Shared Investigator Platform Release · 2020. 6. 15. · Shared Investigator Platform Release 4.2 Job Aid Version 1.12 07-May-2020 For a detailed description on each activity explained

Shared Investigator Platform Release 5.1 Job Aid Version 1.13 03-Nov-2020

For a detailed description on each activity explained in this Job Aid, refer to the SIP Site User Online Help. SIP Help Desk Email: [email protected] | Telephone: See Help Desk ©2020 Cognizant Technology Solutions U.S. Corporation. All rights reserved. Page 1 of 21

Table of Contents

Table of Contents .....................................................................................................................................................................................................................................................................................1

Legal Notice ...............................................................................................................................................................................................................................................................................................2

Site User Registration ......................................................................................................................................................................................................................................................................3

Things to Do Before You Register .....................................................................................................................................................................................................................................................3

Check Your Browser Version and Installed Plugins..............................................................................................................................................................................................................3

Check Your System Requirements (Display Resolution) ....................................................................................................................................................................................................3

Allow Emails from SIP and Exostar Email Addresses ...........................................................................................................................................................................................................3

Are You Already Registered in Exostar? ...................................................................................................................................................................................................................................3

Register in SIP ............................................................................................................................................................................................................................................................................................4

Check Your Email Account for the Invitation Email .............................................................................................................................................................................................................4

Click the registration URL in the Invitation Email .................................................................................................................................................................................................................4

Accept the SIP Terms and Conditions .......................................................................................................................................................................................................................................5

Confirm Your Email Address and SIP Role ..............................................................................................................................................................................................................................4

Complete the Personal Information page ...............................................................................................................................................................................................................................7

Accept Exostar Terms and Conditions and submit the details ........................................................................................................................................................................................8

Logging on to SIP for the First Time ................................................................................................................................................................................................................................................9

Check Your Email Account for Activation Email ....................................................................................................................................................................................................................9

Set your Password and Security/Challenge Questions and Activate your Exostar Account ...............................................................................................................................9

Set your Password and Security/Challenge Questions and Activate your Exostar Account ...............................................................................................................................11

Log on to SIP as an Existing Exostar User ......................................................................................................................................................................................................................................13

Click the Registration URL in the Invitation Email and Select Your Role .....................................................................................................................................................................13

Confirm Your Email Address and SIP Role ..............................................................................................................................................................................................................................13

Forgot Your Password? ...................................................................................................................................................................................................................................................................16

Forgot Answers to Security/Challenge Questions? ..............................................................................................................................................................................................................16

Changing Your Password and Challenge Questions after Logging On..............................................................................................................................................................................17

https://www.sharedinvestigator.com/sipwsstatic/html/index.htm

mailto:[email protected]

https://www.sharedinvestigator.com/sipwsstatic/documents/SIP-Help-Desk.pdf



Change Your Password ...................................................................................................................................................................................................................................................................18

Update Challenge Questions ........................................................................................................................................................................................................................................................18

Manage One Time Password ........................................................................................................................................................................................................................................................19

Register Your Phone ...............................................................................................................................................................................................................................................................................19

Access Exostar Account ...................................................................................................................................................................................................................................................................19

Manage OTP – One Time Password ...........................................................................................................................................................................................................................................19

Register Your Phone .........................................................................................................................................................................................................................................................................20

Register Credentials..........................................................................................................................................................................................................................................................................21

Manage Phone Number .................................................................................................................................................................................................................................................................21

Legal Notice The documentation is provided “as is” and all express or implied conditions, representations and warranties, including any implied warranty of merchantability, fitness for a particular purpose or non-infringement, are disclaimed, except to the extent that such disclaimers are held to be legally invalid. Cognizant shall not be liable for any incidental or consequential damages in connection with the furnishing, performance, or use of this documentation. The information contained in this documentation is subject to change without notice.

Cognizant® and Shared Investigator Platform are either registered trademarks or trademarks of Cognizant in the United States and other countries. Other trademarks referenced herein are the property of their respective owners.






Site User Registration

Things to Do Before You Register

Before you register in SIP, you need to ensure that your system meets the minimum requirements for using SIP:

Check Your Browser Version and Installed Plugins

SIP is best viewed on Microsoft® Internet Explorer (IE) 11, Mozilla® Firefox 50 and above, Google® Chrome 53 and above, or Safari 9 and above, Microsoft ® Edge 11. To confirm your browser and installed plugin versions, ask your local IT Administrator for assistance or contact the SIP Help Desk.

Check Your System Requirements (Display Resolution)

SIP is best viewed with a minimum screen resolution of 1024x768 pixels and a color depth of 16-bit.

To confirm the display resolution of your screen, ask your local IT Administrator for assistance or contact the SIP Help Desk.

Allow Emails from SIP and Exostar Email Addresses

To avoid important emails from SIP and Exostar from going to your email Junk or Spam folder, add the

following email addresses to the Trusted Source Settings in your mailbox:

• [email protected]


Are You Already Registered in Exostar?

If you have previously registered your email address in Exostar, have an Exostar account, and have an invitation email sent by a Sponsor from SIP:

Click the registration URL provided in the invitation email. Perform the following:

• Accept the SIP Terms of Use, Privacy Policy, and Data Consent. • Select your role as an Investigator or a Clinical Research User. • Confirm your email address and follow the on-screen instructions.

For detailed information on this procedure, see Log on to SIP as an Existing Exostar User.













To do this, ask your local IT Administrator for assistance or contact the SIP Help Desk.

From Control Panel, click Internet Options, and then the Security tab. Click Trusted Sites, and then Sites. In the Add this website to the zone, type the following:

• *.sharedinvestigator.com;

Click Add. Click Close. Click Ok.

In addition, you need to disable pop-up blockers in your browser. To do this, ask your local IT administrator for assistance or contact the SIP Help Desk.

Register in SIP

1

Check Your Email Account for the Invitation Email

To register in SIP, you must first receive an invitation from a Sponsor. The invitation email includes the URL and instructions required to register.

Click the registration URL in the Invitation Email

This step initiates the registration process and displays the Consent for

Sharing Data With the SIP and Investigator Registry page in your browser.

Confirm Your Email Address and SIP Role

Verify your email address displayed below Confirm Your email address. To modify the registered email address, contact the Helpdesk.

Click Investigator or Clinical Research User to confirm your SIP Site User Role.









2

Accept the SIP Terms and Conditions

In the Language drop-down-list, English is displayed as the default language.

Select the language to view the SIP Terms and Conditions in the respective language. The list of languages include:

• Arabic • Chinese (Mandarin) • Chinese (Traditional) • English

Click Submit to confirm.






• French (Canadian) • French (European) • German • Italian • Japanese • Korean • Portugese (Brazilian) • Portugese (Portugese) • Russian • Spanish (European) • Spanish (Latin American)

Review all SIP Terms and Conditions. Select all the check boxes. Click Continue. Consent is required for SIP registration.






5

Complete the Personal Information page

On the SIP User Registration page, please complete the Personal Information, Contact Information, and Time Zone sections. Optional fields are indicated on the screen.

• Please do not enter more than 50 characters for the first, middle, or

last name fields. If you have multiple family names, it is recommended that you enter only one name as your last name. You can use a-z A-Z 0-9, # () ?: ; / space ' \_- ISO 8859-1, ISO 8859-15 version of UTF-8 character set as part of your first or last name.






6

Accept Exostar Terms and Conditions and submit the details

Review the Exostar Privacy Policy and select the I agree

to Exostar LLC’s Terms and have read the Exostar Privacy Policy check box.

Click Register. The Submission Confirmation page is displayed.






Logging on to SIP for the First Time

1

Check Your Email Account for Activation Email

After you register in Exostar, you will receive an email from [email protected].

Set your Password and Security/Challenge Questions and Activate your Exostar Account

1. To activate your Exostar account and log on to SIP for the first time, click the activation URL. The Activate Your Account page is displayed.

If you have not activated your account after registration then e-mail reminders for activation to complete the first time login will be sent to your registered e-mail address.

2

2. Click NEXT. The Create New Password page is displayed. 3. On the Create a Password page, enter the new password, confirm by

reentering the password, and then click NEXT.

Refer below link for password creation and reset policy details:

https://my.exostar.com/display/EFD/Password+Policies

Refer below link for Security Question and Answer policy details:

https://my.exostar.com/display/EFD/Security+Question+and+Answer+Policy

4. On the Set Security questions page, select your four security questions and type your response for each of the question, and then click NEXT.





https://my.exostar.com/display/EFD/Password+Policies

https://my.exostar.com/display/EFD/Security+Question+and+Answer+Policy



5. Your account is activated. Click on NEXT.

6. On the Service Agreement page, select the required check boxes, and

then click Accept. You must accept the terms and conditions of the Service Agreement in order to proceed.

If the Exostar Admin creates the site user profile, through the bulk upload process, it is mandatory for the Site User to review and accept the SIP Terms and Conditions. The Site User, in this case will need to perform steps 1-5 of the Set your Password and Security/Challenge Questions and Activate your Exostar Account section below, before proceeding to step 7.

Complete the Mandatory SIP Orientation (Site User Orientation Guide).

Click the link to view the Site User Orientation Guide. After you have viewed the Site User Orientation Guide, close it, and

click Read and Acknowledged. This button will be enabled after you open the Site User Orientation Guide.

You will be redirected to Shared Investigator Platform Home page.






Set your Password and Security/Challenge Questions and Activate your Exostar Account


Select the language to view the SIP Terms and Conditions in the

respective language. The list of languages include: Arabic Chinese (Mandarin) Chinese (Traditional)






English French (Canadian) French (European) German Italian Japanese Korean Portugese (Brazilian) Portugese (Portugese) Russian Spanish (European) Spanish (Latin American)

Review the information on the page and then click Select All. Select your SIP Site User Role. Click Investigator or Clinical Research User. Enter the Invitation Code. Click Continue. Please follow from Step 8 above.






Log on to SIP as an Existing Exostar User

1

Click the Registration URL in the Invitation Email and Select Your Role

If you already have an Exostar account, you do not need to follow the procedure described above in order to register.

Click the registration URL in the invitation email. The Consent for Sharing Data With the SIP and Investigator Registry page is displayed.

2

Confirm Your Email Address and SIP Role

Verify your email address displayed below Confirm Your Email Address. To modify the registered email address, contact the Helpdesk.

Click Investigator or Clinical Research User to confirm your SIP

Site User Role. Click Submit to confirm. The below screenshot is displayed.

On the confirmation message displayed, click Continue. The One

Account, Secure Access page where you can log on to SIP, is displayed.







Select the language to view the SIP Terms and Conditions in the respective language. The list of languages include: Arabic Chinese (Mandarin) Chinese (Traditional) English French (Canadian) French (European) German Italian Japanese Korean Portugese (Brazilian) Portugese (Portugese) Russian Spanish (European) Spanish (Latin American)

Review the information on the page and then click Select All. Click Continue.






3

For information on how to log on to SIP, refer to the SIP Site User Online Help (Logging on to SIP after Registering).

While logging on, you may be taken to the following page. If so, under My

Applications click Icon next to the appropriate application name.

For more information on OTP, refer to Manage OTP Password




https://www.sharedinvestigator.com/sipwsstatic/html/Site_User_Introduction/Logging_on_to_SIP_after_Registering.htm

https://www.sharedinvestigator.com/sipwsstatic/html/Site_User_Introduction/Logging_on_to_SIP_after_Registering.htm



Password Management

1

Forgot Your Password?

You will need to answer two Security/Challenge questions to reset your password.

For information on how to change your password if you are already logged on, refer to Change Your Password.

On the Sign-In page, click Log In. On the Login page, enter Email ID. Click Next. Click Forgot Password. On the Account Recovery page, select Enter Verification Code

from phone to receive an OTP on you registered cell phone. If you have not registered your cell phone for OTP, select Answer Security Questions or Enter verification code from email. Click Next.

The verification code in the email received expires in 30 minutes.

o In the Question drop-down list, select any two questions and

type the corresponding answers in the respective Answer fields.

OR, o Type the verification code that you receive on your registered

email ID.

The verification code in the email received expires in 30 minutes.

For more information on how to register your phone for OTP, please refer to Site User Manage OTP Password Job Aid.

Click Continue. On the Create New Password page, type and re-type your new

password in the New Password and Re-enter New Password boxes respectively.

Refer below link for password creation and reset policy details: https://my.exostar.com/display/EFD/Password+Policies

Click Submit.

2

Forgot Answers to Security/Challenge Questions?

If you have forgotten the answers to your Security/Challenge questions, you can contact the SIP Helpdesk or send an email to [email protected] and follow the instructions in the response email.

OR

Reset your answers after you have logged on to SIP. For details, refer Changing Your Password and Challenge Questions after Logging on.

For information on how to update your Challenge questions, refer to Update Challenge Questions.








Changing Your Password and Challenge Questions after Logging On

After logging on, you can reset your password and Challenge questions from the Settings

menu. To access the Settings menu, on the upper right corner of any page in SIP, click and

then select .






1

Change Your Password

For security reasons, password resets are required every 90 days. You may change your password as often as you like.

Click and then click Change Password. On the Change Password page, enter the following details: o Old Password—Type your current password. o New Password—Type your new password. o Confirm New Password—Re-type your new password.

Refer below link for password creation and reset policy details: https://my.exostar.com/display/EFD/Password+Policies

Click Submit.

2

Update Challenge Questions

The Security questions (also called Challenge questions) allow you to secure your User ID and password. You can update these questions and answers.

Click and then click Update Challenge Questions.

On the Change Security Questions page, select the Change check box(es) next to the question(s) that need(s) to be updated.

In each Question drop-down list, select a question. In the respective Answer drop-down list, type the corresponding answer.

Click Submit.






Manage One Time Password

Register Your Phone

Site Users who have already registered in SIP can use the instructions below to setup or manage their phone for One Time Password (OTP). OTP provides additional security and simplifies the process of resetting a forgotten password. Site Users who have already registered in SIP need to log on to Exostar.

1

Access Exostar Account

To log on to Exostar, click the URL https://secureaccess.exostar.com

On the Login page, in the Email box, enter your User ID or email.

In the Password box, enter the password, and then click NEXT. On the Select a two-step verification method page, select one

of the following options, and then click NEXT: o Answer security questions

OR, Enter the verification code from email.

o If you select Answer security questions then you need to select and answer the security questions that were set at the time of Site User registration and then click CONTINUE.

o If you select Enter verification code from email then

type the verification code that is sent to registered email ID.

2 Manage OTP – One Time Password

On the My Account page, in the left navigation pane, click OTP.




https://secureaccess.exostar.com/



In the Manage OTP – One Time Password section, click Register to register a new device to your account.

3

Register Your Phone

On the Manage OTP – One-time Password page, in the Step 1: Introduction tab, review all Terms and Policies for receiving text messages to your registered phone.

Click Submit.

In the Verfification Code box, type the OTP code received

on your phone. Click Submit.

The OTP code expires within 2 minutes. To regenerate the code click Resend Code.

In the Verfification Code box, type the OTP code and click Submit.

Click Complete.

Click Ok.






2

Register Credentials

In the Step 2: Register Credentials tab, under Register your Phone section, select or enter the required details.

In the Delivery Method drop-down list, select the delivery method

for receiving the OTP. In the Select Country drop-down-list, select your country.

In the Phone Number box, type your phone Number. In the Confirm Phone Number box, type your phone number

again. Click Send Code. A verification code is sent to your registered

phone.

3

Manage Phone Number

The following steps can be used to add or remove phone numbers, change delivery methods, or revoke the OTP feature altogether.

On the Manage OTP – One-time Password page, click Manage.

Under the Manage Phones section, click Add Phone.

To set the default phone number, in the Manage Phones

section, in the Phone Number column, click Set as Default next to the phone number.

To delete a phone number, in the Manage Phones section,

in the Actions column, click Delete Phone. To revoke the OTP feature, click Revoke. After you revoke

the OTP feature, you cannot use the phone to reset your password and will need to register again for availing this service.




Documents

Shared Investigator Platform Release · 2020. 6. 15. · Shared Investigator Platform Release 4.2 Job Aid Version 1.12 07-May-2020 For a detailed description on each activity explained