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What’s New in This Release
|
What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 25.4 Update The following table lists the changes in this revision of the documentation to support this release of the software.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Description
|
LSClinicalTripReportFileTransferQuery Queries the trip report details based on the given trip report Id or Visit name. For more information, see Request Message for TripReportFileTransferQuery. LSClinicalTripReportFileTransferQueryPage Queries the trip report details in pages based on the given filter criteria. For more information, see Request Message for ClinicalTripReportFileTransferQueryPage. LSClinicalTripReportFileTransferUpsert Either updates the trip report and its child components or inserts new child items to the trip report. For more information, see Request Message for TripReportFileTransferUpsert. Request Message for TripReportFileTransferQuery The following table describes the request message for TripReportFileTransferQuery. Note the following about using the Query method: • If no input is provided for any tags in the Query method, then the Web service may return an error – prompting you to refine the search to limit the output result set. • Use the required tags in the Query method to query the data. For example, to query site visits for a particular
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Charge Sheet Library
|
2. A new attribute, ‘Charge Sheet Version’ is added to: a. Master Subject Visit Template level: - You can select from Active’ Charge Sheet Versions only. - Charge Sheet version set at this level will be the default Charge Sheet version applied to a new
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
PII Detection in CTMS
|
PII Service Setup and Configuration If requires a Siebel Administrator can configure the PII detection service. By default, the system is set to ‘N’. As an admin in the CTMS system: 1. Navigate to Administration – Application > System Preferences and search for EnableOCIAILanguage. 2. Set the ‘System Preference Value’ to Y to use the PII service. Once the System Preference is set, you can configure the fields within CTMS that you want to validate for the PII information. Note: A server restart is mandatory for changes to take effect. 3. In Siebel Web Tools, Search for the component that PII information is required to be validated. For example, if the fields under Trip Report section in CTMS are required to be validated: a. Navigate to the Business Component section. b. Search for Clinical Trip Report. Search for Business Component User Props that contain the word Batch. 4. To configure the fields that you would like to validate for the PII detection: a. Go to Business Component User Properties. b. Search for Batch and set the ‘text:FIELD’ property with field names that are required to be validated.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Flow
|
Modified topic. Explains how CTMS provides a outbound API to support pushing protocol/subject/SVT details from CTMS to PowerTrials. 1
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Using CTMS Dashboards
|
Status RollUp Fields:Protocol 7: "# CustomStatus", "# CustomStatus" Status RollUp Fields:Region 7: "# CustomStatus", "# CustomStatus" BC: Clinical Region Status RollUp Fields 7: "# CustomStatus", "# CustomStatus" 5. Map this new field on Applet. 6. Navigate to Applet > Search for LS Clinical Site Subjects Infolet Applet. Add this new field in control and web template items. Note: You may need to inactivate any existing Web Template item since the Dashboard can display only 6 items at a time. System Preferences for Dashboards You need to set these System Preferences for DB and Milestone to function properly: System Preference Name System Preference Value CL - Dashboard TR Target CL - Site Status Dashboard Planned,Initiated,Enrolling,Terminated,Not Initiated,Closed 299
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Using CTMS Milestones
|
You can create, track, and complete the milestones required for the Clinical study success. You can also create a milestone library at a customer level, add and modify Study milestone templates, apply a template, and create milestones. This chapter contains the following topics: • System Preferences for Milestones • Configuring Email Alerts for Upcoming Milestones and Missed Milestones System Preferences for Milestones You need to set these System Preferences for DB and Milestone to function properly: System Preference Name System Preference Value CL - Milestone Alert Days Configuring Email Alerts for Upcoming Milestones and
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
PowerTrials
|
To set up integration between CTMS and PowerTrials system (for ENU customers), perform the following tasks: 1. Enabling Integration Between CTMS and PowerTrials Update the domain address as shown below in Outbound Web Services. Note: This step is a prerequisite for enabling the integration between the CTMS and PowerTrials system. 2. Importing the PowerTrials Certificate to the CTMS Application 3.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Questions
|
(Read-only) Displays the assessment question when you save the assessment template record. Administrators set up questions when they set up the template. 48
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Applications
|
Modified topic. Information on supporting operation systems for disconnected mobile experience. What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 23.3 Update The following table lists the changes in this revision of the documentation to support this release of the software.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
