File ADVERSE_REACTION_REPORTING(120.85) Data List
| DATE/TIME OF EVENT |
PATIENT |
RELATED REACTION |
OBSERVER |
DATE REPORTED |
REPORTING USER |
QUESTION #6 |
QUESTION #7 |
QUESTION #8 |
QUESTION #9 |
QUESTION #10 |
CONCOMITANT DRUGS |
OTHER RELATED HISTORY |
SEVERITY |
REACTIONS |
DATE MD NOTIFIED |
FDA QUESTION #1 |
FDA QUESTION #2 |
FDA QUESTION #3 |
FDA QUESTION #4 |
FDA QUESTION #5 |
DATE REPORTED TO FDA |
DATE OF PATIENT CONSENT TO MFR |
DATE SENT TO MFR |
SUSPECTED AGENT |
*DATE SENT TO RCPM |
DATE SENT TO VAERS |
P&T ACTION FDA REPORT |
P&T ACTION MFR REPORT |
*P&T ACTION RCPM REPORT |
P&T ADDENDUM |
RELEVANT TEST/LAB DATA |
REPORTER NAME |
REPORTER ADDRESS1 |
REPORTER ADDRESS2 |
REPORTER ADDRESS3 |
REPORTER CITY |
REPORTER STATE |
REPORTER ZIP |
QUESTION #1 |
REPORTER PHONE |
RPT QUESTION #1 |
RPT QUESTION #2 |
OCCUPATION |
MANUFACTURER NAME |
MFR ADDRESS #1 |
MFR ADDRESS #2 |
MFR ADDRESS #3 |
MFR CITY |
MFR STATE |
MFR ZIP |
QUESTION #2 |
IND/NDA # FOR SUPPORT DRUG |
MFR CONTROL # |
DATE RECEIVED BY MFR |
REPORT SOURCE |
15 DAY REPORT |
REPORT TYPE |
QUESTION #3 |
QUESTION #4 |
QUESTION #5 |
NO. DAY HOSPITALIZED |