Documents Module User Guide

Transcription

1 Documents Module User Guide Filter and view etmf documents efficiently Version 02 Phlexglobal Inc. 400 Chesterfield Parkway, Suite 120, Malvern, PA 19355, USA T: F: Phlexglobal Ltd. Mandeville House, 62 The Broadway, Amersham, Bucks, HP70HJ, UK T: +44 (0) F: +44 (0) Copyright Phlexglobal Ltd. All rights reserved. Template reference IT008 TP09v08 Page 1 of 21

2 Contents 1. Introduction Navigating the Documents Module Finding documents Filtering documents Searching for free text within a document list Previewing documents Downloading documents Exporting documents Requesting document reviews Potential Duplicate Documents Requesting Potential Duplicate Document Reviews (manual) Reviewing Potential Duplicate Documents Viewing documents Additional Information Revision History Template reference IT008 TP09v08 Page 2 of 21

3 1. Introduction The Documents Module presents the gateway to all documents within PhlexEview etmf through an easy to navigate tree structure of the studies or binders you have permission to see. From the selected study you can drill down to find and view trial-level, country-level or site-level documents according to your role and the rights and permissions assigned to you. Selecting a branch at any stage will display the associated document numbers and the documents list from which you can filter, preview and view selected documents and associated document information. Key functions are also accessible from the Documents Module landing page such as downloading of selected documents, requesting reviews or requesting potential duplicate document reviews. This step-by-step guide takes you through the core functionality within the Documents Module. The Documents Module is fully supported by the following browsers: Internet Explorer 10 and above Firefox 31 ESR and above Chrome 45 and above As this is a generic user guide, client-specific details will be communicated separately. This is a generic user guide. Actual screen layouts may vary slightly dependent on your role and the rights and permissions assigned to you. Template reference IT008 TP09v08 Page 3 of 21

4 2. Navigating the Documents Module 2.1. Finding documents Log in to PhlexEview using your credentials On the PhlexEview home page navigation bar, click Documents to display the Documents landing page (Fig. 2a). Fig. 2a: Navigation bar with Documents highlighted On the document landing page up to three sections may display dependent on your permissions (Fig. 2b): All Documents All documents in the etmf for studies that you have permission to access. Binders Dedicated binders displaying specific documents in the etmf, e.g. Data Management binder only contains data management documents. Please refer to the Binders User Guide for more details. Workspace Draft documents you have created or are collaborating on for submitting to the etmf once complete. Please refer to the Document Creation User Guide for more details. Fig. 2b: Document landing page sections Template reference IT008 TP09v08 Page 4 of 21

5 For full details regarding navigating this landing page are explained in the generic Binder User Guide Click on the product/protocol or drill down the tree to file type, zone, section or artifact of interest in one of the sections. A list of documents will display in the main panel (Fig. 2c). Fig. 2c: Document list displayed in centre panel 2.2 Filtering documents From the Documents landing page with a selected document list displayed, click the icon to expand the available filters (Fig. 2d). Fig. 2d: Document filters (collapsed) Use the dropdowns to filter the document set. The document display list will update to display the filter selection (Fig. 2e). Click the icon to collapse the filter list. Click and drag the corner icon to expand the filter view. Fig. 2e: Document filters (expanded) and filtered document list Template reference IT008 TP09v08 Page 5 of 21

6 2.3 Searching for free text within a document list From the Documents landing page with a selected document list displayed you can search for documents containing specific words and phrases by typing free text into the Search field (Fig. 2f). Fig. 2f: Free text searching A search containing multiple words will automatically display the options available e.g. a search on Trial Management would display as follows: Trial AND Management Trial OR Management Trial Management Click the selected word combination to display the results list in the main panel To search using a single word click the icon or press return to display the results list in the main panel (Fig. 2g). Fig. 2g: Free text searching Template reference IT008 TP09v08 Page 6 of 21

