| 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 |
| CESEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| CEGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records for a
subject within a domain. |
Perm |
| CEREFID |
Reference ID |
Char |
Identifier |
Internal or external identifier. |
Perm |
| CESPID | 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 page. | Perm |
| CETERM |
Reported Term for the Clinical Event |
Char |
Topic |
Term for the medical condition or event. Most likely
pre-printed on CRF. |
Req |
| CEDECOD | Dictionary-Derived Term | Char | Synonym Qualifier | Controlled terminology for the name of the clinical event. The sponsor is expected to provide the dictionary name and version used to map the terms utilizing the define.xml external codelist attributes | Perm |
| CECAT |
Category for Clinical Event |
Char |
Grouping Qualifier |
Used to define a category of related records. |
Perm |
| CESCAT |
Subcategory for Clinical Event |
Char |
Grouping Qualifier |
A further categorization of the condition or event. |
Perm |
| CEPRESP | Clinical Event Pre-Specified | Char | Variable Qualifier | Used to indicate whether the Event in CETERM was pre-specified. Value is Y for pre-specified events, null for spontaneously reported events. | Perm |
| CEOCCUR | Clinical Event Occurrence | Char | Record Qualifier | Used when the occurrence of specific events is solicited to indicate whether or not a clinical event occurred. Values are null for spontaneously reported events. | Perm |
| CESTAT |
Completion Status |
Char |
Record Qualifier |
The status indicates that a question from a pre-specified
list was not answered. |
Perm |
| CEREASND |
Reason Clinical Event Not Collected |
Char |
Record Qualifier |
Describes the reason clinical event data was not
collected. Used in conjunction with CESTAT when value is NOT DONE.
|
Perm |
| CEBODSYS |
Body System or Organ Class |
Char |
Record Qualifier |
Dictionary-derived. Body system or organ class that is involved in an event or measurement from a standard hierarchy (e.g., MedDRA). When using a multi-axial dictionary such as MedDRA, this should contain the SOC used for the sponsor’s analyses and summary tables which may not necessarily be the primary SOC. |
Perm |
| CESEV |
Severity/Intensity |
Char |
Record Qualifier |
The severity or intensity of the event. Examples: MILD,
MODERATE, SEVERE |
Perm |
| CEDTC |
Date/Time of Event Collection |
Char |
Timing |
|
Perm |
| CESTDTC |
Start Date/Time of Clinical Event |
Char |
Timing |
|
Perm |
| CEENDTC |
End Date/Time of Clinical Event |
Char |
Timing |
|
Perm |
| CEDY | Study Day of Event Collection | Num | Timing | 1. Study day of clinical event collection, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics. This formula should be consistent across the submission. | Perm |
| CESTRF |
Start Relative to Reference Period |
Char |
Timing |
Describes the start of the clinical event relative to the sponsor-defined referenceperiod. The sponsor-defined reference period is a continuous period of time defined by a discrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). |
Perm |
| CEENRF |
End Relative to Reference Period |
Char |
Timing |
Describes the end of the event relative to the sponsor-defined reference period. The sponsor-defined reference period is a continuous period of time defined by adiscrete starting point and a discrete ending point (represented by RFSTDTC and RFENDTC in Demographics). |
Perm |
| CESTRTPT |
Start Relative to Reference Time Point |
Char |
Timing |
Identifies the start of the observation as being before or
after the reference time point defined by variable CESTTPT. |
Perm |
| CESTTPT | Start Reference Time Point | Char | Timing | Description or date/time in ISO 8601 character format of the sponsor-defined reference point referred to by --STRTPT. Examples: "2003-12-15" or "VISIT 1". | Perm |
| CEENRTPT |
End Relative to Reference Time Point |
Char |
Timing |
Identifies the end of the event as being before or after
the reference time point defined by variable CEENTPT. |
Perm |
| CEENTPT |
End Reference Time Point |
Char |
Timing |
Description or date/time in ISO 8601 character format of
the reference point referred to by CEENRTPT. Examples:
"2003-12-25" or "VISIT 2". |
Perm |