IBM Clinical Development

Transcription

1 IBM Clinical Development New User Help Effective: 26 January 2018 Copyright IBM corporation

2 IBM Clinical Development 2 TOPICS > > > Click the green icon to jump to the section or use the PDF page navigation to browse. CREATING AN ACCOUNT IN IBM CLINICAL DEVELOPMENT FIRST LOGIN HELP WITH LOGIN

3 IBM Clinical Development 3 Topic: Creating an Account Copyright IBM corporation

4 IBM Clinical Development 4 CREATING AN ACCOUNT All users, regardless of their role in the study team, will use the same website to create an account and log in. The users will be directed to the correct area (general user or team level) based on their account settings. Please note: While the product name has changed from eclinicalos to IBM Clinical Development, the website remains the same as of Feb When the website updates, users will be automatically redirected to the new one. *** IMPORTANT *** Unsupported (or Legacy ) browsers will be identified by the system and you may see a warning message on the login screen. Not all Legacy browsers will be able to access IBM Clinical Development. Known restrictions are: Internet Explorer (IE) v6 Access is blocked as of January 2015 Internet Explorer (IE) v7 Access is blocked as of January 2015 Internet Explorer (IE) v8 Access is blocked as of January 2016

5 IBM Clinical Development 5 CREATING AN ACCOUNT The Login page has both the existing users login (1) and the new user account creation (2). It also includes information for Support Services (3) and helpful videos (4).

6 IBM Clinical Development 6 CREATING AN ACCOUNT All users will create a General User account first. Once created, an IBM manager or a manager on your study team can upgrade you to a team level user, if appropriate. You will only need one account to access both the designer and study EDC. Step Action 1. Navigate to If you are using the StudyConnect app, you will need an IBM Clinical Development account before you can use the app. If you are a subject in a trial, an account should be created for you by your doctor or coordinator and further instructions provided. 2. Click the SIGN UP button on the right side of the login page. 3. Complete each page of the information collection wizard. Use the NEXT button to move forward or the BACK button to return to a previous page. All questions with the asterisk (*) are required. 4. Click the REGISTER button on the final page to create your account.

7 IBM Clinical Development 7 CREATING AN ACCOUNT The following screenshots will walk you through the create an account process. 2 3a Attribute Options Details First Name Free Text up to 48 characters Enter your first or given name. Last Name Free Text up to 48 characters Enter your last or family name. User ID Free Text, 5-15 characters This is the ID you will use to log in and electronically sign items within the system. All fields are required. You can choose any ID you want, but it must be unique within the system and must not be the same as your password. You will see an error message if the ID you chose is already in use. Do Not Use the Study Name or Passcode from your study access details. Do Not Use spaces or special characters such as ~`!@#$%^&*()+ {}.?<>,/; []\=

8 IBM Clinical Development 8 3b CREATING AN ACCOUNT The following screenshots will walk you through the create an account process.

9 IBM Clinical Development 9 CREATING AN ACCOUNT The following screenshots will walk you through the create an account process. 3b Attribute Options Details Company/Organization Free Text up to 200 characters Enter the name of the organization you will represent when you work in the system. Organization Type Dropdown List Select the type of organization you work for. Job Role(s) Selection List Choose one or more labels that describe your role in the clinical trials. Country Dropdown List Select the country you work in. Primary Time Zone Selection List Choose the time zone where you work. The system will display actions and enforce windows based on your local time setting. The Company/Organization, Organization Type, Job Role(s), and Primary Time Zone are required. These details can be updated at any time via My Profile > Edit (User Settings).

10 IBM Clinical Development 10 3c CREATING AN ACCOUNT The following screenshots will walk you through the create an account process.

11 IBM Clinical Development 11 CREATING AN ACCOUNT The following screenshots will walk you through the create an account process. 3c Attribute Options Details Confirm Phone Fax Free Text up to 200 characters Free Text up to 200 characters Free Text up to 200 characters Free Text up to 200 characters Enter your address. This is where you will receive system notifications. Enter your address a second time for confirmation. Accuracy is vital so you can receive appropriate system s. Enter a contact phone number. This will not be used except to return calls or follow up on issues you have reported. If available, enter a fax number. This will not be used except to return calls or follow up on issues you have reported. The , Confirm , and Phone are required. These details can be updated at any time via My Profile > Edit (User Settings).

