Companies that use Oracle’s Siebel Clinical Trial Management System (CTMS) should follow a set of best practices to enable users and administrators to operate efficiently. Best practices maximize the system’s functionality, maintain consistent business processes, and ensure clean records. In short, they save you time and money. Perficient’s Param Singh, director of clinical trial management solutions, examined a variety of best practices that life sciences organizations should consider once they have implemented Siebel CTMS: -SOPs, Work Practices and Administrative Functions -Data Entry and Templates -Protocols and Sites -Reports and Queries -Tips and Tricks

1. 99+ Siebel CTMS Best Practices You Should Follow

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ABOUT PERFICIENT
Perficient is a leading information technology and
management consulting firm serving clients
throughout North America.
We help clients implement digital experience, business optimization,
and industry solutions that cultivate and captivate customers, drive
efficiency and productivity, integrate business processes, improve
productivity, reduce costs, and create a more agile enterprise.

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PERFICIENT PROFILE
Founded in 1997
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2014 revenue $456.7 million
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>2,600 colleagues
Dedicated solution practices
~90% repeat business rate
Alliance partnerships with major technology vendors
Multiple vendor/industry technology and growth awards

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WELCOME/INTRODUCTION
Param Singh
Director of Clinical Trial Management Solutions
Life Sciences, Perficient
CTMS practice lead since 2008
– Leads the team that implements, supports, enhances, and integrates Siebel Clinical
Extensive Siebel Clinical implementation experience
– 15+ years of experience implementing Siebel Clinical
– 30+ implementations and integrations
– Spearheaded the creation of ASCEND, an official Oracle Accelerate Solution for Siebel
Clinical

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CTMS SERVICES
Implementation
Manage implementations of Siebel
CTMS/ASCEND.
Integration
Build interfaces between Siebel CTMS
and other clinical and safety systems.
Training
Develop and/or deliver standard and
custom training classes and materials.
Process Guidance
Provide insight, advice and solutions
for specific CTMS issues based on
industry best practices.

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WHAT IS A BEST PRACTICE?
• A method, process, activity, incentive, or reward that is believed to be more effective at
delivering a particular outcome than any other technique, method, process, etc. when
applied to a particular condition or circumstance. https://en.wikipedia.org/wiki/Best_practice
• A way or method of accomplishing a business function or process that is considered to be
superior to all other known methods. www.qaproject.org/methods/resglossary
• A best practice is a business process with demonstrated ability to achieve superior results.
Best practices represent proven methodologies for consistently and effectively achieving a
business objective. www.hrsdc.gc.ca/eng/workplaceskills/oles/2009/glossary

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STANDARD OPERATING PROCEDURES
Best Practices:
 Finalize system related SOPs and guidelines prior to system go-live.
 Train users on the SOPs as part as part of system training.
 Recommended SOPs:
 Siebel Clinical Administration and Maintenance SOP
 Siebel Clinical Access and Use SOP
SOPs associated with Siebel Clinical typically include information about the setup
and use of the application in conjunction with the day-to-day management of
clinical trials.

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WORK INSTRUCTIONS
Best Practices:
 Finalize work instructions prior to go-live.
 Train users on the work instructions as part of system training.
 Create quick reference cards for various purposes:
 Navigation tips and tricks
 Rarely used functions
 Complicated functions
 Etc…
Work Instructions provide detailed steps on how to perform a specific task or
function in Siebel Clinical

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USER RESPONSIBILITIES
Best Practices:
 Perform a user group/responsibility analysis prior to entering any responsibilities into the
system.
 Keep the total number of responsibilities to a minimum to reduce administrative
maintenance issues.
 If two user groups perform similar functions consider having single responsibility for both
user groups.
 Balance the availability of data with the need to control data access.
Responsibilities in Siebel Clinical control access to the screens and views that
are visible to each logged in user.

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USER POSITIONS
Best Practices:
 A position assignment must be unique to each user.
 Name positions in a manner that eases transitions associated with employee turnover.
 Positions should correspond to the organizational chart.
Positions in Siebel Clinical control access to data (records).

