Manage the Literature Review Process

Learn how to support compliance through faster literature screening and management.

Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.

About Literature Reviews

Vault SafetyDocs offers support for regular monitoring of medical literature to create a more transparent process around Individual Case Safety Report (ICSR) detection and signal identification.

You can review documents in bulk and store them in a centralized location to simplify the management of your reporting obligations. Decisions around relevance can be documented and immediate action can be taken, such as opening a Case when applicable.

The literature review process includes the following steps:

Create a Literature Review record.
Start a Literature Review Workflow.
Begin searching for literature articles as part of the Literature Review Workflow.
Upload literature documents into your Vault.
Create a Literature Article record for each article.
Start a Literature Article Review Workflow for each article.
Review each Literature Article and record ICSRs and new safety information. Document action taken as needed.
Close out each Literature Article Review Workflow.
Close out the Literature Review Workflow.

Go through the information on this page to see how each of these steps should be completed.

Prerequisites

Your Admin must configure your Vault to use the features described on this page. The following pages provide more information:

Working with Literature Documents

When uploading literature documents such as articles or review documents, use the Literature document type. This includes the following subtypes and classifications:

Literature > Literature Article > Full-Text
Literature > Literature Article > Summary
Literature > Review Document > Database Extract

Upload literature documents using the same process as for other document types. For more information, see Adding Documents.

Create a Literature Review

Creating a Literature Review allows users to compile and manage all articles being reviewed for a specific product and time period. This helps keep track of each step in the literature review process.

Within a literature review, you can define the type of review, such as periodic, ad hoc, or signal detection, as well as complete the following actions:

Store search terms
Link related documents
List the literature databases where searches were conducted
Document review outcomes

Complete the following steps to create a Literature Review:

Go to Literature > Literature Reviews.
Select Create.
Complete the fields on the Create Literature Review page.
Select Save.

Field	Description
Name	This is a system-generated field.
Review Period Start	Enter the first date of the review. Use the calendar to select the date or enter the date manually.
Review Period End	Enter the first date of the review. Use the calendar to select the date or enter the date manually.
Product	The primary product that applies to the review. Select a product from the dropdown or use the Advanced Search icon to use filters and refine your search.
Review Type	Select the type of review from the picklist. The available options include the following: Periodic Ad-Hoc Signal Detection
Description	Enter a description of the literature review. This field supports up to 1,500 characters.

Search Terms

Creating records of the search terms relevant to the literature review allows you to keep track of your queries within each database. These records are helpful for maintaining audit trails and ensuring compliance with literature review obligations.

Creating separate records for each search term is recommended.

Complete the following fields to create a Search Term:

Field	Description
Standard Search Term	A query for which a Literature Standard Search Term record has been created in your Vault. Select a record from the dropdown or select the Advanced Search icon to use filters and refine your search. For more information, see Create Literature Standard Search Terms.
Literature Database	The database in which the review was performed. Select a database from the dropdown list or select the Advanced Search icon to view the Search: Literature Database window. In this window, use filters to refine your search or select Create to create a database.
Product	The product related to this search term. Select a product from the dropdown or select the Advanced Search icon to use filters and refine your search.
Search Expression Number	For JAPIC-imported references, enter the unique number associated with this search term. Vault uses this value to identify if a matching Literature Search Term or Literature Standard Search Term record already exists and to populate fields accordingly. For more information on Search Expression Number matching, see Import Literature References from Database Files.
Search Term	Enter the search term that you used. This field supports up to 5,000 characters.

Literature Articles

In the Literature Articles section, add existing Literature Articles using the search bar, or create new records by selecting Create.

See Create Literature Articles for more information.

Documents Section

In the Documents section, link the relevant articles and review documents that have been uploaded to the Vault Safety library.

Field	Description
Document Number	Select the document number of the document you want to link.
Type	Vault populates this field based on the selected literature article's Document Type.
Subtype	Vault populates this field based on the selected literature article's Subtype.
Classification	Vault populates this field based on the selected literature article's Classification.
Status	Vault populates this field based on the selected literature article's Status.

Create Literature Articles

For each article included in your review, you can create records to store details such as the article’s DOI, title, abstract, and the search terms used to find it.

Complete the following steps to create a Literature Article:

Go to Literature > Literature Articles.
Select Create.
Complete the fields on the Create Literature Article page.
Select Save.

