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 for each article.
- Start a Literature Article Review 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 all the steps for this feature before it can be used. See Enable Literature Review Process Management for more information.
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. |
Once you have initiated and completed the Literature Review workflow, you can complete the following sections in the Literature Review:
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.
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. |
Start a Literature Review Workflow
Literature Review workflows help you keep track of each step in your literature review process.
Complete the following steps to start a workflow for each review that you conduct:
- Go to Literature > Literature Reviews.
- Select the Literature Review that you wish to start
- In the Workflow State Change menu (
) on the Action Bar, select Start Review. - On the Start Workflow window, select options in the following fields:
- Reviewer
- Approver
- Due Date
- Select Start.
Result
The lifecycle state changes to Searching. You can now begin searching for articles and uploading them to your Vault.
Upload 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 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.
| Field | Description |
|---|---|
| DOI | The DOI, or Digital Object Identifier, for the article.
Enter the unique string of numbers, letters, and symbols. This field supports up to 255 characters. |
| Title of Article | Enter the title of the article.
This field supports up to 1,500 characters. |
| Abbreviated Title of Journal | The abbreviated title of the journal. This is often used for journal article citations. |
| Date of Publication | Enter the date the article was published.
Use the calendar to select the date or enter the date manually. |
| Language | Select the language of the article from the dropdown list. |
| Vancouver Citation | Enter the citation as it appears according to the Vancouver system. |
| Abstract | The text from the article’s Abstract section.
This field supports up to 20,000 characters. |
| Name | This is a system-generated field. |
| Literature Review | The system populates this field if the Literature Article is being created from a Literature Review. |
Once you have initiated and completed the Literature Article Review workflow, you can complete the following fields in the Literature Article:
| 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. |
| Search Term | Select the relevant Search Term from the dropdown list. |
| Number of Identified Cases | Enter the number of Cases that were identified as a result of the literature article review. |
Start a Literature Article Review Workflow
Literature Article Review workflows help you keep track of each step in your article searching process.
Complete the following steps to start a workflow for each article that you review:
- Go to Literature > Literature Articles.
- Select the Literature Article that you wish to start
- In the Workflow State Change menu () on the Action Bar, select Start Review.
- On the Start Workflow window, select options in the following fields:
- Reviewer
- Due Date
- Select Start.
Result
The lifecycle state changes to In Review.
Close out a Literature Article Review Workflow
After initiating a Literature Article Review workflow, go through each step of the workflow as you review for ICSRs or new safety information, and take action as needed.
The workflow is complete when you reach the Complete lifecycle state.
Close out a Literature Review Workflow
After initiating a Literature Review workflow, go through each step of the workflow as search for articles and review them, and take action as needed.
The workflow is complete when you reach the Complete lifecycle state.
