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Siebel CRM Siebel Clinical Trial Management System Guide
Siebel Innovation Pack 2017, Rev. A
E52416-01
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A  B  C  D  E  F  G  M  N  O  P  R  S  T  U  V  W  X 

A

account assessment templates, creating, 6.5
accounts
assessing, 6.25
associating clinical protocols with, 4.8
associating clinical regions with, 4.10
associating sites with, 4.13
associating with clinical projects, 10.8
associating with contracts, 6.8
associating with sites, 6.9
creating for clinical trials, 4.11
maintaining, 6.6
action items, viewing universal inbox notifications for, 9.13
activities
associating with sites, 6.10
creating for clinical projects, 10.9
creating for document tracking, 6.19
defining for subject visits, 5.2.5
integrating data for subject visits with data for, 12.4, 13.4
activity completion, about integrating data for, 12.6, 13.6
activity plans, creating for sites, 6.16
activity templates
applying to sites, 6.17
creating for clinical projects, 10.4
address types, adding for sites, 6.14
administrative setup tasks, for Siebel Clinical, 3.7
applet properties, in Siebel Clinical, A.5
assignment objects, predefined, 3.9.1
audit trail
using for changes to clinical trip reports, 9.21
using for changes to subject status, 5.26
using for reviews and approvals of clinical trip reports, 9.20
automated notification messages, for clinical trip reports, 9.10
automated validation messages, for clinical trip reports, 9.10

B

batch mode, administering subject visits in, 5.8
business components, user properties for in Siebel Clinical, A.3
business services, user properties for in Siebel Clinical, A.4

C

case report forms
managing tracking activities for, 6.20
tracking, 6.21, 9.9
tracking for partial source data verification during site visits, 7.8
viewing for partial source data verification, 7.7
clinical data capture and query management system integration
activating workflows for, 12.2.1
configuring Web services for, 12.2.2
overview of, 12.1
process of setting up, 12.2
clinical data management system integration
about customizing Web services for, 13.2
activating workflows for, 13.3.1
configuring Web services for, 13.3.2
overview of, 13.1
process of setting up, 13.3
clinical payments
about setting up and making for subject activities, 8.1
generating Oracle BI Publisher reports for, 8.16
scenario for, 8.2
clinical programs, creating, 4.4
clinical projects
about managing, 10.1
associating people and accounts with, 10.8
creating, 10.7
creating activities and tasks for, 10.9
creating activity templates for, 10.4
managing risk for, 10.11
monitoring costs for, 10.10
process of managing, 10.3
scenario for managing, 10.2
setting up employee profiles for, 10.5
clinical protocol site templates, creating, 6.4
clinical protocols
associating with accounts, 4.8
creating and revising versions for, 4.7
generating payment records for sites associated with, 8.11
setting up, 4.5
setting up partial source data verification for, 7.2
viewing status accruals for clinical subjects of, 5.23
viewing training information for, 11.12
clinical regions
associating with accounts, 4.10
generating payment records for sites associated with, 8.11
setting up, 4.9
setting up partial source data verification for, 7.3
viewing status accruals for clinical subjects of, 5.22
viewing training information for, 11.13
clinical subjects
about integrating data for, 13.5
applying protocol amendments to, 5.19
applying revised subject visit templates to, 5.19.2
creating records for, 5.5
enrolling, 5.11
monitoring status accruals for by visit type, 5.25
randomizing, 5.12
recalculating requiring source data verification, 7.9
rescheduling, 5.7
rescreening, 5.10
scheduling, 5.6
screening, 5.9
setting up partial source data verification for, 7.6
terminating clinical trials early for, 5.18
tracking status accruals for, 9.12
transfer information, viewing, 5.15, 5.16
transferring, 5.14
viewing status accruals for, 5.21, 5.22, 5.23
clinical training
about managing, 11.1
setting up training topics for, 11.2
clinical trials
about setting up, 4.1
creating accounts and contacts for, 4.11
creating satellite sites for, 4.12.2
creating sites for, 4.12
performing risk assessments for, 4.14.2
process of managing, 4.3
risk assessment templates, creating, 4.14.1
risk assessments, about, 4.14
scenario for, 4.2
terminating early for clinical subjects, 5.18
clinical trip report templates
applying, 9.5
creating, 9.4
clinical trip reports
about administering and using, 9.1
approving, 9.15
automated validation and notification messages for, 9.10
completing, 9.6
completing questionnaires for, 9.7
creating new versions of, 9.17
creating questions for using Siebel SmartScript, 9.3
deleting unanswered questions form questionnaires of, 9.8
obsolete, 9.16
scenario for managing, 9.2
tracking completion status for, 9.11
using audit trail for changes to, 9.21
using audit trail for reviews and approvals of, 9.20
version information, viewing, 9.18
viewing, 9.14
viewing geographical location details for, 9.19
viewing universal inbox notifications for action items of, 9.13
completed training
designating for contacts, 11.11
designating for training topics, 11.10
completion status, tracking for clinical trip reports, 9.11
contact assessment templates, creating, 6.5
contact assignments, in Siebel Clinical, 3.9.2
Contact Denormalization mode, in Siebel Life Sciences, 3.9.3
contacts
about managing for clinical trials, 6.1
assessing, 6.25
creating for clinical trials, 4.11
designating completed training for, 11.11
maintaining, 6.6
managing for sites, 6.13
process of managing for clinical trials, 6.3
scenario for managing for clinical trials, 6.2
contracts
associating accounts with, 6.8
associating with sites, 6.7
correspondence activities, creating for sites, 6.22
criteria, adding to training plans, 11.4

