KENDLE CLINICAL TRIALS PORTAL USER GUIDE

Transcription

1 KENDLE CLINICAL TRIALS PORTAL USER GUIDE Notes to Users Copyright Copyright by Kendle International Inc., All rights reserved. No part of this document may be downloaded, reproduced, transmitted, transcribed, stored in a retrieval system, or translated into any language in any form by any means, without the express written permission of Kendle International Inc.

2 Kendle Clinical Trials Portal Usage Agreement Disclaimer By logging into the Kendle Clinical Trials Portal, users are agreeing to the Terms of Use. This statement is required for compliance with FDA Regulation 21 CFR Part 11. For more information, see the FDA s website at Kendle International Inc. reserves the right to revise this publication and to make changes to the content thereof without obligation to notify any person of such revision or changes. Printing History First Edition November 2006 Second Edition November 2007 Third Edition October 2009 Fourth Edition July 2010 Fifth Edition August 2010 Corporate Headquarters 1200 Carew Tower 441 Vine Street Cincinnati, OH Tel: (in U.S. only) Tel: Fax: info@kendle.com

3 1 KENDLE CLINICAL TRIALS PORTAL OVERVIEW SYSTEM REQUIREMENTS AND SETTINGS IF YOU NEED HELP USING THE PORTAL GETTING STARTED ACCESSING THE PORTAL LOGIN PAGE USING THE PORTAL LOGIN PAGE PORTAL TERMS OF USE LOGGING INTO THE PORTAL CHANGING YOUR TEMPORARY PASSWORD RULES FOR CREATING A NEW PASSWORD RESETTING YOUR PASSWORD REQUESTING A PORTAL ACCOUNT NAVIGATION BREADCRUMBS TOP TITLE BAR MY TEAM WEBSITES COLLABORATION WEBSITES QUICK LAUNCH WELCOME CONTROL USING THE PORTAL HOME PAGE ANNOUNCEMENTS AND SPECIAL EVENTS KENDLE LINKS MY TEAM WEBSITES (IF APPLICABLE) COLLABORATION WEBSITES (IF APPLICABLE) OTHER APPLICATIONS (IF APPLICABLE) SEARCH TEAM AND COLLABORATION WEBSITES PERMISSIONS MANAGER (KENDLE ONLY) EDITOR-APPROVER AUTHOR READER TEAM SITE HOME PAGE QUICK LAUNCH TEAM DOCUMENTS RELEVANT DOCUMENTS MY ACTIVE TASKS TEAM SITE IMAGE LINKS OTHER APPLICATIONS SEARCH DOCUMENT LIBRARIES READING A DOCUMENT UPLOADING A DOCUMENT Aug-2010 Page i

4 6.3.3 UPLOADING MULTIPLE DOCUMENTS OPEN WITH WINDOWS EXPLORER MULTIPLE CHECK-IN ADDING A FOLDER CHANGING A FOLDER NAME MOVING AN ITEM INTO A FOLDER MOVING AN ITEM OUT OF A FOLDER REMOVING A FOLDER...28 IMPORTANT TO KNOW VERSION CONTROL APPROVAL CHECK OUT/CHECK IN...29 IMPORTANT TO KNOW DISCARD CHECK OUT CHANGES CHECK IN CHANGES, BUT KEEP DOCUMENT CHECKED OUT...30 IMPORTANT TO KNOW FOR EVERY CHECK IN FEATURES AVAILABLE WITHIN EACH DOCUMENT CHECK OUT/CHECK IN EDITING A DOCUMENT DELETING A DOCUMENT EDIT PROPERTIES SPELLING SEND TO Other Location a Link Download a Copy ACTION MENU COMMANDS EXPORTING TO AN EXCEL SPREADSHEET VIEW RSS FEED ALERT ME ING LINKS ING LINKS (ALTERNATIVE) LISTS READING A LIST ITEM ADDING A LIST ITEM EDITING A LIST ITEM DELETING A LIST ITEM USING COLUMNS TO SORT AND FILTER TO SET OR CHANGE A SORT: TO SET, CHANGE OR REMOVE A FILTER:...39 IMPORTANT TO KNOW ANNOUNCEMENTS ADDING AN ANNOUNCEMENT EDITING AN ANNOUNCEMENT DELETING AN ANNOUNCEMENT Aug-2010 Page ii

5 6.9 CALENDAR READING A CALENDAR ITEM ADDING A CALENDAR ITEM NOTIFYING TEAM MEMBERS NOTIFYING TEAM MEMBERS - ALTERNATIVE EDITING A CALENDAR ITEM DELETING A CALENDAR ITEM EXPORT EVENT ALERT ME...42 IMPORTANT TO KNOW TASKS VIEWING A TASK ADDING A NEW TASK EDITING A TASK ITEM DELETING A TASK ITEM DISCUSSIONS VIEWING A TOPIC ADDING A NEW TOPIC RESPONDING TO A TOPIC EDITING A DISCUSSION ITEM DELETING A DISCUSSION ITEM PICTURES VIEWING PICTURES UPLOADING NEW PICTURES EDITING PICTURES DELETING PICTURES MY TEAM RECYCLE BIN RESTORING ITEMS EMPTYING DELETED ITEMS...46 IMPORTANT TO KNOW LINKS VIEWING A LINK ADDING A LINK ITEM EDITING A LINK ITEM DELETING A LINK ITEM TRIALREPORT VIEWING A REPORT PRINTING A REPORT (REQUIRES ACROBAT READER) EXPORTING A REPORT DOWNLOADING A DOCUMENT SEARCH SEARCH ALL CLINICAL TRIALS PORTAL TEAM SITES SEARCH SPECIFIC SITE OR SUB-COMPONENT THE WELCOME CONTROL Aug-2010 Page iii

