configuring your enterprise, organization, and...

© 2008 Clinical Conductor Enterprises, LLC.

The first step in configuring a new Clinical Conductor system is to set up information about your busi-ness. The overall approach to business structure within the Clinical Conductor setting is as follows:

Enterprise – the overall business of the client (e.g. University of XYZ, New York Research, Inc.)

Organization – organizations within the Enterprise. In an academic center, the organizations may be different departments – Anesthesiology, Neurology, etc.

Site – a physical research location that is part of an organization. An example at an academic center might be the hospital OR, the hospital Emergency department or an external community clinic. It can also be a different office (e.g. your Omaha office, your Syracuse office).

To set up information for your Enterprise, Organization and Site:

From the main header menu, navigate to Maintenance Select Business → Business Set up.

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CONFIGURING YOUR ENTERPRISE, ORGANIZATION, AND SITE

This will open your Enterprise information. Here you can enter appropriate contact information, a logo, and cre-ate Organizations currently in your Enterprise.

Organizations are set up with much of the same information as the Enterprise. You may enter contact information for each associated Organization.

Note: You will need to enter in your Organization information and click Apply before you can proceed to setting up your sites.

Click here once you have entered in your Organization Holiday details. The system will apply this holiday to all associated calendars, indicating the time as not available for appointment scheduling. Note, however, that if needed, appointments can be scheduled on Organization Holidays via the Manual Schedule function.

Note: The system expects 24 hour clock values (military time) to be entered in these fields.

All currently entered Organization Holidays will be listed here for review and deletion, if needed.

Click Add New Site and you will be presented with the information form to configure your new Site.

This Quick Start Guide will help you get started with Clinical Conductor and walk you through the preliminary set up steps. Before getting started, please be sure you have your account login information. And remember – we’re here to help if you need us.

The Clinical Conductor Support Team 1-877-279-8377 [email protected]

Version 1.0


Sites are set up with contact information and holidays like Organizations, but they also contain a great deal of detailed information. From this screen you can view/edit which staff members are associated with the site and what clinical role they perform during patient visits, set up QuickBooks integration, as well as many other Site settings (such as what information will show on the printed patient reminders or how many days in the future you are allowed to make patient appointments).

Setting Up Your Treatment Rooms

You will also need to set up your facility treatment rooms for scheduling purposes. To add your site treatment rooms:

From the main header menu, navigate to Maintenance

Select Business → Treatment Rooms

Click the [Add New Room] button.

You will then be brought to the room configuration screen, where you will name your room, include a brief description and associate the room with the appropriate Site and Schedule.

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CONFIGURING YOUR ENTERPRISE, ORGANIZATION, AND SITE SETTING UP YOUR SECURITY GROUPS

A privilege is defined as “the ability to see an element of data or perform a specified action”. The number and detailed level of privileges is continually expanding. At present it includes several hundred distinct settings, which allow for the most flexibility when configuring your site.

A Security Group is a collection of those privileges. Typical security groups may be “Physicians”, “Coordinators”, “Recruiters” or any other group of people that have similar system privileges.

First, Groups must be created then users are linked to Security Groups . Through this method, Users are allowed to see or do various functions within the application.

To access Security Groups, navigate to Maintenance using the main menu, and select System → Security.

You can create a new Security Group by clicking [Add New Security Group] or open an existing Security Group for editing by clicking on its name.

When you click on [Add Functions] or [Add Menu Items], a list of available privileges will display.

You would then check “Select” on the corresponding checkbox for each privilege you want to add to the security group, and then click [Save to Group].

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Note: The menu items are, as the name suggests, the menu at the top of the screen. The functions are tasks that you may or may not want a user to be able to perform.


SETTING UP YOUR STAFF MEMBERS

Activating a Staff MemberWhen a staff member is added to the system, they must be “activated”. This is part of the comprehensive security built-in to Clinical Conductor. There are two ways to activate a staff member: via email or manually.

In the email method, the user is sent an email with an activation code and instructions on how to activate their own account.

To manually activate a user:

Enter in all user account data and click Save.

A notice will appear indicating that the account has not yet been activated.

Click the button at upper right on the staff detail screen as shown below.

A “Set Password” screen will appear as well as a prompt for a security question.

To activate an account via email:

If you entered an email address in as part of your account creation process, upon clicking Save, an automated email with instructions on how to activate their user account is automatically generated.

If you need to reset a user’s account via an activation email, you would return to this screen and you will see a prompt in the upper right corner to resend the activation email.

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Adding Staff MembersThe staff list in Clinical Conductor generally includes all enterprise employees and third-party contractors that are directly involved in the planning, execution and analysis of study visits. The Staff List will also serve as a user list for Clinical Conductor. Any individual who will be accessing Clinical Conductor or performing clinical work for your site should be set up in the staff list.

To access the Staff List, select Staff List from the Business menu.

To add a new staff member, click [Add New Staff Member].

To Edit an existing staff member, click on that staff member’s name.

The Configure Staff Person screen will allow you to enter contact information for the staff member, a photo, a profession, their username for Clinical Conductor, the Site Roles, their schedule, and the privilege groups that they are associated with for each site.