Note: When importing literature references in bulk from a third-party database, Vault creates Literature Article records and maps all fields from the imported RIS file to relevant sections on the article records. For more information and a detailed breakdown of this mapping, see Import Literature References from Database Files.

Field	Description
Title of Article	Enter the title of the article. This field supports up to 1,500 characters.
Title (English)	For non-English articles, enter the title of the article in English. This field supports up to 1,500 characters.
Access Date	The date on which the article was accessed. Use the calendar to select the date or enter the date manually.
Abstract Language	The language of the article's abstract. Vault populates this field by detecting the language of the abstract. This field is populated on the initial save of the article, and is not automatically updated if any information changes. Alternatively, select a language from the picklist or use the Advanced Search icon to use filters and refine your search.
Search Term	The Search Term used to find the article. Select a term from the picklist or use the Advanced Search icon to use filters and refine your search.
Product	The primary product that applies to the article. Select a product from the dropdown or use the Advanced Search icon to use filters and refine your search.
URL	A link to the article. This field supports up to 255 characters.
URL (Full Text)	A link to the full-text version of the article. This field supports up to 1,500 characters.
URL (PDF)	A link to the PDF version of the article. This field supports up to 1,500 characters.

Duplicate

Vault uses this section to link to possible duplicate records using the following fields:

Field	Description
Duplicate Literature Article	If multiple articles have the same Document Number or DOI, Vault links the first of these articles in this field.
Duplicate Literature Review	The Literature Review associated with the Duplicate Literature Article.

Review Outcome

Once you have reviewed the article, use this section to record information about its outcome.

Field	Description
ICSR Review Outcome	Select the outcome of the ICSR review from the picklist. The available options include the following: No ICSR(s) Contained More Investigation Needed Confirmed ICSR(s) If your outcome is Confirmed ICSR(s) and your organization is licensed for Vault Safety, you can directly create Inbox Items from the ICSRs and begin Case processing.
Number of Identified Cases	Enter the number of Cases that were identified as a result of the literature article review.
Investigation Review Outcome	Select the outcome of the investigation review from the picklist. The available options include the following: No Further Action New Safety Information
Special Report Classification Outcome	For JAPIC-imported articles that will be promoted to Cases, select from the following options: Safety Measures Report Research Report For more information, see Create Inbox Items from Literature Articles and Process Special Report Classification Cases.
Article Notes	Enter additional notes about the article. This field supports up to 5,000 characters.
Article Review Notes	Enter additional notes from the article review. This field supports up to 5,000 characters.

Reference Information

Use this section to record general reference information about the article, such as:

DOI
Reference Type
Abbreviated Title of Journal
Date of Publication
Country of Publication
Place of Publication
Primary Author Country
Language
Database Name
Database Provider
Publisher
Institution
Conference
Accession Number
Title (English)
Call Number
ISBN/ISSN
Volume
Issue Number
Section
Edition
Start Page
End Page
Reference ID
Document Number
Search Expression Number

Keywords

Use this section to record keywords from the article.

Literature Author

Use this section to record information about the article’s authors.

Field	Description
Author Type	Select the type of author from the picklist. The available options include: Primary Non-Primary Editor Translator
First Name	The author's first name. This field supports up to 60 characters.
Last Name	The author's last name. This field supports up to 60 characters.
Raw	When importing reference information from a database, Vault maps the complete author reference to this field.

Vancouver Citation

When importing literature reference information from a database, Vault generates a Vancouver Citation for articles that have Journal as their type of reference. The citation is mapped to this section.

For more information, see Import Literature References from Database Files: Vancouver Citation.

Abstract

Use this section to record the article’s abstract.

Abstract (English)

If the article’s abstract is in a non-English language and you request a translation, Vault populates this section with the translated English abstract when it is ready.

For more information, see Translate Literature Abstracts.

Literature Additional Information

When importing literature reference information from a database, Vault maps all additional information from your uploaded RIS file to this section.

For more information, see Import Literature References from Database Files: Literature Additional Information.

Literature Workflows

Vault SafetyDocs supports using workflows to keep track of your literature management process. The following sections describe the default workflows available for configuration in your Vault. Your Admin may configure your Vault with alternate steps based on your organization’s processes.

For more information, see Using Object Workflows.

Literature Review Workflow

This workflow follows all the steps involved in conducting a literature review, including searching for articles, deciding whether to go forward with article reviews, and coordinating these reviews.

Literature Article Review Workflow

This workflow follows all the steps involved in conducting article reviews, including sending them out for review and taking action based on the outcomes.