Buttons and Description.
| Sl.No | ICON | NAME | DESCRIPTION |
|---|---|---|---|
| 1 | Information | This will display the detailed description of that particular field. |
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| 2 | Green Flag | Within the Inbox listing, this allows the user to see the Entire Lifecycle Completion date. Green indicates there is time to complete the Entire Workflow. | |
| 3 | Red Flag | Within the Inbox listing, this allows the user to see the Entire Lifecycle Completion (past) date. Red indicates the time overdue to complete the Entire Workflow. | |
| 4 | Green Tag | Within the Inbox listing, this allows the user to see the Activity Completion date. Green indicates there is still time to complete the activity. | |
| 5 | Red Tag | Within the Inbox listing, this allows the user to see the Activity (past) Completion date. Red indicates overdue time to complete the activity. | |
| 6 | Duplicate | Provides information on Duplicate Citations. | |
| 7 | Claim and Edit | This ensures that only the user who has claimed the citation can work on the same.
|
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| 8 | Reset Claim | Button located on the Top Right-hand corner of the application. Will reset all the claimed citations (by all users). | |
| 9 | Checkbox | Literature Inbox page:
|
|
| 10 | Lock | Indicates that the citation has been claimed by another user and it is being worked on, or it is part of their Workflow. |
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| 11 | Edit | Indicates that the citation is claimed by you. The citation will be enabled for editing in a new window. This ensures that only the user who has claimed the citation can work on the same. | |
| 12 | Quick Action | Quick Action button allows the user to Open the classification Quick Pop-up which allows the user to classify and complete the Activity. User can:
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| 13 | Clear Filter | Clears all the applied filters. | |
| 14 | Refresh List | Refresh the current page. | |
| 15 | Advance Filter | Located at the Top Right-hand corner of the application. A separate box will pop-up which allows user to perform advanced search to find required citation(s). | |
| 16 |  |
Expand | Expands the particular panel. |
| 17 |  |
Collaps | Will close the particular panel. |
| 18 | Pin | Keeps the Hierarchy panel open (fixed). | |
| 19 | Pin | Closed the fixed panel. | |
| 20 | Toggle | Shows the drill down of products and week wise citations.
|
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| 21 |  |
Complete Activity | Select the claimed citation(s) using the Edit column checkbox and then click on the Complete button. that is located on the Top Right-hand corner of the application. This will allow manual Workflow completion.  This allows completion of Activity based on the Workflow rules. |
| 22 | Distributed | Indicates that the citation has been distributed to Business Unit(s). | |
| 23 | Re-initiated | It indicates the citation has been Re-initiated from Repository. | |
| 24 |  |
More | Shows Update Citation and Copy Citation Options. |
| 25 |  |
Home | Navigates to the previous listing page. |
| 26 |  |
Close | Closes the current working page / Edit Citation Window. |
| 27 | Reset claim | Resets the claimed citation. | |
| 28 | Create | Opens a new pop-up as per the sub tabs in edit citation window. | |
| 29 | Delete | Deletes the selected record/data. | |
| 30 | Paste | Pastes the copied citation details. | |
| 31 | Full Text | Takes the user to external link for Full Text Article. | |
| 32 | Save | It saves the data. | |
| 33 |  |
Copy | Creates duplicate of selected case id’s under Case Creation Sub tab. |
| 34 |  |
Save | Saves data input on Full Text Sub tab. |
| 35 | Close | It closes the pop-up window(s) in the overall application. | |
| 36 | More | Displays the ‘About Us’ and ‘Log Out’ options in SAFETYLite. | |
| 37 | Previous / Next | Navigates to the previous / Next page display in SAFETYLite. | |
| 38 | Next | Navigates to the Next claimed citation in the edit citation page. | |
| 39 | Download | Downloads the R2Xml/PDF/CSV/Docx. | |
| 40 |  |
Send | Sends out an email to the authorized user. |
| 41 |  |
Link | Creates a Link between two citations. |
| 42 | Calendar | Option to select Calendar date. | |
| 43 | Navigation | Navigates to the first listing page. | |
| 44 | Left Navigation | Navigates to the Previous listing page. | |
| 45 | Navigation | Navigates to the last listing page. | |