12 IBM Clinical Development 12 CREATING AN ACCOUNT NOTE: If you already have an account with the same contact , you will see additional questions. You can create a second account, if needed, but it will be a general user. If you just need help with your user ID or password, do not create a new account. If you need assistances only and do not need a new account, click Yes on the first box. The system will forward you to the Forgot ID/Password page (see Topic: Help with Login). If you are creating an additional account, choose No for the first box and Yes for the second. 1 st Box 2 nd Box

13 IBM Clinical Development 13 CREATING AN ACCOUNT The following screenshots will walk you through the create an account process. 3d Question Options What is your city of birth? What is your favorite color? What is the maiden name of your mother? What is the middle name of your father? What is the name of your favorite pet? What is the name of your high school? What is the town of birth for your mother? The secret question and answer section will provide details Support Services can use to verify your identity when you contact them. Attribute Options Details Secret Question Secret Question Answer See Question Options list Free Text up to 150 characters Choose one question per screen for security purposes (you will pick a total of three different questions). Provide your personal response to the question you selected.

14 IBM Clinical Development 14 CREATING AN ACCOUNT The following screenshots will walk you through the create an account process. 3e Question Options What is your city of birth? What is your favorite color? What is the maiden name of your mother? What is the middle name of your father? What is the name of your favorite pet? What is the name of your high school? What is the town of birth for your mother? 3f

15 IBM Clinical Development 15 4 CREATING AN ACCOUNT Remember to click REGISTER to submit the account request. If you do not see the confirmation screen (below), you did not complete the process. Click here to return to the main page.

16 IBM Clinical Development 16 CREATING AN ACCOUNT You will receive a system with a temporary password. You will use this password during your first login and then update to one of your choice. The next section of this Help booklet will outline the first login process. MAIN Click here to return to the TOPIC list.

17 IBM Clinical Development 17 Topic: First Login Copyright IBM corporation

18 IBM Clinical Development 18 FIRST LOGIN After you receive the account , return to the main login page. You will now use the Existing Users section.

19 IBM Clinical Development 19 CREATING AN ACCOUNT Use the steps below to log in. Step Action 1. Navigate to 2. Enter your user ID in the first of the boxes in the Existing Users section. 3. Enter the temporary password from the in the second of the boxes in the Existing Users section. 4. Click the LOGIN button below your entries Review and confirm the contact information from your account submission. You can update if needed. Enter a password of your choice in the first New Password field. (Cannot be the same as your User ID.) 7. Enter the same password in the Confirm Password field. 8. Click UPDATE to finish logging in.

20 IBM Clinical Development 20 FIRST LOGIN The following screenshots will walk you through the login process

21 IBM Clinical Development 21 FIRST LOGIN The following screenshots will walk you through the login process

22 IBM Clinical Development 22 CREATING AN ACCOUNT The following screenshots will walk you through the login process. 5 Attribute Options Details Middle Initial Free Text up to 3 characters Enter up to 3 letters for middle name(s) if desired. Address Password Requirements: Passwords must be at least 8 characters but no more than 15 characters. They must contain 3 of the 4 following criteria: Upper case letter (A-Z) Lower case letter (a-z) Number (0-9) Free Text Comment Field Special Character (~`!@#$%^&*()+ {}.?-_<>,/; []\=) Enter a mailing or contact address if desired. This may be used to help verify your identity. These fields are additional settings available in the system and all are optional.

23 IBM Clinical Development 23 FIRST LOGIN Additional Password Notes: Passwords are case sensitive. Passwords expire every 90 days for standard accounts but can be reset as needed through personal settings. If you are creating an API account (specific for automated systems only), contact Support Services for assistance. Passwords cannot match the last five (5) passwords used. Your user account may be locked if any of the following occur: o o o o You have five (5) invalid login attempts. You have five (5) invalid attempts using the forgot ID/password wizard (secret question-answer). You have five (5) invalid attempts at an electronic signature, once logged in. Your company requests your account be disabled.

24 IBM Clinical Development 24 FIRST LOGIN Once you log in, you will see the General User landing page The blue bar is the main menu. My Studies shows your access. My Profile is your user account information. 2. This is the workspace that will list the studies you have access to (EDC). 3. This is the section to request access to a study. Your study team will provide the specific Study Name and Passcode needed. 4. This section has expandable boxes with links for the user manual, release notes, and other materials.