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USER POSITIONS (CONT.)
Best Practices:
 Never assign multiple users the same position.
 Assign a user only one position if possible.
Users should never be deleted; only disabled
 Remove all responsibilities associated to user
 Disassociate them from their old Position and associate them
to a generic “Inactive” Position

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LIST OF VALUES
Best Practices:
 Create guidelines and controls for modifying LOVs.
 Be aware that modifying some LOVs can adversely impact standard Siebel functionality:
 Do not modify lists of values that are used internally by the Siebel application.
 Do not change the Language Independent Code value from the Siebel standard
value even if the associated display value is modified
Lists of Values (LOVs) in Siebel Clinical are the selection options available in the
dropdown menu for a specific field

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LIST OF VALUES (CONT.)
Best Practices:
 Avoid LOV modifications that could result in values being displayed improperly or not at all.
 Do not assume that modifying a display value will automatically update all records that
have been populated with the old value.
 Example: Account Type ‘Central Lab’ to ‘Reference Lab’ in the display value field:
 LOVs should never be deleted; only deactivated by unchecking the Active flag

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HOME SCREEN
Best Practices:
 Encourage each user to edit their Home Screen layout in a manner that works best for
them.
 Rearrange the sections so that the ones used most are in the top area of the Home
Page and any sections that are never used are hidden
 Use hyperlinks on the Home Screen to quickly navigate to specific areas of the application
Home Screen: The first screen displayed when a user logs onto the system. It is
a convenient way to track and access the records that are relevant to the logged
in user.

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LIST APPLETS
Best Practices:
 Each user should display and rearrange columns in list applets so that the information most
relevant to their tasks is displayed in a convenient and logical manner
 Sort records in a column by clicking on the column header
 Use the Advanced Sorts option to sort a list of records, based on up to three fields
List Applet: A list of screen specific records.

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DATA ENTRY
Best Practices:
 Have a single ‘Data Standards’ document that defines:
 Standard ways to enter and format data
 Standard nomenclature and definitions for values available in important fields such as
status fields
 Steps to take to avoid duplicate data entries

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RECORD PROPERTIES
Best Practices:
 Use the About Record feature to retrieve key information about a record such as:
 Use the unique Row # for record identification purposes and as a troubleshooting
reference

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CONTACTS, ACCOUNTS, ADDRESSES
Best Practices:
 The Data Standards document is essential for reference when entering these records
 Create guidelines, controls and request forms for the creation, modification and inactivation
of records
 Creation and revision of these records should be centrally or regionally administered by a
few specially trained individuals
 Contact and account records should not be deleted; only inactivated

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CONTACTS, ACCOUNTS, ADDRESSES (CONT.)
Best Practices:
If a record deletion is being considered, review the following options before clicking [Delete]
 Soft Delete: used for accounts or contacts which were associated to previous studies but
will not be used going forward
 Hard Delete: used only when accounts or contacts are entered incorrectly and no other
data is associated to the record
 Record Merge: used for duplicate records - two or more records contain the same
information and need to be merged into a single record to keep the database accurate

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CONTACTS, ACCOUNTS, ADDRESSES (CONT.)
Best Practices:
 At the contact level, pick a “main” Contact Type for each contact.
 Create standard Contact and Account Assessment templates
 Removing the display of Company Employees from Contact Lists

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RECORD DELETION
Best Practices:
 As a general practice - Do Not Delete Records (including templates that have been
applied)
 Analyze potential cascading effects that could be associated with a specific record deletion
 Remember that the deletion of some records have a more negative impact than the
deletion of others.
 If you do decide to delete records, be sure to delete from the bottom of the hierarchy to the
top (subjects => site => region => etc…)

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TRIP REPORT TEMPLATES
Best Practices:
 Refrain from creating protocol or product specific templates
 Define one generic template per site visit type (initiation, monitoring, close-out, etc…) to
use as the company standard.

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DOCUMENT AND ACTIVITY TEMPLATES
Best Practices:
 Make templates as generic as possible.
 For a template to be available for all protocols, the ‘Protocol Title ‘ field must be blank and
the ‘Public’ field must be checked.
Document and Activity Templates are used to standardize the documents and
tasks associated with a clinical trial.

