Index

A B C D E F G H I L M N O P R S T U V W Y

A

accounts

for RDC users, 17.1

Activity List window

access, 12.3.6

and the Search window, 19.1.1

enabling, 19.1.1

Add Visit button, 17.4

Approval

configure message text, 17.7.5

configure password timeout, 17.7.4

approval

configure message text, 17.7.9

approval status icons, 12.2.4.3.4

approval task tab

components, 13.5.3

description, 13.5.1

overview, 13.5

status, 13.5.1.2

undo CRF approval, 9.5.2

Approve tab, 17.7.4.4

assigned patients, 12.2.2.4

ATTACHMENT prefix, 8.1.2

audit history window

description, 16.2.4

Audit Information window, 16.2.2

audit trail task tab

audit history window, 16.2.4

components, 13.6.3

description, 13.6.1

overview, 13.6

auditing, 17.3

change reason, 17.3

B

batch loaded data

displaying in RDC Spreadsheet, 17.7.2

C

Case Report Form (CRF), 1.1.1

Approval status icons, 12.2.4.3.4

cell, empty, 12.2.4.1

cell, meanings of background colors, 12.2.4.1

discrepancy status icons, 12.2.4.3.2

entry status icons, 12.2.4.3.1

Icons, 12.2.4.3

Multiple status icons, 12.2.4.3.5

phase spreadsheet view, 12.2.5.5

spreadsheet views, 12.2.5

study spreadsheet view, 12.2.5.6

verification status icons, 12.2.4.3.3

Visit selection button, 12.3.3

visit spreadsheet view, 12.2.5.4

change reason

modify default, 17.3

Color

backgrounds of CRF cells, 12.2.4.1

concepts

discrepancy actions, 3.2.3

CRA (Clinical Research Associate) role, 17.1

CRF

cell in spreadsheet, 12.2.4

CRF cell

in RDC Spreadsheet, 12.2.4

significance of empty cells, 12.2.4.2

CRF column, 12.2.3

CRF icon

in CRF Cell, 12.2.4

CRF menu, 11.2.6

Current Patients

RDC Spreadsheet component, 12.2.2

current study

defined, Glossary

D

DATA CHANGE REASON TYPE CODE, 17.3

DATA CHANGE REASON TYPE CODE reference codelist, 17.1.3.1

data collection instrument (DCI)

