Overview (Site Visit Report Tool)

The purpose of the Site Visit Report Tool Overview page is to display the status and update the progress of a single Site Visit Report (SVR), report completion through review and approval.

MANUAL vs INTEGRATED

SVRs can be either Manual or Integrated and the author determines this on the Sites tab > Site Visits menu item > (select a site visit) > click the Site Visit Report tab.

A Manual Report is written outside CTMS in another program, such as Microsoft Word, and uploaded. The user may attach the reports in any order using the Attachments tab or clicking the Site Visit Details button and then the Attachments tab, or the Update Workflow button. The only tabs visible on the Site Visit Report Tool page for a manual report are Overview, Attachments, and History.

An Integrated Report is built from information within CTMS and the user must be connected to CTMS. Data can be integrated from the system, including Deviations, Issues, SAEs, Site Documents, Subjects, and custom subreports. The review process can be completed within CTMS and signed electronically, if desired. The status of the report is updated at the conclusion of each step or "workflow event" by clicking the Update Workflow button. Each event, listed below, must be completed in order and all events must be done.

Events

• First Draft

• First Review

• Comments Returned

• Revisions Completed

• Final Review, Approved

• Approved by Sponsor (optional)

The Integrated Report can have all of these tabs: Overview, Panels, Monitoring, Narrative, Attachments, Documents, Subjects, Consents, Deviations, Issues, SAEs, Review, and History. The administrator makes the tabs available by selecting the appropriate check boxes on the Administration tab > Site Visit Report Templates > Tabs module.

The administrator also can:

• indicate the default method (Manual or Integrated) by using the Site Visit Report Template Default configuration variable under the Site Visit Reports configuration group
• prevent the manual report method by setting the Enable Manual Site Visit Reports configuration variable under the Site Visit Reports configuration group to False

HOW TO SELECT SITE VISIT REPORT

If the project is already selected and you are on the Sites tab, Site Visit Report Tool page, you can either click the <SELECT SITE> button on the header bar, which will display a list of all the sites within the project, or simply select the site if the list is visible. Once a site is selected, the <SELECT SITE> button will change to that site, for example, . To view the list of sites again, click the button again to toggle back to the list of sites.

To view the Visits, click <SELECT SITE VISIT> button, which will display a list of all the visits for the site or simply click the site visit if the list is visible. Once a visit is selected, the Overview page will be visible.

If the administrator checked the Site Visit Report Restricted field, all tabs on the Site Visit Report will be hidden unless the user is one of the Visit Monitors, Reviewers, Approvers, Authors, or has Admin Permission for the Site Visit Reports feature on the Roles module.

Before Selecting a Site

After Selecting a Site

After Selecting a Site Visit, the Site Visit Report Tool Displays

INTEGRATED SITE VISIT REPORT (SVR) - SET UP PROCESS

The following are the steps needed to set up and complete an Integrated Site Visit Report:

Administration Tab

• Write questions that are available to all site visit report templates. These questions are added in the Site Visit Report Fields module.
• Create a template in the Site Visit Report Templates module for each of the system site visit types
• • Closeout
  • Initiation
  • Interim
  • Other
  • Prestudy
• Once the template is designed with no changes planned, Publish it in the Template module to prevent additional changes. Once published, if changes are needed, copy the published version and make changes, then Publish this new template. Each published template carries the date and time as part of its name.
• Map the template under the Project tab > Project Tables menu item in the Site Visit Report Template Map module for the appropriate site visit types.
• Define the three site visit report roles:

(1) the Author, who is the Visit Monitor on the Site Visit tab. The author is defined under the Administration tab, under either System/Domain/Project Configuration depending on your need, Site Visits configuration group, Site Visit Monitor Roles configuration variable.

(2) the Reviewer is defined under the Administration tab, under either System/Domain/Project Configuration depending on your need, Site Visit Reports configuration group, Site Visit Report Reviewer Roles configuration variable.

(3) the Approver, who also may be the Reviewer if defined in both configuration variables. The Approver is defined under either System/Domain/Project Configuration depending on your need, Site Visit Reports configuration group, Site Visit Report Approver Roles configuration variable.

The table below shows the default reviewer and approver roles. The same person can review and approve the report. The role you select to review and/or approve must coincide with the role assigned to the project team member in the Project Team module. In other words, if the contact was assigned the 'project manager' project team member role, then permission must be granted for the 'project manager' to have the reviewer and/or approver roles in both the configuration variables.

Project Tab

• Map the template to the project in the Site Visit Report Template Maps module
• Assign Project Team Members with their corresponding roles in the Project Team module. The roles assigned at this level will indicate whether they have rights to review and/or approve a report based on the Site Visit Reports configuration table on the Project Tables. (see fifth bullet under Administration Tab above)

Site Tab

• When managing a site visit, the author of a site visit report determines whether the report is manual or integrated. The author goes to the Sites tab, Site Visits menu item, selects the site and site visit, which will open the Site Visit module. Alternately, the author can click the Site Visit Details button while on the Site Visit Report Tool to open the Site Visit module where the user can also access the Attendees, Site Visit Report, and Attachments tabs.
• The author is now ready to complete the site visit report by answering all of the questions on the Panels tab, adding information on the other tabs, and clicking the Update Workflow button on the Overview tab to submit the report.
• The Reviewer will read and leave comments for the author and will click the Update Workflow button on the Overview tab to return the report to the author.
• The author, reviewer, and approver will work together in this fashion until the document is approved. See the Panels tab for more information.

