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InfoFileMan FileNo | FileMan Filename | Package |
---|---|---|
120.85 | ADVERSE REACTION REPORTING | Adverse Reaction Tracking |
Package | Total | FileMan Files |
---|---|---|
Adverse Reaction Tracking | 2 | PATIENT ALLERGIES(#120.8)[.03] SIGN/SYMPTOMS(#120.83)[#120.8502(.01)] |
Kernel | 2 | STATE(#5)[48, 58] NEW PERSON(#200)[.5, 1.2, #120.8502(2)] |
Registration | 1 | PATIENT(#2)[.02] |
Field # | Name | Loc | Type | Details |
---|---|---|---|---|
.01 | DATE/TIME OF EVENT | 0;1 | DATE | ************************REQUIRED FIELD************************
|
.02 | PATIENT | 0;2 | POINTER TO PATIENT FILE (#2) | ************************REQUIRED FIELD************************ PATIENT(#2)
|
.03 | RELATED REACTION | 0;15 | POINTER TO PATIENT ALLERGIES FILE (#120.8) | ************************REQUIRED FIELD************************ PATIENT ALLERGIES(#120.8)
|
.5 | OBSERVER | 0;13 | POINTER TO NEW PERSON FILE (#200) | NEW PERSON(#200)
|
1.1 | DATE REPORTED | 0;18 | DATE |
|
1.2 | REPORTING USER | 0;19 | POINTER TO NEW PERSON FILE (#200) | NEW PERSON(#200)
|
2 | REACTIONS | 2;0 | POINTER Multiple #120.8502 | 120.8502
|
3 | SUSPECTED AGENT | 3;0 | Multiple #120.8503 | 120.8503
|
4 | RELEVANT TEST/LAB DATA | 4;0 | Multiple #120.8504 | 120.8504
|
5 | QUESTION #1 | 0;3 | SET |
|
6 | QUESTION #2 | 0;4 | SET |
|
7 | QUESTION #3 | 0;5 | SET |
|
8 | QUESTION #4 | 0;6 | SET |
|
9 | QUESTION #5 | 0;7 | SET |
|
9.1 | NO. DAY HOSPITALIZED | 0;8 | NUMBER |
|
10 | QUESTION #6 | 0;9 | SET |
|
11 | QUESTION #7 | 0;10 | SET |
|
12 | QUESTION #8 | 0;11 | SET |
|
12.1 | QUESTION #9 | 0;16 | SET |
|
12.2 | QUESTION #10 | 0;17 | SET |
|
13 | CONCOMITANT DRUGS | 13;0 | Multiple #120.8513 | 120.8513
|
14 | OTHER RELATED HISTORY | 14;0 | WORD-PROCESSING #120.8514 |
|
14.5 | SEVERITY | 0;14 | SET |
|
22 | DATE MD NOTIFIED | 0;12 | DATE |
|
23 | FDA QUESTION #1 | PTC1;1 | SET |
|
24 | FDA QUESTION #2 | PTC1;2 | SET |
|
25 | FDA QUESTION #3 | PTC1;3 | SET |
|
26 | FDA QUESTION #4 | PTC1;4 | SET |
|
26.1 | FDA QUESTION #5 | PTC1;13 | SET |
|
27 | DATE REPORTED TO FDA | PTC1;5 | DATE |
|
28 | DATE OF PATIENT CONSENT TO MFR | PTC1;6 | DATE |
|
29 | DATE SENT TO MFR | PTC1;7 | DATE |
|
30 | *DATE SENT TO RCPM | PTC1;8 | DATE |
|
31 | DATE SENT TO VAERS | PTC1;9 | DATE |
|
31.1 | P&T ACTION FDA REPORT | PTC1;10 | SET |
|
31.2 | P&T ACTION MFR REPORT | PTC1;11 | SET |
|
31.3 | *P&T ACTION RCPM REPORT | PTC1;12 | SET |
|
31.5 | P&T ADDENDUM | PTC2;0 | DATE Multiple #120.85315 | 120.85315
|
43 | REPORTER NAME | RPT;1 | FREE TEXT |
|
44 | REPORTER ADDRESS1 | RPT;2 | FREE TEXT |
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45 | REPORTER ADDRESS2 | RPT;3 | FREE TEXT |
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46 | REPORTER ADDRESS3 | RPT;4 | FREE TEXT |
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47 | REPORTER CITY | RPT;5 | FREE TEXT |
|
48 | REPORTER STATE | RPT;6 | POINTER TO STATE FILE (#5) | STATE(#5)
|
49 | REPORTER ZIP | RPT;7 | FREE TEXT |
|
50 | REPORTER PHONE | RPT;8 | FREE TEXT |
|
51 | RPT QUESTION #1 | RPT;9 | SET |
|
52 | RPT QUESTION #2 | RPT;10 | SET |
|
52.1 | OCCUPATION | RPT;11 | FREE TEXT |
|
53 | MANUFACTURER NAME | MFR1;1 | FREE TEXT |
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54 | MFR ADDRESS #1 | MFR1;2 | FREE TEXT |
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55 | MFR ADDRESS #2 | MFR1;3 | FREE TEXT |
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56 | MFR ADDRESS #3 | MFR1;4 | FREE TEXT |
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57 | MFR CITY | MFR1;5 | FREE TEXT |
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58 | MFR STATE | MFR1;6 | POINTER TO STATE FILE (#5) | STATE(#5)
|
59 | MFR ZIP | MFR1;7 | FREE TEXT |
|
60 | IND/NDA # FOR SUPPORT DRUG | MFR2;1 | FREE TEXT |
|
61 | MFR CONTROL # | MFR2;2 | FREE TEXT |
|
62 | DATE RECEIVED BY MFR | MFR2;3 | DATE |
|
63 | REPORT SOURCE | 63;0 | SET Multiple #120.8563 | 120.8563
|
64 | 15 DAY REPORT | MFR2;4 | SET |
|
65 | REPORT TYPE | MFR2;5 | SET |
|
ICR LINK | Subscribing Package(s) | Fields Referenced | Description |
---|---|---|---|
ICR #5190 |