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Note: If a user forgets their password in the future, return to this screen to reset their account password!


SETTING UP YOUR STAFF MEMBERS

Configure your organizationEnter contact informationAdd your company logoAdd organizational holidays

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Configure your siteSet your site scheduleAdd site holidays

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Create and configure your staff accountsAssign site access and privilegesSet staff schedule, including any known schedule exceptionsSet the site roles

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Set up Treatment RoomsConfigure via Maintenance → Business → Treatment RoomsBe sure to set up your treatment rooms with a schedule similar to your site’s open hours

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Set up the study protocolStudy VisitsStudy Elements Note: Must include at least one element with an associated role and time > 0Study Patients

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Login Error Messages and What They Mean

Error Message CauseDenied. Account not found.

Your “User ID” was not recognized by the system. Please check to make sure you spelled your User ID correctly. If you spelled it correctly, contact your system administrator to verify that you are using the correct User ID.

Invalid password. Please try again.

You entered the incorrect password for your account. Passwords are case sensitive. Verify that “Caps Lock” is not enabled. If you have forgotten your password, you may use the “Forgot your password?” link to answer your security question and re-activate your account.

The staff user account has not been activated.

This is either a new account that has not yet been activated for the first time, or this account has had a “re-activation” email sent and needs to be re-activated before use.

Denied. No permission to log in.

The user is not part of a privilege group that includes the “Log in” privilege. Make sure the user is associated with a privilege group, and that privilege group includes the functional privilege “Log in”.

Assigning Security and Sites to a UserTwo of the biggest oversights in adding new users is identifying the sites to which they have access and assigning their security rights.

The last step in the process of configuring the users account is to:

Select which sites the account may accessAssociate privilege groups with the account for each site.

This grid is located on the Configure Staff Person screen.

Did you know…..?

That you can view the “Day at a Glance” calendar by clicking on the calendar icon in the upper right?That you can view your personal details by clicking My Account at the bottom of the screen?That you can change your password by selecting Change Password from the My Account menu?That you can track your To Do items via the My Reminders section, available via the My Account menu or the link at the bottom of the screen?

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Select the associated privilege group for the

user at this site.

Note: Leaving the privilege group set as none means the user cannot access the site

Select the associated privilege group for the

user at this site.

Note: Leaving the privilege group set as none means the user cannot access the site

WHAT STEPS DO I NEED TO COMPLETE BEFORE I CAN BEGIN SCHEDULING PATIENTS?


STUDY STATUS CHEAT SHEET

The below table outlines all current Study Status settings in Clinical Conductor, with available functionality in each status. All study status names are configurable in the Table Maintenance section. Status names below are system defaults. Note that statuses are listed below in typical order of use. Those designated with an N are typically used at any point in the trial lifecycle.

Study Status DescriptionCounts Toward

subscription

Enroll Patients

Process Invoices

Schedule Visits

1 Opportunity Initial study status prior to patient enrollment and visit scheduling. Final details of study are being confirmed and study configuration may be underway (e.g. element, personnel and visit set up).

2 Discussion Opportunity has been confirmed and additional requirement gathering and documentation may be in progress, prior to proceeding with selection and submission.

3 Selection Opportunity has been identified, any further requirements have been documented and decision has been made to move forward with study. Status is assumed prior to Enrollment, but after Opportunity.

4 Submission Opportunity is being actively pursued, study configuration underway. X

5 Enrollment (Enrollment permitted) Study is active and patients can now be added to the study. Visits can be scheduled. X X X X

6 Randomization - Underway Patient enrollment is complete study visits are in process of being scheduled/completed. X X X

7 Follow-up Study is in progress, no new patients can be enrolled. Visits can still be scheduled for active patients.

X X X

8 Last Patient - Last Visit Study is nearing completion; final patient and final visit has been scheduled. X X X

9 Pending Closeout Study has just completed Last Patient - Last Visit status and data is in preparation for study closeout.

X X

10 Closeout Study is in the process of trial closeout, which may include the Closeout visit. All patient visits are complete and you are in the process of completing any requirements with the study sponsor.

X X

11 Archiving Closeout has been completed. Study data is being reviewed and finalized in preparation for completion, leading up to final status of “Done-Archived”.

X X

12 Done - Archived All study activities are done. Study is no longer active, no actions other than reporting can be completed.

N Cancelled Study is no longer being pursued. Note that this status does not remove a study from your subscription count if the study was ever in “Enrolling” status.

N Lost Opportunity was not awarded. Study will not progress.

N Not Selected Opportunity was not chosen as a study to pursue.

N On Hold Study progress has been suspended. X X

N Opportunity On Hold Opportunity has been placed on hold, prior to the commencement of patient enrollment or visit scheduling.

N PI Declined PI has declined to move forward with opportunity.

N Pre-Study Potential opportunity is being reviewed prior to progressing with study enrollment.

Note: Once a study has been placed in a status that counts against your subscription number, the ONLY status change that will subsequently remove that study from your count is “Done - Archived”. If you would like to see which studies are currently counting toward your subscription total, select Subscription from the Status Filter on the Study List screen.

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