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

SafetyDocs supports regular monitoring of medical literature to create a more transparent process around Individual Case Safety Report (ICSR) detection and signal identification. You can:

Store your documents in a centralized location, simplifying reporting obligations
Review documents in bulk
Provide independent verdicts for literature articles that reference multiple products or cohorts of patients
Document and immediately action decisions around relevance, such as opening a Case
Mark literature articles for inclusion in aggregate reports
Conduct literature article quality control (QC) sampling

Additionally, if configured by your Admin, Vault can link and submit full-text and summary literature articles with E2B transmissions.

Literature Review Process

In SafetyDocs, the literature review process includes the following steps:

Create a Literature Review.
Start a Literature Review workflow and begin searching for literature articles.
Upload literature documents into your Vault.
Create a Literature Article for each article.
Start a Literature Article Review workflow for each article. Review each Literature Article, recording ICSRs and new safety information and documenting action taken as needed.
Close out each Literature Article Review workflow.
Close out the Literature Review workflow.

Prerequisites

To use all of the features described on this page, your Admin must enable:

Note: If your Admin has configured the Literature Integration to PubMed feature, you can manually test the database connection from within a Literature Search Term record. Learn how to test the PubMed database connection.

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 Export

If your organization uses the Create Inbox Items from Literature Articles feature, for Cases created from Literature Articles, when generating E2B reports Vault includes attachments with the Literature Article classification if the Retransmit field is Yes.

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 record allows you to compile and manage all articles being reviewed for a specific product or product family and time period, helping you 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:

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

To create a Literature Review:

Navigate to Literature > Literature Reviews.
Select Create.
Complete the applicable fields on the Create Literature Review page, then select Save:

Field	Description
Name	Vault populates this value.
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	Select the primary Product that applies to the review from the drop-down or use the Advanced Search () icon to use filters and refine your search.
Product Family	Select the Product Family that applies to the review from the drop-down or use the Advanced Search icon to use filters and refine your search.
Review Type	Select the type of review from the picklist: Periodic Ad-Hoc Signal Detection
Description	Enter a description of the literature review. This field supports up to 1,500 characters.
Literature Search Group	Select the Literature Search Group related to the associated Literature Standard Search Term from the drop-down or select the Advanced Search icon to use filters and refine your search. This field supports up to 1,500 characters. Vault uses this value to group Literature Review records when conducting automatic literature searches, such as the PubMed database search.
Organization	Select the Organization for the literature review. To see how Vault uses the value in this field, see Create Inbox Items from Literature Articles.

Search Terms

Literature Search Term records allow you to keep records of search terms relevant to a literature review, recording your queries within each database and maintaining audit trails to ensure compliance with literature review obligations. We recommend creating a separate Literature Search Term for each search term.

From the Search Terms section, select Create then complete the following fields to create a Literature Search Term:

Field	Description
Standard Search Term	A query for which a Literature Standard Search Term has been created in your Vault. Select a Literature Standard Search Term from the drop-down or select the Advanced Search () icon to use filters and refine your search.
Literature Database	Select the Literature Database in which the review was performed from the drop-down 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. Note: Provided your Admin has configured Literature Integration to PubMed, this integration functionality only works for Literature Search Terms with a Literature Database value of PubMed.
Product	Select the Product related to this search term from the drop-down or use the Advanced Search icon to use filters and refine your search.
Product Family	Select the Product Family related to this search term from the drop-down or use 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 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.

Test the PubMed Database Connection

If your Admin has configured your Vault to integrate with the PubMed database, your Vault runs daily automated literature searches within the PubMed database. This feature simplifies the literature review process by searching PubMed for the Search Term field values on your Literature Search Terms, then using the search results to create and populate new Literature Reviews and Literature Articles in your Vault.

When enabled, this feature automatically connects your Vault to the PubMed database every 24 hours and sends notifications to the user specified on the PubMed Connection record for any connection errors. However, you may also choose to manually test the PubMed database connection from within any Active-state Literature Search Term with a Literature Database value of PubMed.

To manually test the PubMed database connection:

Navigate to Literature > Literature Reviews.
Select a Literature Review.
In the Search Terms section, select a Literature Search Term.
Select the inline All Actions icon then select Search Database.

Result

To indicate a successful PubMed database connection, Vault displays a temporary banner at the top of the page with the message Successfully completed "Search Database".

