| 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 given to ensure uniqueness of subject records within a domain. May be any valid number. |
| 5 | PE | PEGRPID | Group ID | Char | | Identifier | Perm | Used to tie 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 pre-printed 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 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. |
| 8 | PE | PETEST | Body System Examined | Char | | Synonym Qualifier | Req | 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". |
| 9 | PE | PEMODIFY | Modified Reported Term | Char | | Synonym Qualifier | Perm | If PEORRES is modified as part of a defined procedure, then PEMODIFY will contain the modified text. |
| 10 | PE | PECAT | Category for Examination | Char | | Grouping Qualifier | Perm | Used to define a category of examination. Examples: GENERAL, NEUROLOGICAL. |
| 11 | PE | PESCAT | Subcategory for Examination | Char | | Grouping Qualifier | Perm | A further categorization of the examination. Used if needed to add further detail to PECAT. |
| 12 | PE | PEBODSYS | Body System or Organ Class | Char | | Result Qualifier | Perm | Body system or organ class ( MedDRA SOC) that is involved in a measurement from the standard hierarchy (e.g., MedDRA). |
| 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 Standard 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 coded) should appear here. If PEORRES is null, PESTRESC should be null |
| 16 | PE | PESTAT | Completion Status | Char | C66789 | Record Qualifier | Perm | Used to indicate exam not done. Should be null if a result exists in PEORRES. |
| 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 STAT when value is NOT DONE. |
| 18 | PE | PELOC | Location of Physical Exam Finding | Char | C74456 | Record Qualifier | Perm | Can be used to specify where a physical exam finding occurred. Example: ARM for skin rash. |
| 19 | PE | PEMETHOD | Method of Test or Examination | Char | C85492 | Record Qualifier | Perm | Method of the test or examination. Examples: XRAY, MRI. |
| 20 | 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). Should be null for records that contain collected or derived data. Examples: INVESTIGATOR, ADJUDICATION COMMITTEE. |
| 21 | PE | VISITNUM | Visit Number | Num | | Timing | Exp | 1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting. |
| 22 | PE | VISIT | Visit Name | Char | | Timing | Perm | 1. Protocol-defined description of clinical encounter. 2. May be used in addition to VISITNUM and/or VISITDY. |
| 23 | PE | VISITDY | Planned Study Day of Visit | Num | | Timing | Perm | Planned study day of the visit based upon RFSTDTC in Demographics. |
| 24 | PE | PEDTC | Date/Time of Examination | Char | ISO 8601 | Timing | Exp | |
| 25 | PE | PEDY | Study Day of Examination | Num | | Timing | Perm | 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. |