Index
A B C D E F G I K L M N O P Q R S T U V
Numerics
- 3.1-Style Procedures, 4.7.5
A
- accessible data
-
- browsing, 1.6.2
- updating, 1.5.3
- actual event
-
- transfer of batch data to, 7.2.3
- audit trail, 1.4.5
-
- browsing, 1.6.3
- extended example of, 1.4.5.2
- audit_hist, 10.3
- auto fill, 2.3.2
- auto reduction, 2.3.2
B
- batch data load
-
- document number in, 7.5
- error diagnosis in, 7.5
- error messages in, 7.5
- and inserts, 7.5
- load/prepare process, 7.5
- logging status of, 7.5
- overwritten error log in, 7.5
- prepare process, 7.5
- and privileged transfer, 7.5
- transfer process, 7.5, 7.5
- and updates, 7.5
- Batch Data Loader
-
- creating a data file group, 7.4.3
- document number in, 7.1.2.1
- file format for, 7.1.2
- load process, 7.2.1
- prepare process, 7.2.2
- transfer process, 7.2.3, 7.2.3, 7.4.4
- updatability of files in, 7.4.2.2, 7.4.2.2
- batch jobs
-
- loading external views as, 8.4.1
- as method of freezing and locking, 9.1.2, 9.1.4, 9.1.5.1
- as method of unfreezing, 9.1.4
- batch queue
-
- name, 8.3.1, 8.3.6
- batch validation
-
- of nonstandard RDCIs, 1.3.3, 1.3.6
- Blank flag, 3.3.2.3
C
- C (Clean) validation status, 8.3.3.3.4
- case report forms. See CRFs
- CDS
-
- clearing, 6.4.3
- counting, 6.3.2.3
- creating, 6.3.1.2
- criteria syntax, 6.3.2.2
- Change Layout button, 4.7.4.1, 4.7.4.2
- Clean (C) validation status, 8.3.3.3.4
- codelists
-
- OCL_DE_CONFIG, 1.3.3, 1.3.6
- RDCI CHANGE REASON TYPE CODE, 1.4.2
- comparison reconciliation, 1.3.7.3
- Confirmed (K) validation status, 8.3.3.3.3
- copying
-
- values in data entry, 2.3.2
- CPE schedule, 3.2.2
- CRF page numbers
-
- and group updating discrepancies, 4.8.8
- CRFs
-
- entering data in a DCI, 1.3
- logging in header information, 1.3.2
D
- Data Collection Instrument (DCI)
-
- locked
-
- in batch data load, 7.5
- Data Collection Instruments. See DCIs
- Data Collection Module (DCM)
-
- expected, 3.2.1, 3.3.2.5
- locked, 9.1.5
-
- in batch data load, 7.5
- missing, 3.2.1, 3.2.1, 3.3, 3.3.2.5
- off-target, 3.3.2.5
- overdue, 3.3, 3.3.2.5
- reported validation status of, 3.3
- scheduling
-
- reported, 3.3
- status of
-
- in reports, 3.3
- tracking, 3.3
-
- via optional visits, 3.2.2
- Data Collection Modules. See DCMs
- data entry
-
- and lists of values, 2.3.2
- making adjustments during, 1.4
- navigating during, 2.2
- reported status of DCMs in, 3.3, 3.3.2.3
- setting values in, 2.3.1
- understanding process, 1.1
- Update mode, 1.3.3, 1.3.6, 2.3.2.1
-
- Privileged, 9.1.1
- validating, 1.3.5
- data entry operator
-
- for both first- and second-pass, 1.3.6
- exceeding Max Repeats expected, 2.3.1.2
- modifying locked RDCIs and RDCMs, 1.3.3, 1.3.6, 9.1.5
- modifying values of repeating Question Groups, 2.3.2
- overriding protected repeating defaults, 2.3.1.2
- Data Extract View
-
- creating, 8.2.4
- file-naming algorithm
- listing, 8.3.5
- Oracle and SAS
- test, 8.2.2
- validation status variables for, 8.3.3.1
- see also Snapshots