6 8.1.1 CHANGE MY PASSWORD MY PROFILE MY ALERTS LOGOUT PORTAL SUPPORT LINKS PORTAL HELP CONTACT PORTAL SUPPORT FAQS WHAT IS PORTAL? WHAT ARE THE SYSTEM REQUIREMENTS AND SETTINGS FOR PORTAL? HOW DO I GET ACCESS TO PORTAL? WHAT ABOUT LOGGING IN AND OUT OF PORTAL? WHAT ABOUT MY PORTAL PASSWORD? WHAT IF I FORGET MY PASSWORD OR IT EXPIRES? HOW DO I MOVE AROUND WITHIN PORTAL? HOW DO I GET FURTHER HELP FOR PORTAL? WHERE DO I GET HELP FOR APPLICATIONS WITHIN THE PORTAL? HOW DO I CREATE A SHORTCUT TO THIS SITE? HOW DO I CREATE A NEW LIBRARY (OR LIST, OR LINK)? Aug-2010 Page iv

7 1 Kendle Clinical Trials Portal Overview Kendle works with a variety of partners in order to successfully conduct clinical trials. Project team members may be Kendle associates or external users. A variety of team members contribute to the successful execution of the clinical study; including internal Kendle associates, sponsors, investigators, and study partners such as drug suppliers or laboratories. In order to improve the efficiency of the project team, Kendle's Clinical Trials Portal provides global access by sponsors, investigators, and Kendle team members with a single-login to various Kendle proprietary clinical development systems System Requirements and Settings Internet Explorer 6.x and above supported and recommended for full functionality, including Office integration; Firefox, Safari and Chrome latest versions useable. Always set your browser to not cache temporary internet files Your browser must be able to accept cookies Your browser must have Java Script enabled 800 X 600 display resolution or better If You Need Help If you are having trouble logging in, click the Portal Support link on the Login Page to contact the Portal support team. If you need general help, click the Portal Help link near the bottom of the Login page to access help topics, the Clinical Trials Portal User Guide, and FAQs. Or once authenticated, click the Help link in the upper right hand corner of any page. To contact the Portal Support team, click the Contact Support link from the login page. Or once authenticated, click the Contact Us link in the upper right hand corner of any page. If you need help with an application within the Portal, contact that particular application support team. See the Portal Support Links section of this guide for additional details. 27-Aug-2010 Page 5

8 2 Using the Portal Getting Started Upon account activation, new Portal users will receive two system-generated s. The first contains the user s Portal username and login instructions and the second the user s temporary password Accessing the Portal Login Page 1. Launch Internet Explorer or other appropriate browser. 2. Type into the Address bar. Or, from the Kendle web site, click the Kendle Clinical Trials Portal link. 3. The Portal Login Page appears. 27-Aug-2010 Page 6

9 3 Using the Portal Login Page You can access the following functions from the Portal Login Page: Read the Portal Terms of Use Login to the Portal Request a new password for an existing account Request a Portal account Sign up for our Investigator Database (for investigators) Portal Terms of Use By logging into the Kendle Clinical Trials Portal, you are agreeing to the terms of use. Review the terms of use before logging in. To view the terms of use, click the Terms of Use link near the bottom of the Portal Login Page. If you have questions or concerns regarding the Terms of Use, please contact the Portal support team at: support.portal@kendle.com Logging into the Portal 1. To access the Portal and associated applications, you must first log into your Portal account: 2. Enter your Portal User ID for the user name. 3. Enter your Portal password. 4. Click the Login button. If this is your first time logging in, or your password has just been reset, you will be prompted to change your temporary password (see the next section). 27-Aug-2010 Page 7

10 3.1.3 Changing Your Temporary Password Each Portal user is assigned a temporary password when his or her account is created or when it is reset. When you log into the Portal for the first time with your temporary password, you will be required to change this temporary password Rules for Creating a New Password Your new password must contain at least eight (8) characters and a combination of at least one character from three of the four classes listed in the table below: Class English uppercase characters English lowercase characters Numeric characters Non-alphanumeric or special characters Example A through Z a through z 0,1,2,.9 A punctuation symbol such as a comma or period; OR the following Remember, your password is case-sensitive (e.g., MYpassword$7 is not the same as mypassword$7). 27-Aug-2010 Page 8

11 3.1.5 Resetting your Password If you already have a Portal account, and have forgotten your password, you can request that your password be reset. 1. From the Portal Login Page, click the Forgot Password? link. 2. The Forgot your Password? window appears. 3. Enter your Portal user name. 4. Enter your address. As an added security precaution, the address you provide must match the address recorded in your Portal account. 5. Click the Reset Password button. 6. A new password will be ed immediately. 7. Once you have logged in, you will be required to change your password. 27-Aug-2010 Page 9