in Siebel Clinical
|
Modified topic. Added the following user properties for Clinical Trip Report: • BIP Report Template Name • Enable FollowUp Activities for Approved TR • Enable FollowUp Activities with Status Not Equal To • Enable Question Number • Enable SmartScript Page Save •
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Enable Unblinding
|
What’s New in Siebel Clinical Trial Management System Guide, Siebel CRM 23.1 Update The following table lists the changes in this revision of the documentation to support this release of the software.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Oracle Clinical One
|
Integrating CTMS with Oracle Clinical One involves: • Setting up the User Access for REST APIs • Creating a Communication Profile 248
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Clinical
|
The following table describes the business component user properties that you can use to enable and configure functionality for Siebel Clinical.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
About Site Visit Name
|
The site visit Name is user generated by default when you manually type in the name of the site visit during site visit creation. However, you can enable the site visit Name to be automatically generated. The following procedure shows how to enable the automatic generation of site visit Name by configuring the Calculate Site Visit Name user property in Siebel Tools. Once enabled, the site visit Name is automatically generated when you create a new site visit. To enable the automatic generation of site visit Name 1. Log in to Siebel Tools. 94
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Grouping Site Visits
|
You can group site visits together according to the following categories: All Visits, Pending Visits, Pending Approval, and Closed Visits. • The All Visits category groups all site visits together irrespective of the Visit or Trip Report status. • All other categories group site visits according to various combinations of Visit and Trip Report status.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Trip Reports
|
The Approvals view provides a summary audit trail of the changes to the trip report status, including the dates and times of review and approval operations, and the details applicable to the users who complete those operations. To use audit trail for reviews and approvals of a clinical trip report 1. Navigate to the Site Visits screen, then the Clinical Site Visits List view. 2. In the Clinical Site Visits list, drill down on the Visit Start field of the site visit for the required trip report. The Trip Report form for the selected site visit appears. 3. Navigate to the Approvals view. Some fields are described in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
eTMF
|
To set up integration between CTMS and eTMF, perform the following tasks: 1. Enabling Integration Between CTMS and eTMF Integrating Siebel Clinical with Oracle Business Intelligence Publisher (BI Publisher) to generate reports is a prerequisite to this step. 2. Configuring Email Recipients 3. Configuring the LS Clinical Trip Report File Transfer Web Service 4. (Optional) Manually Generating Trip Report Files 242
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
for Clinical Trials
|
Supporting Blinded and Unblinded Users for Clinical
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Overview of Siebel Clinical Trial Management System
|
This guide documents Siebel Life Sciences with the optional modules installed. In addition, the Sample database includes data for optional modules. If your installation does not include some of these modules, then your software interface differs from that described in some sections of this guide. The exact configuration of Siebel Life Sciences screens and views depends on your company’s configuration of Siebel Life Sciences. For more information about Siebel Life Sciences, see Siebel Life Sciences Guide . For introductory information about using the Siebel Life Sciences interface, see Siebel Fundamentals . Note: The Siebel Bookshelf is available on Oracle Technology Network (http://www.oracle.com/technetwork/ indexes/documentation/index.html) and Oracle Software Delivery Cloud. It might also be installed locally on your intranet or on a network location. 9
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Management System
|
Overview of Siebel Clinical Trial Management System This chapter provides an overview of Oracle’s Siebel Clinical Trial Management System. It includes the following topics: • About Siebel Clinical Trial Management System • Features of Siebel Clinical Trial Management System • Product Modules and Options for Siebel Clinical Trial System About Siebel Clinical Trial Management System Siebel Clinical Trial Managements System allows biotechnology companies, pharmaceutical companies, and CROs (clinical research organizations) to better manage the clinical trial process, maintain quality of clinical trials, and manage investigator relationships. It provides a comprehensive set of tools for CRAs (clinical research associates), clinical investigators, and site coordinators, and includes a personalized Internet portal to conduct study activities more efficiently. The following products are supported: • Siebel Clinical Trial Management System • Siebel Clinical Trial Management System Cloud Service Features of Siebel Clinical Trial Management System Siebel Clinical supports the following functionality: • Support for full clinical trial hierarchies of Subject-Site-Region-Protocol-Program • Support for global trials running in multiple countries, multiple languages, and multiple currencies • Support for randomized trials • Support for multi-arm, epoch, and adaptive trials • Site management tools for CRAs (clinical research associates), including a site calendar, trip reports, document tracking, and payment generation • Personalized Internet portal to help site coordinators, clinical investigators, and CRAs better manage clinical