- Data Extract View Loader, 8.4
-
- deleting files from, 8.4.5
- error checking, 8.4
- file name syntax for, 8.4.2
- Oracle table examples of, 8.4.2.1
- purpose of, 8.4
- Data File Name, in batch data load, 7.4.2.2
- DCF
-
- and multivariate procedure variables, 5.2.1
- creating, 5.2
- discrepancy query details, 5.5
- tracking pages, 5.6
- DCF COMMENT TEXTS codelist, 4.7.3
- DCF STATUS CODES codelist, 5.1, 5.7, 5.8.2
- DCIs
-
- accessing, 1.3.1
- changing header information for, 1.5.2
- definition, 1.1
- entering CRF data in, 1.3
- modifying, 1.5
- Received. See RDCIs
- structure, 1.2
- DCM Detail Tracking Matrix report, 3.3, 3.3.2
-
- example of, 3.3.2
- uses of, 3.3.2.1
- dcmli, 2
- DCMs
-
- definition, 1.1
- expected, 3.2.2
- logging in, 1.3.2.4
- tracking, 3.1
- discrepancy
-
- grouping, 4.8.6
- history, viewing, 4.7.7
- including status of, in data extract views, 8.3.3.3.5
- management, 4.1
- open, 3.3.2.4
- reported in DCM Detail Tracking matrix, 3.3
- status for distribution, 5.2
- status for resolved status, 5.2
- types, 4.2
- univariate
-
- Update Patient Data, 4.8.2
- DISCREPANCY RESOLU TYPE CODE codelist, 4.7.3
- DISCREPANCY_REVIEW_STATUS codelist, 4.7.3
- document number
-
- in batch data load, 7.5
- in Batch Data Loader, 7.1.2.1
- duplicate records
-
- resolving, 1.3.7.2
- DX_INDEX_TABLESPACE codelist, 8.2.6
- DX_VIEW_TABLESPACE codelist, 8.2.6
- dynamic grouping, 4.7.4
E
- Early Termination, 3.2.3
- enrollment. See patient enrollment
- error messages, in batch data load, 7.5
F
- field
-
- long, in data entry, 2.3.1.3
- first-pass data entry, 1.3.3
- freezing
-
- definition of, 9.1.1
- investigators, 9.1.1
- patients, 9.1.1
- studies, 9.1.1
- see also unfreezing
G
- Get Directory button, 7.4.3
- Get Image, 4.8.2
- group and form validation, 1.3.5.5
- Group Function utility, 4.8.6
I
- I (Irresolvable) validation status, 8.3.3.3.2
- image, get, 4.8.2
- Initial Log-In screen
-
- completing, 1.3.2.1
- Irresolvable (I) validation status, 8.3.3.3.2
K
- K (Confirmed) validation status, 8.3.3.3.3
L
- layout
-
- discrepancy database form, 4.7.4
- List of Values (LOV)
-
- in data entry, 2.3.2
- Load External Views function, 8.4.2
- locking
-
- data, by batch job, 9.1.5.1
- definition of, 9.1.1
M
- manual discrepancies, 4.7.7
- manual status, in data extract, 8.3.3.3.5
- mass changes, 6
- Missing DCMs, 3.1
- missing records
-
- resolving, 1.3.7.2
- multivariate
-
- adding procedure variables to DCF, 5.2.1
- multivariate status, in data extract, 8.3.3.3.5
N
- N (None) validation status, 8.3.3.3.5
- None (N) validation status, 8.3.3.3.5
- Not-received DCM statuses, 3.3.2.5
O
- O (Outstanding) validation status, 8.3.3.3.1
- OCL_STATE codelist, 7.1.1
- offsets
-
- as basis for DCM tracking, 3.2.1
- OPTIONAL DCF STATUS CODES codelist, 5.7
- Out of Study Batch Data Loader
-
- and inserts
-
- purging, 7.4.4, 7.4.4
- Outstanding (O) validation status, 8.3.3.3.1
P
- PASS 1 COMPLETE, 1.3.6, 3.3.2.3