Literature Articles Section

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

Documents Section

In the Documents section, link the relevant articles and review documents that have been uploaded to the Vault 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 a Literature Article to store details such as the article’s DOI, title, abstract, and the search terms used to find it. To support independent verdicts for literature articles with multiple products, when you create a Literature Article, Vault links it to related Products and Product Families through Literature Article Products.

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.

To create a Literature Article:

Navigate to Literature > Literature Articles.
Select Create.
Complete the applicable fields on the Create Literature Article page, then select Save:

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	Enter 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 when you initially save the Literature Article. Vault does not automatically update this value 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	Select the Literature Search Term used to find the article from the picklist or use the Advanced Search icon to use filters and refine your search.
Product	Select the primary Product that applies to the article from the drop-down or use the Advanced Search icon to use filters and refine your search. Vault updates this field in the following instances: If you set the Rank field on a Literature Article Product for a different Product to `1`, Vault updates this field to reflect the new primary Product. The Product in this field becomes the primary Product on related Cases. If the Literature Article includes only one (1) Literature Article Product and you change its selected Product, Vault sets this field to the new Product.
Product Family	Select the Product Family that applies to the article from the drop-down or use the Advanced Search icon to use filters and refine your search. If the associated Literature Review includes a value in the Product Family field, Vault populates the same value on the Literature Article. Vault updates this field in the following instances: If you set the Rank field on a Literature Article Product for a different Product Family to `1`, Vault updates this field to reflect the new Product Family. If the Literature Article includes only one (1) Literature Article Product and you change its selected Product Family, Vault sets this field to the new Product Family.
Product Overridden?	Indicates whether the Product on the Literature Article has been changed from the primary Product. When Vault sets the Product in the Literature Details section based on the Literature Article Product with the Rank field set to `1`, Vault sets this field to Automatic. If you manually update the Product on the Literature Article, Vaults sets this field to Overridden.
URL	Enter a link to the article. This field supports up to 255 characters.
URL (Full Text)	Enter a link to the full-text version of the article. This field supports up to 1,500 characters.
URL (PDF)	Enter a link to the PDF version of the article. This field supports up to 1,500 characters.
Organization	Select the Organization for the article. To learn how Vault uses the value in this field, see Create Inbox Items from Literature Articles.
Vancouver Citation (English)	When importing literature reference information from a database, Vault generates a Vancouver Citation for articles that have Journal as their Reference Type, then maps the citation to this section. For Cases created from Literature Articles, when generating E2B reports, Vault maps the Vancouver Citation value to the applicable data element: E2B(R2): A.2.2 Literature Reference(s) E2B(R3): C.4.r.1 Literature Reference(s)
Aggregate Report Outcome	Select a value from the picklist to indicate whether to include this Literature Article in the next aggregate report cycle: New and Significant for Aggregate Reporting Not Relevant for Aggregate Reporting Whenever this value changes on the Literature Article, Vault maps the updated value to its Literature Article Products in the following cases: If the Literature Article has no Literature Article Product records, Vault creates a Literature Article Product and maps its Aggregate Report Outcome value. If the Literature Article has only one (1) Literature Article Product, Vault maps the Aggregate Report Outcome value to that Literature Article Product.
Aggregate Report Special Type	Select one (1) or more values from the picklist to indicate any special categories for the Literature Article for inclusion in aggregate reports: Pregnancy outcomes (including termination) with no adverse outcomes Use in paediatric populations Compassionate supply, named patient use Lack of efficacy Asymptomatic overdose, abuse or misuse Medication error where no adverse events occurred Important non-clinical safety results Whenever these values change on the Literature Article, Vault maps the updated value to its Literature Article Products in the following cases: If the Literature Article has no Literature Article Product records, Vault creates a Literature Article Product and maps its Aggregate Report Special Type values. If the Literature Article has only one (1) Literature Article Product, Vault maps the Aggregate Report Special Type values to that Literature Article Product.
PubMed ID	For PubMed articles, enter the article's unique PubMed database identifier.
Medline ID	For MEDLINE articles, enter the article's unique MEDLINE database identifier.

Literature Article Product Section

When you set a Product or Product Family on a Literature Article, Vault creates a Literature Article Product with a Rank of 1 and a link to the Product or Product Family. This is helpful if you review articles that reference either multiple separate cohorts of patients or groups of patients taking multiple company products.