| 46 | Right Navigation | Navigates to the Next listing page. | |
| 47 | Add | Adds the entered data in the text field. | |
| 48 | User | Displays user menu. | |
| 49 | Rejected | Rejected Citation by QC. | |
| 50 | QC OK | Approved Citations from QC. | |
| 51 | QC Issue | Indicates Issue by QC. | |
| 52 | Accepted | Accepted Citation by QC. | |
| 53 | On Time | Indicates that the Workflow activity is completed on time. | |
| 54 | Time Exceeded | Indicates the Workflow activity time is exceeded. | |
| 55 | Change Password | User can change/Update the Current Password. | |
| 56 | Logout | Ends the current session. Logs out of the application. | |
| 57 | About | Shows Information on the Application Version / Copyrights, Server and Local Time zones. | |
| 58 | Password expire | Password expiry Date & Time information. | |
| 59 | Help Page | Help index which shows information on overall application navigation, FAQs, buttons / icons description. | |
| 60 | Duplicate | Shows all the Duplicate records for the literature item in edit citation page. | |
| 61 | Source document | Downloads the Source document of manually created citation. | |
| 62 |  |
Miminize | Minimizes the window. |
| 63 |  |
Maximize | Maximizes the window. |
| 64 | Close | Closes the current window. |
Definitions and Key Terms
| Term | Definition |
|---|---|
| CSV | Comma-Separated Value |
| XML | Extensible Markup Language |
| IE | Internet Explorer |
| NLP | Natural language processing |
| URL | Uniform Resource Locator |
| AE | Adverse Event |
| LLT | Low Level Term |
| HLT | High Level Term |
| CSV | Comma-Separated Value |
| PT | Preferred Term |
| SOC | System Organ Class |
| HLGT | High Level Group Term |
| WF | Workflow |
| ADS | Active Directory Sign On |
| ICSR | Individual Case Safety Report |
| FTA | Full Text Article |
| MLM | Medical Literature Monitoring |
| Portable Document Format |
Frequently Asked Questions.
User(s) can navigate to different sections of ReTrans 6.2 using the Navigation Menu.
ReTrans 6.2 has the following Menu(s).
- Literature
- NLP Admin
- Library
- Security
- Reports
Note: Based on the ‘Role profile’ the user(s) will be able to see the appropriate ‘Menu’.
Literature Menu has multiple functions that allows User(s) to create Queries around Citation, monitor progress of workflow via the Inbox, access Repository etc.
Click on the menu ‘Literature’ and then click on ‘Queries’ menu.
Queries Menu allows User(s) to create Citations, create Query, create Blank Query and retrieve Query list.
A citation typically refers to a documented reference or source of information that supports or substantiates findings related to adverse drug reactions, medication errors or other safety concerns associated with pharmaceutical products.
Citations could be from scientific literature, regulatory documents, clinical trial reports, or other credible sources used to gather and analyze safety data.
Citations play a crucial role in assessing the safety profile of drugs and informing regulatory decisions.
- Click on the menu ‘Literature’, then click ‘Queries’, then click ‘Create Citation’.
- In the ‘Upload Literature’ page, User(s) should enter all mandatory fields (fields with red *) and click on “Save & Publish” button.
User(s) can also upload additional supporting documents related to the Citation in PDF or CSV format.
Click on the menu ‘Literature’ and then click on ‘Inbox’ menu.
Inbox Sub-Menu allows User(s) to view all citations available in uploaded CSV files as well as Manually created citations will be displayed based on the various filter options like – Business unit, Product Code, Search title, Search date, Count, Created date, Current activity and Claim Status.
- Literature Inbox helps in creating Workflows for a particular Business Unit.
- User can check status of each workflow of each Citations.
- Workflows can be reviewed, edited/modified, and completed directly from the Inbox page.
In the Literature Inbox table, user(s) can filter and view information relating by Business Unit, Product Code, search title, search date, count, created date, current activity and Claim Status .
Click on Clear Filter Button which is located to the Right-Hand corner of the application.
- Click on Advance Filtering Options button, which is located to the Right-Hand corner of the application.
- A separate dialog box will pop-up which allows user to perform advanced filter to find required citation(s).
Yes, as part of the Advance Filter Search, user(s) can use Wild Card search option using % symbol at the beginning and ending of the search string .