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
trials over the Web
|
• Project and resource management • A flexible audit trail engine 7
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
System
|
N/A N/A Viewing Universal Inbox Notifications for Action Items of
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Setting Up Siebel Clinical
|
5. In the Integration Object Map list, query for Clinical*Position*. 20
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Siebel Life Sciences
|
• Activating workflows for accounts
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Contacts
|
Use this view to maintain a list of contacts associated with the project. Enter names of employees in subcontracting or partner organizations.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
accounts contacts
|
• Generating column maps for accounts
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
contacts list
|
• Creating product data to appear in accounts contacts list Siebel Life Sciences Guide Creating a clinical program •
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Revising protocols
|
• (Optional) Setting up regions • Defining a subject visit template Setting Up Clinical Trials Administering Clinical Subjects and Clinical
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Visits
|
Site visit data integration SWI LS Clinical Subject Inbound - Activity Clinical data management system integration 280
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Managing sites
|
• Creating protocol site templates • Creating assessment templates for
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
contacts and accounts
|
• Maintaining contact and account
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
information
|
• Setting up contracts for sites Managing Sites and Contacts for Clinical
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Trials
|
This chapter describes blinded and unblinded support in Siebel Clinical, how to control access to data for blinded and unblinded users, and how to administer blinded and unblinded users for clinical trials. It includes the following topics: • What is a Blinded and Unblinded Clinical Trial? • Blinded and Unblinded Support in Siebel Clinical • Controlling Access to Data for Blinded and Unblinded Users • Site Management for Blinded and Unblinded Users • Inheritance Hierarchy for Blinded and Unblinded Users • Blinded and Unblinded Support in Siebel Mobile Disconnected Applications • Blinded and Unblinded Customization Support Note: This feature is available in Siebel CRM 20.7 Update and later releases. What is a Blinded and Unblinded Clinical Trial? A blinded clinical trial is one where participants do not know which treatment or medical intervention they have been allocated. In a blind clinical trial, certain information which may influence the participants in the trial (including subjects, CRAs, and evaluators) is withheld or hidden (blinded) until after the trial is complete. Good blinding can reduce or eliminate experimental biases that arise from participant expectation, observer bias, confirmation bias, and so on. An unblinded clinical trial is one where information is not withheld from trial participants and, in such cases, both participants and researchers know which treatment is being administered. During the course of a clinical trial, a participant becomes unblinded if they obtain information that has been withheld or hidden (blinded) from them. However, if this occurs unintentionally before the end of the trial, then this can be a source of experimental error. Blinded and Unblinded Support in Siebel Clinical Siebel Clinical provides the option to have and the ability to manage both blinded and unblinded users for clinical trials in Siebel CRM 20.7 Update and later releases. 203
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
projects
|
• Creating activity templates for projects Managing Clinical Projects
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Importing data
|
• Importing data with Siebel Enterprise
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Integration Manager
|
• Importing, extracting, and routing
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
syndicated data
|
• Charting denormalized syndicated data Siebel Life Sciences Guide Configuring Siebel Clinical • Configuring user properties for business
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
components
|
• Configuring user properties for business
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
services
|
• Configuring applet properties • Configuring field properties •
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
Configuring workflows
|
Developer’s Reference for Siebel Clinical 15
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
For More Information
|
• Customizing Web services About the My Team’s Filter The visibility filter appears on many screens. It provides a list of filters, such as My Contacts, My Team’s Contacts, and All Contacts. These filters determine the records that appear in the view. The behavior of the My Team’s filter varies from screen to screen. In some screens, this filter displays those records where the primary member of the team reports to the user. In other screens, this filter displays records where any of the team members report to the user. The Manager List Mode user property in the business component determines this behavior. If the Manager List Mode user property is active and set to Team, then the My Team’s filter displays all records where the user’s subordinate is on the team but is not necessarily the primary member. The following information lists the default setting of the Manager List Mode user property for some Siebel Clinical screens and business components.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