You can add or change Literature Article Products, which is useful for articles that reference multiple products and for updating the primary Product, using the following fields:

Field	Description
Name	Vault populates the name for the record.
Product	Select Edit to add or change the Product. When you create a Literature Article that specifies a Product, Vault maps the value to this field. If the Product on the Literature Article changes and there is only one (1) Literature Article Product record, Vault updates the value in this field. Note: Every Literature Article must include at least one (1) Product or Product Family.
Product Family	Select Edit to add or change the Product Family. When you create a Literature Article that specifies a Product Family, Vault maps the value to this field. If the Product Family on the Literature Article changes and there is only one (1) Literature Article Product, Vault updates the value in this field. Note: Every Literature Article must include at least one (1) Product or Product Family.
Rank	Upon Literature Article record creation, Vault sets the Literature Article Product to Rank `1`. If you add a Literature Article Product and set the Rank to `1`, Vault updates the previous Rank `1` Literature Article Product to `2` and updates the Product and Product Family fields on the Literature Article to the new primary values.
ICSR Review Outcome	When you create a Literature Article record that specifies the ICSR Review Outcome, Vault maps the value to this field. If the value in the ICSR Review Outcome field of the Review Outcome section changes and there is only one (1) Literature Article Product, Vault updates the value in this field. If the ICSR Review Outcome field in the Review Outcome section of the Literature Article is populated and you add or change the value in this field on a Literature Article Product to a more conservative outcome, Vault updates the ICSR Review Outcome value in the Review Outcome section to the new value. ICSR review outcomes include the following options, listed from least conservative to most: No ICSRs Contained More Information Needed Confirmed ICSR(s)
Investigation Review Outcome	When you create a Literature Article that specifies the Investigation Review Outcome, Vault maps the value to this field. If the value in the Investigation Review Outcome field of the Review Outcome section changes and there is only one (1) Literature Article Product, Vault updates the value in this field. If you add or change the Investigation Review Outcome value on any Literature Article Product, Vault updates the Investigation Review Outcome value in the Review Outcome section to the new value.
Literature Article	Vault populates a link to the associated Literature Article.
Number of Identified Cases	When you create a Literature Article that specifies the Number of Identified Cases, Vault maps the value to this field. If the value in the Number of Identified Cases field of the Review Outcome section changes and there is only one (1) Literature Article Product, Vault updates the value in this field.
Special Report Classification Outcome	When you create a Literature Article that specifies a Special Report Classification Outcome, Vault maps the value to this field. If the value in the Special Report Classification Outcome field of the Review Outcome section changes and there is only one (1) Literature Article Product, Vault updates the value in this field.
Aggregate Report Outcome	Select a value from the picklist to indicate whether to include this Literature Article Product in the next aggregate report cycle: New and Significant for Aggregate Reporting Not Relevant for Aggregate Reporting Whenever this value changes on the Literature Article Product, Vault maps the updated value to its parent Literature Article in the following cases: If the Literature Article has only one (1) Literature Article Product, Vault maps its Aggregate Report Outcome value to the Literature Article. If the Literature Article has multiple Literature Article Products and at least one (1) of these records has an Aggregate Report Outcome value of New and Significant for Aggregate Reporting, Vault maps that value to the Literature Article.
Aggregate Report Special Type	Select one (1) or more values from the picklist to indicate any special categories for the Literature Article Product for inclusion in aggregate reports: Pregnancy outcomes (including termination) with no adverse outcomes Use in paediatric populations Compassionate supply, named patient use Lack of efficacy Asymptomatic overdose, abuse or misuse Medication error where no adverse events occurred Important non-clinical safety results Whenever these values change on the Literature Article Product, Vault maps the updated values to its parent Literature Article in the following cases: If the Literature Article has only one (1) Literature Article Product, Vault maps its Aggregate Report Special Type values to the Literature Article. If the Literature Article has multiple Literature Article Products, Vault maps all Aggregate Report Special Type values from all child Literature Article Products to the Literature Article.

