The Select Study screen is displayed when you click on the More Studies button at the bottom-left corner of your User Home page when the Study Grid is shown.

The Select Studies screen is used to find and navigate to the studies you need to work on. You can also mark these studies as Favorites so that they show on your User Home Page.

How to Find a Study on the Select Studies Screen

If your list of studies is short, use the scroll-bar on the right side of the screen to scroll down to your study.

Use the page numbers and paging arrows at the bottom of the screen to jump to other pages in the list of studies.

If your list of studies is long, use the boxes at the top to filter the list. Enter your filter criteria into one or more of the field, and then click Go.

How to Add a Study to your User Home Page

If you are going to be working with a study often, click on the star in the second column to mark a study as a “Favorite”. Click Close to close the Select Studies screen and go back to the User Home page.

Once a study is marked as a “Favorite” it will be displayed in the list of studies on your User Home page, allowing you to view quick statistics and navigate directly to the study. As shown below, the study that was “favorited” in the previous image is displayed first in the list of Favorites on the User Home page.

To unfavorite a study, select the star again, either on your User Home page or within the Select Studies screen.

How to Go to Study Home for a Study

To see the Study Home page for a study, either double-click on that study row in the Select Studies screen or select the study with the round radio-button in the first column and  then click Apply.

You can upload one or more documents at once by using the Upload Documents button in your Work Area. When using this operation, the documents will need to be indexed to study items as part of a separate action.

When you click the Upload Document(s) button, the Upload to Work Area screen is displayed, as shown below. 

Click the Add Files button to browse to and select the files you want to upload. The selected files will be added to the list on the Upload to Work Area screen. To remove files from this list, click the x next to an individual file or select the check box for multiple files and click Remove selected files.

You can choose to upload all documents within a specific Study, Country, or Site by selecting the corresponding values at the top of the screen. Any Study, Country, or Site values specified will be retained if the Add files button is selected again.  You can also specify a study, country or site for an individual file by using the corresponding fields within the file list. Any settings specified for an individual file override settings specified for the list as a whole.

Or, you can upload without choosing study, country, or site values, if those values are not known.

When finished, click the Upload button. The documents will now appear in the your Work Area. 

The Match to Document Type screen can be accessed by selecting the TMF Master List hyperlink at the bottom of the Match to Study Item or Match Program/Enterprise Document screen.

How to Match a Document to a Document Type

The Match to Document Type screen will display all document types by default. The Document Types list can be updated to display only ad hoc document types by selecting the Show Ad Hoc Only check box on the left side of the screen.

From the Match to Document Type screen, select a document type from the list to propose a new study item. From the Propose Study Item window, review the details for each field. Fields that are gray may not be changed. Fields that are red are required. For a description of a field, select the “i” next to it.

Note: You will be proposing a new study item with these attributes which may be subject to approval.

When you are satisfied with the information in the data fields, click Save. You are returned to the Match to Document Type screen, and the proposed study item is listed at the top.

To match to additional document types, select another type from the list and complete the fields in the Propose Study Item window as instructed above. To remove a proposed study item, select the X next to the proposed item in the grid above the list of document types.

To complete the matching, click Save on the Match to Document Type form.

Use the Match to Study Item screen to match a document Uploaded to your Work Area with a specific Study Item in the eTMF. This step takes place after you have uploaded the document  and before you submit the document to Quality Control. The Match to Study Item Screen is also used when Authoring a document within the eTMF.

On the Match to Study Item screen, use the Change Study button at the top to select or change the study to which the document should be associated. If needed, select a Country, Site, Level, Organization and Category to filter the list of available Study Items. If you want to associate the document with a study item that is already indexed to a document and finalized, select the Show Fulfilled check box to display study items fulfilled with existing content. The new document will be treated as a new version.

If you are indexing uploaded content, you can click View Document Content to check the content against the study item without leaving the screen. The content of the document will display in place of the list. To return to the list, click Show Search Results.

Once you have found the appropriate study item(s), select the corresponding check box and click Save.

If you select a Study Item that already has pending and/or final content, an informational message displays, stating that a new version will be created once the content is finalized. To ensure you are not creating a duplicate, do the following for the study item selected:

• Check the date (in the Study Item Name).
• View the content by clicking the Study Item Name hyperlink.
• To view earlier versions, click View Versions.

If creating a new version is not your intent, deselect the study item and locate the correct one.

Match to a Document Type

If your document does not match any existing study items, you can click TMF Master List in the bottom-left to match to a document type. Select the document type, complete required fields on the Propose Study Item form, and click Save.

When you submit the study item to QC, it will first be sent to the Study Owner for approval to create a new study item. If approved, it will then be sent to QC. If not approved, it will be returned to you with the Study Owner’s comments.

Match to a Program/Enterprise Document

To match to a program or enterprise-level document, click Program/Enterprise Document Types. Select the Document Type from the list, review and update fields  on the New Program/Enterprise Document form as necessary, and click Save. When the document is finalized, Study Owners will receive and email notification so that they can associate the document with the appropriate studies.