12 3.1.6 Requesting a Portal Account If you would like to access applications and other features of the Portal and you do not already have a Portal account, you can request that one be created. 1. From the Portal Login Page, click the Contact Support link. 2. Enter your name, address, and other pertinent information into the fields in the Kendle Clinical Trials Portal Support window. 3. Click the Submit button. A Portal support team member will respond to your request in a timely manner. 27-Aug-2010 Page 10

13 4 Navigation This section describes various ways to navigate within the portal site. There are links in the portal that may navigate the user to sites outside of the portal Breadcrumbs Breadcrumbs appear (horizontally), just above the name of the list or library. They provide links back to each previous page the user navigated through to get to the current page or in some cases the parent pages of the current one. Breadcrumbs provide a trail for the user to follow back to the site page or entry point. You can quickly navigate to different levels by clicking a link in the trail. Breadcrumbs also appear above the Kendle Logo. These breadcrumbs provide links to the current website s home page, and to the Portal Home page Top Title Bar Every page in the Portal has a Title Bar. The Title Bar is also a link to the Home Page of that site. 27-Aug-2010 Page 11

14 4.1.3 My Team Websites The Portal Home page contains links to the Team Websites to which the user has access. Click on the My Team Website links to navigate to those Team Websites Collaboration Websites The Portal Home page contains links to the Collaboration Websites to which the user has access. Click on the Collaboration Website links to navigate to those Collaboration Websites. 27-Aug-2010 Page 12

15 4.1.5 Quick Launch Once inside a Team or Collaboration website, the Quick Launch bar is displayed vertically on the left hand side. It contains links to various libraries, lists, and functions of the website Welcome Control Every page in the portal displays the Welcome Control in the upper right-hand corner of the page. It says Welcome, user. When clicked, it drops down to show four links; Change My Password, My Profile, My Alerts, and Logout. The first three links navigate to their respective pages. The Logout link logs the user out and navigates to the Login page. 27-Aug-2010 Page 13

16 5 Using the Portal Home page Once you have logged into the Portal, additional functionality is available from the Portal Home page. Here s what a typical Portal Home page might look like: You will see the following: Announcements and Special Events Used by Kendle to inform users of any new information necessary when using the Clinical Trials Portal Kendle Links A list of links to anonymously accessible Kendle internet websites My Team Websites (if applicable) A list of Team Website links that is visible only to those who are members of a Team Website Collaboration Websites (if applicable) A list of Collaboration Website links that is visible only to those who are members of a Collaboration Website Other Applications (if applicable) There are several Kendle applications that a user may be signed up to use. These include edocs, KendleConnect, Investigator Maintenance, etc. The web parts for these other applications are only visible to those users who have been explicitly granted access Search The search bar at the Portal Home Page level returns results from the Announcements and Special Events list, as well as any Team or Collaboration Website to which the user has access. It does not return results from Team or Collaboration Sites to which the user does not have access. 27-Aug-2010 Page 14

17 6 Team and Collaboration Websites Team and Collaboration Websites are places where Kendle and its customers can collaborate securely using many tools, such as document libraries, calendars, and discussions. 6.1 Permissions The following are the four permission levels that are used within a Team or Collaboration website: Manager (Kendle only) Read, create, edit, delete, and approve content in a team website. Assign or revoke access privileges for Kendle associates Editor-Approver Read, create, edit, delete, and approve content in a team website Author Read, create, edit, and delete content in a team website Reader Only read content in a team website. Cannot create, edit, or delete content. NOTE: Much of this document describes creating, editing, and deleting content. These descriptions apply only to those who have the permissions that allow those functions. 27-Aug-2010 Page 15

18 6.2 Team Site Home Page Once you have clicked on a link to a Team or Collaboration website from the Portal Home Page, additional functionality specific to that site becomes visible on the Team Site Home Page. 27-Aug-2010 Page 16

19 6.2.1 Quick Launch The Quick Launch bar is displayed vertically on the left hand side. It contains links to various libraries, lists, and functions of the website Team Documents This web part summarizes the first 15 documents of the Team Documents document library Relevant Documents A web part that summarizes the Team Documents document library to show only those documents that the authenticated user has created or edited My Active Tasks A web part that summarizes the Tasks lists with only tasks assigned to the authenticated user Team Site Image A custom image may be placed in this web part by Team Members or Portal Support Links This is a list of links to internet sites that can be set by Team Members Other Applications There are several Kendle applications that a user may be signed up to use. These include edocs and KendleConnect. The web parts for these other applications are only visible to those users who have been explicitly granted access Search The search bar at the Team Site Home Page level returns results from all lists within that Teams Site. 27-Aug-2010 Page 17

20 6.3 Document Libraries A document library is a place to store and share files with other associates who have access to this team site. Document libraries are just another type of list. Please review the Lists section for general list functionalities that also apply to document libraries. Version Control is enabled for every Document Library. Please review the Version Control section for details. Important to know Every time a document is checked in to a library or deleted from a library, a comment is required. Once you have accessed the site, you can see the document libraries listed under Documents on the QuickLaunch navigator. The default library provided with a team site is Team Documents (unless the site owner has changed the name of the library). 27-Aug-2010 Page 18