VIEW SITE VISIT REPORT

To view the report as it will print, click the Preview Report button.

• This button will be hidden if the current Site Visit Report does not have a Site Visit Report Template assigned on the Site Visit Report tab of the Site Visit module, or if the Site Visit Report Status is Approved or higher.

• A PDF file opens with the report status as Current Version Preview and the signature section is left blank

• The responses and data fields on the report will represent the current values at the time the button was clicked, except for any subreport sections, which will reflect the current data up to the time the Site Visit Report Status is changed to First Draft. This prevents changes in subreport data made after the First Draft from inadvertently updating the Site Visit Report.

  The site visit report will be locked when the author signs a report that is in First Draft, First Review, or Final Review.

• if the Principal Investigator address does not appear on the PDF, make sure the Include on Project field is checked on the Global Contact's Communication record.

• Print Date can be set by an administrator in the Site Visit Reports configuration variable Site Visit Report Print Date Time Zone to the:

• • Project Time Zone - The report will display the date/time in the Time Zone specified in the Project Time Zone Configuration Variable in the Project Configuration Group

  • System Time Zone - The report will display the date/time in the Time Zone specified in the System Time Zone Configuration Variable in the Application Configuration Group

  • UTC (default) - The report will display the date/time in UTC format, which is the default

• The Report Review section will only display if the Site Visit Report Status is less than Approved and if the Show Review Comments checkbox on the Site Visit Report Template is checked. The content of this section is defined in the Subreport entered in the Review Comments Subreport field of the Site Visit Report Template.

• Subreport Sections

• Any columns that cause the Subreport to exceed the width of the Site Visit Report (6.5 inches) will be hidden when the Subreport is displayed

• The data on the Subreport will be linked to the Site Visit Report based on the value of the field entered in the Parent Report Link Field field on the Report module.  If the link field is left blank, then the data will be filtered based on the Site of the Site Visit Report.

• The data on the Subreport will be filtered to include only those records which meet the following criteria, based on the Base Table of the Subreport Datasource:

• For Subject records, the Subject Enrollment Date must be on or before the last date of the Site Visit

• For Subject Visit records, the Subject Visit Date must be on or before the last date of the Site Visit and the Subject Visit must have a status of “Completed”

• For Site Document records, the earliest of the Document Dates must be on or before the last date of the Site Visit

• For Deviation records, the Deviation Date must be on or before the last date of the Site Visit

• For Site Issue records, the Site Issue Date must be on or before the last date of the Site Visit, and the Site Issue must not have appeared on any other Site Visit Report with a Site Issue Status of “Closed”

• For SAE records, the SAE Start Date must be on or before the last date of the Site Visit

• Report Signatures Section

• Attestation field is defined in the Site Visit Report Author Signature Text configuration variable under the Site Visit Report configuration group.

• Signature and Date Signed fields are left blank and are intended for the Author to physically sign the report. This field is visible when the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to False.

• Name field will print the full name of the user who updated the status of the report as the Report Author and will be visible if the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to False.

• Electronic Signature Date field will print the UTC date and time of the electronic signature of the Report Author. This field is visible if the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to True.

• Electronic Signature Name field will print the full name of the user who signed the report as the Report Author. This field is visible if the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to True.

• Title field will print the title of the user who updated the status of the report as the Report Author.

• Approver Section

• Attestation field is defined in the Site Visit Report Approver Signature Text configuration variable under the Site Visit Report configuration group.

• Signature field is left blank and is intended for the Approver to physically sign the report. This field is visible when the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to False.

• Date Signed field is left blank and is intended for the Approver to enter the date they signed the report. This field is visible when the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to False.

• Name field will print the full name of the user who updated the status of the report as the Report Approver. This field is visible when the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to False.

• Electronic Signature Date field will print the UTC date and time of the electronic signature of the Report Approver. This field is visible if the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to True.

• Electronic Signature Name field will print the full name of the user who signed the report as the Report Approver. This field is visible if the Enable Electronic Signature on Site Visit Report configuration variable under the Site Visit Report configuration group is set to True.

• Title field will print the title of the user who updated the status of the report as the Report Approver.

• Page Footer Section will repeat on all pages. It will include:

• Company Name, Print Date and Time. If a Saved Version of the Site Visit Report is viewed, the Date and Time will be prefixed with the value of the Site Visit Report Print Verb configuration variable under the Site Visit Report configuration group in place of the standard Printed prefix. The date and time will be based on the time zone indicated in the Site Visit Report Print Time Zone configuration variable under the Site Visit Report configuration group. The available choices  include either the System Time Zone – the time zone selected in the System Time Zone configuration variable under the Application configuration group or the UTC time zone.

• Report Message text is defined in the Report Footer Message configuration variable. Page X of Y (where X is the page number and Y is the total number of pages)

STANDARD SITE VISIT REPORT (SVR) NOTIFICATIONS

Notifications are set in the Notifications module by an Administrator. The following table suggests the standard notifications and the associated roles that should receive them. If a notification is not received, please check the Notification Queue Troubleshooting section for the possible reasons why.