25/25
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
- See also Randomization Access Status
- access view, 6.3.4
-
- creating, 6.3.4.1
- active substances, 5.1.1
- ad hoc copy groups, 13
- Adverse Event Log, 1.3.1.1
- affiliations areas
-
- creating, 8.3.2
- age, in lab reference ranges, 15.2.5.1
- aggregate functions
-
- overview, 16.5.2
- restrictions, 16.5.2.2
- setting up, 16.5.2.3
- aggregate lag functions
-
- overview, 16.5.3
- restrictions, 16.5.3.2
- using, 16.5.3.3
- variables, 16.5.3.1
- alias$question_name||occurrence#$suffix, 16.6.2.2
- alias.question_name||occurrence#$suffix, 16.5.2.1, 16.5.3.1, 16.5.4.1
- Amend the Randomization Access Status window, 6.3.3
- annotated CRF
-
- definition, 11.1.1
- discussion, 11.1
- general, 11
- procedure, 11.2.1
- requirements to implement, 11.1.2
- annotations
-
- general procedure, 11.2.1
- placement style, 11.1.2
- Apply Lab Assignment Criteria window, 15.3.2
- attributes
-
- extended, 7.1.6
- Available Factors window, 6.1.3
B
- baseline, of a plan, 2.14
- Baselined? box
-
- Design enrollment plans, 2.13
- baselining clinical study plans, 2.13
- 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, 17.5.6
- 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, 12.9.3
- 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, 2.12.1
- Clinical Study Enrollment Criteria system table, 2.12.1
- Clinical Study modules, and study design information, 1.2.2.2
- Clinical Study Objectives system table, 2.12.1
- Clinical Study Versions system table, 2.12.1
- Closed access randomization, 6.2.2.1
- comb format, 12.9.3.3
- 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, 2.14
- Create DVG Sub menu option, 7.3.5
-
- See also subsets
- Create Initial Plans button, 2.15
- CRF Annotation Tool
-
- access, 11.3.1
- components, 11.3.2
- DCM Block Annotations tab, 11.3.1
- Field Annotations tab, 11.3
- usage, 11.3
- CRFs. See case report forms
- cursor visitation order, 9.2.4, 12.9.6
- cursors
-
- overview, 16.4.1
- types
-
- patient information cursor, 16.4.1.1
- procedure question group cursor, 16.4.1.2
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, 12.9.6.1
- 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, 2.13
- 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, 12.4.1
- migrating data, 12.7.5
- page definitions, 12.2.1
- DCIF_IMAGES, 12.9.1
- DCIs. See data collection instruments
- DCM Block
-
- annotating, procedure, 11.2.1
- 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, 12.9.6
- pull handles, 9.2.3.3, 12.9.2.4
- selecting objects, 9.2.3.3.1, 12.9.2.4.1
- 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
-
- for testing, 17
- samples of using, 17
- STANDARD, 17
- 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
- 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, 4.3.7.2
- plans for, 2.13
- 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
- See also study stratification factor
- failure type, 16.12.2.1
- First-Pass Entry
-
- direct access to, in test, 17.5.4
- FLT
-
- annotating, procedure, 11.2.1
- FLV. See form layout version
- form layout templates
-
- copying, 12.8.2
- editing, 12.9.10
- maintaining, 12.8
- previewing, 12.9.10.3
- validating, 12.8.3
- form layout versions
-
- maintaining, 12.7.4
- rules for status change, 12.7.4.1
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
- See also objects, Global Library
- graphic layout editor
-
- overview, 12.4.1.3
