| 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 |
| HOSEQ |
Sequence Number |
Num |
Identifier |
Sequence Number given to ensure uniqueness of subject
records within a domain. May be any valid number. |
Req |
| HOGRPID |
Group ID |
Char |
Identifier |
Used to tie together a block of related records in a
single domain for a subject. |
Perm |
| HOREFID |
Reference ID |
Char |
Identifier |
Internal or external healthcare encounter identifier. |
Perm |
| HOSPID | Sponsor-Defined Identifier | Char | Identifier | Sponsor-defined identifier. It may be pre-printed on the CRF as an explicit line identifier or defined in the sponsor’s operational database. Example: Line number on a Healthcare encounters page. | Perm |
| HOTERM |
Reported Term for the Healthcare Encounter |
Char |
Topic |
Verbatim or preprinted CRF term for the healthcare
encounter. |
Req |
| HODECOD | Dictionary-Derived Term for the Healthcare Encounter | Char | Synonym Qualifier | Dictionary or sponsor-defined derived text description of HOTERM or the modified topic variable (HOMODIFY). | Perm |
| HOCAT |
Category for Healthcare Encounter |
Char |
Grouping Qualifier |
Used to define a category of topic-related values. |
Perm |
| HOSCAT |
Subcategory for Healthcare Encounter |
Char |
Grouping Qualifier |
A further categorization of HOCAT values. |
Perm |
| HOPRESP | Pre-Specified Healthcare Encounter | Char | Record Qualifier | A value of “Y” indicates that this healthcare encounter event was pre-specified on the CRF. Values are null for spontaneously reported events (i.e., those collected as free-text verbatim terms) | Perm |
| HOOCCUR | Healthcare Encounter Occurrence | Char | Record Qualifier | Used when the occurrence of specific healthcare encounters is solicited to indicate whether or not an encounter occurred. Values are null for spontaneously reported events. | Perm |
| HOSTAT |
Completion Status |
Char |
Record Qualifier |
The status indicates that the pre-specified question was
not answered. |
Perm |
| HOREASND | Reason Healthcare Encounter Not Done | Char | Record Qualifier | Describes the reason data for a pre-specified event was not collected. Used in conjunction with HOSTAT when value is NOT DONE. | Perm |
| HODTC |
Date/Time of Event Collection |
Char |
Timing |
Collection date and time of the healthcare encounter. |
Perm |
| HOSTDTC |
Start Date/Time of Healthcare Encounter |
Char |
Timing |
Start date/time of the healthcare encounter (e.g., date of
admission). |
Exp |
| HOENDTC |
End Date/Time of Healthcare Encounter |
Char |
Timing |
End date/time of the healthcare encounter (date of
discharge). |
Perm |
| HODY |
Study Day of Event Collection |
Num |
Timing |
Study day of event collection relative to the
sponsor-defined RFSTDTC. |
Perm |
| HOSTDY |
Study Day of Start of Healthcare Encounter |
Num |
Timing |
Study day of the start of the healthcare encounter
relative to the sponsor-defined RFSTDTC. |
Perm |
| HOENDY |
Study Day of End of Healthcare Encounter |
Num |
Timing |
Study day of the end of the healthcare encounter relative
to the sponsor-defined RFSTDTC. |
Perm |
| HODUR | Duration of Healthcare Encounter | Char | Timing | Collected duration of the healthcare encounter. Used only if collected on the CRF and not derived from the start and end date/times. Example: P1DT2H (for 1 day, 2 hours). | Perm |
| HOSTRTPT | Start Relative to Reference Time Point | Char | Timing | Identifies the start of the observation as being before or after the sponsor-defined reference time point defined by variable --STTPT. | Perm |
| HOSTTPT | 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 |
| HOENRTPT |
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 HOENTPT. |
Perm |
| HOENTPT |
End Reference Time Point |
Char |
Timing |
Description or date/time in ISO 8601 character format of
the reference point referred to by HOENRTPT. Examples:
"2003-12-25" or "VISIT 2". |
Perm |