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SUBJECT VISIT TEMPLATES
Best Practices:
 Use visit Lead Times to indicate the time between one subject visit and the next scheduled
visit.
 Use Min/Max units if the tracking and maintenance of subject visit windows is important for
the trial
 When creating a new SVT version, copy the existing version and then edit as necessary
• NEVER delete a SVT that has been applied to a subject
Subject Visit Templates allow users to set up a subject visit schedule based on the
protocol.

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TEAM MEMBERS
Best Practices:
 Always ‘save’ the protocol, region or site record before adding team members
 Remove team members if they should no longer have access to a protocol, region or site.
 Use the Position Rolldown and Position Rollup functionality whenever possible
Position Rolldown: When a team member is added to a protocol, click the
Position Rolldown button to add the user to all regions and all sites under the
Protocol.
Position Rollup: When a team member is added to a site, click the Position
Rollup button to add the user to the region and protocol associated with the site.

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CLINICAL PROGRAMS
Best Practices:
 Use the Clinical Program Explorer view to see the overall clinical hierarchy under a clinical
program.
A Clinical Program is a logical combination of protocols.

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SITE MANAGEMENT: SITE CONTACTS
Best Practices:
 Maintain a current list of all site staff and their roles in terms of study specific
responsibilities
 Include relevant contact information
 Keep the list current as staff, information or responsibilities change
Site Contacts: A list of site staff and their roles on a study

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SITE MANAGEMENT: SITE VISITS
Best Practices:
 Create a list of scheduled site visits as soon as the information is available to provide
metrics and support scheduling and resourcing
Site Visits: Visits to a site by the clinical research associate throughout the
period of a clinical trial.

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PROTOCOL AMENDMENTS
Best Practices: (for protocol amendments that affect the subject visit schedule)
 Create a new protocol version record via Protocol > Protocol Version view
 Address Subject Visit Template issues by creating a new SVT or creating a new version of
an existing SVT
 Apply the new SVT to Protocol Sites
 Apply the new SVT to enrolled subjects
Protocol Amendment: A formal revision or clarification to a protocol mid-study.

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PROTOCOL AMENDMENTS (CONT.)
Best Practices:
 Enroll the subjects under the new Subject Visit Template version.
Note: The system will prompt the user on whether the Uncompleted Visits from the Old
Version and the Completed Visits from the New Version need to be deleted.
 Select OK in response to the message IF the IRB Approval Date for modified/new SVT
AND the Subject’s Informed Consent date is greater than the new SVT created date
 Select CANCEL in response to the message if the above criteria are not met.

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EXPENSES AND PAYMENTS
Best Practices:
Expenses (configured module)
 Enter Study Start Up costs at the Protocol Expense view so they can be tracked as soon
as the protocol is created in the system
Payments
 Correct erroneous Payment Requests - that have not been paid yet - by deleting the
payment request and then regenerating the correct payment request
 Use ad hoc payments to track site specific fees such as IRB fees and to correct previous
incorrect payment amounts

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FINAL INVESTIGATOR PAYMENTS
Best Practices:
 In the Site Management > Payment Activities view, mark all activities that have been
completed, but for which a payment request has not been generated as “Completed” and
generate a payment request
 In the Site Management > Payments view, confirm that all paid payment requests have a
status of ‘Paid’ and that the payment amount has been entered
 In the same view, create a new payment with a ‘Payment Type’ of ‘Final Payment’

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QUERIES
Best Practices:
 Use the “wild card” operator of an asterisk (*) at the beginning or end of your search term to
bring back results that end or begin with your search term.
 Use the “wild card’ asterisk (*) by itself to find all records that have any value in a certain
field.
 Use the operator “IS NULL” to find all records that have no value in a certain field.
 Search for multiple terms in a single field by using “AND” or “OR”
Queries: Allows users in to narrow down a list of records and create ad hoc
reports.

