Patient views.
- If you are a manufacturer:
- Make sure that the Facility Type field in the Importer view is blank. By default, this field is set to blank.
- Complete the fields in the Manufacturer view.
These fields populate section G of the 3500A form. Some fields are described in the following table. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.
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(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 |
10-day |
Select the check box to indicate 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 |
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. |
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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 |
- 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. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.
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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 can 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 |
- 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. Note that the letter and number combination in the last column indicates how this field maps to the 3500A form.
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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 |
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