siebel ctms best practices

Siebel Clinical

Best Practices

Alice Crawford

Welcome & Introductions

Alice Crawford Senior Consultant Clinical Trial Management Solutions

• 15+ years of experience in the

Clinical Trials industry

Today’s Agenda

Time (ET) Topic

2:00-2:05 Welcome and Introductions

2:05-2:15 SOPs, Work Practices and Admin Functions

2:15-2:25 Data Entry and Templates

2:25-2:30 Protocols and Sites

2:30-2:35 Reports and Queries

2:35-2:45 Tips and Tricks

2:45-3:00 Q&A

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.

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

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.

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

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.

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).

User Positions (cont.)

Best Practices (cont.)

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

Lists 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

Lists of Values (cont.)

Best Practices (cont.):

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

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.

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

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

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

Contacts, Accounts and 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

Contacts and Accounts (cont.)


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

Contacts and Accounts (cont.)


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

Record Deletion

Best Practices:

As a general practice - Do Not Delete Records

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…)

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.

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.

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.

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.

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.

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

Site Management: Site Visits

Best Practice

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

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

Protocol Amendments (cont.)


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.

Expenses and Payments

Best Practices

Expenses

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

Final Investigator Payments

Best Practice

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’

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.

Queries (cont.)


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

Queries (cont.)


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.

Reports

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

Reports

Exports to Excel – Data exported from a list applet to an excel spreadsheet or other format.

Best Practice

Sort records and arrange columns before exporting data

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

Reports (cont.)

Quick Print – An html snapshot of the current view

Reports (cont.)


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)

Purge BIP reports on a regular basis to conserve server space.

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

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

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


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


You can freeze columns in a list applet to maintain a point of reference when scrolling to the right

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.

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


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.

Siebel Clinical 8.1.x Specific

Questions?

Closing

Thank you for attending!

This webinar will be posted on www.biopharm.com

within 24 hours

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+1 877-654-0033

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siebel ctms best practices

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