21 To access a particular library, click its name. In this example, Team Documents and Reports are two separate document libraries. If you click the word/link Reports, the Reports document library will open: Reading a Document 1. To read a document, click once on the name (title) of the item. 2. To read the actual file/attachment, click once on the attachment icon Uploading a Document Uploading is the same as importing a file. 1. Open the desired Document Library (if it is not already open). 27-Aug-2010 Page 19

22 2. Click Upload Document from the Upload menu. 3. Locate the file to be uploaded using the Browse button. You can browse from your hard drive or network drives. 4. After you have chosen a file and enter a description in the Comment box click OK. The document title will be the same as the file name. 27-Aug-2010 Page 20

23 If you upload a file that has the exact name of a file which already exists in this library, it will be replaced by the file you are currently uploading. If you do not want the file to be replaced, uncheck the Overwrite existing files checkbox. 5. Click Check-In. Users will not be able to view documents unless they are checked-in Uploading Multiple Documents Click Upload Multiple Documents from the Upload menu, or click the Upload Multiple Files link in the Upload Document window. 27-Aug-2010 Page 21

24 6.3.4 Opening with Windows Explorer Use this feature to drag-copy files into a list or library from your local hard drive or shared drive. 1. From the Actions menu, click Open with Windows Explorer. 2. You will see the folders and files contained in the list/library on the right side. This represents the Reports library on the Project Team Website. 3. Open another Windows Explorer window (from the Start menu) to locate the file(s) on your pc or shared drive. 4. Right-click the Start button. 5. Click Explore. 6. Locate the file(s) to copy. 27-Aug-2010 Page 22

25 7. Drag them to the list/library on the Windows Explorer window opened by SharePoint. 8. Drag-copy file(s) to the library/list in the other window. If there are folder(s) in the library, you can drag files to the folder Checking in Multiple Documents While in a document library, use this feature to check-in multiple documents. This feature comes in handy when you have uploaded multiple files to the portal in bulk, and need to quickly check them all in to make them visible to other team members. 1. From a document library, click on the Actions menu then select Multiple Check-in. 27-Aug-2010 Page 23

26 2. On the multiple check-in screen, select the checkboxes next to the documents you want to check-in, supply check-in comments that apply to all documents, and then click the Check-in button Adding a Folder While in a Document Library, you can create folders to help organize documents. 1. From the New menu, click New Folder. Not all libraries will have the New Folder option. 27-Aug-2010 Page 24

27 2. Enter a name for your new folder. Click OK when finished. 3. Your new folder will appear in the Document Library Changing a Folder Name 1. Point at the folder s title until you see a drop-down arrow to the right of the title. 2. Click the drop down arrow. 27-Aug-2010 Page 25

28 3. Click Edit Properties. 4. Edit the Name field, and then click OK Moving an Item into a Folder 1. Have the desired library (such as the Reports library) open. 2. From the Actions menu, click Open with Windows Explorer. 3. You will see the folders and files contained in the list/library on the right side. This represents the Reports library on the Project Team Website. 4. Drag item(s) into the folder. Do not alter the Forms folder in any way. 27-Aug-2010 Page 26

29 6.3.9 Moving an Item out of a Folder 1. Have the desired folder open. 2. From the Actions menu, click Open with Windows Explorer. You will see the folders and files contained in the list/library on the right side. For example, this is the Marketing Metrics folder on the Project Team Website. 3. Open the Reports (another example) folder in Windows Explorer. Arrange the two windows so you can see the contents of both. 4. Drag the file from the Marketing Metrics window to the Reports window. 27-Aug-2010 Page 27

30 Removing a Folder 1. Point at the document s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Delete from the drop-down menu. A dialog box will appear warning that everything inside the folder will be deleted also. 4. Click OK or Cancel. Important to know If you remove a folder, all the documents in the folder will be removed as well Version Control Libraries can be set up to track two kinds of versions: minor versions and major versions. You will know this if you check in a file and you are asked to choose between the two. Here is what each one means: A minor version is a version that is in progress; for example, a version that contains incomplete sales figures. A major version is one that is ready for a larger group to see; for example, if you typed in the final sales figures. If you are prompted to choose between these two versions, the library may react differently depending on which one you choose. For example, if you specify a minor version, the library may automatically hide that file from certain people's view of the library people who do not have permissions to review works in progress. If you specify a major version, the file may get published to a larger group of people so that they can see it. Or other people may be automatically alerted to approve your changes before the file is seen by more people. If you want to know if your library does this, ask the project lead or Portal Support. 27-Aug-2010 Page 28