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QUERIES (CONT.)
Best Practices:
 After receiving your query results, use the Refine Query feature if necessary
 To query for documents with specific expiration dates, create a dynamic query such as:
<today() or <today()+30
 Use the Query Assistant for more complex queries

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QUERIES (CONT.)
Best Practices:
 Save queries that are complicated or used on a regular basis
 Instruct an administrator to create a Predefined Query when a query should be made
“public” and shared with all users
 Clear query results by clicking [Query] and then [Go] without entering any search terms or
operators.

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REPORTS
Canned Reports:
Generated by clicking the report button icon on the tool bar of specific screens.

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REPORTS (CONT.)
Exports to Excel:
Data exported from a list applet to an excel spreadsheet or other format.
Best Practices:
 Sort records and arrange columns before exporting data

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REPORTS (CONT.)
Quick Print:
An html snapshot of the current view
Best Practices:
 Sort records and arrange columns before clicking the Quick Print icon
 Define Quick Print settings in the User Preferences > Printing view

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REPORTS (CONT.)
Quick Print:
An html snapshot of the current view

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REPORTS (CONT.)
Best Practices:
 Access and review archived BIP reports run in the past via Reports Icon > My BIP Reports
(Note: Only available in Siebel Clinical 8.1.x or higher)
 Purge BIP reports on a regular basis to conserve server space.

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CHANGE CONTROL
Best Practices:
 Maintain an up-to-date change and enhancement list post go-live
 For proposed changes or enhancements, consider whether it would be better to change an
existing business practice instead
 Create a prioritization scale and rate each item on the change and enhancement list

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TIPS AND TRICKS
 Multiple email addresses for a contact can be entered in a single email field if they are
separated by commas
 Remember that you can only ‘undo’ records that have not been saved
 If you right-click in a form or a list applet, you can access the same menu of actions
provided by the menu button in that form or list applet.
 Clicking on a hyperlink creates a thread bar that can be used for ‘back’ navigation
purposes
 The thread bar resets when you navigate to another screen via a screen tab or the
Site Map

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TIPS AND TRICKS (CONT.)
 Sorting records:
 Sorting a large number of records (e.g., All Contacts) can be very slow. Instead, it is
better to query first and then sort.
 Advanced Sort is the ability to sort records by up to three criteria via the Menu >
Advanced Sort for the list applet.
 The sort order is reset when you leave the screen
 Change multiple field values at the same time via Edit > Change Records in the application
menu toolbar

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TIPS AND TRICKS (CONT.)
 You can save a Siebel Clinical chart for use in other applications such as Microsoft
PowerPoint.
 Navigate to the chart you want to copy.
 Select ALT + CTRL + Right-click on the chart and select ‘Save Picture As’.
 In the Save Picture dialog box, save the chart as an image file

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TIPS AND TRICKS (CONT.)
 You can freeze columns in a list applet to maintain a point of reference when scrolling to the right (Note:
Does not work for Open UI prior to IP 2014)
 For non Open UI
 Within the selected list, double-click the column header of the right-most column you want to
freeze.
 The frozen column headers will display with a darker gray background and a dark gray
vertical line appears to separate the frozen columns from the unfrozen columns.
 To unfreeze columns, double-click the header of the right-most frozen column.
 For Open UI: IP 2014+
 Choose “Lock” and “Unlock” on the column header menu option to freeze and unfreeze
column.
 Do not close the browser window to exit the Siebel application. Instead choose File, then Log Out from
the application-level menu
 Ensures that the most recent changes have been saved
 Avoids hanging sessions in the database which can use database resources and potentially affect
performance for other users

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TIPS AND TRICKS (CONT.)
Siebel Clinical 8.1.x+ Specific:
 You can now use the web browser’s back and forward buttons to navigate in Siebel Clinical
 You can locate screens and views that you recently accessed by using the web browser’s
history function.

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QUESTIONS
Type your question into the chat box

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Next up:
October 15, 2015
How to Load Data More Quickly and Accurately into
Oracle's Life Sciences Data Hub
http://www2.perficient.com/How-to-Load-Data-More-Quickly-and-
Accurately-into-Oracle-Life-Sciences-Data-Hub

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THANK YOU