| STUDYID |
Study Identifier |
Char |
Identifier |
Unique identifier for a study. |
Req |
| DOMAIN |
Domain Abbreviation |
Char |
Identifier |
Two-character abbreviation for the domain. |
Req |
| USUBJID |
Unique Subject Identifier |
Char |
Identifier |
Identifier used to uniquely identify a subject across all
studies for all applications or submissions involving the product. |
Req |
| RPSEQ |
Sequence Number |
Num |
Identifier |
Sequence number to ensure uniqueness of records within a
dataset for a subject (or within a parameter, in the case of the
Trial Summary domain). May be any valid number (including decimals)
and does not have to start at 1. |
Req |
| RPGRPID |
Group ID |
Char |
Identifier |
Optional group identifier, used to link together a block of
related records within a subject in a domain. Also used to link
together a block of related records in the Trial Summary dataset. |
Perm |
| RPREFID |
Reference ID |
Char |
Identifier |
Optional internal or external identifier such as lab
specimen ID, or UUID for an ECG waveform or a medical image. |
Perm |
| RPSPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined identifier. Example: pre-printed line
identifier on a case report form. |
Perm |
| RPLNKID |
Link ID |
Char |
Identifier |
Identifier used to link related records across domains. This
may be a one-to-one or a one-to-many relationship. |
Perm |
| RPLNKGRP |
Link Group ID |
Char |
Identifier |
Identifier used to link related records across domains. This
will usually be a many-to-one relationship. |
Perm |
| RPTESTCD |
Short Name of Reproductive Test |
Char |
Topic |
Short character value for RPTEST used as a column name when
converting a dataset from a vertical format to a horizontal format.
The short value can be up to 8 characters. Examples: "CHILDPOT",
"BCMETHOD", "MENARAGE". |
Req |
| RPTEST |
Name of Reproductive Test |
Char |
Synonym Qualifier |
Long name For RPTESTCD. Examples: "Childbearing Potential",
"Birth Control Method", "Menarche Age". |
Req |
| RPCAT |
Category for Reproductive Test |
Char |
Grouping Qualifier |
Used to define a category of topic-variable values.
Examples: "No use case to date, but values would be relative to
reproduction tests grouping". |
Perm |
| RPSCAT |
Subcategory for Reproductive Test |
Char |
Grouping Qualifier |
Used to define a further categorization of RPCAT values.
Example: "No use case to date, but values would be relative to
reproduction tests grouping". |
Perm |
| RPORRES |
Result or Finding in Original Units |
Char |
Result Qualifier |
Result of the measurement or finding as originally received
or collected. Examples: "120", "<1", "POS". |
Exp |
| RPORRESU |
Original Units |
Char |
Variable Qualifier |
Unit for RPORRES. Examples: "in", "LB", "kg/L". |
Perm |
| RPSTRESC |
Character Result/Finding in Std Format |
Char |
Result Qualifier |
Contains the result value for all findings, copied or
derived from RPORRES in a standard format or in standard units.
RPSTRESC should store all results or findings in character format;
if results are numeric, they should also be stored |
Exp |
| |
|
|
|
in numeric format in RPSTRESN. For example, if various tests
have results "NONE", "NEG", and "NEGATIVE" in RPORRES, and these
results effectively have the same meaning, they could be represented
in standard format in RPSTRESC as "NEGATIVE". |
|
| RPSTRESN |
Numeric Result/Finding in Standard Units |
Num |
Result Qualifier |
Used for continuous or numeric results or findings in
standard format; copied in numeric format from RPSTRESC. RPSTRESN
should store all numeric test results or findings. |
Perm |
| RPSTRESU |
Standard Units |
Char |
Variable Qualifier |
Standardized units used for RPSTRESC and RPSTRESN. Example:
"mol/L". |
Perm |
| RPSTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate that a question was not asked or a test was
not done, or a test was attempted but did not generate a result.
Should be null or have a value of "NOT DONE". |
Perm |
| RPREASND |
Reason Not Done |
Char |
Record Qualifier |
Reason not done. Used in conjunction with RPSTAT when value
is "NOT DONE". |
Perm |
| RPLOBXFL |
Last Observation Before Exposure Flag |
Char |
Record Qualifier |
Operationally-derived indicator used to identify the last
non-missing value prior to RFXSTDTC. The value should be "Y" or
null. |
Perm |
| RPBLFL |
Baseline Flag |
Char |
Record Qualifier |
Indicator used to identify a baseline value. Should be "Y"
or null. Note that RPBLFL is retained for backward compatibility.
The authoritative baseline for statistical analysis is in an ADaM
dataset. |
Perm |
| RPDRVFL |
Derived Flag |
Char |
Record Qualifier |
Used to indicate a derived record. The value should be "Y"
or null. Records which represent the average of other records or
which do not come from the CRF are examples of records that would be
derived for the submission datasets. If RPDRVFL = "Y", then RPORRES
may be null, with RPSTRESC and (if numeric) RPSTRESN having the
derived value. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
Clinical encounter number. Numeric version of VISIT, used
for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
Protocol-defined description of a clinical encounter. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of VISIT. Should be an integer. |
Perm |
| TAETORD |
Planned Order of Element within Arm |
Num |
Timing |
Number that gives the planned order of the Element within
the Arm for the Element in which the assessment was made. |
Perm |
| EPOCH |
Epoch |
Char |
Timing |
Epoch associated with the date/time at which the assessment
was made. |
Perm |
| RPDTC |
Date/Time of Collection |
Char |
Timing |
Collection date and time of an observation. |
Exp |
| RPDY |
Study Day of Visit/Collection/Exam |
Num |
Timing |
Actual study day of visit/collection/exam expressed in
integer days relative to the sponsor-defined RFSTDTC in
Demographics. |
Perm |
| RPDUR |
Duration |
Char |
Timing |
Collected duration of an event, intervention, or finding
represented in ISO 8601 character format. Used only if collected on
the CRF and not derived. |
Perm |
| RPTPT |
Planned Time Point Name |
Char |
Timing |
Text description of time when a measurement or observation
should be taken as defined in the protocol. This may be represented
as an elapsed time relative to a fixed reference point, such as time
of last dose. |
Perm |
| RPTPTNUM |
Planned Time Point Number |
Num |
Timing |
Numeric version of planned time point used in sorting. |
Perm |
| RPELTM |
Planned Elapsed Time from Time Point Ref |
Char |
Timing |
Planned elapsed time in ISO 8601 character format relative
to a planned fixed reference (RPTPTREF) such as "Previous Dose" or |
Perm |
| |
|
|
|
Previous Meal. This variable is useful where there are
repetitive measures. Not a clock time or a date/time variable, but
an interval, represented as ISO duration. |
|
| RPTPTREF |
Time Point Reference |
Char |
Timing |
Description of the fixed reference point referred to by
RPELTM, RPTPTNUM, and RPTPT. Examples: "PREVIOUS DOSE", "PREVIOUS
MEAL". |
Perm |
| RPRFTDTC |
Date/Time of Reference Time Point |
Char |
Timing |
Date/time for a fixed reference time point defined by
RPTPTREF in ISO 8601 character format. |
Perm |