31 Approval Document Libraries may have document approval enabled if preferred. Enabling approval requires that any new version of a document be approved by Editor-Approvers or Managers before being made visible to the rest of the Project Team Check Out/Check In Using the Check Out/Check In feature ensures document integrity. Here s a basic description. When you want to edit a document, use the Check Out feature; when you are done editing, use the Check In feature to make the document available for editing by others. What happens if someone tries to edit a file which is checked out? They will get the "File in Use" message explaining that the file is locked for editing and the name of the person who checked it out. They can open it as read-only, but they will see the version of the file prior to being checked out. When someone creates a new file or adds a new file to a library, the file is initially checked out. The person who creates or adds the file must check it in before other people can see it. Check-out is also required to update information about the file, such as the title or when the file is due. When a file is checked out, no one can edit it except the person who checked it out. Its icon in the library changes to indicate that the file is checked out. When you rest the mouse pointer on the checked-out icon, the name of the person whom the file is checked out to appears in a ScreenTip. Changes that someone makes to a file while it is checked out are not visible to others until the file is checked back in. Important to know For a one-step check out, click Edit in. (Office application name) from the drop down menu instead of Check out Discard Check out Changes If you check out a file, make changes, and then decide you don't want to keep those changes, you can effectively undo the check out. The changes that you made to the file since you checked it out are discarded, and the file is made available again for other people to edit. The person who checked out the file or a site owner can discard the check out changes. Be careful if you are undoing the check out for a file that is checked out to someone else, because any changes that the person made to the file after checking it out are overwritten. If versions are being tracked, the changes discarded will not be kept in the version history. Point at the checked-out item s title until you see a drop-down arrow to the right of the title. Click the arrow, and then click Discard Check Out as shown below. 27-Aug-2010 Page 29

32 Check In Changes, but Keep Document Checked Out If you would like others to see the changes you have made, but need to keep the document checked out to make more changes, use this feature. It will allow others to see the changes you have saved up until now, but you can keep the document checked out to make additional changes. 1. Point at the checked-out item s title until you see a drop-down arrow to the right of the title. 2. Click Check in. 3. Click Yes as the option for Keep the document checked out after checking in this version? 4. Click OK. 27-Aug-2010 Page 30

33 Important to know for every Check In Do not use the Check in link in the Shared Workspace sidebar when you are editing a document. Instead, close the document (or Save and close). You will be prompted to: 27-Aug-2010 Page 31

34 6.4 Features available within each document Check Out/Check In See previous section for a description of Check In/Check Out Editing a Document 1. Point at the document s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Edit in xxx (xxx is a document type, such as Microsoft Word, Excel). 4. Make your changes within the application, then save the changes. Your document will be updated. As long as SharePoint recognizes the document type, you will have the option to edit using that application. NOTE: If you do not see a command titled Edit in xxx, then you will need to save the document to your hard drive, make the changes, save, and upload back to SharePoint. 27-Aug-2010 Page 32

35 6.4.3 Deleting a Document 1. Point at the document s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Delete. 4. You will see a dialog box confirming that you want to send the document to the Recycle bin. You are required to enter comments before continuing with the delete. 5. Click Delete. 27-Aug-2010 Page 33

36 6.4.4 Edit properties 1. Point at the document s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Edit Properties Spelling A simple spell-checker feature is available when you are editing the properties of a document Send to This feature provides different ways for sharing a document Other Location This feature allows you to copy this document to another SharePoint document library. Before you can send a document to another library, you have to already have permissions (appropriate access) to the destination library. 1. Point at the document s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Send to, then click Other Location from the submenu. 4. Replace the destination document library or folder URL with the desired location s URL. (You must have access to the desired location to copy a document there. 5. Click OK a Link This creates an which contains a link to this document. Address the , and add any desired text to the body of the . The recipient must already have permissions (appropriate access) to the destination in order to view the linked document Download a Copy This allows you to save a copy of this document to your PC or a shared drive. 27-Aug-2010 Page 34

37 6.5 Action Menu Commands All lists, including Document libraries, have an Action menu button. The Action menu contains different functions that can be performed to the list Exporting to an Excel Spreadsheet 1. On the page that displays the list, under Actions, click Export to spreadsheet. 2. In the File Download dialog box, click Open. 3. In the Opening Query dialog box in Excel, click Open. 4. If no workbook is open, Excel creates a new blank workbook and inserts the list on a new worksheet. 5. If a workbook is open, in the Import Data dialog box, select one of the following options: To insert the list in the active worksheet, click Existing worksheet. In the worksheet, click the cell where you want to place the upper-left corner of the list, and then click OK. To insert the data in a new worksheet, click New worksheet and click OK. To insert the data in a new workbook, click New workbook and click OK. To create a PivotTable report based on the list, click Create a PivotTable report, and follow the steps in the PivotTable and PivotChart Wizard. 27-Aug-2010 Page 35

38 6. After exporting the list to an Excel spreadsheet, you can use the link between the Excel list and the SharePoint list: To synchronize the SharePoint list with changes you make to the Excel list, use the Synchronize List command in Excel ( Data menu, List submenu, Synchronize List command). To discard changes to the Excel list and re-import the list from the SharePoint list, use the Discard Changes and Refresh command in Excel ( Data menu, List submenu, Discard Changes and Refresh command). To remove the link between the Excel list and the SharePoint list, use the Unlink List command in Excel ( Data menu, List submenu, Unlink List command). NOTE: The list data types supported by Windows SharePoint Services are text, currency, dates, numbers, and hyperlinks. If the Excel list that is linked to a SharePoint list uses other data types, synchronizing the lists may create inconsistencies between the lists View RSS feed With Really Simple Syndication (RSS) it is easy to track changes to important lists and libraries. If you have an RSS reader, simply subscribe to RSS feed by clicking the link, and your reader will record the changes for you. You can also browse the RSS feed here in your browser Alert me 1. Create an alert notifying you when there are changes to the specified item. 2. Click the link for the item. 3. Click the Alert me link. 4. Follow the instructions on the New Alert page, then click OK. 27-Aug-2010 Page 36