7 2.4 Previewing documents From the Documents landing page with a selected document list displayed you can preview a selected document in the document list by hovering over the associated preview icon (Table 1). Table 1: Preview icons PREVIEW ICON DESCRIPTION Trial-level document Country-level document Site-level document Click the preview to display the document pop-out and use the scroll bar to move through the document pages. Hover over the bottom end of the document to display the Adobe Reader toolbar for saving a copy, printing a copy, moving through the document pages or zooming in/out of the document (Fig. 2h) Click the arrows in the centre bar to move seamlessly to the previous or next document in the document list Click the icon to close the document pop-out. Fig. 2h: Document pop-out Template reference IT008 TP09v08 Page 7 of 21

8 2.5 Downloading documents From the Documents landing page with a selected document list displayed click the icon alongside the selected document to display the document download options (Fig. 2i). Fig. 2i: Download options Click PDF to download or print the document in PDF with a watermark Click Without Watermark to download the document in PDF without a watermark (Permissioned users only). This is a generic user guide. Actual screen layouts may vary slightly dependent on your role and the rights and permissions assigned to you. 2.6 Exporting documents From the Documents landing page with a selected document list displayed tick the box against the document(s) for bulk export (Fig 2j) Click the Bulk Export button to display the bulk export option pop-up (Fig. 2j) Choose the required options for export by checking the appropriate boxes (Fig. 2k) To enable regular export of documents using the same options, type a name in the provided field (e.g. PDF files included) and click Save Click Export to save or open the file as an Excel spreadsheet. Template reference IT008 TP09v08 Page 8 of 21

9 Fig. 2j: Bulk export Fig. 2k: Bulk export options Template reference IT008 TP09v08 Page 9 of 21

10 2.7 Requesting document reviews From the Documents landing page with a selected document list displayed tick the box alongside the document(s) for review (Fig. 2l). Fig. 2l: Request review Click the Request Review button to display the review pop-up (Fig. 2l) To invite document reviewers click the Users dropdown, select the company name and select the required user names (Fig. 2m). Click Add Company Users to add the names of all company users to the request. Click Remove All Users to remove all company user names from the request Add a comment if required (Fig. 2n) Check the Require acknowledgement box if the user must acknowledge receipt of the review request alert (Fig. 2n) Select a Due date and click Save (Fig. 2n) All invited users will receive an notification and an alert requesting them to review the document Clicking on the alert message in PhlexEview will take the reviewer to the document (Fig. 2o). If the due date passes the sender of the request will receive an alert notifying them of the recipients that have not yet reviewed the document. Template reference IT008 TP09v08 Page 10 of 21

11 Fig. 2m: Select reviewers Fig. 2n: Requesting reviewers Template reference IT008 TP09v08 Page 11 of 21

12 Fig. 2o: Alert message 2.8 Potential Duplicate Documents The system offers both manual and automated potential duplicate document review. The automated workflow runs seamlessly in the background, checking submitted documents for the same metadata as specified by your organisation. When the system identifies potential duplicate documents, an alert is automatically sent to users with the right permissions to review potential duplicate documents Alert messages can be read by selecting the alert flag on the PhlexEview navigation bar. In addition, you can manually request a review of potential duplicate documents by other permissioned PhlexEview users Requesting Potential Duplicate Document Reviews (manual) From the Documents landing page with a selected document list displayed, invite users to review potential duplicate documents by ticking the box alongside each document (Fig. 2p). Template reference IT008 TP09v08 Page 12 of 21

13 Fig. 2p: Duplicate review Click the Duplicate Review button to display the duplicate document request pop-up To invite reviewers click the Users dropdown, select the company name and select the required user names (Fig. 2q). Click Add Company Users to add the names of all company users to the request. Click Remove All Users to remove all company user names from the request. Template reference IT008 TP09v08 Page 13 of 21

14 Fig. 2q: Select reviewers Add a comment and click Save (Fig. 2r). Fig. 2r: Duplicate document review request All invited users will receive an notification and an alert requesting them to review the potential duplicate documents. Template reference IT008 TP09v08 Page 14 of 21