Active
|
• Cannot delete Sheet version • New charge sheet items can be added • Restricted update to following fields: ◦
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Account
|
• Initiation completed date •
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Account Brick
|
The source table for Account Brick is changed to S_CON_ADDR, and the source column for Account Brick is changed to BRICK_ID.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
Contact
|
• Contact Medical Specialty Code •
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Contact Zip Code
|
• Contact City State Country •
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Position
|
Contact Assignments in Siebel Clinical In most Siebel Business Applications, contact assignment is based on the primary address. This process is different for Siebel Life Sciences. A contact in Siebel Life Sciences can have multiple addresses, and each representative on the 17
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
File
|
Complete the procedure in this topic to export DTE data maps from the server database to an XML file. To export DTE data maps from the server database to an XML file 1. In Siebel Clinical, connect to the server database. 2. Navigate to the Administration - Integration screen, then the Data Maps view. 3. In the Integration Object Map list, query for Clinical*. The query returns the following records: Clinical Region Position to Protocol Position Map, Clinical Site Position to Account Position Map, Clinical Site Position to Protocol Position Map, and Clinical Site Position to Region Position Map. 4. Click Menu (the cogwheel icon), and select Export Data Map. 5. In the dialog box, check Export All Rows in Current Query and click Export. 6. In the dialog box, select Save to Disk, select a location, and save the data maps as PositionRollupDataMap.xml. Importing DTE Data Maps to a Local Client From an XML File Complete the procedure in this topic to import DTE data maps to a local client from an XML file. To import DTE data maps to a local client from an XML file 1. In Siebel Clinical, connect to the local client. 2. Navigate to the Administration - Integration screen, then the Data Maps view. 3. In the Integration Object Map list, click Menu (the cogwheel icon), and select Import Data Map. 4. In the dialog box, select Browse and find PositionRollupDataMap.xml. For information about creating this file, see Exporting DTE Data Maps From the Server Database to an XML File. 19
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Setting Up Clinical Trials
|
3. In the Assessment Templates list, create a new record and complete the necessary fields. Some fields are shown in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
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glossary.json
| null | null |
End-User Procedures
|
The following list shows the tasks end users typically perform to manage clinical projects: • Creating Clinical Projects. You associate protocols with projects. • Associating People and Accounts with Clinical Projects. Give employees access to the project; add contacts and accounts to the project team workbook. • Creating Activities and Tasks for Clinical Projects. Standalone activities are not associated with tasks. • Monitoring Costs for Clinical Projects. View costs for clinical projects. • Managing Risk for Clinical Projects. Document project risks and resolution activities. Creating Activity Templates for Clinical Projects You can create activities in the Projects screen. If the study managers primarily enter activities in the Projects screen, then creating activity templates for projects is advantageous. To create an activity template for projects, you create an activity template with a Project type. The Protocol Type field is optional because you can apply the activity template to any project, regardless of the protocol associated with the project. In the Activity Template Details list, create records to describe activities and milestones for the project. For information about how to create activity templates, see Siebel Applications Administration Guide . This task is a step in Process of Managing Clinical Projects. Setting Up Employee Profiles for Clinical Projects End users can use Siebel Assignment Manager to automatically search the employee database for the available employees whose skills best fit the needs of the project. Siebel Assignment Manager requires that you set up profiles of skills and competencies for employees. For information about using Siebel Assignment Manager, see Siebel Assignment Manager Administration Guide . Use of Siebel Assignment Manager is not required. End users can assign team members directly into the Team Workbook view, without using Siebel Assignment Manager. This task is a step in Process of Managing Clinical Projects. Setting Up Position Types and Rate Lists for Billing If project team members bill their time to the project through the Team Workbook view, then set position types and rate lists. 167
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Program
|
Select the name of the program for the clinical trial.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Mechanism
|
Select the partners associated with the clinical program.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Application