- troubleshooting, 12.11
- Graphic Layout Editor
-
- create annotate layouts, 11.1.2
- graphical layout
-
- annotating, 11.2.1
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
- See also access
- interval
-
- creating, 5.2.2, 5.2.3
- and creating phases, 5.2.2
- listed in the Treatment Pattern Regimens window, 5.1.8.1
- planned study, as component of Easy Study Design, 3.1.1
- and scheduling planned processes, 3.2.2, 5.3
- intervention, 2.1
- investigators
-
- creating records for, 4.2.1
- dummy, 17.1.2, 17.5
- and number of sites responsible for, 4.2.2
- principal, 4.2.2
- records for, 4.2.1
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, 4.3.7.2
- 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, 12.9.3
- 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
- See also parent objects, child objects
- OCL_DOMAINS, 8.2.4, 8.2.5.1
- offsets
-
- for planned events, 5.3.1
- open access randomization, 6.2.2.1
- Oracle Thesaurus Management System
-
- using question set questions in, 7.1.1
- using thesaurus DVGs with, 7.3.2.2
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, 4.3.4
- dummy, 17.1.2, 17.5
- linked to sites, 4.3.6, 4.4.2
- linked to treatment assignments, 4.3.6, 6.3.6.7
- linking to sites by range, 4.3.3.3
- linking to treatment assignments, 4.3.1.1
- multiple, per patient, 4.3.8
- 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, 2.13, 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 #, 2.13
- 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
- See also visit
- planned procedures
-
- creating, 5.2.5.1
- deleting, 5.2.5.1
- planned process
-
- compared with planned event, 1.2.2.5
- scheduling, 3.2.2, 5.3
- planned study intervals. See interval
- planning attributes, 6.3.3
- planning status, 6.3.3
- plans
-
- creating, 2.14
- for studies and sites, 2.13
- pre-code
-
- and executing packaged procedures, 16.12.1
- Preferred Conversion Groups, 15.1.4
- preferred copy groups
-
- defining, 15.2.2
- programs
-
- assigning compounds to, 2.3
- maintaining, 2.1
- projects
-
- creating, 2.2
- prompt
-
- position, 9.2
- text, 9.2
- protocol, 2.12.2.1
- provisional objects
-
- testing, 17.4.3
- pull handles, 9.2.3.3, 12.9.2.4
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
-
- 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
- Questions
-
- in date format, 9.1.11
- with default repeat values, 9.1.8.1
- sequence of, 9.2
R
- randomization
-
- converting, 6.2.5.3
- and copying of study versions, 2.12.2.1
- create access view, 6.3.4
- definition, 6
- in different study versions, 2.12.2
- 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
- See also access
- Randomizations system table, 6.3.1
- Range/Value box in the Factors window, 6.1.1.1
- RDCM window, 15.3.3.1
- Received DCMs, 9.3.2
-
- display sequence of, 9.3.2
- inheriting planned events, 9.3.2
- reference codelists
-
- BLIND TYPE CODE, 5.2.1
- BOOK_USAGE, 12.7.5.1
- CLINICAL PHASE, 2.6
- CRF PAGE NUMBERING SCHEME, 10.7.2
- DCIF CHECKBOX SIZE, 12.4.1.4
- DCIF FONT TYPESIZE, 12.4.1.4
- DCIF PAGE DEFINITION, 12.2.1.1
- DCM DCI QG TYPE CODE, 7.2.6.2, 7.2.6.2
- DISCRETE VAL GRP TYPE CODE, 7.3.3
- DX_EXTENDED_ATTRIBUTES, 14.1.1.5.3
- EXP DESIGN TYPE CODE, 2.6
- installation
-
- and Domains, 8.2.4
- LAB RANGE SUBSET CODE, 15.2.6
- OBJECTIVE TYPE CODE, 2.7.1
- OCL_DE_CONFIG, 7.3.3
- OCL_DOMAINS, 8.2.4
- OCL_STATE, 16.9.1
- PATIENT STATUS CODE, 16.12.1
- PLAN STUDY INT TYPE CODE, 5.2.1
