Contents
Title and Copyright Information
Preface
1 Know your basics
- Log in
- Change your password
- Begin on the Personal Argus Status page
- Use the Quick Launch Toolbar
- Use field validations
- Acceptable date formats
- Use other (than English) language text
- Enter reasons for missing (Null Flavor) data
- Log out
- Dynamic workflow indicator
- Integrate with Argus Insight
- Case form user preferences
- FAQs
2 Enter case data
- Create a new case
- Enter general information
- Enter patient information
- Enter current medical status
- Copy patient information from reporter information
- Patient information—field descriptions
- Enter patient notes
- Enter patient details
- Enter patient death details
- Enter other relevant history
- Enter lab data—lab test and test results
- Enter additional test information
- Enter parent information
- Enter product information
- Enter event information
- Add attachments to your case
- Review local labeling
- Enable local data entry for Japan
3 Process case data
- Access cases
- Process cases
- View assigned and unassigned cases
- View the case workload for one or more individuals or sites
- View the workflow status for cases
- Route a case to another workflow state
- Add a follow-up event to a case
- Unblind cases to a study
- Copy a case
- Lock or unlock a case
- Delete a case
- Undelete a case
- Formally close a case
- Print case details for a case
- Print letters and attachments for a case
- Review cases
- View correspondence contacts for a case
- Generate a letter on a case
- Track correspondence for a case
- View case action items
- View revisions for a case
- View the audit log for a case
- View the coding status of a case
- Perform a medical review of a case
- Perform a coding review of a case
- Perform a regulatory submission review of a case
- FAQs
- What is a case owner?
- Can I reassign a case to another owner?
- When does a case become open?
- How do I create a query-type action item for a case?
- What happens to a query-type action item after its due date has passed?
- How can I view a summary of all the open cases?
- How can I view a summary of cases with open action items?
- When can I formally close a case?
- What happens to a study if I unblind the cases that are associated with it?
- How can I track which case revision contains significant follow-up information for the case?
- How can I interpret the differences between two narratives for a case?
- What other case details can I retrieve from the Routing Comments log?
- Can I view the original case from a copied case?
- What are the lock states for a case?
- Can I apply a local lock on a case that already has a local lock for another country?
- If I am an Argus Safety Japan user, can I enter local data, copy or modify a case that has a global lock?
- If I am an Argus Safety Japan user, can I apply both a local and a global lock on a Local PRPT case that I entered?
- Can I change the outcome of a case as part of my medical review for the case?
- Can I change the causality for a case during my medical review?
- What do the case assessment values stand for?
- Who is the MDR contact person?
- How does Argus set the Receipt Date for a case?
- How does Argus set the Aware Date for a case?
- How does Argus set the Date Received value for a case?
- Which actions can I perform on a saved letter?
- Can I edit or remove a letter after it was sent for a case?
- If I change the Date Sent value for a letter, must I also change the Due Date for the action item associated with the letter?
- Where can I view action items for letters?
- Why do only some action items for a case appear as Sent in Letter?
- Can I auto-generate a letter for a case?
- Which actions can I do on an auto-generated letter?
- What does the coding status icon indicate for a case?
- Why does a border appear for a coding action item for a case?
- Why is there a green dot in the Notes area of a case summary?
- Why do only some user names appear in bold in the Case Workload?
- Why does the (
) icon appear as the lock state icon for a case? - Why do some letter icons from the Contact Log have an exclamation mark?
- Why does an asterisk (*) symbol appear next to the username for some users in the Case Routing dialog?
- What if
4 Filter cases with advanced conditions
- Create a single filter
- Create a set of related filters
- Share filters with other users
- Modify a filter
- Use filters to view the case series list
- Export the case series list to a spreadsheet
- Import a case series list from the spreadsheet and save
- Find filters
- Access filters from the Advanced Condition Library
- FAQs
- What if
5 Code an adverse event term
- Autocode a term
- Manually code a term
- FAQs
- Which dictionaries does Argus Safety support?
- What is the MedDRA browser?
- What are the five levels of the MedDRA dictionary?
- What is a synonym?
- What is autocoding?
- What happens if you don't enable autocoding?
- What are Standard MedDRA Queries (SMQs)?
- What is a full search?
- What is a non-current term?
- How can I view details for a coded term?
- How can I narrow my search in the MedDRA browser?
- Why does a dictionary coding appear highlighted in yellow in the MedDRA browser?
- Why can't I use the Export button to export a coding?
- What is Null Flavor data?
- What if
6 Manage your Expedited Report submissions
- Schedule an Expedited Report
- Submit your Expedited Reports
- Track your Expedited Report submissions
- Manage your Incoming ICSRs
- FAQs
- What is a scheduled report?
- What is a generated report?
- What happens when a report is approved?
- What is the difference between submitting and transmitting a report?
- What happens when manually scheduling a Local Japan report?
- What happens when auto-scheduling a Local Japan report?
- What components are affected by the expedited reporting rules algorithm?
- When are follow-up reports created?
- Why can't I view a draft report?
- Why doesn't my draft report print a follow-up number?
- How does the Lock State Column under Reports > Compliance > Expedited allow me to sort my cases?
- How do I view the status of my Expedited Report?
- How do I know if an unscheduled report is due soon or needs to be submitted?
- Where can I view single reports which have been generated as part of a periodic report?
7 Manage your periodic report submissions
- Prepare content for periodic reports
- View scheduled periodic report information
- Submit a periodic report
- Track your periodic report submission
8 Work in a multi-tenant Argus environment
- Access your global worklist items
- FAQs
- What is a tenant?
- What is multi-tenancy?
- Can I open both the Global Portal homepage and the Argus Safety application in my browser?
- Can I open the Argus Safety application a second time for the same or a different tenant?
- Can I open the Argus Safety application for different tenants?
- Can I launch different Argus applications in separate browser windows?
- Is there a Japanese version of the Global Portal homepage?
- Which actions can I perform from my global worklist?
- Can I perform actions on multiple cases from my global worklist?
- Can I open Argus Safety cases for multiple tenants from my global worklist?
- What If
- There are no items in my global worklist
- I can't see cases for a tenant even though I used its Enterprise ID as search criteria for my global worklist
- The results list from my global worklist includes case data items that are not referred to by worklist menu actions
- A case data item appears in my Argus Safety worklist, but does not appear in the results list from my global worklist