|
Select a record containing details of the application for the clinical program. If necessary, create an application record. This record contains values for the following fields: Number. The number assigned to the application when it is submitted to the regulatory agency, for example the (A)NDA or IND number. Type. The type of application, such as CTN, IND, or CTX. Sub-Type. The application filer, for example, a company or an investigator. Filed. Whether the application is filed with the specified regulatory agency. Product. The applicable product for the application. You must complete this field before you can create a protocol for the program. Indication. The clinical indication for the application. 3. (Optional) Drill down on the Program field of the new record and associate files with the clinical program. 24
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Favorite
|
Select this field and then select the star icon that appears to indicate that this site is a favorite. Deselect the star icon to remove the star icon from the Favorite field. A star icon appears in the Favorite field of each favorite site. Favorite sites appear first in the Protocol Site List.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Title
|
Type a descriptive title for the protocol. 4. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 5. If required, click Cancel at any time to cancel the task. 6. Click Submit to submit the task - that is, create the new protocol. Creating Protocols and Regions The following procedure shows how to create a protocol and region using Siebel Clinical task-based UI. To create a protocol and region 1. Click the Tasks icon on the application taskbar to open the Task Pane applet for Siebel Clinical. 2. Click Create Protocol in the Task Pane applet. 3. Enter protocol data on the page that appears: ◦ Fields to complete are described in Creating Protocols. ◦ Select the Regions Required check box. 4. Click Submit. 5. Click Yes when prompted with the following question: Do you want to create Region now? 6. Click Submit. 192
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Status
|
About Integrating Data for Activity Completion Oracle Health Sciences InForm controls the integration of activity completion data between Siebel Clinical and Oracle Health Sciences InForm. In Oracle Health Sciences InForm, when patient data is entered that complies with the criteria for the clinical item value for a visit or activity, Siebel Clinical receives a message containing a completion date. The visit or activity is updated with the status of Complete, and the completion date is populated. If the message from Oracle Health Sciences InForm does not contain a completion date, and the visit or activity in Siebel Clinical already has a status of Complete, then no change is made to the completion date or status in Siebel Clinical. Oracle Health Sciences InForm integrates activity completion data with Siebel Clinical as follows: • Siebel Clinical searches for the subject using the unique subject identifier (row ID). When the subject is found, it searches for the activity as follows: ◦ Siebel Clinical searches for the activity using the clinical item for the visit and the clinical item for the visit activity as follows: - If the clinical item in the update corresponds to a subject visit, then the completed date for that visit is updated. - If the clinical item in the update corresponds to an activity for a subject visit, then the completed date for that activity is updated. ◦ If the clinical item sent from Oracle Health Sciences InForm cannot be mapped to an activity completion item in Siebel Clinical, then an error is generated to indicate that the update failed. 219
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Product
|
Select the product for the clinical trial. You can select only the products that are associated with the clinical program. # Planned Sites Type the number of planned sites for the protocol. 191
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Phase
|
Select the phase of clinical trial, such as, Phase I, II, or III.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Objective
|
Type the objective for the clinical trial.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Sponsor
|
Select the clinical trial sponsor.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Design
|
Select the type of study. 25
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Regions Required
|
Select this check box only if the sites for the protocol must belong to a region (and see Creating Protocols and Regions for more information). When you select this check box, you cannot create sites directly under protocols. You must create regions first, and then create sites that are associated with regions. Deselect this check box to indicate that the sites for this protocol must not belong to a region. Protocol # Type an identifying number for the protocol.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Type
|
Select the purpose of the protocol.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Team
|
Read-only field. The team for the satellite site, inherited from the parent site. For more information, see Creating Sites for Clinical Trials (Step 3.). 6. Drill down on the Satellite Site Number field to complete more fields as necessary. Some data is inherited from the parent site and cannot be changed. Some fields are shown in the following table.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Approval Date
|
Select the date that the regulatory authority approves the protocol.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Currency Code
|