25 IBM Clinical Development 25 FIRST LOGIN If you need to update your account information or change your password. Click the My Profile link. On your profile, click the Edit link and it will open your details. NOTE: If you make changes or update your password, you will need to enter your current password to save the changes.

26 IBM Clinical Development 26 FIRST LOGIN OTHER THINGS TO KNOW The system has an automatic time-out function. This is a required feature for systems that support 21 CFR part 11. If your session is inactive for more than 30 minutes (this is activity in IBM Clinical Development, not the browser or elsewhere on your computer), the system will log you out. This timeout also applies to modules and tools associated/interfaced with IBM Clinical Development, such as the DICOM uploader or Apple iphone apps. The following features have been added to alert you to time-outs: The system has been updated to check for keystrokes and mouse movement as well as button clicks, so that data entry without a page save will be captured as activity. An alert window will appear when you are within 3 minutes of the time-out. This allows you to click or move your mouse to delay the action. If a time-out occurs, the system will return to the login page. MAIN Click here to return to the TOPIC list.

27 IBM Clinical Development 27 Topic: Help with Login Copyright IBM corporation

28 IBM Clinical Development 28 HELP WITH LOGIN There are 4 options for help on the login screen. 1. Forgot your password? This wizard can send a reminder for your ID or password. See the following pages for instructions. 2. Need help logging in? This link provides access to this manual. 3. Need Help? This is contact information for Support Services. If your account is locked, you will need to contact them for assistance. 4. Helpful Videos

29 IBM Clinical Development 29 HELP WITH LOGIN Help for a forgotten user name or password is available on the main login screen by clicking the Forgot your password link. The system will also prompt you when you enter your ID/Password incorrectly and will display how many attempts you have left. A total of 5 attempts are allowed before your account is locked. Step Action 1. Click the Forgot your password? link. Use the NEXT button to move forward or the BACK button to return to a previous page. All questions with the asterisk (*) are required. 2. Select the type of assistance you need. 3. Complete the requested verification information. 4. The system will send you an with the information requested. NOTE: If your account is locked, you will need to contact Support Services for a reset.

30 IBM Clinical Development 30 2 HELP WITH LOGIN The following screenshots will walk you through the Help process. FORGOT USER ID 3a

31 IBM Clinical Development 31 HELP WITH LOGIN The following screenshots will walk you through the Help process. 3b FORGOT USER ID Random Secret Question Random Secret Question Random Secret Question 4

32 IBM Clinical Development 32 HELP WITH LOGIN The following screenshots will walk you through the Help process. FORGOT USER ID Sample Detail

33 IBM Clinical Development 33 2 HELP WITH LOGIN The following screenshots will walk you through the Help process. FORGOT PASSWORD 3a

34 IBM Clinical Development 34 HELP WITH LOGIN The following screenshots will walk you through the Help process. 3b FORGOT PASSWORD Random Secret Question Random Secret Question Random Secret Question 4

35 IBM Clinical Development 35 HELP WITH LOGIN The following screenshots will walk you through the Help process. FORGOT PASSWORD Sample Detail You will need to provide a new password on your first login after the reset. The same password requirements are in effect.

36 IBM Clinical Development 36 2 HELP WITH LOGIN The following screenshots will walk you through the Help process. ACCOUNT LOCKED MAIN Click here to return to the TOPIC list.

37 IBM Clinical Development 37 HELP WITH LOGIN SUPPORT SERVICES WEBSITE PHONE act-support-ibm-clinical-development Help Desk US: (toll free) Additional numbers are available on the website LIVE CHAT is available via the website

38 IBM Clinical Development 38 Notices Licensed Materials Property of IBM Copyright IBM Corp US Government Users Restricted Rights Use, duplication or disclosure restricted by GSA ADP Schedule Contract with IBM Corp. All rights reserved. No parts of this work may be reproduced in any form or by any means - graphic, electronic, or mechanical, including photocopying, recording, taping, or information storage and retrieval systems - without the written permission of the publisher. Products that are referred to in this document may be either trademarks and/or registered trademarks of the respective owners. The publisher and the author make no claim to these trademarks. While every precaution has been taken in the preparation of this document, the publisher and the author assume no responsibility for errors or omissions, or for damages resulting from the use of information contained in this document or from the use of programs and source code that may accompany it. In no event shall the publisher and the author be liable for any loss of profit or any other commercial damage caused or alleged to have been caused directly or indirectly by this document. Copyright IBM corporation