Version Domain Sequence Variable Label Type Controlled Terminology or Format Role CDISC Notes Core
SDTMIG 3.3 PE 1 STUDYID Study Identifier Char Identifier Unique identifier for a study. Req
SDTMIG 3.3 PE 2 DOMAIN Domain Abbreviation Char PE Identifier Two-character abbreviation for the domain. Req
SDTMIG 3.3 PE 3 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
SDTMIG 3.3 PE 4 PESEQ Sequence Number Num Identifier Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number. Req
SDTMIG 3.3 PE 5 PEGRPID Group ID Char Identifier Used to link together a block of related records in a single domain for a subject. Perm
SDTMIG 3.3 PE 6 PESPID Sponsor-Defined Identifier Char Identifier Sponsor-defined reference number. Perhaps preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF. Perm
SDTMIG 3.3 PE 7 PETESTCD Body System Examined Short Name Char Topic Short name of a part of the body examined in a physical examination. 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" is not valid). PETESTCD cannot contain characters other than letters, numbers, or underscores. Examples: "HEAD", "ENT". If the results of the entire physical examination are represented in one record, value should be "PHYSEXAM". Req
SDTMIG 3.3 PE 8 PETEST Body System Examined Char Synonym Qualifier Long name of a part of the body examined in a physical examination. The value in PETEST cannot be longer than 40 characters. Examples: "Head", "Ear/Nose/Throat". If the results of the entire physical examination are represented in one record, value should be "Physical Examination". Req
SDTMIG 3.3 PE 9 PEMODIFY Modified Reported Term Char Synonym Qualifier If the value of PEORRES is modified for coding purposes, then the modified text is placed here. Perm
SDTMIG 3.3 PE 10 PECAT Category for Examination Char Grouping Qualifier Used to define a category of topic-variable values. Examples: "GENERAL". Perm
SDTMIG 3.3 PE 11 PESCAT Subcategory for Examination Char Grouping Qualifier Used to define a further categorization of --CAT values. Perm
SDTMIG 3.3 PE 12 PEBODSYS Body System or Organ Class Char Record Qualifier Body system or organ class (MedDRA SOC) that is involved for a finding from the standard hierarchy for dictionary-coded results (e.g., MedDRA). Perm
SDTMIG 3.3 PE 13 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
SDTMIG 3.3 PE 14 PEORRESU Original Units Char (UNIT) Variable Qualifier Original units in which the data were collected. The unit for PEORRES. Perm
SDTMIG 3.3 PE 15 PESTRESC Character Result/Finding in Std 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 encoded) should appear here. If PEORRES is null, PESTRESC must be null. Exp
SDTMIG 3.3 PE 16 PESTAT Completion Status Char (ND) Record Qualifier Used to indicate exam not done. Must be null if a result exists in PEORRES/PESTRESC. Perm
SDTMIG 3.3 PE 17 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 PESTAT when value is "NOT DONE". Perm
SDTMIG 3.3 PE 18 PELOC Location of Physical Exam Finding Char (LOC) Record Qualifier Anatomical location of the subject relevant to the collection of the measurement. Example: "ARM" for skin rash. Perm
SDTMIG 3.3 PE 19 PELAT Laterality Char (LAT) Variable Qualifier Qualifier for anatomical location or specimen further detailing laterallity. Examples: "RIGHT", "LEFT", "BILATERAL". Perm
SDTMIG 3.3 PE 20 PEMETHOD Method of Test or Examination Char (METHOD) Record Qualifier Method of the test or examination. Examples: "PALPATION", "PERCUSSION". Perm
SDTMIG 3.3 PE 21 PELOBXFL Last Observation Before Exposure Flag Char (NY) Record Qualifier Operationally-derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null. Perm
SDTMIG 3.3 PE 22 PEBLFL Baseline Flag Char (NY) Record Qualifier A baseline defined by the sponsor (could be derived in the same manner as PELOBXFL or ABLFL, but is not required to be). The value should be "Y" or null. Note that PEBLFL is retained for backward compatibility. The authoritative baseline flag for statistical analysis is in an ADaM dataset. Perm
SDTMIG 3.3 PE 23 PEEVAL Evaluator Char (EVAL) 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). Example: "INVESTIGATOR". Perm
SDTMIG 3.3 PE 24 VISITNUM Visit Number Num Timing 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. Exp
SDTMIG 3.3 PE 25 VISIT Visit Name Char Timing 1. Protocol-defined description of a clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. Perm
SDTMIG 3.3 PE 26 VISITDY Planned Study Day of Visit Num Timing Planned study day of VISIT. Should be an integer. Perm
SDTMIG 3.3 PE 27 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
SDTMIG 3.3 PE 28 EPOCH Epoch Char (EPOCH) Timing Epoch associated with the observation date/time of the physical exam finding. Perm
SDTMIG 3.3 PE 29 PEDTC Date/Time of Examination Char ISO 8601 Timing Date and time of the physical examination represented in ISO 8601 character format. Exp
SDTMIG 3.3 PE 30 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