Index

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

A

access

and randomization

See randomization

to Maintain Planned Studies, 3.2

revoking, 6.3.4.2

B

baseline, of a plan, 2.13

Baselined? box

Design enrollment plans, 2.12

baselining clinical study plans, 2.12

batch data delete, 17.4.3

batch data load

and test mode, 17.4.2

batch loading

of lab ranges, 15.4

batch validation, 16.10.2.1, 17.5.3

and debug mode, 17.5.7

blind break, 6.3.8

deleting, 4.5.1

record of, 6.2.2.3

report, 1.2.2.8

blinding, 6.2.2.1

and access views, 6.3.4

box set mask, 11.9.3

branching

conditional, 2.8

definition of, 2.8

Indicator, 2.8

C

case report forms

section of, equivalent to a DCM, 9.1

character grid, 9.2.3.2

child objects, 8.2.2, 8.2.6.1, 8.2.7.2

CLEAR_STAT packaged procedure, 16.12.1

Clinical Studies system table, 2.11.1

Clinical Study Enrollment Criteria system table, 2.11.1

Clinical Study modules, and study design information, 1.2.2.2

Clinical Study Objectives system table, 2.11.1

Clinical Study Versions system table, 2.11.1

Closed access randomization, 6.2.2.1

comb format, 11.9.3.3

Combination Strata window, 6.1.3, 6.1.3

comment

of a study in study design, 2.7.9

compounds

assigning to a program, 2.3

conditional branching, 9.1.9

procedure for, 9.1.9

copy groups

adding objects, 13.2

creating, 13.1

overview, 13

types, 13

Copy Ques Group menu option, 7.2.4

Copy Schedule for CPE pop-up window, 9.1.12.3

Copy Schedule for DCM pop-up window, 9.1.12.4

Copy Treatment Patterns, 5.1.8.3

COPYOF, 9.1.2

CPEs. See planned events

Create a new study plan, 2.13

Create DVG Sub menu option, 7.3.5

D

data capture, 1.3

data collection

defining, 1.3.1.1

data collection instruments

Active, 9.3.1

copying, 9.3.4

copying into Global Library, 8.1.2

creating, 9.3.1

manual method, 9.3.1

in data definition workflow, 1.3

date, 9.3.2

Library, 9.3.4

name of, 9.3.1

optional, 10.6.1

overview, 1.3.1.2

study, 9.3.4, 9.3.4

time field, 9.3.1

type code for, 7.2.6.2

data collection modules

associating, with DCIs, 9.3.2

base, 9.1

copying, 9.1.2

copying into Global Library, 8.1.1

creating

new, 9.1.1

Library, 9.1.2

locating, 9.1.2

multiple, in one study, 9.1

multiple, per DCI, 9.3.1

optional, 9.3.2

overview, 1.3.1.1

populating, with question groups

procedure, 9.1.3

Provisional, 9.1

scheduling

copying, 9.1.12.2

sequence number, 9.1.12.5

sequencing, 9.1.12.2, 9.1.12.5

study, 9.1.2

subset name and DCI, 9.3.1

type code for, 7.2.6.2

data definition, 1.3

See also Study Data Definition subsystem

data entry

generation time, 9.2.1

ordering cursor visitation order, 9.2.4.1, 11.9.6.1

screens, 1.3

procedure to create, 9.2

testing, 17.5

tools to create, 9.2

testing, 17.5.4

Data Entry Display Format, 9.1.11

Data Extract View

and default repeat values, 9.1.8.1

database

model of, 1.3

procedure for synchronizing patient data, 16.12.2

relational, 1.3

test, 17.4

date

of DCI, 9.3.2

in the Study Plans window, 2.12

date format

country, 9.1.11

DCI Book

in data definition workflow, 1.3

defining, 10.6.1

names for, 10.6

pages, 10.6

numbers of, 10.6.1

purpose of, 10.6

DCI forms

local study settings, 11.4.1

migrating data, 11.7.5

page definitions, 11.2.1

DCIF_IMAGES, 11.9.1

DCIs. See data collection instruments

DCM Block

annotating, procedure, 12.2.1

DCM layout

Data Entry Generation Time value, 9.2.1

generating default, 9.2.1

DCM layout editor

boxes, 9.2.3.5

character grid, 9.2.3.2

editing, 9.2.3.1

illustrated, 9.2.3

introduction, 9.2

ordering, 9.2.4, 11.9.6

