Sections in This Article
About the Feature
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 relevancy 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.
- 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.
Prerequisite
Your Admin must configure all the steps for this feature before it can be used. See Enable Literature Review Process Management for 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 Upload a Document to the Library.
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 Family | Select the Product Family that applies to the literature article from the dropdown list. |
| Review Type | Select the type of review from the picklist.
The available options include the following:
|
| Description | Enter a description of the literature review. This field supports up to 1,500 characters. |
Search Terms Section
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 |
|---|---|
| Name | This is a system-generated field. |
| Literature Database | The database in which the review was performed.
Select a database from the dropdown list or select the binoculars icon to view the Search: Literature Database window. In this window, use filters to refine your search or select Create to create a database. |
| Search Term | Enter the search term that you used.
This field supports up to 5,000 characters. |
Literature Articles Section
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 |
|---|---|
| Name | This is a system-generated field. |
| Document Number | Select the document number of the document you want to link. |
| Type | The system populates this field based on the selected literature article's Document Type. |
| Subtype | The system populates this field based on the selected literature article's Subtype. |
| Classification | The system populates this field based on the selected literature article's Classification. |
| Status | The system 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, the system 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. |
| Access Date | The date on which the article was accessed.
Use the calendar to select the date or enter the date manually. |
| Language | The language of the article.
Select a language from the picklist or use the Advanced Search icon to use filters and refine your search. |
| Abstract Language | The language of the article's abstract.
The system 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. |
| Keywords | Keywords from the article, separated by commas.
This field supports up to 25,000 characters. |
| Link | A link to the article.
This field supports up to 255 characters. |
| Link (Full Text) | A link to the full-text version of the article.
This field supports up to 1,500 characters. |
| Link (PDF) | A link to the PDF version of the article.
This field supports up to 1,500 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
- Database Name
- Database Provider
- Publisher
- Accession Number
- Title (English)
- Call Number
- ISBN/ISSN
- Volume
- Issue Number
- Section
- Edition
- Start Page
- End Page
- Reference ID
- Article Notes
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:
|
| 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. |
| Value | When importing reference information from a database, the system maps the complete author reference to this field. |
Vancouver Citation
When importing literature reference information from a database, the system 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 the Vancouver Citation section in Import Literature References from Database Files.
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, the system populates this section with the translated English abstract when it is ready.
For more information, see Translate Literature Abstracts.
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:
|
| Investigation Review Outcome | Select the outcome of the investigation review from the picklist.
The available options include the following:
|
| Article Review Notes | Enter additional notes from the article review. This field supports up to 5,000 characters. |
| Number of Identified Cases | Enter the number of Cases that were identified as a result of the literature article review. |
Literature Additional Information
When importing literature reference information from a database, the system maps all additional information from your uploaded RIS file to this section.
For more information, see the Literature Additional Information section in Import Literature References from Database Files.
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 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.