- PASS 1 STARTED, 3.3.2.3
- PASS 2 COMPLETE, 3.3.2.3
- PASS 2 STARTED, 1.3.6, 3.3.2.3
- patient data
-
- transferring, 1.4.2
- patient enrollment, 1.4.1
- patients
-
- assignment of
-
- in batch data load, 7.5
- frozen, 1.3.3, 1.3.6, 9.1.1, 9.1.4.2
-
- in batch data load, 7.5
- updating DCM data for, 3.3.1
- pdr, 10.2
- privileged update, 1.5.3.2
- privileges
-
- and locking and freezing, 9.1.1
- Proc Print report, 8.3.7
- profile
-
- new, 4.6.4
- selecting, 4.6
- Purge Inserts menu option, 7.4.4
- Purge Updates menu option, 7.4.4
Q
- Query Data Extract View module, 8.3.5
- Question Groups
-
- repeating
-
- copying values of, in data entry, 2.3.2
- queue name to submit to SAS, 8.3.1, 8.3.6
R
- RDCIs
-
- auditing, 1.4.5
- definition, 1.3.3
- locked, 1.3.3, 1.3.6
- status of, 1.3.3
- RDCM see Received DCM
- RDCM window, 1.3.3
- RDCMs
-
- auditing, 1.4.5.2
- status of, 1.3.3
- Received DCIs
-
- locking, 9.1.1, 9.1.5
- transfer to, of TBDCIs, 7.2.3
- Received DCMs
-
- locked, 3.3.2.3
-
- in batch data load, 7.2.2
- locking, 9.1.1, 9.1.5
- transfer to, of TBDCMs, 7.2.3
- validating, 3.3.2.4
- validation status, 3.3.2.4
- resolving records
-
- duplicate, 1.3.7.2
- missing, 1.3.7.2
- Response
-
- defining a default value for, 2.3.1.1
- transfer to, of TBDRs, 7.2.3
- review status codes, 4.8.1.2
-
- group updating, 4.8.7
S
- SAS
-
- datasets
-
- creating, 8.3.6
- creating Proc Print reports on, 8.3.7
- directory structure of, 8.2.4
- see also Data Extract View
- schedule intervals, 3.2.2
- Second-Pass comparison failure alert, 1.3.6
- second-pass data entry
-
- procedure for, 1.3.6
- and sight verification, 2.3.1.3
- toggling requirement for, 1.3.6
- security
-
- levels of, for Responses, 9.1.1
- by locking and freezing, 9.1.1
- Select Server Files window, 7.4.3
- sequence number
-
- of Discrete Value, 2.3.2
- sequencing
-
- DCI Book, 1.3.6
- query, 1.3.6
- sight verification, 1.3.6, 1.3.6, 2.3.1.3
- single_procedure, 4.5
- Snapshots, 8.2.2
- Stable data extract views, 8.2.2
- Batch Data Loader
-
- and inserts, 7.4.2.2
-
- pending, 7.2.2
- purging, 7.4.4
- and timestamps, 7.4.2.2
- and updates, 7.4.2.2
-
- pending, 7.2.2
- purging, 7.4.4
- studies
-
- frozen, 9.1.1
- study schedule, 3.2.1
T
- Temporary Batch Data Item (TBDI), 7.2.1
- Temporary Batch DCI (TBDCI), 7.2.2
- Temporary Batch DCM (TBDCM), 7.2.2
- test views, 8.2.2
- tracking DCF pages, 5.6
U
- unfreezing
-
- investigators, 9.1.4
- patients, 9.1.4
- procedures, 9.1.4
- studies, 9.1.4, 9.1.4.2
- univariate status, in data extract, 8.3.3.3.5
- univariate validation
-
- criteria, 1.3.5.1
- failure, 1.3.5.2
- unplanned visits, 1.4.3
- Unreviewed review status, 4.8.1.2
V
- validation procedures
-
- excluded, in frozen studies, 9.1.1
- validation status variables, 8.3.3.1
- views
-
- external see Data Extract View Loader
- visit
-
- algorithm for calculating date of, 3.2.1
- and DCM scheduling, 3.3
- expected. See CPEs
- optional, 3.2.2, 3.2.2
- unplanned. See unplanned visits