D

document tracking
creating activities for, 6.19
generating Oracle BI Publisher reports for, 6.26
documents
associating with sites, 6.11
tracking and adding at sites, 6.18
DTE data maps
exporting from server database to XML file, 3.10.1.1
importing to local client from XML file, 3.10.1.2

E

employee profiles, setting up for clinical projects, 10.5

F

field properties, in Siebel Clinical, A.6
final payments, generating for sites, 8.14

G

geographical location details
viewing for clinical trip reports, 9.19

M

mobile Web clients, setting up for position rollup, 3.10
My Team’s filter, about, 3.8

N

notes, adding to sites, 6.23

O

Oracle BI Publisher reports
generating for clinical payments, 8.16
generating for document tracking, 6.26
generating for site enrollment status, 5.27
generating for site visits, 9.22
Oracle Health Sciences InForm integration, configuring protocol integration fields for, 12.3

P

partial source data verification
about, 7.1
about for protocol amendments, 7.10
setting up for clinical protocols, 7.2
setting up for clinical regions, 7.3
setting up for clinical subjects, 7.6
setting up for sites, 7.5
setting up for subject visit templates, 7.4
tracking case report forms for during site visits, 7.8
viewing case report forms for, 7.7
payees, splitting payment activities between multiple, 8.5
payment activities
creating for sites, 8.9
generating payment records for unplanned, 8.12
reversing splits for, 8.7
splitting between multiple payees, 8.5
payment amounts, adjusting and generating payment records for sites, 8.13
payment exceptions, setting up for sites, 8.4
payment records
creating for sites, 8.10
generating for sites, 8.13
generating for sites associated with clinical protocols and clinical regions, 8.11
generating for unplanned payment activities, 8.12
reverting, 8.15
payment splits, copying details for, 8.6
people, associating with clinical projects, 10.8
position rollup, setting up for mobile Web clients, 3.10
position types, setting up for billing, 10.6
Projects screen, about views in, 10.12
protocol amendments
about partial source data verification for, 7.10
applying to sites and clinical subjects, 5.19
rules for applying, 5.19.3
protocol integration fields
configuring for Oracle Health Sciences InForm integration, 12.3

R

rate lists, setting up for billing, 10.6
risk assessments
for clinical trials, about, 4.14
performing for clinical trials, 4.14.2
templates, creating for clinical trials, 4.14.1

