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

and inserts

pending, 7.2.2

purging, 7.4.4

and updates

pending, 7.2.2

purging, 7.4.4

creating a data file group, 7.4.3

document number in, 7.1.2.1

file format for, 7.1.2

and inserts, 7.4.2.2

load process, 7.2.1

prepare process, 7.2.2

and timestamps, 7.4.2.2

transfer process, 7.2.3, 7.2.3, 7.4.4

updatability of files in, 7.4.2.2, 7.4.2.2

and updates, 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

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

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

and updates

purging, 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

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