defined, Glossary

Data Entry window

CRF header, 8.4

database roles

for RDC, 17.1, 17.1

default study

defined, Glossary

DeriveDocumentNumber function, 17.7.3

discrepancies

actions, 3.2.3

in RDC, 17.2

reference codelists, 17.1.3.2, 17.1.3.2

type codes, 17.5

univariate, 17.5

initiating a discrepancy, 3.2.3.1

internal, 3.2.3.2.1

routing a discrepancy, 3.2.3.2

discrepancy

resolution, 13.3.2

routing, 13.3.2

section, 8.8

discrepancy actions, 3.2.3, 13.3.2

Discrepancy for CRF Section window, 8.8

discrepancy management, 3.2.3.1, 3.2.3.2

discrepancy status icons, 12.2.4.3.2

discrepancy task tab

access, 13.3.1.1

actions, 13.3.2

description, 13.3.1

discrepancy history window, 16.4.7

individual discrepancy tab, 13.3.4

list of discrepancies tab, 13.3.3

overview, 13.3

view discrepancies, 9.1.5

document number

using DeriveDocumentNumber function, 17.7.3

E

edit check error, 17.5

electronic signature, 17.7.4

entry status icons, 12.2.4.3.1

extended text fields, 8.1.2

F

focus

in RDC Spreadsheet, 12.1.3

Frozen patient numbers, 12.2.2.7

function keys

usage, 1.5.2

G

get_approval_header function, 17.7.5, 17.7.9

get_undo_header function, 17.7.6, 17.7.10

getConfigurationModule

in RDC_CLIENT package, 17.7.8

getConfigurationModule function, 17.7.8

Group Activities menu, 11.2.7

groupings, page, 12.2.5

H

Help menu, 11.2.9

I

icons in RDC, 17.2

initiating a discrepancy, 3.2.3.1

Insert menu

new patient, 12.2.2.4.1

insert new patient, 12.2.2.4.1

internal discrepancy, 3.2.3.2.1

Investigator Comment window, 8.2, 9.2.4

Investigator role, 17.1

IParse_news

in RDC_CLIENT package, 17.7.7

L

links task tab

access, 13.7.2

context, 13.7.1.1

description, 13.7.1

general links, 13.7.3.2

navigation, 13.7.2

overview, 13.7

patient/visit links, 13.7.3.4

study/site links, 13.7.3.3

M

Main Application window, 11.2.1

Title bar, 11.2.1.2

Menu bar, 11.2.2

File menu, 11.2.3

menu commands

access, 1.5.1

Multiple-status icons, 12.2.4.3.5

N

News procedure, 17.7.1

News system, 17.6, 17.7.7.1

definition form, 17.6.2

site users, 17.6.2

O

online help, 14.9.2

access, 14.9.2.1

components, 14.9.2.2

help topics window, 14.9.5

P

password

confirmation, 17.7.4.1

timeout during CRF approval, 17.7.4

Password Confirmation window

modify message in Group Approval, 17.7.9

patient

insert new, 12.2.2.4.1

select, 12.2.2.5

view, 12.2.2.6

Patient Data Report

Patient CRFs, 10.2.1

Patient List, 12.2.2

Patient Range drop-down list, 12.3.7

PDR

Blank CRFs, 10.2.2

running, 10.2

phase summary, 13.2.9

Preferences window

access, 14.4.1

components, 14.4.2

CRF Progression section, 14.4.4.1

default settings

general

progression sequence, 14.4.4.1.4

privilege

in RDC, 1.7.2

listed and described, 1.7.2

strategy in assignment, 1.7.2

privileges

in RDC, 18.1

RDC study security, 18.2.7

site security, 18.3.3

progression sequence

R

RDC

Add Visit, 17.4

Add Visit button, 17.4

administration of, in OC, 17

and discrepancies, 17.2

configure approval process, 17.7.4, 17.7.5

modify Password Confirmation message, 17.7.9

configure undo approval process, 17.7.6, 17.7.10

DeriveDocumentNumber function, 17.7.3

enrolling users, 17.1

icons, 17.2

News procedure, 17.7.1

News system, 17.6, 17.7.7.1

privileges, 18.1

RdciAccess function, 17.7.2

security, 17.7.4.1, 18.1

timeout_mins function, 17.7.4

unscheduled pages, 17.4

RDC Configuration settings

process assignment parameters, 17.7.8

settings affect RDC Workspace, 11.1.2.1

RDC Help

help topics window, 14.9.5

Help window, 14.9.2

RDC help

access, 14.9.2.1

components, 14.9.2.2

RDC security

study-level, 18.2.7

RDC session

description, 1.3.1

RDC Spreadsheet

and RdciAccess function, 17.7.2

components illustrated, 12.2.1

CRF column, 12.2.3

current patients, 12.2.2

general, 12.1

new patient, insert, 12.2.2.4.1

organization, 12.1.1

Show/Hide unplanned pages, 12.2.3.7

RDC toolbar, 11.2.11

button descriptions, 11.2.11.2

RDC Workspace

main application window, 11.2.1

overview, 11.1

toolbar, 11.2.11

RDC_CLIENT package, 17.7.7, 17.7.8

contents, 17.7

overview, 17.7

RDCI

differentiate input source, 17.7.3

RdciAccess function, 17.7.2

red icons, 17.2

reference codelists

DATA CHANGE REASON TYPE CODE, 17.1.3.1, 17.3

DISCREPANCY ACTIONS, 17.1.3.2

DISCREPANCY STATUS, 17.1.3.2

Remote Data Capture

see RDC

reports

Blank CRFs, 10.2.2

role

default, 1.7.1

in RDC, 1.7.1

routing a discrepancy, 3.2.3.2

RXC_CRA database role, 17.1

RXC_INV database role, 17.1

RXC_SITE database role, 17.1

S

Search window

tasks, 6

section discrepancy

initiate, 8.8

security in RDC, 18.1

session, 1.3.1

shortcut keys

CRF menu, 11.2.6

Edit menu, 11.2.4

group activities menu, 11.2.7

Help menu, 11.2.9

Insert menu, 11.2.5

Validate menu, 11.2.8

Window menu, 11.2.10

Show/Hide Unplanned button, 12.2.3.7

SITE role, 17.1

SITE user group

News system, 17.6.2

source data verification, 9.4.2

Spreadsheet

assigned patients, 12.2.2.4

Color coding, 12.2.3.6

components, 12.2

Page, 12.2.3.4

page column header, 5.5.1

Patient List, 12.2.2

Patient Range drop-down list, 12.3.7

Patient selection drop-down list, 12.3.7

Search button, 12.3.5

status line, 12.3.4

Visit number, 12.2.3.3

spreadsheet view, visit, 12.2.5.4

spreadsheet views, 12.2.5

standard texts, 17.5

status

approval, 13.5.1.2

study summary, 13.2.9

summary task tab

"summary of CRFs retrieved" section, 13.2.9.2

components, 13.2.3

CRF summary view, 13.2.6

CRF view, 5.4.4

description, 13.2.1

overview, 13.2

page summary view, 13.2.5

patient summary view, 13.2.4

select a view, 13.2.10.1

spreadsheet summary view, 13.2.9

T

task

add unplanned page, 5.4.6

add unplanned visit, 5.5.2

approve a CRF, 9.5.1

change book, 5.7.4

change site, 5.7.5

change study, 5.7.2

close a CRF, 8.9

create a CRF, 8.1.1

delete a CRF, 5.4.5

hide unplanned visits, 5.5.1

initiate section discrepancy, 8.8

insert investigator comment, 8.2

insert manual discrepancy, 8.8

insert new patient, 5.3.4

mark CRF blank, 8.4

open a univariate discrepancy, 9.3.2

open an investigator comment, 9.2.4

resolve a discrepancy, 9.3.3.2

route a discrepancy, 9.3.3.1

select a patient, 5.3.1

show unplanned visits, 5.5.1

source data verification, 9.4.2

undo CRF approval, 9.5.2

update data, 9.2.3

view CRF summary, 5.4.4

view discrepancies, 9.1.5

work with CRFs, 5.4

task tab

approval, 13.5

audit trail, 13.6

discrepancy, 13.3

links, 13.7

summary, 13.2

verification, 13.4

timeout_mins function, 17.7.4

U

Undo approval

configure message text, 17.7.6, 17.7.10

univariate discrepancies, 17.5

unplanned pages, 12.2.3.7

unscheduled pages, 17.4

user accounts, 17.1

user group roles

default, 17.2.1, 17.2.2

user groups

creating new, 17.1.3

user privileges, see privileges

V

Validate menu, 11.2.8

verification status, 13.4.2

verification status icons, 12.2.4.3.3

verification task tab

components, 13.4.3

description, 13.4.1

overview, 13.4

statuses, 13.4.2

Verify tab, 17.7.4.4

Visit selection button, 12.3.3

visit summary, 13.2.9

W

window

audit history, 16.2.4

discrepancy history, 16.4.7

editor, 14.1.6

help topics, 14.9.5

Window menu, 11.2.10

Workspace, 11.1

Y

yellow icons, 17.2