- QUESTION CATEGORY TYPE CODE, 7.1.2
- SAS_FORMATS, 14.3.2.8
- and standards affiliations types, 8.3.2
- STUDY STATUS TYPE CODE, 2.7.8
- VALIDATION FAILURE TYPE CODE, 16.8.8.6
- Region Code Sequence, 2.5.3.1
- Region Contains window, 2.5.2
- regions
-
- child See Part Of
- in design
-
- deleting, 2.7.9
- parent See Made From
- planning
-
- creating, 2.5
- deleting, 2.5.1
- updating, 2.5.2
- See also Made From, Part Of
- relational database, 1.3
- release access randomization, 6.2.2.1
- repeat values
-
- default, 9.1.8.1
- purpose of, 9.1.8.1
- replacement rule, 6.3.6.3, 6.3.6.4
-
- in Easy Study Design, 3.2
- Replicate a Clinical Study form, 2.12.1
- Replicate Randomization menu option, 6.3.1
- replication
-
- in Easy Study Design, 3.2
- of randomizations, 6.3.1
- of studies, 5.1.5.1
- requirements
-
- annotations, 11.1.2
- Resequence DCM menu option, 9.1.12.5
- resequencing, 5.2.4.1
- Revoke an Access View menu option, 6.3.4.2
- RXC_RAND, 6.2.2.2, 6.2.2.2, 6.3.8
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, 4.3.6
- linked to treatment assignments, 4.4.2
- owning location of, 4.4.2
- site plans, 2.13, 2.15
- site records
-
- creating, 4.1.1
- Sites button, 2.15, 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
- See also affiliations areas
- status
-
- and Domains, 8.2.4.2, 8.2.8.3
- strata
-
- adding, 6.1.3.1
- assigning to a study, 6.1.4, 6.1.4.2
- combination, 6.1.3
- combined combination, 6.1.3
- creating, 6.1.1.1
- list of, assigned to a factor, 6.1.3.1
- list of, assigned to a study, 6.1.4.2
- modifying, 6.1.3
- purpose of, 6.1
- removing, 6.1.3.1, 6.1.3.2
- selection of, 6.1
- single, 6.1.2
-
- deleting, 6.1.2.2
- translating, 6.2.5.3
- See also study stratification factor
- Strata for Factor window, 6.1.3
- stratification
-
- in different study versions, 2.12.2
- Stratification menu option, 6.1.4.1, 6.1.4.2
- studies
-
- comments, 2.7.4
- as component of Easy Study Design, 3.1.1
- copying details, 2.12
- defining, 1.3
- deleting, 2.7.9
- history, 2.7.6
- naming, 1.3
- objectives, 2.7.1
- replicating, 2.12.1
- rollover, 4.3.8
- states, 2.16
- updating statuses, 2.7.8
- See also study design
- study code sequence, 6.3.3
- Study Data Definition subsystem
-
- features, 1.3
- See also data definition
- study design
-
- testing, 17.3.1
- Study Design subsystem, 1.2
-
- and Easy Study Design data structures, 3.1.2
- structure of, 1.2
- Study Replace button, 6.3.6.4
- study stratification factor
-
- maintaining, 6.1.4
- study termination criteria
-
- maintaining, 2.7.3
- study version
-
- copying, 2.12.2.1
- creating, 2.12.2
- definition of, 1.2.2.3
- deleting, 2.7.9
- live, 2.12.2, 6.3.3
- test mode, 17.3
- sub-period, 1.2.2.4
-
- creating, 3.2.1.3
- deleting, 5.2.2, 5.2.3, 5.2.4
- resequencing, 3.2.1.4, 5.2.4.1
- subsets
-
- of DVGs, 7.3.5
- synonyms
-
- in test, 17.5.4
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, 17.5.6
- provisional objects, 17.4.3
- timeline, 2.12.2
-
- composition of, 1.2.2.4
- defining, 5.2
- timestamp
-
- of copied study version, 2.12.2.1
- 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, 4.3.6, 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, 2.12.2
- 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, 17.5.7
- unit conversion in, 16.7
- variables
-
- user
-
- reported, 16.12.2.1
- verbose mode, 17.5.6
- 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, 12.9.3
W
- Where clause
-
- creating, 14.3.8
- purpose, 14.3.8