pull handles, 9.2.3.3, 11.9.2.4

selecting objects, 9.2.3.3.1, 11.9.2.4.1

text, 9.2.3.4

DCMs. See data collection modules

debug mode, 17.5.2

Default Domain List. See Domain List

default domain lists, 8.2.5.1

default layout generator, 9.2

Default Repeat Values button, 9.1.8.1

Delete Study menu option, 2.7.9

derivation procedures

and calculations

re-executed, 16.10.2.1

correlation processing, 16.5.1

in data definition workflow, 1.3

decimal precision in, 16.12.6

defining, 16.3

examples, 16.2.2

execution order of, 16.10.2.1

overview, 16.2

restrictions, 16.2.1

and standards affiliations, 8.3.1

synchronizing patient data for, 16.12.2, 16.12.2

testing, 17.1, 17.5.2

type conversion in, 16.12.6

design See study design

discrepancies

and test, 17.5

viewing, from Validation or Derivation Procedures, 17.5.1

discrete value groups

adding values to, 7.3.4

assigning to questions, 7.3.5.1

creating, 7.3

definition of, 7.3

maintaining, 7.3.6.2

modifying, 7.3.6.1

subsets of, 7.3.5

types of, 7.3.3

discrete values, 7.3

Domain List, 8.2.1, 8.2.6.1, 8.2.7.1

defining defaults for, 8.2.5.1

overriding defaults for, 8.2.5.2

sequence in, 8.2.4.1, 8.2.5.1, 8.2.5.4, 8.2.6.2

Domain Searchlist, 8.2.5.3, 8.2.5.4

study-level, 9.1.2

Domains

creating, 8.2.4

deleting, 8.2.5.1, 8.2.5.1, 8.2.5.4

examples of using, 8.2.8

modifying, 8.2.3, 8.2.6.3

and names, 8.2.7, 8.2.7.1

as part of unique key, 8.2

and standards, 8.2.8.1

summary overview, 8.2

domains

for testing, 17

samples of using, 17

STANDARD, 17

dosages

specifying by range of patient characteristics, 5.1.4.1

drugs

assigning, to treatment regimens, 5.1.5.1

definition, 5.1.2

deleting, 5.1.1

NOT AVAILABLE, 5.1.5.1

recording, 5.1.1

Drugs window

via treatment patterns, 5.1.8.2

DVGs. See discrete value groups

E

Easy Study Design

allocating patient positions to sites after, 3.3

and codes for planned studies, 3.2

components of, 3.1.1

creating planned studies from, 3.2

data structures, 3.1.2

defining planned study intervals in, 3.2.1

deleting patient positions, 3.2.4.2

displaying patient positions, 3.2.4.1

patient positions by site, 3.2.4.1

querying, 3.1.3

replacement rules, 3.2

study versions in, 3.1.1, 3.2

Edit Gen Proc menu option, 16.9.2

Edit Layout menu option, 9.2.3

enrollment of patients

criteria for, 2.7.9

dates of, 16.12.1

loading dates of, 4.3.6.2

plans for, 2.12

synchronizing data for, 16.12.2

Execute in Test menu option, 17.5.2

Execute Single Procedure menu option, 17.5.2

extract macros

associating to questions, 14.1.1.6

creating, 14.3.2

F

factors

and creating single strata, 6.1.2.1, 6.1.2.2

definition of, for strata, 6.1.1

deleting, 6.1.1.1

form for maintaining, 6.1.1

status of, 6.1.1.1

G

generating default DCM layout, 9.2.1

generation time

data entry, 9.2.1

production, 9.2.5.1

Global Librarian

and setting status

of DVGs, 7.3.6.2

of questions, 7.1, 7.2.6.1

and locating objects, 8.3.1

and maintaining questions, 7.1

and standards, 8.3

Global Library

copy groups, 8.4

copying DCIs into, 8.1.2

copying DCMs into, 8.1.1

copying procedures into, 8.1.3

copying view definitions into, 8.1.4

populating, 7.2

H

Having clause

purpose, 14.3.5.6

history

of a study in study design, 2.7.8, 2.7.9, 6.3.3

and creating a phase, 5.2.2

I

INSTALL_TEST domain, 17

interim analysis

definition of, 6.2.2

K

key mapping

for test menus, 17.5.4

key templates

purpose, 14.1.1.2

keys

in lab assignment criteria, 15.3

unique, for Global Library, 8.2, 8.2.6.4

L

lab assignment criteria (LAC)

