Index

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

Numbers

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
and inserts, 7.5.1
and privileged transfer, 7.5.1
and updates, 7.5.1
document number in, 7.5.1
error diagnosis in, 7.5.1
error messages in, 7.5.1
load/prepare process, 7.5.1
overwritten error log in, 7.5
prepare process, 7.5.1
transfer process, 7.5.1
Batch Data Loader
and inserts
pending, 7.2.2
purging, 7.4.4
and inserts, 7.4.2.2
and timestamps, 7.4.2.2
and updates
pending, 7.2.2
purging, 7.4.4
and updates, 7.4.2.2
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
as method of freezing and locking, 9.1.2, 9.1.4, 9.1.5.1
as method of unfreezing, 9.1.4
loading external views as, 8.4.1
batch queue
name, 8.3.1, 8.3.8
batch validation
of nonstandard RDCIs, 1.3.3, 1.3.6
Blank flag, 3.3.2.3

C

C (Clean) validation status, 8.3.5.3.4
case report forms. See CRFs
entering data in a DCI, 1.3
logging in header information, 1.3.2
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, 8.3.5.3.4
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, 8.3.5.3.3
copying
values in data entry, 2.3.2
CPE schedule, 3.2.2
CRF page numbers
and group updating discrepancies, 4.8.8

D

Data Collection Instrument (DCI)
locked
in batch data load, 7.5.1
Data Collection Instruments. See DCIs
accessing, 1.3.1
changing header information for, 1.5.2
definition, 1.1
entering CRF data in, 1.3
modifying, 1.5
structure, 1.2
Received. See RDCIs
Data Collection Module (DCM)
expected, 3.2.1, 3.3.2.5
locked, 9.1.5
in batch data load, 7.5.1
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
definition, 1.1
expected, 3.2.2
logging in, 1.3.2.4
tracking, 3.1
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
exceeding Max Repeats expected, 2.3.1.2
for both first- and second-pass, 1.3.6
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, 8.3.7
Oracle and SAS
test, 8.2.2
validation status variables for, 8.3.5.1
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
DCM Detail Tracking Matrix report, 3.3, 3.3.2
example of, 3.3.2
uses of, 3.3.2.1
dcmli, 2
discrepancy
grouping, 4.8.6
history, viewing, 4.7.7
including status of, in data extract views, 8.3.5.3.5
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, 7.5.1
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
error messages, in batch data load, 7.5.1

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, 8.3.5.3.2
image, get, 4.8.2
Initial Log-In screen
completing, 1.3.2.1
Irresolvable (I) validation status, 8.3.5.3.2

K

K (Confirmed) validation status, 8.3.5.3.3

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

See M see Received DCM
manual discrepancies, 4.7.7
manual status, in data extract, 8.3.5.3.5
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, 8.3.5.3.5

N

N (None) validation status, 8.3.5.3.5
None (N) validation status, 8.3.5.3.5
Not-received DCM statuses, 3.3.2.5

O

O (Outstanding) validation status, 8.3.5.3.1
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
and updates
purging, 7.4.4
Outstanding (O) validation status, 8.3.5.3.1

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, 7.5.1
frozen, 1.3.3, 1.3.6, 9.1.1, 9.1.4.2
in batch data load, 7.5.1
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, 8.3.9
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, 8.3.7
Question Groups
repeating
copying values of, in data entry, 2.3.2
queue name to submit to SAS, 8.3.1, 8.3.8

R

RDCIs
auditing, 1.4.5
definition, 1.3.3
locked, 1.3.3, 1.3.6
status of, 1.3.3
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, 8.3.8
creating Proc Print reports on, 8.3.9
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
and sight verification, 2.3.1.3
procedure for, 1.3.6
toggling requirement for, 1.3.6
security
by locking and freezing, 9.1.1
levels of, for Responses, 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
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, 8.3.5.3.5
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, 8.3.5.1
views
See ernal see Data Extract View Loader
visit
algorithm for calculating date of, 3.2.1
and DCM scheduling, 3.3
optional, 3.2.2, 3.2.2
expected. See CPEs
unplanned. See unplanned visits