# Manage the Literature Review Process SafetyDocs supports regular monitoring of medical literature to create a faster, 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: 1. [Create a _Literature Review_][5]. 2. [Start a _Literature Review_ workflow][6] and begin searching for literature articles. 3. [Upload literature documents into your Vault][7]. 4. [Create a _Literature Article_][8] for each article. 5. Start a [_Literature Article Review_ workflow][9] for each article. Review each _Literature Article_, recording ICSRs and new safety information and documenting action taken as needed. 6. Close out each _Literature Article Review_ workflow. 7. Close out the _Literature Review_ workflow. ### Prerequisites To use all of the features described on this page, your Admin must enable: * Literature Review Process Management * Literature Integration to PubMed * Creation of Inbox Items from Literature Articles * Importing Literature References from Databases * Literature Abstract Translation * JAPIC Literature Intake * Literature Coding to Product Family * Literature Multi-Product Support * Literature E2B Retransmission
## 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. ## 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_: 1. Navigate to **Literature > Literature Reviews**. 2. Select **Create**. 3. 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 (binoculars-icon) 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 Terms_ 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 of a _Literature Review_, select **Create** then complete the following fields to create a _Literature Search Term_:
Field Description
Standard Search Term

Select a Literature Standard Search Term from the drop-down or select the Advanced Search (binoculars-icon) icon to use filters and refine your search.

If your Admin has configured Literature Integration to PubMed Enhancements, Vault can use this Literature Standard Search Term to map Product, Product Family, Search Term, and Literature Database values when creating ad-hoc Literature Search Terms.
Literature Database

Select the literature database in which the review was performed from the drop-down or select the Advanced Search icon to use filters and refine your search. Alternatively, select Create Literature Database to create a database.

If your Admin has configured Literature Integration to PubMed, Vault can automatically search the PubMed database 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.
Search Term Enter the search term that you used. If your Admin has configured Literature Integration to PubMed, Vault uses this value to search the PubMed database when conducting automated PubMed literature database searches.
#### 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: 1. Navigate to **Literature > Literature Reviews**. 2. Select a **Literature Review**. 3. In the _Search Terms_ section, select a **Literature Search Term**. 4. 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 a Literature Article {#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_.
To create a _Literature Article_: 1. Navigate to **Literature > Literature Articles**. 2. Select **Create**. 3. Complete the applicable [fields][10], then select **Save**. ### Literature Article Fields {#literature-article-fields} The following fields may be available:
Field Description
Title of Article Enter the title of the article.
Title (English) For non-English articles, enter the title of the article in English.
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

Upon initially saving the Literature Article, Vault populates this field by detecting the language of the abstract. Vault does not update this value if any information changes.

Alternatively, select a language from the picklist or use the Advanced Search (binoculars-icon) 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 Literature Article Product and you change its selected Product, Vault populates 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 has a Product Family value, 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 Literature Article Product and you change its selected Product Family, Vault populates 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 populates Automatic. If you manually update the Product on the Literature Article, Vault populates Overridden.
URL Enter a link to the article. If your Admin has configured Literature Integration to PubMed, Vault populates the PubMed record URL when conducting article intake during automated PubMed literature searches.
URL (Full Text) Enter a link to the full-text version of the article.
URL (PDF) Enter a link to the PDF version of the article.
Organization Select the Organization for the article. Vault uses this value when mapping values from Literature Articles to Inbox Items for ICSRs detected during literature article reviews.
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.

When 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 Products, Vault creates a Literature Article Product and maps its Aggregate Report Outcome value.
  • If the Literature Article has only one Literature Article Product, Vault maps the Aggregate Report Outcome value to that Literature Article Product.
Aggregate Report Special Type

Select one or more values from the picklist to indicate any special categories for the Literature Article for inclusion in aggregate reports.

When 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 Products, Vault creates a Literature Article Product and maps its Aggregate Report Special Type values.
  • If the Literature Article has only one 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 Literature Article Product record, Vault updates the value in this field.
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 Literature Article Product, Vault updates the value in this field.
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 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 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 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 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 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 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 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 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
### 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_ A Literature Article record with highlight functionality enabled 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).
### 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. [1]: #translate-non-english-abstracts [2]: #highlight-literature-abstract-terms [3]: #note-highlight-read-mode [4]: #test-the-pubmed-database-connection [5]: #create-a-literature-review [6]: #literature-review-workflow [7]: #working-with-literature-documents [8]: #create-literature-articles [9]: #literature-article-review-workflow [10]: #literature-article-fields