15 Reviewing Potential Duplicate Documents Click on the alert message in PhlexEview navigation bar to view the potential duplicate documents (Fig. 2s). Fig. 2s: Alert message The potential duplicates and their associated document information panels display alongside each other to enable easy review (Fig. 2t). Click the icon to increase the document view. Click the icon to return to the potential duplicate documents with document information panels. Fig. 2t: Potential duplicate documents Template reference IT008 TP09v08 Page 15 of 21

16 In the Alerts panel click Not Duplicate if the documents are not duplicates In the Alerts panel click Acknowledge if the documents are duplicates If the documents are duplicates, use Queries to raise a query to have one of the duplicate documents deleted. 2.9 Viewing documents From the Documents landing page with a selected document list displayed click on the document row of the document of interest to view the document The document with its standard file name and status will display alongside the Document Information Panel (Fig. 2u). 1. Back arrow 2. Standard file name 3. Document Status 4. Document Document Information Panel Document Toolbar Fig. 2u: Document displayed with Document Information Panel Click the required tab in the Document Information Panel to display the required function (Table 2). Template reference IT008 TP09v08 Page 16 of 21

17 Table 2: Document Information Panel tabs Tab Function Tab Function View document alerts (ealerts User Guide) View document queries or raise a document query (Queries User Guide) View document metadata (PhlexEview User Guide) View document approval status or create approvals (eapprovals User Guide) Review and QC document (PhlexEview User Guide) Edit document and view document revision history (Document Creation User Guide) Link the document and add it to a folder (PhlexEview User Guide) Produce a document audit report or user activity audit report (PhlexEview User Guide) Use the Document Toolbar to access document-related tools (Fig. 2u; Table 3). Table 3: Document Toolbar Tool button Function Displays the number of documents in the list. Use the arrows to move through the document list Use Compare to compare the document with another document (PhlexEview User Guide) Use Subscribe to subscribe to alerts for document changes (ealerts User Guide) Use Request Review to invite selected users to review the document (Documents User Guide) Click the back arrow (Fig. 2u) to return to the document list with the document row of the document that was viewed highlighted in green (Fig. 2v). Template reference IT008 TP09v08 Page 17 of 21

18 Fig. 2v: Document list displaying highlighted document row Template reference IT008 TP09v08 Page 18 of 21

19 3. Additional Information 3.1 Customise the display screen columns From the Documents landing page click Preferences (Fig. 3a). Fig. 3a: Documents landing page with Preferences highlighted On the Preferences pop-up double click or drag columns to add or remove selected columns (Fig. 3b) To re-order the column, simply drag the column name to the required position (Fig. 3b). Fig. 3b: Display column preferences Template reference IT008 TP09v08 Page 19 of 21

20 3.1.4 Click Save (Fig. 3b) The updated column order will display (Fig. 3c). Fig. 3c: Updated display screen columns Template reference IT008 TP09v08 Page 20 of 21

21 PHLEX 4. Revision History Effective Date Version No. Description of changes 23 JUN 2016 v02 Version numbering changed to reflect the standard version numbering system. 18 3AN Revised Review Document alert details and included automated duplicate document detail following review (Claire larmey-swan) 29 OCT New draft (Claire larmey-swan) Author/Editor: Claire Vyv-swan., Product Development Manager Date: 2-3 -ju'v -z-0 lf. Reviewed by: Date: Barry Silverstein,, Director of Project Management N Approved by: Date: Peter McNa DISCLAIMER: The original version of this user guide was produced in English by Phlexglobal Limited. Any subsequent changes (such as, but not limited to translation into alternative languages) made to the original version by a third party have not been reviewed or authenticated by Phlexglobal Limited. No liability is assumed by Phlexglobal Limited for any errors, omissions or ambiguities in the changes to the original version. Any person that makes changes to the original version does so at their own risk; and Phlexglobal Limited shall not be liable for any errors caused by the reliance upon and accuracy of the changes. Template reference IT008 TP09vO8 Page 21 of 21