| 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 |
| PESEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| PEGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a
single domain for a subject. |
Perm |
| PESPID |
Sponsor-Defined Identifier |
Char |
Identifier |
Sponsor-defined reference number. Perhaps pre-printed on
the CRF as an explicit line identifier or defined in the sponsor’s
operational database. Example: Line number on a CRF. |
Perm |
| PETESTCD |
Body System Examined Short Name |
Char |
Topic |
Short name of the measurement, test, or examination
described in PETEST. It can be used as a column name when
converting a dataset from a vertical to a horizontal format. The
value in PETESTCD cannot be longer than 8 characters, nor can it
start with a number (e.g.”1TEST”). PETESTCD cannot contain
characters other than letters, numbers, or underscores. |
Req |
| PETEST |
Body System Examined |
Char |
Synonym Qualifier |
Verbatim term part of the body examined. The value in
PETEST cannot be longer than 40 characters. Examples:
Cardiovascular and Respiratory. For subject-level exam, value
should be “Physical Examination”. |
Req |
| PEMODIFY |
Modified Reported Term |
Char |
Synonym Qualifier |
If PEORRES is modified as part of a defined procedure,
then PEMODIFY will contain the modified text. |
Perm |
| PECAT |
Category for Examination |
Char |
Grouping Qualifier |
Used to define a category of examination. Examples:
GENERAL, NEUROLOGICAL. |
Perm |
| PESCAT |
Subcategory for Examination |
Char |
Grouping Qualifier |
A further categorization of the examination. Used if
needed to add further detail to PECAT. |
Perm |
| PEBODSYS |
Body System or Organ Class |
Char |
Result Qualifier |
Body system or organ class ( MedDRA SOC) that is involved
in a measurement from the standard hierarchy (e.g., MedDRA). |
Perm |
| PEORRES |
Verbatim Examination Finding |
Char |
Result Qualifier |
Text description of any abnormal findings. If the
examination was completed and there were no abnormal findings, the
value should be NORMAL. If the examination was not performed on a
particular body system, or at the subject level, then the value
should be null, and NOT DONE should appear in PESTAT. |
Exp |
| PEORRESU |
Original Units |
Char |
Variable Qualifier |
Original units in which the data were collected. The unit
for PEORRES. |
Perm |
| PESTRESC |
Character Result/Finding in Standard Format |
Char |
Result Qualifier |
If there are findings for a body system, then either the
dictionary preferred term (if findings are coded using a
dictionary) or PEORRES (if findings are not coded) should appear
here. If PEORRES is null, PESTRESC should be null |
Exp |
| PESTAT |
Completion Status |
Char |
Record Qualifier |
Used to indicate exam not done. Should be null if a result
exists in PEORRES. |
Perm |
| PEREASND |
Reason Not Examined |
Char |
Record Qualifier |
Describes why an examination was not performed or why a
body system was not examined. Example: SUBJECT REFUSED. Used in
conjunction with STAT when value is NOT DONE. |
Perm |
| PELOC |
Location of Physical Exam Finding |
Char |
Record Qualifier |
Can be used to specify where a physical exam finding
occurred. Example: ARM for skin rash. |
Perm |
| PEMETHOD |
Method of Test or Examination |
Char |
Record Qualifier |
Method of the test or examination. Examples: XRAY, MRI. |
Perm |
| PEEVAL |
Evaluator |
Char |
Record Qualifier |
Role of the person who provided the evaluation. Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain collected or derived data. Examples: INVESTIGATOR, ADJUDICATION COMMITTEE. |
Perm |
| VISITNUM |
Visit Number |
Num |
Timing |
1. Clinical encounter number. 2. Numeric version of VISIT,
used for sorting. |
Exp |
| VISIT |
Visit Name |
Char |
Timing |
1. Protocol-defined description of clinical encounter. 2.
May be used in addition to VISITNUM and/or VISITDY. |
Perm |
| VISITDY |
Planned Study Day of Visit |
Num |
Timing |
Planned study day of the visit based upon RFSTDTC in
Demographics. |
Perm |
| PEDTC |
Date/Time of Examination |
Char |
Timing |
|
Exp |
| PEDY |
Study Day of Examination |
Num |
Timing |
1. Study day of physical exam, measured as integer days.
2. Algorithm for calculations must be relative to the
sponsor-defined RFSTDTC variable in Demographics. |
Perm |