maintaining, 15.3

Lab Assignment Type field, 15.3.3.1

lab panels

defining, 15.2.3

lab ranges

batch load, 15.4

copying, 15.2.8

textbook, 15, 15.2.1

lab reference ranges

age values, 15.2.5.1

examples, 15.2.5.2

incorrect data in, 15.3.3.2

maintaining, 15.2.4

and patient data changes, 16.12.2

lab test question units

defining, 15.1.2

lab units

defining, 15.1.1

labs

assigning, 15.3.3.1

lag checks

examples, 16.5.4.3

overview, 16.5.4

setting up, 16.5.4.2

layout

DCM, 9.2

creating default, 9.2.1

testing, 17.1, 17.5.4

tools to create, 9.2

layout systems, for data entry and report output

character-based, 1.3.2.1

graphic-based, 1.3.2.2

linking

single strata, 6.1.3

Load Patient Enrollment Dates form, 4.3.6.2

Locate Active Questions form, 9.1.5

Locate Library DCIs form, 9.3.4

Locate QG by SA option of the Special menu, 7.2.6

Locate Study DCIs form, 9.3.4, 9.3.4

Log-In

setting the Data Entry Display Format during, 9.1.11

M

Made From, 2.5.1

Maintaining treatment patterns, 5.1.8

masks, 11.9.3

medical evaluation type, 7.1

Move to Prod menu option, 9.2.5.1

N

name spaces, 8.2

O

objectives

deleting, 2.7.9

objects, Global Library

adding, 8.2.6.5, 8.2.7.2

copying, 8.2.6.4

to a study, 8.2.7.1

creating, 8.2.6.2

in a study, 8.2.7.1

and Domains used in the Library or in studies, 8.2.8.4, 17

locating, 8.2.6.5, 8.2.7.2

locating through standards affiliations, 8.3.1

names of as part of unique key, 8.2, 8.2.3

querying, 8.2.6.1

referencing

after modifying the Domain, 8.2.3

renaming, 8.2.6.4

and standards, 8.3

status of, 8.2.8.3

testing, 8.2.8.4, 17

P

parent objects, 8.2.2, 8.2.6.1, 8.2.7

Part Of, 2.5.1

PAT_SYNCH procedure, 16.12.2

and error reporting, 16.12.5.1

executing, 16.12.2

pre-code for, 16.12.2.1, 16.12.4

using, 16.12.2.1

patient positions

as component of Easy Study Design, 3.1.1

definition of, 1.2.2.7

deleting, 4.3.3

dummy, 17.1.2, 17.5

linked to sites, 4.3.5, 4.4.2

linked to treatment assignments, 4.3.5, 6.3.6.7

linking to sites by range, 4.3.2.3

linking to treatment assignments, 4.3.1.1

multiple, per patient, 4.3.7

normal, 4.3.1.1

number of, 4.3.1.1

replacement, 4.3.1.1, 6.3.6.3

screening, 4.3.1.1

synchronizing data for, 16.12.2

Patient Positions table, 16.12.2, 16.12.2, 16.12.2.1

Patient Status Derivation Packaged Procedure, 2.12, 16.12.5.2

using, 16.12.2

Patient Statuses table, 16.12.1, 16.12.1.1

patients

normal, 1.2.2.7

replacement, 1.2.2.7, 6.3.6.4

status of, 16.12.1

and date, 16.12.1

deleting, 16.12.1

tracking, 16.12.2

pattern code, 5.1.8.3, 5.1.9

Patterns system table, 5.1.7

patterns, use of, 5.1.7

period, 1.2.2.4

creating, 3.2.1.1, 5.2.3

deleting, 5.2.3

resequencing, 3.2.1.2, 5.2.4.1

phase, 1.2.2.4

creating, 5.2.2

deleting, 5.2.2

resequencing, 5.2.4.1

Phases button, 5.2.2, 5.2.3, 6.3.3, 6.3.3

pivotal study, 2.7

Plan #, 2.12

planned events

as component of Easy Study Design, 3.1.1

copying, 9.1.12.2

creating and deleting, 3.2.2, 5.3, 5.3.1

in data definition workflow, 1.3

inherited by Received DCM, 9.3.2

missing, 5.3.1

name of, given to DCI Book page, 10.6.1

Q

qualifying questions

associating with a DCM, 9.1.7

configuring, 9.1.7

qualifying value, 9.3.2

question category, 7.1, 7.1.2

question groups

adding questions to, 9.1.5

assigning questions to

conditions for, 7.2.2

procedure for, 7.2.2

copying, 7.2.4

creating

summary of related tasks, 7.2.1

definition of, 7.2

deleting, 7.2.5

expandable, 9.1.5

maintaining, 7.2.6

modifying, 7.2.4

populating with questions, 7.2.1

procedure, 16.5.4.3.1

repeating, 9.1.8

status of, 7.2.5, 7.2.6.1

type code for, 7.2.6.2

Questions

in date format, 9.1.11

with default repeat values, 9.1.8.1

sequence of, 9.2

questions

adding to question groups, 9.1.5

assigning DVGs to, 7.3.5.1

assigning to question groups

conditions for, 7.2.2

procedure for, 7.2.2

indicator. See indicator questions

modifying, 7.1

qualifying. See qualifying questions

status of, 7.1, 7.1.1

See also discrete values, discrete value groups

R

randomization

converting, 6.2.5.3

and copying of study versions, 2.11.2.1

create access view, 6.3.4

definition, 6

in different study versions, 2.11.2

dummy, 6.2.2.1

loading, 6.2.5.3

multiple instances of, 6.3.6.6

and overlapping, 6.2.1

replicating, 6.3.1

revoking an access view, 6.3.4.2

sequence for entering or changing, 6.2.1

stratum version block definition-level, 6.2.3.4

stratum-level, 6.2.3.2

study version block definition-level, 6.2.3.3

type codes, 6.2.3.1, 6.2.3.2, 6.2.3.3, 6.2.3.4

validating, 6.2.5.2, 6.2.5.3

version-level, 6.2.3.1

See also access, conversion specifications

Randomization Access Status

and creating a phase, 5.2.2

S

Schedule DCMs menu option, 9.1.12.2

scheduling

matrix, 9.1.12.1

planned processes, 3.2.2, 5.3

Second Pass Required box, 16.10.2.1

second-pass data entry

and Easy Study Design, 3.2

security

and Domain access, 8.2.7.1

sequencing

of DCIs, 10.6

by visit, 10.6

SET_STAT packaged procedure, 16.12.1

Single Regimen menu option, 5.1.4

Single Strata menu option, 6.1.2

site

assigning to studies, 4.4.2

dummy, 17.1.2, 17.5

linked to patient positions, 4.3.5

linked to treatment assignments, 4.4.2

owning location of, 4.4.2

site plans, 2.12, 2.14

site records

creating, 4.1.1

Sites button, 2.14, 4.4.2

sponsors. See organization unit

STANDARD domain, 17

standards affiliations

associating objects and procedures with, 8.3.1.2

definition of, 8.3

status of, 8.3.2

types, 8.3.1

creating, 8.3.1

T

termination of patients

criteria for, 2.7.9

synchronizing data for, 16.12.2

test

creating a database for, 17.4

data, naming for, 17.5

for DCM layouts, 17.5.4

and reports, 17.5

Test a Study menu option, 17.1.2, 17.5

test mode, 17.5.3

domain for, 17

keeping data separate for, 17.1.2

naming conventions, 17.3

Provisional DCMs in, 9.1

synonyms, 17.3.1

testing

batch data load, 17.4.2

batch validation, 17.5.3

in data definition workflow, 1.3

Global Library objects, 8.2.8.4, 17

in Debug mode, 17.5.2, 17.5.7

provisional objects, 17.4.3

timeline, 2.11.2

composition of, 1.2.2.4

defining, 5.2

timestamp

of copied study version, 2.11.2.1

titration, non-linear

steps for treatment regimen, 5.1.4.2

TMS. See Oracle Thesaurus Management System

tracking

DCMs, 5.3.1

Questions, 9.1.12.1

treatment assignments

linked to patient positions, 4.3.5, 6.3.6.5, 6.3.6.7

linked to sites, 4.4.2

linking to sites, 4.4.2

linking to sites by range, 4.4.2.1

locked, 6.2.5.2

modifying in a flat file, 6.2.5.1.1

Treatment Assignments system table, 6.3.1

Treatment Pattern Block Definitions system table, 6.3.1

Treatment Pattern Regimens window, 5.1.8.1

treatment patterns

codes, 5.1.9

as component of Easy Study Design, 3.1.1

copying, 5.1.8.3

definition of, 1.2.2.6, 6.2

in different study versions, 2.11.2

disclosing, 4.5

modifying in a flat file, 6.2.5.1.1

and sequence of application, 6.2.3.1

translating, 6.2.5.3, 6.2.5.3.1

validating, 6.2.5.2

treatment regimen

and changing drug assignments, 5.1.5.1

assigning to intervals, 5.1.8.1

combined

maintaining, 5.1.6

sequencing regimens in, 5.1.6.3

daily dosage details for, 5.1.5

locating, 5.1.8.2

non-linear titration steps for, 5.1.4.2

single

and replication, 5.1.5.1

definition of, 5.1.3

maintaining, 5.1.3

treatments

overview, 5.1

type code

for question groups, DCMs, and DCIs, 7.2.6.2

type conversion, in derivation procedures, 16.12.6

U

union views

cross-study, 14.3.7

in-study, 14.3.7

User Synonyms Table, 17.3.1

user_domain_lists, 8.2.5.3

V

Validate a Loaded Randomization module, 6.2.5.3.3

validation

test mode, 17.5.3

validation procedures

algorithms, 16.12.1, 16.12.1.1.6

correlation processing, 16.5.1

creating

design considerations in, 16.7

defining, 16.3

details for, 16.12.2.1

and patient status, 16.12.5.1

examples, 16.1.1

order of execution, 16.10.2.1

overview, 16.1

and standards affiliations, 8.3.1

synchronizing patient data for, 16.12.2, 16.12.2

testing, 17.1, 17.5, 17.5.1, 17.5.2

and discrepancies, 17.5.8

unit conversion in, 16.7

variables

user

reported, 16.12.2.1

verbose mode, 17.5.7

view builder structure

overview, 14.1

view definitions

copying into Global Library, 8.1.4

maintaining, 14.3.5

View Patient Positions window, 15.3.3.2

visit

associating with DCMs, 9.1.12.1

in data definition workflow, 1.3

and planned process, 1.2.2.5, 5.2.5

visualization objects, formatting, 11.9.3

W

Where clause

creating, 14.3.8

purpose, 14.3.8