In the Literature Inbox table, click on Refresh List button which is located to the Right-Hand corner of the application.
Type the search criteria on the Simple Search window, that is located on the Top Right-Hand corner of the application and Press Enter or click on the Search Icon.
- Embase
- PubMed
- Legacy
- MLM/Others
- Medline
- ProQuest
- Valid ICSR
- Invalid Case
- Awaiting FTA
- Duplicate
- Rejected
- Migrated
- Safety Relevant
- Ambiguous
- Non-relevant
- Legacy (ICSR and PSURYes)
- Non-case
- Rejected review
- Safety medical Review
- Duplicate review
- End
- ICSR Medical review
- ICSR Client review
- Safety Peer review
- Safety Client review
- ICSR Peer Review
- Awaiting FTA
- Master Initial Review
- Unclaimed
- Claimed
- Claimed by me
- Click on the information Button within the Inbox table row
- A pop-up window appears that provides summarised details pertaining to that particular query.
- Click on the Duplicate button within the Inbox table row
- A pop-up window appears that provides information on Duplicate Citations.
Hover on Red Tag Icon within the Inbox table row and you will see the Activity Completion date.
Hover on Red Flag icon within the Inbox table row will allow the user to see the Lifecycle Completion date (Entire Workflow Completion date).
In the Duplicate Citations Window, there are 4 categories.
- Exact Match – This is denoted by a RED marker before each Serial number. Here the PUI, Title and Abstract is exactly matching.
- Potential Match – This is denoted by an AMBER marker before each Serial number. Here either the PUI or DOI or Both are matching.
- Probable Match – This is denoted by a YELLOW marker before each Serial number. Here 90% (or as configured) text match with Title/Author is found.
- Legacy Match – This is denoted by a GREY marker before each Serial number. Here any of above match is found (need to be defined/explained more) but in Legacy data.
Click on the Serial Number of a Citation from the Inbox table to open the Citation in Read-Only Mode.
On the Literature Inbox, Click on Claim Button to Claim that particular Citation. This feature ensures that only the user who has claimed the citation can work on the same.
On the Literature Inbox, Under the Edit column, click on the checkbox(s) to select multiple citations and then click on Claim Button located on the Top Right-Hand corner of the application to Claim the selected Citations.
- Clicking on the Edit/Claim button of any citation available in Literature Inbox page would bring up the Citation details page as shown below.
- In the Citations details page the following information is displayed.
- Serial number of citations.
- Business unit Id, Product, search title, Search date, no of citations, Auto Classifications.
- Clicking on the Pencil Button, you can update the citation, you will be able to enter values in fields and save the citation manually of all entered values in fields.
- Copy all citation content by clicking on more and click on Copy Citation.
- Close the item and reset the claim by clicking on unlock icon button available in top right corner in citation detail page.
- (i) icon located after the authors field provides access to the individual details of each author.
- Select the claimed citation(s) using the Edit column checkbox and then click on the Reset Claim Button, that is located on the Top Right-Hand corner of the application.
- User(s) will get a confirmation dialog box requesting for confirmation before resetting the citation. Note: Users who have access to to particular Business Unit can reset the claimed citations.
- Select the claimed citation(s) using the Edit column checkbox and then click on the Complete Activity Button, that is located on the Top Right-Hand corner of the application.
- Note: The Three dots(…) will allow the user to complete the activity based on Workflow Activity Rules.
- Lock icon indicates that the Citation has been claimed by another User and they are working on it or it is part of their workflow. Note:Clicking on the Citation that is locked opens the citation in read-only mode.
Pencil /Edit icon indicates that the Citation is claimed by you. Clicking on this icon the Citation would be enabled for editing – a Citation is opened in the window. (Refer Editing Citation for more details on this step)
Clicking on Quick Action button allows you to Open the ‘Quick Action’ options.
a) In Quick Action Page.
a) In Quick Action Page.
- User will be able to view Abstract citation text.
- User will be able to select Classification’s.
- User will be able to select safety information, assessment in respective dropdown.
- User can select literature Reference Evaluation list.
Evaluation Summary can be found in the Evaluation Column of the Literature Inbox. It appears as a progress % box.
