Article Screening

In this page, all details of the citation are presented in order for users to complete their assessment. Here, users can:

• Record screening decisions according to the desired workflow: Individual Case Safety Reports, Signal detection, etc

• Upload supporting documentation as attachments: full text articles, translations, etc. in pdf format

  • Learn more in: Attachments and Full text Screening

• Enter adverse event details for case processing and export as an E2B file (R2 or R3)

• Review all decisions recorded by users in chronological order in the Audit Log

The Main tab in the displays citation details: title, abstract and keywords, and a side bar with navigation, highlighting and input fields for recording decisions:

Navigation Pane

Use the arrows to navigate to previous/next articles according to the criteria selected in the Review Details screen.

Click the filter icon to see a summary of chosen sort and filter options in use. (recall that selected tab, filters and sort options "follow" the user to the detail screen)

Highlighted Annotations

MLM-AI automatically annotates the abstract for patient information, special situations, medications, etc. You can toggle highlights on/off for these annotations to help screen abstracts quicker.

• Any identifiable patients immediately found in the abstract can be found with the patient highlighter:

• Sections of interest relate to passages in the abstract where adverse events descriptions are likely to be discussed

• The Target highlighter indicates the target product, while the Medications highlighter indicates all other medications mentioned in the abstract.

• The special situation highlighter will indicate any occurrence of terms related to pregnancy, elderly or pediatric uses, occupational exposure, drug misuse, etc:

Saving Decisions

When screening is done, add results and click Submit. The decision pane provides a number of options to suit your workflow:

• The Serious Event, Aggregate Reporting and Safety Signal checkboxes to mark articles of interest for later reporting

• Select one or more special situations relevant to the abstract

• Select one or more categories (exclusions)

  • When the review decision is of type "Not ICSR - Exclusion Required", selecting at least one category is mandatory

• You can optionally add free text commenting on your decision

Expand Decision View

An expanded view of the decision window is available by clicking the widget next to the Submit button:

Clicking on it opens an expanded view which also shows the article audit log for reference. This view is useful when the comments box requires more space for editing:

Related Articles

When the same article is returned on different monitors, they become visible in the "Related" tab. Users can directly inspect related articles and also save decisions to all articles from a single operation. Learn more on:

Tips for Faster Screening

When saving screening decisions, users can type into the drop down to narrow the available options:

Selecting Next Article on Submit using the settings toolbox will automatically move to the next article to screen after saving a decision.

Page Locking

When Article page locking is enabled, users will see a lock icon indicating lock status:

• A green lock means the article has been locked by the user and editing is allowed

• A red lock means the article is locked by another user, editing the article is not allowed.

After a configured number of seconds, users will see a prompt warning the lock on the page is about to expire. This ensures articles don't remain locked indefinitely:

• See also: Article Locking in System Settings

Editing Annotations

Users can modify the annotations presented by MLM-AI and save their changes. This information can be used in later stages of case management.

The highlighter toolbox on the right-side menu allows users to add and remove annotations as needed:

• Select the "editor" tool and select text with the mouse anywhere in the abstract to display the annotations pop-up

• Select the "eraser" tool and select any highlighter to remove it

Reviewing Changes

The Data tab summarizes captured terms by category.

• Removing a term from this page will remove all the annotations for that term

• Clicking the Reset button restores the original annotations captured by MLM-AI

Any changes will be saved together with the article decision when user clicks the Submit button.

Article Details

Additional information about the article such as authors, journal and publication date are available from the "Details" tab. This tab will also provide external links to the article and full text (if freely available).

Email Article

From this screen articles can be shared out to an approved (to add to this list please contact your system administrator) list of recipients using the button highlighted below:

The Audit Log

All decisions saved by users or automatically generated by MLM-AI will be timestamped and recorded in the article's audit log ("Audit Log" tab):

• The article audit log is also visible on data exports (see below)

• The E2B icon details whether any changes were performed on the E2B record associated with this citation, if applicable

Exporting Data

It is possible to export article and assessment data in various formats. From the Article screen the download icon presents possible options:

Formats available:

• Excel containing article and assessment decision data. The "QC" version includes a column view of all recorded decisions for the article

• HTML containing the article abstract and latest assessment decision (if any)

• E2B export in XML format (R2 or R3, see E2B section below)

• ZIP: A single zip file containing:

  • HTML version of the abstract

  • E2B XML (if enabled)

  • All associated attachments

Attachments

It is possible to upload reference data related to the assessment as Attachments, keeping all relevant information in a single place for the entire team.

Attachments are seamlessly displayed from the application and support automatic machine translation from a source language into English.

Learn more in the Attachments page.

E2B

When screening for cases, it may be useful to also record detailed adverse reaction information from the article. Reaction data can be directly exported as an E2B XML file in either R2 or R3 formats, for processing in a safety database.

• In the E2B tab you can create one or more patients corresponding to cases from the article by clicking "Add Patient"

• Each patient can be populated with verbatim information describing the event

• MLM-AI will suggest terms for patient, medication and events, based on highlights from the abstract text

• MLM-AI will auto-populate reporter as the article's main author

Once data is saved, an E2B R2 or R3 XML file can be generated directly from the download icon in the article page: