Smart Measurement System for Late Phase

Smart Measurement System for Late Phase Electronic Data Capture (EDC) User Guide - Site Staff Version 6.6

Contents Contents 2 Section 1: Signing into Smart Measurement System (SMS) for Late Phase 4 1.1 Signing In for the First Time 4 1.2 Logging Into SMS for Late Phase 6 1.3 Session Timeout 6 Section 2: Home Page Overview 7 2.1 Navigation Icons 7 2.2 General 8 Section 3: Working with Subjects 9 3.1 Searching for a Subject 9 3.2 Managing Subject Details Information 10 Section 4: Entering CRF Data 12 4.1 Subject Visit Schedule 12 4.2 Selecting a Visit Date 12 4.3 Entering CRF Data 13 4.4 Saving CRF Data 15 4.5 Data Entry Checks 16 4.6 CRF Status 16 Section 5: Editing CRF Data 18 5.1 Reason for Change 18 5.2 Editing the Visit Date 19 5.3 Audit Trail 19 Section 6: Queries 22 6.1 What Is A Query? 22 6.2 Types of Queries 22 6.3 Responding to a Query 23 6.4 Query Status 24 6.5 Auto-Queries Created by Edit Check 24 Section 7: Alerts 25 7.1 Monitoring Alerts 25 Section 8: Call Tracking 28 8.1 Call Tracking Overview 28 8.2 Call Tracking Setup/Notifications 33 Section 9: Reminders 34 9.1 Reminder Overview 34 9.2 Reminder Setup/Schedule 35 Section 10: Unplanned and Missed Visits 37 2014 Optum, Inc. Confidential 2

10.1 Skipped Visits 37 10.2 Deleting Visits 37 Section 11: Reviewing and Signing CRFs 38 11.1 Signing CRFs 38 11.2 Reviewing the Impact of Data Changes and Queries on CRF Status 40 Section 12: Sites 41 12.1 Site Screen 41 Section 13: Reports 43 13.1 CRF Reports 43 13.2 Query Reports 46 13.3 Subject Reports 48 13.4 User Reports 49 13.5 Alert Reports 49 13.6 Site Reports 50 13.7 Data Selector 50 Section 14: Roles 55 2014 Optum, Inc. Confidential 3

Section 1: Signing into Smart Measurement System (SMS) for Late Phase 1.1 Signing In for the First Time When you are selected to participate in an upcoming study, you will receive a welcome email containing confidential information and your username. Most users will also receive a separate email with a temporary password and details on how to log into SMS for Late Phase. 1. Open the email that contains your username and take note of the username. 2. Open the email with your temporary password and click the SMS for Late Phase link in the email. The login screen displays. 3. In the Username field, enter your username that was provided in the email. 4. In the Password field, enter the temporary password that was provided in the second email. 5. Click Sign In. Some users will not receive a second email with a temporary password, and instead will be directed to reset their password using the Forgot Password? link. When signing into SMS for the first time you must change the temporary password that you have been provided. You are also asked to provide the answer to a security question to be used to reset your password in the future. 1. In the Password field, type a new personalized password. 2. In the Confirm Password field, type the new password again. 3. Click the My Security Question drop-down menu and select a question. The security question and answer are used in the event you forget your password. Select a question for which you will be able to remember the answer. 4. In the My Security Answer field, enter the answer. 5. Click Save. 6. Click Exit. As with many systems, and as referenced in 21 CFR, Part 11, there are a set of rules and regulations that must be followed when using SMS for Late Phase. When you sign in for the first time you will need to read and accept the user agreement in order to gain access to the system. 2014 Optum, Inc. Confidential 4

You have the option of accepting or declining the agreement. If you accept the agreement, the login process continues. If you decline the agreement, SMS for Late Phase closes. You are only required to accept a user agreement once, although there may be multiple user agreements to accept/reject. Over time, the SMS for Late Phase system user agreements may be modified. Following such events, you are required to accept the new agreement when you attempt to access the system. As a result, multiple user agreements will be on file in the system. You can print each user agreement by clicking the Print button, if desired. Accepting or Declining the User Agreement 1. Read the agreement and click Accept User Agreement. If you click Decline User Agreement, you cannot access SMS for Late Phase. 2. You can print the agreement before clicking Next by clicking the Print button. 3. Click Next. 4. If there are multiple User Agreements, the next one displays. Repeat steps 1 and 2 for each agreement. 5. Once all user agreements have been completed and accepted, then the study selection screen 2014 Optum, Inc. Confidential 5

displays. 6. Click the Launch EDC button for the applicable study. 1.2 Logging Into SMS for Late Phase You must enter your user name and password each time you sign in to SMS. 1. In the Username field, enter your username. 2. In the Password field, enter your password. 3. Click Sign In. 4. If you are signing in through CTMS, the Study Selection screen opens. Click Launch EDC for the study you would like to view. 5. The Home screen appears. 1.3 Session Timeout Your sign-in session times out after 20 minutes of inactivity. After this period of inactivity, you will be signed out and prompted to sign in again. 1. Click the Log Back In button. 2. In the Username field, enter your username. 3. In the Password field, enter your password. 4. Click Sign In. 2014 Optum, Inc. Confidential 6

Section 2: Home Page Overview The home page is the main navigation page for the SMS Late Phase Study. The Home icon on each page links back to this screen. 2.1 Navigation Icons Subjects Clicking on the Subjects icon will allow the user to perform data entry for an existing subject, add a new subject, or review all Subjects in a study, depending on the user's level of access. For more information on roles and levels of access, refer to Section 14: Roles For more information on the tasks associated with this screen, refer to Section 3: Working with Subjects. Sites This icon only appears if you have access to sites. If you want to perform Data Entry for an existing site, click on the Sites icon. For more information on the tasks associated with this screen, refer to Section 12: Sites. Tools Depending on your level of access, if you want to sign a CRF, click the Tools icon. Depending on your level of access, if you want to verify a CRF, click the Tools icon. 2014 Optum, Inc. Confidential 7

Depending on your level of access, if you want to review all queries, click the Tools icon. For more information, refer to Section 6: Queries Depending on your level of access, if you want to review all alerts, click the Tools icon. For more information, refer to Section 7: Alerts For more information on roles and levels of access, refer to Section 14: Roles Reports If you want to analyze data and would like to run a report, click the Reports icon. For more information, refer to Section 13: Reports. Administration If you want to update your own information or change your password, click the Administration icon. Depending on your level of access, you may also edit a User's details and/or site associations, register a new User,edit a site's details and/or user associations, or register a new site. For more information on roles and levels of access, refer to Section 14: Roles 2.2 General This section of the screen allows you to select the study and site by using the dropdown menus. Study setup details are displayed under the Administrative icon. 2014 Optum, Inc. Confidential 8

Section 3: Working with Subjects Subjects are members who are included in the study. Each subject has a unique identification number called a Subject ID. The Subject ID is used to identify the subject, determine Subject Status, and track key activities throughout their participation in the study. The system also allows the site to track the subject's age, gender, and additional identifiers, such as screening number and enrollment date. Your study team will advise you of the fields available for your study, and how they will be used. 3.1 Searching for a Subject To access a subject's Visit Schedule to enter data into their CRFs or update the Subject Status, you must first search for the subject. 2014 Optum, Inc. Confidential 9

1. Click the Subjects icon in the navigation menu. 2. In the Subject Search Criteria section, enter a Subject ID or part of a Subject ID into the Subject ID field. (Optional) Note: You can search for all subjects located at a site by leaving the Subject ID field blank. 3. Select a status from the list. All Statuses is selected by default. 4. If you have access to more than one site, select a site from the list. 5. Click the search button. 6. The Subject Search screen is displayed. From here, you can: Add CRF data for each visit by clicking Visit Schedule/Add Data Edit a subject's details by clicking Edit Subject Delete a subject by clicking Delete Subject 3.2 Managing Subject Details Information The Site Staff is responsible for maintaining subject information. As a subject moves through a study, the subject status and subject details can be updated by the Site Staff. In SMS for Late Phase, there is both required and optional information. A site may find it useful to track subjects within a study by including optional information. Additionally, this information may help the site ensure accuracy. 2014 Optum, Inc. Confidential 10

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Section 4: Entering CRF Data 4.1 Subject Visit Schedule In SMS for Late Phase, a subject examination or interview is referred to as a Visit. A visit may be an in-person office visit or a telephone contact, and can also be a collection of assessments made within a certain time span rather than on a single visit date. In many studies, there is a predefined set of visits called the Visit Schedule. For example, the subject may be examined every three months for a year. Each expected visit is represented in SMS for Late Phase as a Visit section. Each Visit section displays all the CRFs that will need to be collected when the subject visits your site for an appointment. For more information, refer to the previous section: Section 3: Working with Subjects. 1. From the Subjects screen, click the Visit Schedule link in the Actions column for a particular subject. 2. The Subject Visit Schedule screen appears. 4.2 Selecting a Visit Date When you are ready to start entering data for a subject, you must first enter a visit date. This should be the date that the subject attended their first appointment at your site. For studies that do not have defined visits, this date should be the date the data was entered. 1. Open a subject's visit schedule. 2. Find the visit to be entered on the visit schedule. Typically, you will find Baseline, 3 Month Followup, and 6-Month Follow-up visits listed. The rows under Forms To Be Collected are grayed out until a visit date is entered. 3. To enter a visit date, click on the calendar icon. The Update Visit Date screen appears. 2014 Optum, Inc. Confidential 12

4. Click on the calendar icon manually enter the date. on this screen to select the date from a calendar. You can also 5. Click the Update button. The Update Visit Date screen closes and the items under Forms To Be Collected are no longer grayed out. You can now enter data on a specific CRF. 4.3 Entering CRF Data The CRF contains data entry fields to enter subject data and buttons to either Save as Draft or Submit data. 1. From the Subject Visit Schedule, click the Create CRF link to open a form and begin data entry. 2. A separate window opens, showing the selected CRF. 2014 Optum, Inc. Confidential 13

3. Read-only header information is displayed at the top of the CRF. Use this information to verify that you have opened the CRF for the correct subject. 4. Enter data into each field. Navigate using the mouse or tab key. Date fields have a calendar icon. Select the date from the calendar by clicking on that date. The calendar dialog will close and display the date selected. For fields where partial dates are expected, the date shows as a three-part date, and has a drop-down for each field. 2014 Optum, Inc. Confidential 14

4.4 Saving CRF Data Once you have entered data into a CRF, you can either save the information as a draft by clicking the Save as Draft button, or submit the information by clicking the Submit button. Additionally, you can discard any changes to the CRF by clicking the icon. Save as Draft The Save as Draft functionality allows a user to save the data entered into a CRF and return later to update information. Saving a CRF changes the status to Draft and saves the CRF data. A CRF can be saved as a draft multiple times before being submitted. When editing a CRF that has been saved as a draft, any changes that you make to the data on the form will not require a reason for change. When saving as a draft, no automated consistency or quality checks will be performed on the data, and no automatic queries will be generated. Submit CRF The Submit functionality allows a user to submit a CRF. Submitting a CRF changes the status to Submitted and saves the CRF data. After a CRF has been submitted, any changes to the form will require a reason for the change. If anything is changed, the CRF must be submitted again. Once submitted, edit checks run against the CRF, which could result in the generation of automatic queries. Once the CRF has been saved, a confirmation message appears. From here, you can navigate to another CRF or close the window. 2014 Optum, Inc. Confidential 15

Discard Changes in CRF If you make changes to a CRF and then attempt to close the form without submitting or saving as a draft, a message window will be displayed. If you click the OK button, the data you entered or modified will be discarded. 4.5 Data Entry Checks When a CRF is submitted, you will sometimes receive a message for certain users if pre-defined criteria for entered data are not met. These messages occur when Serious Adverse Events or Serious Adverse Drug Reactions are entered. The data discrepancy should be addressed before the CRF is submitted. An example message is shown below. 1. If you receive a data entry message, click the OK button to proceed. 2. You are returned to the CRF where you can resolve the error. Once you have resolved the error, click the Submit button to submit the CRF. If you cannot resolve the error at this time, click the Save as Draft button to resolve the error when you have the necessary data. 4.6 CRF Status Once a visit date is entered, the CRFs become available for entry and review with a status of New. Each CRF is assigned a status in order to easily track it at different stages throughout the process. When all required data has been entered and submitted to the database, the CRF is marked as Submitted. CRFs with no data are marked as New. 2014 Optum, Inc. Confidential 16

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Section 5: Editing CRF Data Depending on your level of access, Site Users can edit, view, or clear CRFs that have already been created and submitted. Links are available in the Action column for eligible CRFs. 5.1 Reason for Change If Site Users make edits to CRF data for a CRF that has already been submitted, a Reason for Change must be provided. 1. From the Subject Visit Schedule, click the View CRF link to open a CRF. 2. Review the data on the CRF. If you need to make changes, click the Edit button. 3. Make the required changes, then click Submit. 4. The Reason for Change screen appears. 2014 Optum, Inc. Confidential 18

5. Select the most suitable reason from the dropdown list. 6. Provide a comment detailing the reason in the comment field. 7. Click the Submit button. 5.2 Editing the Visit Date When a user edits a visit date that has been saved, a reason for the change must be provided. Select the reason from the drop-down list and provide additional details using the comment field. 1. Find the visit that needs to be edited on the Visit Schedule screen. 2. To edit the visit date, click the calendar icon. The Update Visit Date window appears. 3. Click the calendar icon on this window and select the date from the calendar dialog. 4. Select a reason from the dropdown list. 5. Provide a comment detailing the reason for change. 6. Click Update. 5.3 Audit Trail Site Users can view an audit trail for each field that has been edited, or for the entire CRF. 2014 Optum, Inc. Confidential 19

1. From the Subject Visit Schedule, click the View CRF link to open a CRF. 2. To view the audit trail for a particular field, click the magnifying glass icon next to the field. To view the audit trail for the entire CRF, click the Audit button at the bottom of the form. 3. The audit trail window opens. 2014 Optum, Inc. Confidential 20

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Section 6: Queries A critical task is to ensure that the data you enter into the system is valid, consistent, and logically sound. When any data you enter is analyzed, a query may be created. When a query exists against any data you have entered, you must review the issue and resolve it. 6.1 What Is A Query? A query is a documented instance of unexpected or questionable data that must be explained. Queries are generated to check the validity or accuracy of data entered in a CRF. Once a query has been generated, it is identified with a red exclamation point next to the data point in the CRF. In the example below, the Height field and Cholesterol-Total field both have queries that need to be addressed. 6.2 Types of Queries Manual Query Data that is questioned by visual inspection. Manual queries are generated in response to discrepant data that is identified in a CRF. Manual queries must be closed manually by an authorized User. 2014 Optum, Inc. Confidential 22

Auto Query Auto queries are generated from predetermined edit checks to validate the data entered in a CRF. Auto queries will be automatically closed when the data rendered invalid is updated within the set parameters. Void Query Voided queries are generated automatically. Voiding occurs when an automatic query is updated and the parameters of the query are no longer valid. 6.3 Responding to a Query 1. Verify the data entered is accurate by reviewing the original subject source data. If you find an error after checking the source data, edit the value in the CRF. 2. If the data you entered matches the subject source data and the question was left blank, you must provide an explanation as to why the question was not answered in the text box provided. 3. Click the Send button. 4. Enter an explanation in the Send Response box. This may be as simple as, "The blood pressure was not taken" or "The value matches the subject source data." Enter any additional information that may help someone understand why the given data is acceptable. Example: "Subject's blood pressure was higher than expected because he or she was very nervous," or "Subject has history of high blood pressure and cannot afford medication." (Note: Data regarding patient's health still must be captured on the CRF.) 2014 Optum, Inc. Confidential 23

5. If you read the question and need additional guidance on how to resolve the issue, use the Send Response field to submit a question. Someone will review the question and provide an answer as soon as possible. 6.4 Query Status Each query in the application is assigned one of the following statuses: Open - Occurs when discrepant data is identified, either through a manual query or by a systemgenerated auto-query. Answered - Occurs when a response is entered by the site user. After reviewing the query, the respondent might need to edit data to ensure that the data matches the data in the source documents and must provide a data explanation. Re-queried - Occurs when a user requests more information from the Site User if the answer to the first query is unsatisfactory. Closed - Occurs when data related to an auto query is amended and the new value satisfies the condition of the query and is no longer an issue. Closed status is also assigned to answered manual queries and answered auto queries where the value does not satisfy the condition of the query and a satisfactory explanation has been provided by the site. Void - Occurs after data verification, when the changes made to the CRF data render the query no longer valid. 6.5 Auto-Queries Created by Edit Check Electronic edit checks in SMS for Late Phase check for illogical, incomplete, or inconsistent data, and in some cases generate queries in the system. This is an automated process intended to reduce errors by assessing the content of a data field against expected logical values, format, range, or other properties. Types of Edit Checks Data Entry Checks - This type of edit check looks for unexpected or illogical data entered into a CRF and prevents the CRF from being submitted until the data issue is resolved. Pre-submission checks do not generate queries. (Example: "Not Done" is selected for the Pulse Rate, but a pulse rate is recorded in the CRF.) Cross Form - This type of edit check searches for inconsistent data entered across multiple CRFs. Entries are cross-checked on multiple fields and variables to ensure data is logical and consistent. This type of edit check can result in queries. 2014 Optum, Inc. Confidential 24

Section 7: Alerts Alerts are triggered from certain CRFs submitted on a per study basis. When an alert occurs, an email is sent to certain roles defined by an administrator. When you receive an alert, you can view and manage the alert on the Monitor Alerts Screen, which can be accessed via the Tools menu for studies that are set up to use Alerts. 7.1 Monitoring Alerts You can view a list of all current alerts from the Monitor Alerts screen. Monitor Alerts screen lists the CRF and description details for all current alerts. You can also search for alerts by CRF Type (only if sites are active), Subject ID, Site, Visit, Priority, and Status. From this screen, you can access the Alert Details, Status History, and the CRF by clicking the links in the Actions column. 1. Click Monitor Alerts from the Tools menu. 2. In the Search Criteria section, enter a Subject ID or part of a Subject ID into the Subject ID field. 2014 Optum, Inc. Confidential 25

(Optional) 3. Select a status from the list. (Optional) 4. If you have access to more than one site, select a site from the list. (Optional) 5. Select a visit from the list. (Optional) 6. Select a priority from the list. (Optional) 7. Click the search button. Alert Details The Alert Details screen shows all details associated with the alert. The screen is divided into three tabs. The Summary tab shows the status, priority, whether the alert has been read, notification date and details, and acknowledged date and details. These fields are editable, and you can save changes by clicking the Update button at the bottom of the window. The Details tab shows the user the information that triggered the alert.this information is read-only. The Logs tab lists who received the alert and on what date. This information is read-only. 2014 Optum, Inc. Confidential 26

Alert Status History The Alert Status History is an audit trail of each time the alert changed status. 2014 Optum, Inc. Confidential 27

Section 8: Call Tracking Some studies may require calling subjects to remind them when it is time to take their survey. Depending on the settings of the study, Call Tracking capability may be enabled to help facilitate the scheduling and monitoring of subject calling. When Call Tracking is enabled, an email notification is sent on a weekly basis to all appropriate staff members designated with the task of following up with subjects. You will receive a reminder to log into SMS to access Call Tracking reports to see if any of your subjects need to be called. 8.1 Call Tracking Overview To access Call Tracking information, click the Tools icon. If Call Tracking is turned on for the study, the Call Tracking section appears in the Tools screen. 1. Click Call Tracking Overview from the Tools menu. 2014 Optum, Inc. Confidential 28

2. In the Search Criteria section, enter a Subject ID or part of a Subject ID into the Subject ID field. (Optional) 3. Select a visit from the list. (Optional) 4. If you have access to more than one site, select a site from the list. (Optional) 5. Select a status from the list. (Optional) 6. Enter a Call Start Date and Call End Date. (Optional) 7. Click the search button. The results appear in a list below the search criteria. From here, you can view the number of Missing CRFs and Total Required CRFs, details, status history, and visit schedule. Call Tracking Details The Call Tracking Details screen shows all details associated with the call. The screen is divided into two tabs. The Summary tab shows general information about the call, such as the Subject ID and phone number, the visit the call is associated with, the call status, and the scheduled date. 2014 Optum, Inc. Confidential 29

The Messages tab shows messages associated with the call. From the Details screen, you can also set a follow-up call or close the call. To set a follow-up, click the Set Follow-up button. 2014 Optum, Inc. Confidential 30

You can then specify a follow-up date and include any additional details in the text box. To save these changes, click the Update button. Similarly, if you would like to close a call, click the Close Call button. You can also add details in the text box, and click Update to close the call and save your changes. You can also access Call Tracking Details for a particular visit from the Visit Schedule. To view Call Tracking Details from the Visit Schedule, click the phone icon next to the visit you would like to see. 2014 Optum, Inc. Confidential 31

Call Tracking Status History The Call Tracking Status History is an audit trail of each time the call has changed status. 2014 Optum, Inc. Confidential 32

8.2 Call Tracking Setup/Notifications Depending on your level of access, you can access the Call Tracking Setup and Notifications from the Tools Menu. From the Call Tracking Setup/Notifications screen, you can view which visits are flagged to be call tracked and specify which roles and email addresses will receive Call Tracking Notifications. To specify which roles and email addresses will receive Call Tracking Notifications, click the Call Tracking Notifications link. From this screen, you can specify which roles will receive Call Tracking Notifications by checking the box next to each role. You can also specify individual email addresses by clicking the Emails tab. 2014 Optum, Inc. Confidential 33

Section 9: Reminders Some studies may require reminding subjects when it is time to take their survey. Depending on the settings of the study, Reminders capability may be enabled to help facilitate the scheduling and monitoring of subject reminders. 9.1 Reminder Overview If Reminders are turned on for the study, the Reminder section appears in the Tools screen. 1. Click Reminder Overview from the Tools menu. 2014 Optum, Inc. Confidential 34

2. In the Search Criteria section, enter a Subject ID or part of a Subject ID into the Subject ID field. (Optional) 3. Select a status from the list. (Optional) 4. Select a reminder type from the list. (Optional) 5. If you have access to more than one site, select a site from the list. (Optional) 6. Select a Delivery Method from the list. (Optional) 7. Enter a Reminder Start Date and Call End Date. (Optional) 8. Click the search button. The results appear in a list below the search criteria. From here, you can view the status of the reminder, the reminder date, and the reminder type. You can also click the Details link to view more information. 9.2 Reminder Setup/Schedule Depending on your level of access, you can access the Reminder Setup and Schedule from the Tools Menu. From the Reminder Schedule screen, you can view the reminder name and schedule for a particular visit schedule. 2014 Optum, Inc. Confidential 35

To specify which roles and email addresses will receive reminders, click the Reminder Notifications link. From this screen, you can specify which roles will receive reminder notifications by checking the box next to each role. You can also specify individual email addresses by clicking the Emails tab. 2014 Optum, Inc. Confidential 36

Section 10: Unplanned and Missed Visits 10.1 Skipped Visits Depending on your level of access, Site Users can mark a visit as skipped. A visit should be marked as skipped if the subject missed that scheduled visit and, as a consequence, the data cannot be collected. Each trial will have clearly defined rules on how to deal with subjects who miss a visit. If you are unfamiliar with the consequences of a skipped visit, contact your trial representative or CRA. In some cases, a skipped visit could result in forced early termination of the subject's participation in the trial. 10.2 Deleting Visits Depending on your level of access, Site Users can delete unplanned visits if the visit does not have any submitted CRFs associated with it. The Delete Visit link appears next to the eligible Visit heading in the Visit Schedule screen. If a CRF is associated with the unplanned visit, the user must clear all CRFs and then delete the site visit. 2014 Optum, Inc. Confidential 37

Section 11: Reviewing and Signing CRFs 11.1 Signing CRFs CRFs can be signed only by the PI; however, the Study Coordinator has view-only access to the CRFs that are eligible for signature in the system. Depending on the study, some CRFs can only be signed once a CRA has marked it as Monitored or Verified. These two statuses indicate that the CRF has no outstanding queries against it and is ready for signature. To search for a CRF to sign: 1. Click Tools. 2. The Tools options are displayed. 3. Click the CRF Overview link. 4. Enter a Subject ID or part of a Subject ID into the Subject ID text box. (Optional) 5. Select a CRF from the list. All CRFs is selected by default. (Optional) 6. If you have access to more than one site, select a site from the list. 7. Select a visit from the list. All Visits is selected by default. (Optional) 8. Select a status from the list. All Statuses is selected by default. (Optional) 9. Click the Search button. 2014 Optum, Inc. Confidential 38

10. CRF search results are displayed in the table below. To sign a CRF: 1. Locate the CRF in the CRF Search Results. 2. If the CRF data matches the subject source data and you are ready to sign the CRF, select it by clicking the check box on the far left of the table. If multiple CRFs have been verified and are ready to be signed, you can select multiple CRFs. 3. Click the Sign button in the upper right corner. The Mark CRF(s) as Signed window will appear. 4. Enter your username and password to confirm the signature. 5. Once you have signed the CRF(s), you will receive a confirmation and summary. 2014 Optum, Inc. Confidential 39

11.2 Reviewing the Impact of Data Changes and Queries on CRF Status In certain situations, the status of a CRF can revert back to a Submitted status. If a CRF has been signed by the PI, the status reverts back to Submitted if any data changes have been made to the CRF. Once the CRF data is resubmitted the CRF has to be re-verified. The PI must sign the CRF again. 2014 Optum, Inc. Confidential 40

Section 12: Sites If Site CRFs have been enabled for your study, the Sites icon will appear in navigation bar. Clicking the Sites icon will take you to the Sites list, where you can collect forms and edit CRFs by site. To view forms for a site listed, click the Visit Schedule/Add Data link. 12.1 Site Screen The individual site screen allows you to view the forms that need to be collected for each visit. From here, you can edit, view, clear and audit CRFs. 2014 Optum, Inc. Confidential 41

When Sites are enabled in a study, a radio button appears in the CRF Overview screen allowing the user to search for CRFs. 2014 Optum, Inc. Confidential 42

Section 13: Reports SMS for Late Phase offers several customizable reports to help you visualize your data. To access and customize reports, click the Reports icon in the navigation bar. All reports can be generated in HTML, Excel, or CSV format. Tabled Report Tabled reports allow you to retrieve the raw Session, Subject, Visit and CRF data from SMS. The core data is at the item response level of each CRF. Data can be filtered at various levels including Study, Site, and CRF. Audit Trail Report The Audit Trail report is a comprehensive report outlining the various changes that have been made to the subject, visit and CRF data. 13.1 CRF Reports CRF Detail by Status The CRF Detail by Status reports allows you to view the status of every CRF within your study. The report can be run on either Subject CRFs or Site CRFs. Output can be filtered by Site, Visit, CRF status, Subject ID (Subject CRFs only) and Subject Status (Subject CRFs only). You can also opt to include visits with No Visit Date (i.e. visits that have been skipped or not started). Output details if the CRF is optional, skipped, CRF status (new (not started), draft, submitted etc.), locked and if there are open queries. The Patient CRF output will also allow you to then determine the status of the subject. 2014 Optum, Inc. Confidential 43

Overdue CRF The Overdue CRF Report lists missing (not completed) CRFs when a visit date has been entered for the visit. The report indicates how many days since the visit date have elapsed grouped by 7 Days or Less, 8 to 14 Days, 15 to 28 Days, or 29 Days or more. The report can be run on either Subject CRFs or Site CRFs. Output can be filtered by Site, Visit, CRF name, and Subject ID (Subject CRFs only). Missing CRF The Missing CRF report allows you to view all missing CRFs linked to a particular study. The report can be run on either Subject CRFs or Site CRFs. You can customize results by Site, Subject ID (Subject only), Subject Status (Subjects only), Visit and CRF status. You can also opt to include visits with No Visit Date (i.e. visits that have been skipped or not started) and Optional CRFs. 2014 Optum, Inc. Confidential 44

Subject - CRF Status The Subject - CRF Status report allows you to view the Subject Status, Number of Completed, Incomplete, and Skipped visits for each subject in a study. You can customize results by Site, Subject ID and Subject Status. Subject Visit - CRF Status The Subject Visit - CRF Status report lists the number of CRFs each subject in a study has for each visit by CRF status. You can customize results by Site, Subject ID, Subject status and Visit. 2014 Optum, Inc. Confidential 45

Summary CRF by Site The CRF Summary by Site Report provides you with a count of the various CRF statuses and the percentage of the total CRFs available for entry for that site. The report can be run on either Subject CRFs or Site CRFs. Output can be filtered by Site and Subject Status (Subject CRFs only). Output details the total CRFs, missing CRFs, Draft CRFs, Submitted CRFs, CRF with queries, CRFs with alerts, Verified CRFs, Monitored CRFs, Signed CRFs and Locked Subjects (Patient only). 13.2 Query Reports Query Aging Per Site The Query Aging Per Site report lists the number of open or answered queries in a study by age for each site. The report can be run on either Subject CRFs or Site CRFs. You can filter output by Site. 2014 Optum, Inc. Confidential 46

Query Backlog for Open & Answered Queries The Query Backlog for Open & Answered Queries report lists query details for a particular study. The report displays four columns representing the number of days the query has spent in each status. These columns include: Open to Answered, Answered to Re-queried, Re-queried to Closed, and Answered to Closed. Results can be filtered by Site, CRF Status, and Query Source Type. Query Count by CRF The Query Count by CRF report lists the number of outstanding queries for each CRF in a study. Results can be filtered by Site, Visit, CRF, and Query Description. Query Detail The Query Detail report lists query details of each query in a study. The report can be run on either Subject CRFs or Site CRFs. Results can be filtered by Site, Visit, CRF name, Query Status, Query Priority, Query Source, and the date the query was opened. 2014 Optum, Inc. Confidential 47

Subject - Query Status The Subject - Query Status report lists the number of queries by status for each subject in a study. You can customize the results by Site and Subject ID. Subject Visit - Query Status The Subject Visit - Query Status report lists the number of queries by status and visit for each subject at each visit in a study. You can filter the results by Site, Subject ID, Subject Status and Visit. 13.3 Subject Reports Subject Detail by Status 2014 Optum, Inc. Confidential 48

The Subject Detail by Status report allows you to view a number of subject details by study, including Subject Status, Screening Date, and whether the subject is locked. You can filter the results by Site, Subject ID, and Subject Status. Subject Locked/Unlocked Audit Trail The Subject Locked/Unlocked Audit Trail report shows audit trail details for subjects in a study that have been locked and unlocked. Results can be filtered by Site, Subject ID, Subject Lock Status, User ID, EDC Role, Start Date, and End Date. 13.4 User Reports User Listing The User Listing report lists details for all Users associated with a particular study. Results can be filtered by Site, User Name, Active State of the User, or EDC Role. 13.5 Alert Reports Alert Summary Report 2014 Optum, Inc. Confidential 49

The Alert Summary report lists details for all alerts that have been set up in a study. Results can be filtered by Site, Subject ID, Visit, CRF, Alert Status, and Alert Priority. 13.6 Site Reports Site Association The Site Association report lists User details and roles associated with a particular study and site. Results can be filtered by Site, State, Country, and Active State of the site. Site Listing The Site Listing report lists details of all sites involved in a particular study. Results can be filtered by Site, State, Country, and Active State of the site. 13.7 Data Selector The Data Selector report is a fully customizable report that allows you to choose data by site, visit, and CRF. You can also save the report criteria to run at a future date. When you click the Data Selector link, you can search for a saved Data Selector report or create a new report. When a report is saved it s either classified as public or private. If a report is Public, all users with access to Data Selector for that particular study can view the report, however only the user that created the report can edit the parameters. If a report is Private, only the user that created the report can view and edit the report. From this page, you can run saved reports, edit reports you have created, or delete reports you have created. 2014 Optum, Inc. Confidential 50

Creating a New Report When you choose to create a new report, the Report Filter screen appears. From here, you can choose the site, visit, and CRF to report on. To choose multiple filters, hold down the CTRL key while selecting. When you have selected your filters, click Next. If you want to return to the prior page, click the Previous button or the Data Selector Home link at the top of the page. The Data Selection screen appears. From this screen, you can choose which fields to report on. To add fields, select the field names from the lists on the left side of the screen and click the Add button. To remove fields, select the field names from the Selected Fields list on the right side of the screen and click the Remove button. To choose multiple filters, hold down the CTRL key while selecting. You can reorder the fields by 2014 Optum, Inc. Confidential 51

selecting a field on the Selected Fields list and clicking the Up or Down button. When you are done selecting fields, click the Next button. If you wish to return to the prior selection screen, click the Previous button. If you wish to start over, click the Data Selector Home link at the top of the page. When you have clicked Next, the Field Naming screen appears. The Field Name Alias is the field label that appears on the report. On this screen, you can specify new aliases for each field name. When you have finished, you can save the report criteria for future use by clicking Save. The Report Name screen will appear and you are asked to specify a name for the report. Alternatively, if you would like to run the report without saving the report criteria, click Next. If you wish to return to the prior selection screen, click the Previous button. If you wish to start over, click the Data Selector Home link at the top of the page. 2014 Optum, Inc. Confidential 52

After you save the report, you can determine the name of the report and whether it s Public or Private. Private reports are saved only for the user currently signed in. Public reports are saved for use by any user that has access to Data Selector for that particular study. Reports can only be edited by the report owner. When saving an edited report, you can choose to overwrite the existing report with the modifications by clicking "Save," or you can save the report under a new name by clicking "Save As." The Subject and Format Selection screen appears. To run the report on a single subject or group of subjects, enter all or part of the Subject ID in the Subject ID field. You can run the report as a Web Page, Excel file, or CSV file. 2014 Optum, Inc. Confidential 53

Editing and Deleting an Existing Report From the Data Selector Home screen, you can edit or delete existing reports that you have created. The Edit Report and Delete Report links are located in the Actions column. When the edit report is chosen, the user is brought to the Report Filter screen. 2014 Optum, Inc. Confidential 54

Section 14: Roles The following matrix details access to specific functions in SMS for Late Phase by role. CRA EDC Principal Investigat or Sponsor Study (Clinical Coordina Research tor Associat Data Entry Data EDC Regi LP Administ Manager strar rator Project Manager SMC Super SMS Progra visor mmer e) CRFs Access CRF Ov erview Y Y Y Y Y Y N Y Y Y Y View Single CRF Y Y Y Y Y Y N Y Y Y Y Submit/Edit CRF Y N Y N Y N N N N N N Clear CRF Y N Y N Y N N N N N N Display CRF Audit Trail Y Y Y Y Y Y N Y Y Y Y Mark CRF as Source Data N N N Y N N N Y N N N Verified Mark CRF as Remote N N N Y N N N Y N N N Monitored Sign CRFs with an esignature Y N N N N N N N N N N Lock CRFs N N N N N Y N Y N N N Unlock CRFs N N N N N Y N Y N N N CRA Principal Investigato r Sponsor Study (Clinical Coordina Research tor Associat Data Entry Data EDC Regi LP Administ Manager strar rator Project Manager SMC Super SMS Progra visor mmer e) Visits View All Visits Y Y Y Y Y Y N Y Y Y Y Submit/Enter Visit Date Y N Y N Y N N N N N N Enter Unplanned Y N Y N Y N N N N N N Visit Skip Visits Y N Y N Y N N N N N N Delete a Visit Y N Y N Y N N N N N N 2014 Optum, Inc. Confidential 55

CRA Principal Investigato r Sponsor Study (Clinical Coordina Research tor Associat Data Entry Data EDC Regi LP Administ Manager strar rator Project Manager SMC Super SMS Progra visor mmer e) Queries Access Query Overview Y Y Y Y Y Y N Y Y Y N View Query Details Y Y Y Y Y Y N Y Y Y Y Request more info for a Y N Y Y N Y N Y N N N Query Respond to Query Y N Y N N N N N N N N Close a Query N N N Y N Y N Y N N N Create a Manual Query N N N Y Y Y N Y N N N View Edit Check Specifications N Y N Y N Y N Y Y Y Y CRA Principal Investigato r Sponsor Study (Clinical Coordina Research tor Associat Data Entry Data EDC Regi LP Administ Manager strar rator Project Manager SMC Super SMS Progra visor mmer e) Subjects Access Subject Search Y Y Y Y Y Y N Y Y Y N Add a Subject N N N N N Y N Y Y N N Edit a Subject Y N Y N N Y N Y Y N N Lock a Subject N N N N N Y N Y N N N Unlock a Subject Upload Subjects Access to Blinded Subject Data N N N N N Y N Y N N N N N N N N Y N Y N N N N N N N N N N N N N N Principal Sponsor Study CRA Data Data EDC Regi LP Administ Project SMC Super SMS Progra 2014 Optum, Inc. Confidential 56

Investigato r Coordina tor (Clinical Research Associat e) Entry Manager strar rator Manager visor mmer Reports Access Tabled Reports Access Data Selector Access Audit Trail Reports Access CRF Reports Access Query Reports Access Subject Reports Access Alert Reports Access User Reports Access Site Reports Access Visit Reports Access Call Tracking Reports Access Reminder Reports N Y N Y N Y N Y Y Y Y N Y N Y N Y N Y Y Y Y N Y N Y N Y N Y Y Y Y N Y N Y N Y N Y Y Y Y N Y N Y N Y N Y Y Y Y N Y N Y N Y N Y Y N Y Y Y Y Y N Y N Y Y Y N N N N Y N Y Y Y Y Y N N N N Y N Y N Y Y Y N N N N Y N Y N Y Y Y N N N N N N N N N N N N Y N Y N N N N N N N N CRA Principal Investigato r Sponsor Study (Clinical Coordina Research tor Associat Data Entry Data EDC Regi LP Administ Manager strar rator Project Manager SMC Super SMS Progra visor mmer e) Study Administration Edit Subject Registration Set Up Administer Alerts N N N N N N N Y N N Y N N N N N Y N Y N N Y 2014 Optum, Inc. Confidential 57

Access Alert Overview Y N Y Y N Y N Y N Y Y Add User * N N N N N N Y Y N N N Edit User * N N N N N N Y Y N N N Add Site * N N N N N N Y Y N N N Edit Site * N N N N N N Y Y N N N Download Data Files N Y N Y N Y N Y Y Y Y Access Site Search Y Y Y Y Y Y N Y Y Y N Access Call Tracking N N N N N N N N N N N Overview Access Call Tracking N N N N N N N N N N N Notifications Access Reminder Y N Y N N N N N N N N Overview Access Reminder Y N Y N N N N Y N N N Schedule Access Reminder Notifications N N N N N N N Y N N N 2014 Optum, Inc. Confidential 58