Analysis Tab
In Study cases, in the PMDA tab > 被疑薬ライセンスの情報 (Drug Information section) section, the non-company suspect drugs that are study drugs (irrespective of whether they are configured in English data entry or J data entry or both) are displayed as a single record similar to the records displayed for the company product licenses. This is applicable only for the non-company suspect drugs configured as part of study and are displayed in the Event Assessment tab.
- Up and Down buttons have been added to the PMDA tab.
- By default, the focus is on the first record. No action is performed when the user clicks on Up button when the focus is on the First record. If the focus is on any other record other than the first record, the system interchanges the position of the current record and previous record by clicking the Up button.
- No action can be performed when the user clicks on Down button when the focus is on the Last record. If the focus is on any other record other than the last record, the system interchanges the position of the current record and next record by clicking the Up button.
- If there is no row in this section, then clicking on Up and Down buttons does not cause action.
- For existing customer data, the sort order value for existing records is populated as same as the order in which these were displayed to the user.
- The change in ordering of these product license rows in PMDA General tab is audit-logged.
- The product license ordering on the PMDA General sub-tab is also respected by the following:
- PMDA Comments sub-tab > Product License dropdown
- Case Form Print > PMDA General and Comments tab
- PMDA E2B Report > Ordering of product dosages in DRUG section as per the logic specified below
- PMDA Paper Report > Ordering of product dosages in DRUG section as per the logic specified below
- The common profile switch "Japan License to be available in case for Assessment and reporting" in Console > System configuration > Common profile switch > Argus J has the following values:
- Option 1: All valid Japan Licenses (default)
- Option 2: User Selected License only
All the changes made to this profile switch are audit logged.
- PMDA E2B and Paper Reports (Marketed Form 1-6 and Investigational Form 1-6) list the suspect products using the order of products specified in PMDA tab. Logic to be considered for PMDA E2B report is provided below, with the only change from the previous logic being for point b:
- The company product for which the ICSR is scheduled is always listed first.
- For the other company suspect Japanese products which are displayed on the PMDA tab, the order of products is considered from the PMDA tab.
- The remaining suspect products (which are not listed on the PMDA tab).
- Other concomitant products.
- For each of the above categories (c), and (d), if there are multiple products, then the "Product details/First Dose" are used for the ordering of products. Earlier dates are before the later dates.
- If there are multiple products with the same "Product details/First Dose" under any of the above category (c) and (d), then they are ordered using the product sort ID used in the case itself.
- Within a product, if there are multiple dosage regimens, then they are ordered based on the dosage start dates.
- If the date being used for ordering is null, then the product is put at the end in the same category.
- For the Partial date, if the date is considered as 15th of the month, the month is considered as June of the year.
Figure 1-3 Case Form - PMDA tab
For more information, see: