SDTM.PE

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	PE	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	PE	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	PE	USUBJID	Unique Subject Identifier	Char		Identifier	Req	Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product.
4	PE	PESEQ	Sequence Number	Num		Identifier	Req	Sequence number to ensure uniqueness of records within a dataset for a subject. May be any valid number.
5	PE	PEGRPID	Group ID	Char		Identifier	Perm	Used to link together a block of related records in a single domain for a subject.
6	PE	PESPID	Sponsor-Defined Identifier	Char		Identifier	Perm	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.
7	PE	PETESTCD	Body System Examined Short Name	Char		Topic	Req	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".
8	PE	PETEST	Body System Examined	Char		Synonym Qualifier	Req	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".
9	PE	PEMODIFY	Modified Reported Term	Char		Synonym Qualifier	Perm	If the value of PEORRES is modified for coding purposes, then the modified text is placed here.
10	PE	PECAT	Category for Examination	Char		Grouping Qualifier	Perm	Used to define a category of topic-variable values. Example: "GENERAL".
11	PE	PESCAT	Subcategory for Examination	Char		Grouping Qualifier	Perm	Used to define a further categorization of --CAT values.
12	PE	PEBODSYS	Body System or Organ Class	Char		Record Qualifier	Perm	Body system or organ class (e.g., MedDRA SOC) that is involved for a finding from the standard hierarchy for dictionary-coded results.
13	PE	PEORRES	Verbatim Examination Finding	Char		Result Qualifier	Exp	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.
14	PE	PEORRESU	Original Units	Char	C71620	Variable Qualifier	Perm	Original units in which the data were collected. The unit for PEORRES.
15	PE	PESTRESC	Character Result/Finding in Std Format	Char		Result Qualifier	Exp	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.
16	PE	PESTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate exam not done. Must be null if a result exists in PEORRES/PESTRESC.
17	PE	PEREASND	Reason Not Examined	Char		Record Qualifier	Perm	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".
18	PE	PELOC	Location of Physical Exam Finding	Char	C74456	Record Qualifier	Perm	Anatomical location of the subject relevant to the collection of the measurement. Example: "ARM" for skin rash.
19	PE	PELAT	Laterality	Char	C99073	Variable Qualifier	Perm	Qualifier for anatomical location or specimen further detailing laterallity. Examples: "RIGHT", "LEFT", "BILATERAL".
20	PE	PEMETHOD	Method of Test or Examination	Char	C85492	Record Qualifier	Perm	Method of the test or examination. Examples: "PALPATION", "PERCUSSION".
21	PE	PELOBXFL	Last Observation Before Exposure Flag	Char	C66742	Record Qualifier	Perm	Operationally derived indicator used to identify the last non-missing value prior to RFXSTDTC. Should be "Y" or null.
22	PE	PEBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	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.
23	PE	PEEVAL	Evaluator	Char	C78735	Record Qualifier	Perm	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".
24	PE	VISITNUM	Visit Number	Num		Timing	Exp	Clinical encounter number. Numeric version of VISIT, used for sorting.
25	PE	VISIT	Visit Name	Char		Timing	Perm	Protocol-defined description of a clinical encounter. May be used in addition to VISITNUM and/or VISITDY.
26	PE	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of VISIT. Should be an integer.
27	PE	TAETORD	Planned Order of Element within Arm	Num		Timing	Perm	Number that gives the planned order of the element within the arm for the element in which the assessment was made.
28	PE	EPOCH	Epoch	Char	C99079	Timing	Perm	Epoch associated with the observation date/time of the physical exam finding.
29	PE	PEDTC	Date/Time of Examination	Char	ISO 8601 datetime or interval	Timing	Exp	Date and time of the physical examination represented in ISO 8601 character format.
30	PE	PEDY	Study Day of Examination	Num		Timing	Perm	Study day of physical exam, measured as integer days. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.