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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 |
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. |
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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 |