Clicking on Evaluation Progress Bar will display the Evaluation Summary pop-up.
- Click on the Inbox Hierarchy Expand button which is on the Top Left-Hand side of the application.
- Hierarchy pannel will open on the left-hand side of the application.
- User(s) can select (drill down) from Business Unit to Product to Week level citation information.
Within ReTrans, Scoreboard is a page that presents the user(s) the summarised information related to status of various activity in the Citation Workflows.
User(s) get an ‘Overall Summary’ about the status of the Citation workflows within the Inbox for the selected Business Unit.
User(s) get to see the status related various ‘Activity’ of the workflow.
For example, How many Auto Triage related activity is Open, Claimed, Unclaimed,or Overdue.
For example, How many Auto Triage related activity is Open, Claimed, Unclaimed,or Overdue.
User(s) can select the Business Unit by choosing from the drop-down menu.
User(s) can refresh the summary tables by clicking on the ‘Refresh score’ button.
Note: The Scoreboard page will refresh automatically every Two hours.
Note: The Scoreboard page will refresh automatically every Two hours.
Operational Reports provides information on the day-to-day activities, performance, or status of a review and completion. They include various reports such as overall summary of incoming records, summary on QC Matrix, summary of user timelines completion etc for the defined period.
From the Literature menu, Click on Operational Reports.
The Operational Reports page containing all Operations reports will be display.
User can view the full list of Operational Reports with details pertaining to Title, Description, Business Unit, Start Date, End Date, generated by and generated on.
Users can scroll through full list of pages using the Page Navigation function.
Users can scroll through full list of pages using the Page Navigation function.
User can download any specific report by clicking on the Download button found on the right end corner of each row containing the report details.
Generated Report CSV file by clicking on the Download icon, and the file will be downloaded.
Generated Report CSV file by clicking on the Download icon, and the file will be downloaded.
Advance Filter button can be found on the Top-Right-hand side of the Operational Reports Summary page
Clicking on this button gives the User a Dialog Box in which the User can search for certain report based on any of the combination viz., Title, Description, Business Unit, Start Date, End Date, Generated On Date (from), and Generated on Date (To).
User can download (Generate) any specific report by clicking on the Download button found on the right end corner of each row containing the report details.
The downloaded Operational Report is in Excel Format and it contains information in various sheet tabs. Viz.
- Summary of Literature Reference
- Product Summary
- Sub Classification Summary
- Final Assessment
- Abstract and FTA Review Summary
- User Activity Summary
- WF Pending By Activity
- Quality QCer
- Timeline Summary
- Current WF Management Summary
The User needs to click on Clear button to remove any filter(s) that is applied on the Operational Reports summary page.
The User can sort the details shown on the summary page by Title, Start Date, End Date, and Generated On columns. The user can click on the Headings mentioned above to sort the table in ascending or descending order of that column.
Trackers allow User to track the information of Workflow, Citation, submissions, actions etc. based on certain actions completed on them.
Click on Literature Menu, then click on TRACKER, this will display the list of Trackers available on the software.
- Literature Actions
- ICSR Meto Info
- ICSR Periodic Report
- Workflow Activities
- Master Tasks
- Master Distribution
- Email Submissions
Literary actions encompass all the actions that have been created, allowing users to update them according to their preferences.
- User can click on Edit and update the action as notes in the Dialog box that opens.
- User can filter the Literature using the Advance Filter button.
- User can place a request for generating certain reports by clicking on the Generate Reports button and choosing the required field. The generated reports can be viewed under Saved Reports Screen.
Under the main menu click on Reports>Inbox Reports>Generated Reports. (refer Reports).
Click on Literature and click on Tracker > ICSR Meta Information. Users can access the citation in read-only mode by clicking on serial numbers.
User can update Case Number, Case Submission Status, Submission Due Date, Case Status and Remarks.
Updated data will reflect in the citation’s Case Creation sub tab (refer Inbox>Case Creation sub tab)
Updated data will reflect in the citation’s Case Creation sub tab (refer Inbox>Case Creation sub tab)
User can apply the Advance Filter to filter the respective record as shown below, by entering valid credentials with respective to the fields.
The User needs to click on Clear button to remove any filter(s) that is applied on the ICSR Meta Information page.