Duplicate Section

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

Field	Description
Duplicate Literature Article	If multiple Literature 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 Section

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

Field	Description
ICSR Review Outcome	Select an ICSR review outcome from the following options, listed from least conservative to most: No ICSRs Contained More Information Needed Confirmed ICSR(s) Vault updates this field in the following instances: If this field is blank and you populate the ICSR Review Outcome field on a Literature Article Product record, Vault applies the value to this field. If this field is populated and then you log a more conservative ICSR review outcome on an associated Literature Article Product record, Vault maps that value to this field. For example, if the ICSR Review Outcome field in this section is set to More Information Needed and you subsequently set the same field on a Literature Article Product record to Confirmed ICSR(s), Vault sets this field to Confirmed ICSR(s). If your outcome is Confirmed ICSR(s) and your organization is licensed for Veeva 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. When multiple Literature Article Products include outcomes, Vault updates this value with the total number of identified cases across all Literature Article Products.
ICSR(s) Serious?	When importing an EMA MLM RIS file, Vault populates this field depending on the value of the Serious (SR) tag in the file: If the tag value is `Y`, Vault sets this field value to Serious. If the tag value is `N`, Vault sets this field value to Non-serious.
Investigation Review Outcome	Select an investigation review outcome from the following options, listed from least conservative to most: No Further Action New Safety Information Vault updates this field in the following instances: If this field is blank and you populate the Investigation Review Outcome field on a Literature Article Product, Vault applies the value to this field. If this field is populated and then you log a more conservative investigation review outcome on an associated Literature Article Product, Vault overrides the value in this field. For example, if the Investigation Review Outcome field in this section is set to No Further Action and you subsequently set the same field on a Literature Article Product to New Safety Information, Vault sets this field to New Safety Information.
Special Report Classification Outcome	For JAPIC-imported articles that will be promoted to Cases, select from the following options, listed from least conservative to most: Safety Measures Report Research Report Vault updates this field in the following instances: If this field is blank and you populate the Special Report Classification Outcome field on a Literature Article Product, Vault applies the value to this field. If this field is populated and then you log a more conservative special report classification outcome on an associated Literature Article Product, Vault overrides the value in this field. For example, if the Special Report Classification Outcome field in this section is set to Safety Measures Report and you subsequently set the same field on a Literature Article Product to Research Report, Vault sets this field to 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 Section

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
EMA Inclusion/Exclusion Criteria
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

Note: When importing an EMA MLM RIS file, Vault populates the Inclusion/Exclusion (IE) tag value in the EMA Inclusion/Exclusion Criteria field.

Keywords Section

Use this section to record keywords from the article.

Literature Author Section

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

Field	Description
Author Type	Select the type of author from the picklist: Primary Non-Primary Editor Translator
First Name	Enter the author's first name. This field supports up to 60 characters.
Last Name	Enter 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 Section

When importing literature reference information from a database, Vault generates a Vancouver Citation for articles that have Journal as their Reference Type, then maps the citation to this section.

Abstract Section

Use this section to record the article’s abstract.

When the Abstract field is updated, Vault searches the field value for any mention of company products. If a company product is found, Vault automatically tags it with a new Literature Article Product record.

Translate Non-English Abstracts

When your Literature Article has an Abstract Language field value other than English, the Abstract section displays a drop-down that allows you to toggle the abstract between English and the original language. Alternatively, you can use the keyboard shortcut.

Highlight Literature Abstract Terms

Depending on your Admin’s configuration, Vault can automatically highlight relevant terms in the Abstract field, allowing you to quickly review highlighted terms in order to determine whether a full-text review is necessary.

When in Read mode on a Literature Article, the Abstract section displays a row of buttons above the Abstract field, with each button labeled with the term type and a count of the number of times it appears in the abstract. Within the body of the Abstract field, Vault underlines and highlights each term using the color of the term type’s button.

Vault determines which terms to highlight (and which terms to include in the button count) based on the following:

Product button: All records for the following objects:
- Product
- Product Family
- Product Alias
- Study
- Substance
- Substance Alias
Medical Events button: All records for the following objects:
- MedDRA
- MedDRA Query
- MedDRA Synonym
Patient button: All Literature Highlighted Term records in the Active state with a Term Category value of Patient
Seriousness button: All Literature Highlighted Term records in the Active state with a Term Category value of Seriousness
Literature Term button: All Literature Highlighted Term records in the Active state with a Term Category value of Company Term

To turn off term highlighting for a specific term type, select its term type button. To toggle term highlighting on or off for the entire Abstract field, press Alt + H on your keyboard (Opt + H on Mac).

Note: Highlight Literature Abstract Terms only works when the Abstract field is in Read mode and the language setting is English. If your Literature Article is in Edit mode or if your Abstract section is set to a non-English language, the highlight functionality is not available.

Literature Additional Information Section

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

Literature Workflows

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. When configured by your Admin, Vault routes a percentage of Literature Articles with an Aggregate Report Outcome value of New and Significant for Aggregate Reporting through an additional quality control (QC) review step.