Paper Reports
Argus J is able to generate and submit the following expedited paper report formats specified by PMDA (both E2B (R2) and E2B (R3)) for drugs.
PMDA forms for Marketed Drugs:
- Drug AE/Infection case report form 1
- Drug AE/Infection case form 2 (5pages)
- Surveillance report on drug, quasi drug, cosmetic case report form 3
- Surveillance report on drug, quasi drug, cosmetic case report form 4
- Surveillance report on measures taken for drug outside Japan such as production termination, recall, rejection, etc. form 5
- Surveillance report on measures taken for drug outside Japan such as production termination, recall, rejection, etc. form 6
PMDA forms for Investigational Drugs:
- Investigational product AE/Infection case report form 1
- Investigational product AE/Infection case form 2
- Surveillance report on investigational product research report form 3
- Surveillance report on investigational product research report form 4
- Surveillance report on measures taken for investigational product outside Japan such as production termination, recall, rejection, etc. form 5
- Surveillance report on measures taken for investigational product outside Japan such as production termination, recall, rejection, etc. form 6
Besides, for PMDA (R2) Report—Paper Report generation logic for PMDA Marketed Form 1 and 2, and PMDA Investigation Form 1 and 2 are enhanced to be in synchronization with CIOMS and MedWatch reports for different type of users.
The Report Form List is used in the following sections:
- Console J - Expedited Report Rules - Form section (irrespective of whether Japanese module is enabled or disabled)
- Schedule New Expedited Report dialogue - Form section (only if Japanese module is enabled)
- Medical Review - Preview of Expedited Report (only if Japanese module is enabled)