39 6.6 ing links 1. Open an item. 2. In Internet Explorer, click the File menu. 3. Point to Send and click Link by Add recipients to the . Recipient(s) must already have permission (appropriate access) to read the linked document. 5. Modify the subject and body. Be sure to leave the URL link and link attachment in place ing links (alternative) 1. Open an item. 2. In Internet Explorer, click the File menu. 3. Point to Send and click Link by Add recipients to the . Recipient(s) must already have permission (appropriate access) to read the linked document. 5. Modify the subject and body. Be sure to leave the URL link and link attachment in place. 6.7 Lists A list is a collection of related items. They can be documents, tasks, calendar entries, etc Reading a list item Click once on the title of the item Adding a list item 1. While in a List, click New item from the New menu. 2. Populate the fields. 3. Click OK. 4. For example, in a standard Tasks list, the new item will contain fields for Title, Priority, Status, %Complete, Assigned To, Description, Start Date and Due Date. Note that fields labeled with asterisks (*) must contain a value before the new item is saved Editing a list item 1. Point at the item s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Edit Item. 4. Make desired changes. 5. Click OK. 27-Aug-2010 Page 37

40 6.7.4 Deleting a list item 1. Point at the item s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Delete Item. You will see a dialog box confirming that you want to send the item to the Recycle bin. 4. Click OK Using Columns to Sort and Filter All lists (including Document Libraries) have columns that can be set to sort and/or filter records. In the Reports list below, the Modified column is sorted ascending, indicated by the upward-pointing arrow. In the Reports list below, the Modified column is sorted ascending, indicated by the upward-pointing arrow To Set or Change a Sort: 1. Point at a column s title until you see a drop-down arrow to the right of the column title. 2. Click the arrow. 3. Click Ascending or Descending. 27-Aug-2010 Page 38

41 6.7.7 To Set, Change or Remove a Filter: 1. Point at a column s title until you see a drop-down arrow to the right of the column title. 2. Click the arrow. 3. Select one of the data points listed below the sort options. When the 10/19/2009 data point is selected, only the records last modified on October 19th will display: You know a column has a filter applied when the funnel symbol displays with or without the sort arrow at the top of the column: 4. To remove the filter from this column, repeat #1 2 above, and then click Clear Filter from Modified. Important to know You can sort and filter on multiple columns. Less data will be displayed as you increase the number of filtered columns. If you are not seeing records you expect to see, remove filters from the columns. 27-Aug-2010 Page 39

42 6.8 Announcements Use announcements to post messages for site members on the home page of the site Adding an announcement 1. Click the link Add an announcement located at the bottom of the Announcements list. 2. Enter a title and description for the announcement. 3. Enter an expiration date for the announcement. The announcement will no longer display after the expiration date Editing an announcement 1. Click the announcement title. 2. Click Edit Item. 3. Make changes. 4. Click OK Deleting an announcement 1. Click the announcement title. 2. Click Delete Item. You will see a dialog box confirming that you want to send the item to the Recycle bin. 3. Click OK. 6.9 Calendar Use the Calendar list to keep informed of upcoming meetings, deadlines, and other important events Reading a calendar item Click once on the title of the calendar item Adding a calendar item 1. Click the day for which you would like to create a calendar item. 2. From the New menu, click New item. Required fields are Title, Start Time, and End Time. (See the next topic for instructions on creating a meeting workspace.) 3. Click OK when you have finished setting up the calendar item s details. 27-Aug-2010 Page 40

43 6.9.3 Notifying team members 1. Open the calendar item. 2. In Internet Explorer, click the File menu. 3. Point to Send and click Link by Add recipients to the Modify the subject and body. Be sure to leave the URL link and link attachment in place Notifying Team Members - Alternative 1. Open the calendar item. 2. Right-click the contents of the Address bar. 3. Click Copy to copy the URL address of the item. 4. Create a new in your client. 5. Paste the URL link in the body of the Add recipients to the Modify the subject and body. Be sure to leave the URL link in place Editing a calendar item 1. Click the calendar item which you would like to edit. 2. Click Edit Item. 3. Make desired changes. If changing the date or time, be sure to check the values in the Start Date and End Date fields. 4. Click OK Deleting a calendar item 1. Click the calendar item which you would like to edit. 2. Click Delete Item. You will see a dialog box confirming that you want to send the item to the Recycle bin. 3. Click OK. 27-Aug-2010 Page 41