Select the currency that will be used to display the payments, costs, and budgets for the region. The default value is USD (US dollars).
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Planned Start Date
|
Select the planned start date for the study.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Exchange Date
|
Select the date that determines the exchange rate of the currency. By default, the exchange date for the region is the date that you create the region.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Planned End Date
|
Select the planned end date for the study.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Withholding Amount
|
Type the amount to withhold from each of the payments to the investigators until the trial completes. Withholding Percent (%) Type the percentage to withhold from each of the payments to investigators until the trial is complete.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Actual Start Date
|
Select the date that the study begins. # Planned Sites Type the number of planned sites for the protocol. # Planned Subjects Type the number of planned subjects for the protocol. Withholding % Type the percentage to withhold from each of the payments to the investigators until the trial is complete. You can overwrite this value at the region and site levels.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Actual End Date
|
Select the date that the study concludes. 26
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Comments
|
◦ Active flag (on Charge Sheet Items)
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Central Lab
|
Select the name of the laboratory associated with the study. You create this name in the Accounts screen.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
CRO
|
Select the Account name to assign the associated CRO. # Planned Sites Type the number of planned sites for the region. # Planned Subjects Type the number of planned subjects for the region.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Role
|
The role of the contact.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Start Date
|
The date when the contact record is active.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
End Date
|
Displays the date that the contact record is archived. Adding Address Types for Sites Users can add a specific type of addresses for each site. This task is a step in Process of Managing Sites and Contacts for Clinical Trials. To add an address type for a site 1. Navigate to the Site Management screen, then the Protocol Site List view. 2. In the Protocol Site list, drill down on the site number field of the site for which you want to add an address type. 3. Navigate to the Addresses view. 99
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Lock Record
|
Select this field to make the record read-only and to make the End Date field a required field. Automatically Assigning Team Members to a Protocol Using the Position Rolldown Button When you add a team member to a protocol, click the Position Rolldown button to add the member to all regions and all sites under the protocol. You can add a member to the team only once. When you click the Position Rolldown button to add a member to the team of a protocol, a record is created, where applicable, in each of the Team History views for all regions and all sites belonging to the protocol. The Position Rolldown mechanism automates the addition of team members to the Team History view for sites and the Team History view for regions as if they are manually added. About Removing Team Members From the Team of a Protocol When you remove a team member from the protocol, the team member is removed from either the protocol, or from all protocols, regions and sites belonging to the protocol. When you remove a member from the team of a protocol (either manually or through Position Rollup or Position Rolldown), the End Date field of the team member’s record, if present, is updated with the system date. However, if 28
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Original Version
|
Select this field if this version is the first version of the protocol. If this field is checked, then the Amendment Version field is read-only.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Amendment Version
|
Select the version number of the protocol version, for example, Version 1, Version 2, and so on.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Date
|
Displays the timestamp of the change.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Central IRB
|
Select this field to indicate that all sites use a central institutional review board.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Regional CRO
|
Select this field to indicate that a clinical research organization provides services to all sites in the clinical region. Creating Accounts and Contacts for Clinical Trials An account is the institution from which you manage clinical trials. Typically, it is the facility where the investigators conduct the trials. You can track as accounts IRBs (institutional review boards), central laboratories, CROs (clinical research organizations), and other subcontractors. You can associate multiple sites with an account, and an account can carry out multiple protocols. A contact is a person working at a clinical site. Contacts include investigators, typically medical professionals who are also researchers, and site coordinators, who might be the practicing nurses administering the treatment plan according to the clinical protocol. 33
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Region
|
The geographical region to which the site belongs. Principal Investigator The principal investigator for the site (contact associated with the site).
