Drug Dosage Regimen Details Available for Device Product in the Case Form
(Doc ID 3044242.1)
Last updated on SEPTEMBER 06, 2024
Applies to:
Oracle Life Sciences Argus Safety - Version 8.2.1 and laterInformation in this document applies to any platform.
Symptoms
When user change the product from drug to device, the data related to drug dosage regimens information are retained in the database and when user generate the CIOMS report, the drug dosage regimens related information is appearing in the suspect drug section of CIOMS report.
STEPS TO REPEAT:
1. Book-in a case in Argus Safety with Drug Product.
2. Open the case and go to Product tab
3. Under Drug Dosage Regimens, enter Batch/Lot OR Expiration Date etc...
4. Save the case.
5. We can see one record in CASE_DOSE_REGIMENS table.
6. Go back to the product and encode it to a company device product.
7. Save the case.
8. CASE_DOSE_REGIMENS table still have the record with DELETED column as NULL.
9. Schedule and generate CIOMS report for the Device Product. Under suspect drug section, drug dosage regimen information is appearing.
1. Book-in a case in Argus Safety with Drug Product.
2. Open the case and go to Product tab
3. Under Drug Dosage Regimens, enter Batch/Lot OR Expiration Date etc...
4. Save the case.
5. We can see one record in CASE_DOSE_REGIMENS table.
6. Go back to the product and encode it to a company device product.
7. Save the case.
8. CASE_DOSE_REGIMENS table still have the record with DELETED column as NULL.
9. Schedule and generate CIOMS report for the Device Product. Under suspect drug section, drug dosage regimen information is appearing.
Cause
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In this Document
| Symptoms |
| Cause |
| Solution |
| References |