S

satellite sites
creating for clinical trials, 4.12.2
Siebel Assignment Manager, using in Siebel Clinical, 3.9
Siebel Clinical
about setting up, 3.1
activating workflow policies for, 3.5
administrative setup tasks for, 3.7
configuring properties for in Siebel Tools, 3.2
configuring Siebel Mobile disconnected application for, 14.3
configuring Web services for, 3.6
contact assignments in, 3.9.2
enabling or disabling Siebel Open UI for, 3.3
enabling Siebel Server component groups for, 3.4
using Siebel Assignment Manager in, 3.9
Siebel Clinical Trial Management System
about, 2.1
features of, 2.2
product modules and options for, 2.3
using Siebel REST API with, A.1
Siebel Mobile disconnected application
about, 14.1
configuring for Siebel Clinical, 14.3
for Siebel Clinical, about, 14.2
for Siebel Clinical, managing site visits, 14.5
for Siebel Clinical, managing sites, 14.6
for Siebel Clinical, using, 14.4
Siebel Open UI, enabling or disabling for Siebel Clinical, 3.3
Siebel Server component groups
enabling for Siebel Clinical, 3.4
Siebel SmartScript, creating questions for clinical trip reports using, 9.3
Siebel Tools
configuring properties for Siebel Clinical in, 3.2
site enrollment status, generating Oracle BI Publisher reports for, 5.27
site teams, assigning employees to, 6.15
site visits
creating and managing, 6.12
generating Oracle BI Publisher reports for, 9.22
tracking case reports forms for partial source data verification during, 7.8
sites
about exporting data for, 12.5
about managing for clinical trials, 6.1
adding address types for, 6.14
adding notes to, 6.23
adding training plans to, 11.8
adjusting payment amounts and generating payment records for, 8.13
applying activity templates to, 6.17
applying protocol amendments to, 5.19
applying revised subject visit templates to, 5.19.1
associating contracts with, 6.7
associating with accounts, 4.13, 6.9
associating with activities, 6.10
associating with documents, 6.11
changing training topics for, 11.9
creating activity plans for, 6.16
creating correspondence activities for, 6.22
creating for clinical trials, 4.12
creating payment activities for, 8.9
generating final payments for, 8.14
generating payment records for, 8.10, 8.11
managing contacts for, 6.13
process of managing for clinical trials, 6.3
scenario for managing for clinical trials, 6.2
setting up partial source data verification for, 7.5
setting up payment exceptions for, 8.4
tracking and adding documents at, 6.18
tracking status accruals for clinical subjects of, 9.12
viewing status accruals for clinical subjects of, 5.21
viewing status history for, 6.24
source data verification, recalculating clinical subjects requiring, 7.9
standard payment amounts, setting up in subject visit templates, 8.3
status accruals
monitoring for clinical subjects by visit type, 5.25
tracking for clinical subjects of sites, 9.12
viewing for clinical subjects of clinical protocols, 5.23
viewing for clinical subjects of clinical regions, 5.22
viewing for clinical subjects of sites, 5.21
status history, viewing for sites, 6.24
subject activities
about setting up and making clinical payments for, 8.1
marking as complete, 8.8
subject enrollment
about rolling up information for, 5.20
monitoring rates for, 5.24
subject status
about automatic tracking of, 5.4
overriding initial, 5.13
using audit trail for changes to, 5.26
subject visit templates
about, 5.1
applying to clinical subjects, 5.19.2
applying to sites, 5.19.1
approving, 5.3
creating, 5.2.1
defining versions for, 5.2.2
process of defining, 5.2
setting up partial source data verification for, 7.4
setting up standard payment amounts in, 8.3
subject visits
administering in batch mode, 5.8
creating unscheduled, 5.17
defining, 5.2.3
defining activities for, 5.2.5
defining planned, 5.2.4
generating reports for actual, 6.27
generating reports for planned and actual dates of, 6.28
integrating data with data for activities, 12.4, 13.4
rules for deleting when deemed non-applicable by early termination, 5.19.4
system preferences
in Siebel Clinical, A.7

T

tasks, creating for clinical projects, 10.9
team assignment history, tracking and revising, 4.6
tracking activities, managing for case report forms, 6.20
training plans
about publishing, 11.6
adding criteria to, 11.4
adding to clinical sites, 11.8
creating, 11.3
creating versions of, 11.5
publishing, 11.7
training topics
changing for clinical sites, 11.9
designating completed training for, 11.10
setting up for clinical training, 11.2

U

universal inbox notifications, viewing for action items of clinical trip reports, 9.13
user properties
for business components in Siebel Clinical, A.3
for business services in Siebel Clinical, A.4
overview of for Siebel Clinical, A.2

V

versions
creating and revising for clinical protocols, 4.7
creating for training plans, 11.5
defining for subject visit templates, 5.2.2
visit type, monitoring status accruals for clinical subjects by, 5.25

W

Web services
about customizing for clinical data management system integration, 13.2
configuring for clinical data capture and query management system integration, 12.2.2
configuring for clinical data management system integration, 13.3.2
configuring for Siebel Clinical, 3.6
in Siebel Clinical, A.9
workflow policies, activating for Siebel Clinical, 3.5
workflows
activating for clinical data capture and query management system integration, 12.2.1
activating for clinical data management system integration, 13.3.1
in Siebel Clinical, A.8

X

XML file
exporting DTE data maps from server database to, 3.10.1.1
importing DTE data maps from local client to, 3.10.1.2