44 6.9.7 Export Event The Export Event feature is not supported Alert me 1. Create an alert notifying you when there are changes to the specified item. 2. Click the item for the meeting, appointment, etc. 3. Click the Alert me link. 4. Follow the instructions on the New Alert page, then click OK. You can include other people on the alert . Important to know The SharePoint calendar is not accessible from your local client; you can t send invitations to the calendar. A SharePoint calendar item does not automatically generate an invitation Tasks Use the Tasks list to assign tasks to team members, and to view and manage those tasks Viewing a task Click once on the title of the topic Adding a new task 1. While in the Tasks list, click New Item from the New menu. 2. Populate the fields. 3. Click OK Editing a task item 1. Point at the item s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Edit Item. 4. Make desired changes. 5. Click OK Deleting a task item 1. Point at the item s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Delete Item. You will see a dialog box confirming that you want to send the item to the Recycle bin. 4. Click OK. 27-Aug-2010 Page 42

45 6.11 Discussions Use the Team Discussion list to hold newsgroup-style discussions on topics relevant to your team Viewing a topic Click once on the title of the topic Adding a new topic 1. While in a Discussion board, click Discussion from the New menu. 2. Populate the fields. 3. Click OK Responding to a topic 1. Point at the topic s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click View Item. 4. Click Reply. 5. Type your reply. 6. Click OK Editing a discussion item 1. Point at the item s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Edit Item. 4. Make desired changes. 5. Click OK Deleting a discussion item 1. Point at the item s title until you see a drop-down arrow to the right of the title. 2. Click the arrow. 3. Click Delete Item. You will see a dialog box confirming that you want to send the item to the Recycle bin. 4. Click OK. 27-Aug-2010 Page 43

46 6.12 Pictures Picture Libraries are basically document libraries, but designed for images. A default Picture Library is provided called Project Images Viewing pictures Pictures are immediately viewable from the default view Uploading new pictures Click on Upload from the Action menu Editing pictures Select the pictures to edit, and then select Edit from the Actions menu. Pictures can be edited in a compatible picture editor, such as Microsoft Office Picture Manager Deleting pictures Select the pictures to delete, and then select Delete from the Actions menu. You will see a dialog box confirming that you want to send the item to the Recycle bin. Click OK My Team Click on the My Team link from the Quick Launch menu to view the members of that website s team. Click on a user s name to see that user s profile. Click on a user s address to send an to that user. 27-Aug-2010 Page 44

47 6.14 Recycle Bin Use the Recycle Bin to restore items that you have deleted from this site or to empty deleted items Restoring items 1. Click the Recycle Bin link in the QuickLaunch. 2. In the left-most column, select the items you would like to restore: 3. Click the Restore Selection button. 4. You will see a dialog box confirming that you want to restore the item. You are required to enter comments before continuing with the restore. 5. Click Restore, then OK. 27-Aug-2010 Page 45

48 Emptying deleted items 1. Click the Recycle Bin link in the QuickLaunch. 2. In the left-most column, select the items you would like to delete from the Recycle Bin: 3. Click the Delete Selection button. 4. You will see a dialog box confirming that you want to delete the item. 5. Click OK. Important to know Items deleted from the Recycle Bin will not be permanently deleted. They are moved to a Secondary Recycle Bin, where they can be restored by Portal Support if necessary Links This area may contain links to websites on the internet Viewing a link To open the link in the same browser window, left-click on the link title. To open the link in a new browser window, right-click the link title, and then click Open in new window Adding a link item 1. Click Add new link located on the right hand side of the webpage. 2. Enter the URL (web address). Test the link by clicking the Click here to test link. 27-Aug-2010 Page 46

49 3. Enter a description. This description will appear as a label for the URL in the list. If you do not enter a description, the URL address itself will be the label. 4. Click OK Editing a link item 1. Click the Links title. 2. Point at the link item s title until you see a drop-down arrow to the right of the title. 3. Click the arrow. 4. Click Edit Item. 5. Make desired changes. 6. Click OK. 27-Aug-2010 Page 47

50 Deleting a link item 1. Click the Links title. 2. Point at the link item s title until you see a drop-down arrow to the right of the title. 3. Click the arrow. 4. Click Delete Item. You will see a dialog box confirming that you want to send the item to the Recycle bin. 5. Click OK TrialReport Viewing A Report 1. While on the Project Team Site or Kendle Team Site home page, click the TrialReport link on the right. 27-Aug-2010 Page 48

51 2. Using the report selection list, click the report s title to view. 3. If the report prompts for parameters, enter those values. 4. If the report prompted for parameters, click OK when all values have been entered. 27-Aug-2010 Page 49

52 5. To close the report click Close Report to return to the selection list Printing a Report (Requires Acrobat Reader) 1. While the report is in view mode, click the Printer button in the toolbar. 27-Aug-2010 Page 50

53 2. Enter a page range and click OK. 3. The print operation is essentially an export to PDF, therefore a depending on the Internet Browser setup an Open or Save dialog may appear. If so, click Open to view the export. 4. In the Acrobat Reader, click the Printer button or select File > Print in the top menu. 27-Aug-2010 Page 51

54 5. Close the Acrobat Reader. 6. Close the Page Range select window Exporting a report 1. While the report is in View mode, click the Export button. 2. Select the Export format and click OK. 27-Aug-2010 Page 52