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Protocol Region
|
Displays the name of the region. This field is automatically populated with the protocol number and region name.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
No Site Info
|
Select this option to indicate that no site information will be available under the region. In such cases, only summary information about site enrolment will be available for the region. Deselect this option to indicate that site information will be available under the region. 8. If required, click Pause at any time to pause the task. The task moves to your Inbox where you must go when you want to resume work on the task. 9. If required, click Cancel at any time to cancel the task. 10. Click Submit to submit the task - that is, create the new protocol and region. 193
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
and Rolldown Buttons
|
When you click the Position Rolldown and Position Rollup button, a record is created, where applicable, in each of the Team History views for the protocol and all sites belonging to the region. The Position Rolldown mechanism automates the addition of team members to the Team History view for sites and the Team History view for protocols as if they are manually added. To remove a team member from the protocol, see About Removing Team Members From the Team of a Protocol. Creating Assignment Team History for Regions The Team History view allows you to administer and track team members who work in the region. It also provides details about the roles as well as the start and end dates. To create assignment team history for a region 1. Navigate to the Administration - Clinical screen, then the Region List view. 2. In the Region list, drill down on the Region field of the region for which you want to create a new team assignment history. 3. Navigate to the Team History view. 4. In the History list, create a new record and complete the necessary fields. 32
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Creating Accounts
|
Complete the procedure in this topic to create an account.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
To create an account
|
1. Navigate to the Accounts screen, then the Accounts List view. 2. In the Accounts list, create a new record and complete the necessary fields. Some fields are shown in the following table. To access more fields, click the show more button in the account form.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Site
|
The site associated with the trip report file.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Account Type
|
Select the type of account, such as Hospital, Clinic, IRB, and so on.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Account Team
|
Select the members assigned to the account team. The team member who creates the account record is the primary team member.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Address
|
The address for the contact.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Synonyms
|
Select the synonyms for the account. This field allows you to refer to accounts in the way that you prefer. For example, an account named A/B Products, Inc., might have the following synonyms: AB, A/B, and AB Products. When you search for an account or enter an account in another part of your Siebel Business Application, you can use a synonym instead of the actual name.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Territories
|
Select the territories that are associated with the account. 34
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
My Address
|
Select the addresses for the contact. A contact can have more than one address. You must specify one address as the primary address. Each CRA (clinical research associate) assigned to the contact can specify a different address as the primary address. For example, one CRA might specify a private office as the primary address, while another CRA might specify a hospital department as the primary address.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Satellite Site
|
Read-Only field. A star in this field indicates that this is a satellite site. Site # Type the number to assign to the site. This field is not required when the Status field for the site is Planned or Not Initiated. This field becomes required after a site is initiated. Protocol # Select the protocol from the list of existing protocols in the Pick Protocol dialog box.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
Parent Site
|
Read-only field. The parent site for the satellite site.
|
[
"clinical-trial-management-system-guide.pdf"
] |
clinical-trial-management-system-guide.pdf
|
pdf
|
glossary.json
| null | null |
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