Siebel Life Sciences Guide > Regulatory Reporting >
Field Mapping for the MedWatch Report
Table 37 shows how the fields in the Regulatory Reports screen map to the fields in the MedWatch 3500A report. If the content for text fields extends to continuation pages, it starts from the third page. Note the following about the different areas on the Location MedWatch Form 3500A:
- A: Patient Information
- B: Adverse Event or Product Problem
- C: Suspect Medication(s)
- D: Suspect Medical Device
- E: Initial Reporter
- F: For Use by User Facility/Importer (Devices Only)
- G: All Manufacturers
- H: Device Manufacturers Only
Table 37. Mapping of Fields from the Siebel AECM UI to the MedWatch 3500A Form
Location on MedWatch Form 3500A |
|
View (Applet) on the Regulatory Reports and the Product Issues screen |
A1 |
Patient Identifier |
Patient |
A2 |
Age |
Patient |
A2 |
Date of Birth |
Patient |
A3 |
Gender |
Patient |
A4 |
U/M |
Patient |
A4 |
Weight |
Patient |
B1 |
Event Type |
More Info (Event Detail) |
B2 |
Congenital Anomaly |
More Info (Event Detail) |
B2 |
Date of Death |
More Info (Event Detail) |
B2 |
Death |
More Info (Event Detail) |
B2 |
Disability |
More Info (Event Detail) |
B2 |
Hospitalization |
More Info (Event Detail) |
B2 |
Life Threatening |
More Info (Event Detail) |
B2 |
Other |
More Info (Event Detail) |
B2 |
Required Intervention |
More Info (Event Detail) |
B3 |
Event Date |
More Info (Event Detail) |
B4 |
Report Date |
More Info, Regulatory Reports screen only |
B5 |
Description |
More Info (Event Detail) |
B6 |
Tests/Data |
More Info (Event Detail) |
B7 |
Relevant History |
More Info (Event Detail) |
C1 |
Product |
More Info (Products) |
C2 |
Dose Per Unit |
More Info (Products) |
C2 |
Frequency |
More Info (Products) |
C2 |
Route Used |
More Info (Products) |
C3 |
Therapy From Date |
More Info (Products) |
C3 |
Therapy To Date |
More Info (Products) |
C4 |
Indication |
More Info (Products) |
C5 |
Event Abated |
More Info (Products) |
C6 |
Lot # |
More Info (Products) |
C7 |
Expiration Date |
More Info (Products) |
C8 |
Reintroduce Reoccur |
More Info (Products) |
C9 |
NDC# |
More Info (Products) |
C10 |
External Products |
More Info (Event Detail) |
D1 |
Product |
More Info (Products) |
D2 |
Common Device Name |
More Info (Products) |
D3 |
City |
More Info (Products) |
D3 |
Mfg Name |
More Info (Products) |
D3 |
Postal Code |
More Info (Products) |
D3 |
State |
More Info (Products) |
D3 |
Street Address |
More Info (Products) |
D4 |
Asset # |
More Info (Products) |
D4 |
Catalog # |
More Info (Products) |
D4 |
Expiration Date |
More Info (Products) |
D4 |
Lot # |
More Info (Products) |
D4 |
Model # |
More Info (Products) |
D4 |
Part # |
More Info (Products) |
D4 |
Serial # |
More Info (Products) |
D5 |
Device Operator |
More Info (Products) |
D6 |
Implant Date |
More Info (Products) |
D7 |
Explant Date |
More Info (Products) |
D8 |
Reprocessed |
More Info (Products) |
D9 |
Reprocessor |
More Info (Products) |
D10 |
Device Available |
More Info (Products) |
D10 |
Return Date |
More Info (Products) |
D11 |
External Products |
More Info (Event Detail) |
E1 |
Account |
More Info |
E1 |
Address |
More Info |
E1 |
City |
More Info |
E1 |