55 3. Once the file has been generated by the system, the Internet browser will prompt to download the file. For example, in Internet Explorer, click Open to view the file or Save to save it to the local computer Downloading a Document 1. While on the Project Team Site or Kendle Team Site home page, click the TrialReport link on the right. 2. Using the report selection list, look for items with the Report Run Type of File Download. 27-Aug-2010 Page 53

56 3. Select an item to download by clicking on the title. 4. Once the file has been generated by the system, the Internet browser will prompt to download the file. For example, in Internet Explorer, click Open to view the file or Save to save it to the local computer. 27-Aug-2010 Page 54

57 7 Search The search feature will allow you to search across the Clinical Trials Portal environment, or to limit your search to a site and/or sub site, etc. Search results listed will only include sites and items to which you have been granted access Search all Clinical Trials Portal Team Sites 1. To search all Clinical Trials Portal Team Sites, click Clinical Trials Portal in the breadcrumb links: 2. Enter text in the search box: 3. Click the magnifying glass icon to the right of the search box. Results will be displayed which are automatically sorted by relevance; you can also sort by modified date. 27-Aug-2010 Page 55

58 7.1.2 Search Specific Site or Sub-component You can search sub-components (sites, sub sites, libraries, lists, etc) in the same way. Navigate to a site, sub site, library, and list; wherever it is you would like to search. Note in the examples below how the scope of the search is indicated. Search scope is the entire Clinical Trials Portal Site: Search scope is the Reports library in the Clinical Trials Portal Site: Search scope is the Tasks list in the Clinical Trials Portal Site: Repeat instructions #2-3 in the Search All Kendle SharePoint Sites topic above. 27-Aug-2010 Page 56

59 8 The Welcome Control As discussed earlier in this document, the Welcome Control is located in the upper righthand corner of every page in the Portal. This section details the Welcome Control and its various functions Change My Password 1. If you would like to change your password at any time, click the Change My Password link from the Welcome dropdown on any page in the portal. 2. Enter your current password. 3. Enter and confirm your new password. (See Rules for creating a new password section). 4. Click the Change password button. 5. Once you change your password, navigate back to the Portal Home page by clicking the Home tab in the navigation menu, or by clicking Clinical Trials Portal at the top of the page, or in the breadcrumb navigation trail above the Change My Password web part. 27-Aug-2010 Page 57

60 8.1.2 My Profile The My Profile link takes you to your user profile page My Alerts The My Alerts link takes you to your alerts page for that website. 27-Aug-2010 Page 58

61 8.1.4 Logout Logout when you are finished with your work. Click the Logout link in the top right hand corner on any page in the portal. The Portal Home page appears and displays the message, You have been successfully logged out of the portal as confirmation. 27-Aug-2010 Page 59

62 9 Portal Support Links Portal Help Help documentation is available on many topics. If you have a question, it is advisable to browse the Help as your question may have already been answered. From the Portal Login page, click the Portal Help link near the bottom of the page to access general help topics as well as answers to frequently asked questions. Click the Help link near the top of the page to access general help topics as well as a link to the Portal User Guide (this document) Contact Portal Support If you do not find an answer in the help documentation or simply require additional assistance, contact the Portal support team. You should contact the Portal support team if you already have a Portal account and are having trouble logging in or you have forgotten both your user name and password. There are two places to find the link to contact Portal Support. If on the Portal Login page, click the Portal Support link near the bottom of the page. If authenticated to the Portal, click Contact Us in the upper right hand corner next to the Help link. 27-Aug-2010 Page 60

63 The Portal Support window appears. Enter your name and address. In the Message area, describe your support issue. If you have forgotten both your user name and password, note this in the Message area. Click the Submit button. A Portal support team member will respond to your request in a timely manner. 27-Aug-2010 Page 61

64 10 FAQs What is Portal? Kendle's Clinical Trials Portal provides global access by sponsors, investigators, and Kendle team members with a single-login to various Kendle proprietary clinical development systems What are the system requirements and settings for Portal? Portal is recommended and supported for Internet Explorer 6.0 and higher. Current versions of Firefox, Safari and Chrome are useable with some loss of functionality (i.e. Office integration). Your browser must be able to accept cookies, process JavaScript and your browser should be set to not cache. Portal is best viewed at 800 X 600 display resolution or better How do I get access to Portal? First you need to request a new account from the Portal login page. Your login information will be ed to you once your Portal account has been created. You will then need to log in by supplying your user name and password What about logging in and out of Portal? Your single-set of login credentials to Portal (user name and password) also serve as your login to the Portal applications that you have been granted access. You should always log out of Portal by clicking the Logout link located on every page of Portal, and then close your browser window What about my Portal Password? Your Portal password must be at least 8 characters long and must follow three of the following four rules: 1. Must contain at least one numeric character 2. Must contain at least one uppercase alpha character 3. Must contain at least one lower case alpha character. 4. Must contain at least one special character What if I forget my password or it expires? If you forget your password or it expires, you may reset it yourself from the Portal login page by clicking on the "Forgot Password?" link How do I move around within Portal? The Portal Home page that appears once you have successfully logged in provides access links to all the areas and applications to which you have access rights. 27-Aug-2010 Page 62