Your Work Area contains all documents you have uploaded that have not yet been finalized. Your Work Area also contains all expected documents you have created as part of the scanning process. Work Area documents are visible only to you and to other users who have permissions to manage other users’ Work Areas.

You can access your Work Area from your User Home Page or from the primary header. The Work Area displays the following elements:

1.  Narrow Choices Panel (Left)
2.  Work Area List Panel (Center)
3.  Breadcrumb Trail (Top Left)
4.  Search Work Area Bar (Top Right)
5. Buttons (next to Search Bar)

Narrow Choices Panel

The Narrow Choices panel is located on the left side of the page. The Narrow Choice panel allows the user to narrow down the documents shown in the study item list. This is done by selecting a filter value in the Narrow Choices panel. Once selected, the list will be updated to include study items that match the specified filter value. If multiple values are selected, the list will be updated to include items that match all specified values. Filters can be cleared or saved by clicking on the cogwheel at the top of the panel.

See Also: How to “Narrow Choices” with Facets

Document List Panel

The Document List panel is located in the center of the page. The Document List panel displays the documents for which you are responsible (i.e., documents you’ve uploaded and expected documents). If you accessed the Work Area from the Work Area tab or by selecting the Documents link count on your User Home page, the Work Area displays your documents across all studies by default. If you accessed the Work Area by selecting the Over 30 Days count on your User Home page, the Work Area is automatically filtered to display only those documents. You can also apply additional filters using the Narrow Choices panel and/or the Studies, Countries, and Sites Breadcrumbs.

For each item, the Document Type ID, Due Date, Level, Milestone, and Document Status will be displayed.

Many actions can be accessed for each item by selecting the associated cogwheel. These actions may include any of the following:

• Generate Transmittal:  Displayed for an expected document, this option allows you to generate a transmittal page for scanning
• View Native Content:  Displayed if the original content uploaded is not PDF; allows you to download the original content in its native format
• View PDF in Acrobat: Displayed if a PDF rendition of the content exists; allows you to download the PDF
• View PDF in Browser:  Displayed if a PDF rendition of the content exists; allows you to open the PDF in a new browser tab/window
• View Audit Trail:  Allows you to view the audit trail for the item
• Delete:  Allows you to remove the document from the TMF

Breadcrumb Trail

The Breadcrumb Trail, located at the top left side of the page, contains a series of breadcrumbs that helps you figure out where you are and which items are displayed (e.g., items for all studies and all countries). You can use the breadcrumbs in the Work Area to update the display of items in your Work Area:

• By study, by country within a study, and/or by site within a study
• By study level documents only, across all studies

You can also use a breadcrumb to navigate to other list views easily. 

Quick Search Bar

The Quick Search Bar is located in the top right corner of the page. The Quick Search bar allows you to search for study items using keywords. The keywords work as a filter which can be removed by clicking the X next to the keyword at the top of the Study Item List panel.

When using the Quick Search bar, enter full words, and enclose phrases within quotation marks. You can use the asterisk wildcard character after a letter or number to represent a series of unknown characters. For example, enter Inv* to match to any item containing the letters “Inv” in that order. If the full text indexing feature has been enabled for your environment, you can choose to match your search text against attributes, content, or both.

Buttons

Buttons adjacent to the Quick Search bar can be used to upload documents:

• Upload Document(s)
• Create Expected Documents
• Author Document

Users with appropriate permissions can download an ISF Export package from the Study Item list by selecting “ISF Export” from the list’s Actions menu. This will display the ISF Export window with a warning about potential privileged and confidential information within the export. Review the warning before continuing.

Select a Country and Site to export from by using the drop-down arrows next to each field. When the fields have been selected, choose Export. The system creates a Zip file containing the requested information, which is available on the Downloads page. You will be notified of export success or failure via email. If the export is successful, the email will contain a link to the file on the Downloads page.

ISF Exports include only the native content and PDF rendition (if exists) for each Final study item marked as Needed for SMF at the program/enterprise/study level, at the country level for the selected country, or at the site level for the selected site.

The Upload to Study Item screen is displayed when you choose either of the following options:

• Upload to Study Item (accessed from the Actions menu for a study item in the study item list)
• Import Document (accessed after choosing the Author Document button in your Work Area)

The Upload to Study Item screen allows you to browse for the file to upload. On the Upload to Study Item screen, click Select file, navigate to the file within the file explorer window, and double-click on the file to select it. The maximum file upload size is 2 gigabytes.

If you would like to continue processing the document you are uploading, select the Navigate to document after uploading check box*. If you would like to upload other documents before Indexing, leave the Navigate to document after uploading check box unchecked.

Note: This check box does not appear if you accessed the screen via the Author Document button in your Work Area.

Click Upload to upload the file.