Contacts (Contact Last Name in list) |
More Info |
E1 |
CSN # |
More Info |
E1 |
First Name (Contact First Name in list) |
More Info |
E1 |
Phone # |
More Info |
E1 |
Postal Code |
More Info |
E1 |
Site |
More Info |
E1 |
State |
More Info |
E2 |
Provider |
More Info |
E3 |
Occupation |
More Info |
E4 |
Reported FDA |
More Info |
F1 |
Facility Type |
Importer |
F2 |
Report # |
Importer |
F3 |
Address |
Importer |
F3 |
City |
Importer |
F3 |
Country |
Importer |
F3 |
Importer |
Importer |
F3 |
Postal Code |
Importer |
F3 |
State |
Importer |
F4 |
Contact Name |
Importer |
F4 |
First Name |
Importer |
F5 |
Phone # |
Importer |
F6 |
PI Received |
Importer |
F7 |
Follow-up # |
Importer |
F7 |
Report Type |
Importer |
F8 |
Report Date |
More Info |
F9 |
Age UoM |
Importer |
F9 |
Device Age |
Importer |
F10 |
Device Codes |
Importer |
F10 |
Patient Codes |
Importer |
F11 |
FDA Report Date |
Importer |
F11 |
Reported FDA |
Importer |
F12 |
Event Location |
Importer |
F13 |
Mfg Report Date |
Importer |
F13 |
Reported Mfg |
Importer |
G1 |
Address |
Manufacturer |
G1 |
City |
Manufacturer |
G1 |
Contact Name |
Manufacturer |
G1 |
Contact Office |
Manufacturer |
G1 |
Country |
Manufacturer |
G1 |
First Name |
Manufacturer |
G1 |
Postal Code |
Manufacturer |
G1 |
State |
Manufacturer |
G2 |
Phone # |
Manufacturer |
G3 |
Consumer |
Manufacturer |
G3 |
Foreign |
Manufacturer |
G3 |
Distributor |
Manufacturer |
G3 |
Literature |
Manufacturer |
G3 |
Other |
Manufacturer |
G3 |
Professional |
Manufacturer |
G3 |
Representative |
Manufacturer |
G3 |
Study |
Manufacturer |
G3 |
User Facility |
Manufacturer |
G4 |
PI Received |
Manufacturer |
G5 |
(A)NDA # |
Manufacturer |
G5 |
IND # |
Manufacturer |
G5 |
OTC Product |
Manufacturer |
G5 |
Pre-1938 |
Manufacturer |
G6 |
Protocol # |
More Info (Product Issues) and Manufacturer |
G7 |
10-day |
Manufacturer |
G7 |
15-day |
Manufacturer |
G7 |
5-day |
Manufacturer |
G7 |
Follow-up |
Manufacturer |
G7 |
Follow-Up # |
Manufacturer |
G7 |
Initial |
Manufacturer |
G7 |
Periodic |
Manufacturer |
G8 |
AE Terms |
Manufacturer |
G9 |
Mfg Report # |
Manufacturer |
H1 |
Death |
Investigation |
H1 |
Malfunction |
Investigation |
H1 |
Other |
Investigation |
H1 |
Serious Injury |
Investigation |
H2 |
Additional Information |
Investigation |
H2 |
Correction |
Investigation |
H2 |
Device Evaluation |
Investigation |
H2 |
Response to FDA Request |
Investigation |
H3 |
Evaluated by Mfg |
Investigation |
H3 |
Evaluation |
Investigation MDV |
H3 |
Non-Evaluation Codes |
Investigation |
H4 |
Mfg Date |
Investigation More Info (Products) |
H5 |
Labeled Single Use |
More Info (Products) Investigation |
H6 |
Conclusion Codes |
Investigation |
H6 |
Method Codes |
Investigation |
H6 |
Result Codes |
Investigation |
H7 |
Inspection |
Investigation |
H7 |
Modification |
Investigation |
H7 |
Notification |
Investigation |
H7 |
Other |
Investigation |
H7 |
Patient Monitoring |
Investigation |
H7 |
Recall |
Investigation |
H7 |
Relabeling |
Investigation |
H7 |
Repair |
Investigation |
H7 |
Replace |
Investigation |
H8 |
Usage of Device |
Investigation |
H9 |
Correction # |
Investigation |
H10 |
Mfg Narrative |
Investigation MDV |
H11 |
Corrected Data |
Investigation |
|