Content Management Features

The improved version of Trial Interactive 10.1 comprises of following Content Management features

ROLE-BASED CONTENT VIEWS

With CMS 10.1, Users who check-out documents for editing will now by default use the online collaborative editing feature. Users may decide they will be offline or may need to use their local MSOffice™ application for editing a document. Selecting this option will now open the document in the local application automatically, allowing the user to save the document for offline editing. Once they have completed their changes, they can check-in the document, which will prompt them to upload their locally saved version. This change will simplify the options available to users. NOTE: Any document checked-out using the online editor can always be edited later in the native MSOffice™ format.

ROLE-BASED CONTENT VIEWS

When Editors are looking for documents, they always want to see the latest, most CURRENT draft version, so they know what’s in progress, what needs to be reviewed, and what is currently approved and effective. They want to see the latest edits. Conversely, when casual Readers are looking at documents, they always want to see the current, EFFECTIVE version. In 10.1, the TI CMS will provide users with the most logical views for each role, showing Readers the EFFECTIVE version, and Editors the CURRENT version.

SIMPLIFIED WORKFLOW START

No longer will a document need to go through a round of editing prior to being able to start a workflow. With CMS 10.1, upon upload, the user will be able to set a document as ready for workflow and the workflow can be initiated right after saving. Immediate approvals and E-signatures can be obtained.

FLEXIBLE CONTROLLED DOCUMENT STATES

For Controlled Documents, there may be a need to make a document Effective immediately or make a document Effective with or without a Periodic Review Period. With 10.1, Document managers will be able to control what does or does not apply to a document providing the ability to meet the business requirements of the document with ease. Document owners will be able to:

• Control the duration of a document's Effective Period and Periodic Review Period; and

• Set a document to be Effective immediately after approval with or without a Periodic Review Period.

IMPROVED WORKSPACE NAVIGATION

Now users can easily navigate between the Document Repository and Collaborative workspace or Document Lifecycle for a single document. Within the Document Repository, users can click on the collaborative icon to take them to that document in the Collaborative workspace. Users can click on the workflow icon to go directly to the document and its status in the Document Lifecycle. Within the Collaborative workspace click on the right-facing arrow on the document row to view the document in its folder in the document repository. Within the Collaborative workspace click on the right-facing arrow on the document row to view the document in its folder in the document repository.

COLLABORATE WITHIN A CONTROLLED DOCUMENT WORKFLOW

In CMS 10.1, Document Owners have more workflow choices for their Controlled document. Workflows can be created for business needs providing review steps that allow a document edit, approval steps which will provide an approval event in the document history as well as an E-Signature step to obtain signatures on the document.

VERSION LABELS

Upon document upload, users will be able to set the initial version in Trial Interactive allowing the document in Trial Interactive to be able to inherit previously defined versions. Trial Interactive will allow for the initial version of a draft document to be set as 0.1. The control of the document version labels will allow organizations to easily follow their own procedure for document management.

ADDITIONAL DESIGNATION FOR TI E-SIGN

Roles can be defined and leveraged during the E-Signature step. The standard definitions will create consistency across all signatures. During the creation of the E-Signature request, each signer can be associated with a role for the document. This allows not only the user’s title, and reason for the signature to be displayed as part of the E-Signature record but the role of the person in the lifecycle of the document. Title and Role inclusion in the E-signature step provide a high level of visibility and clarity for each signer of a controlled document.

COLLABORATE WITH OUTSIDE USERS

This improvement will allow document collaboration to occur with room participants that may not have direct access to the document in the document repository. Documents can be managed in a folder by one set of users and then as needed for collaborative review new distinct users can be invited and their edits controlled to only during the collaborative review. This will provide an easy way to gain input from subject matter experts, outside organizations, or other departments in a controlled timeframe without leaving the document open and editable for all the editors at all times.

CANCEL CHECK-OUT

This improvement will allow room administrators in a Content Management room to check back in a document checked out by another user. In cases where a user may unexpectedly be unavailable or unresponsive a room admin can free up the document locked by a collaborative edit or an individual edit.

SITE USER RESTRICTIONS

This improvement will restrict users assigned to sites to only see their assigned sites in the Investigator site list when adding documents or updating document metadata. This provides an additional security measure eliminating other site names or numbers from site-specific users.