User can generate CSV report for the searched records by clicking on Generate report(CSV) and adding title and description to the pop-up box.
As part of periodic submission, if any of the records needs to be tagged for periodic reporting, this module can be used.
Click on Literature and click on Tracker > ICSR Periodic Report. Users will view the summary table containing fields/information of Case Number, Report Type, Business Unit, Next Due Date, Remarks, Report Status, and Created Date that is linked to a Serial number. The user can change this information and the same will be promptly reflected in the citations edit page.
Click on Literature and click on Tracker > ICSR Periodic Report. Users will view the summary table containing fields/information of Case Number, Report Type, Business Unit, Next Due Date, Remarks, Report Status, and Created Date that is linked to a Serial number. The user can change this information and the same will be promptly reflected in the citations edit page.
User can click on the Pencil Button next to the case number and Edit the information.
User can apply the Advance Filter to filter the respective record as shown below, by entering valid credentials with respective to the fields.
The User needs to click on Clear button to remove any filter(s) that is applied on the the ICSR Periodic Report Listing page.
The User can sort the details shown on the summary page by Next Due Date and Created Date columns. The user can click on the Headings mentioned above to sort the table in ascending or descending order of that column.
Click on Literature and click on Tracker > Workflow Activities. User can change the Activity of the citation and verify in Tracker for the respective activity by its Serial number also user can verify in Activity Sub tab in citation edit page. (Refer Activity Sub Tab).
Click on serial number to view read only page. User can view:
User can apply the Advance Filter to filter the respective record as shown below, by entering valid credentials with respective to the fields.
Master tasks are designed to capture unexpected events, failure events, and those requiring corrective actions or verification. Here are a few examples of when tickets should be created:
• When a search query returns zero hits, which could be due to the actual result being zero or a technical error.
• If there is a mismatch between the total number of hits mentioned in the summary and the total number of items created.
• During the execution process, if there is unexpected behavior or any exceptions, such as missing configurations or API call failures.
Please note that tickets can be created and tracked manually. Upon ticket creation, an email notification will be sent to the designated admin user. Tickets must be closed manually after verification.
• When a search query returns zero hits, which could be due to the actual result being zero or a technical error.
• If there is a mismatch between the total number of hits mentioned in the summary and the total number of items created.
• During the execution process, if there is unexpected behavior or any exceptions, such as missing configurations or API call failures.
Please note that tickets can be created and tracked manually. Upon ticket creation, an email notification will be sent to the designated admin user. Tickets must be closed manually after verification.
user can update the created Master Task by clicking on pencil button. It will open Update Master Task pop-up window. Except Title and Executed By field, all other fields can be updated. Remarks can be added as well.
Distributed citation will be tracked under Master Distribution. In the distribution section, user will be able to view the serial number, the user who distributed it, the source business unit, the business unit, the description and the date of distribution. User can click on the serial number to access literature read only page.
The editing privileges are not available for the user on this page.
Yes, Refer To Advance Filter and Generate report (CSV) sections.
User can track the Email submission records. Shows all the case that have been created, allowing users to update them according to their requirement.
User can click on the pencil icon to update/modify, Can also add remarks.
Yes, Refer To Advance Filter and Generate report (CSV) sections.
1. Note: How to clear the Filter selection on any page?
The User needs to click on Clear button to remove any filter(s) that is applied on the page.
2. Note: Can a report be generated for the searched/filtered records on all sub tabs/pages under Tracker Menu?
User can generate CSV report for the searched records by clicking on Generate report(CSV) and adding title and description to the pop-up box. After the user enters the Title and clicks on submit a success notification with request Id will be displayed.
User can then navigate to Generated reports to download the report.
User can download the report by clicking on download icon from the Saved Reports Page Listing
The User needs to click on Clear button to remove any filter(s) that is applied on the page.
2. Note: Can a report be generated for the searched/filtered records on all sub tabs/pages under Tracker Menu?
User can generate CSV report for the searched records by clicking on Generate report(CSV) and adding title and description to the pop-up box. After the user enters the Title and clicks on submit a success notification with request Id will be displayed.
User can then navigate to Generated reports to download the report.
User can download the report by clicking on download icon from the Saved Reports Page Listing