SDTM.RP

Variable_order	Dataset_name	Variable_name	Variable_label	Type	Codelist	Role	Core	CDISC_notes
1	RP	STUDYID	Study Identifier	Char		Identifier	Req	Unique identifier for a study.
2	RP	DOMAIN	Domain Abbreviation	Char		Identifier	Req	Two-character abbreviation for the domain.
3	RP	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	RP	RPSEQ	Sequence Number	Num		Identifier	Req	Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5	RP	RPGRPID	Group ID	Char		Identifier	Perm	Used to tie together a block of related records in a single domain for a subject.
6	RP	RPREFID	Reference ID	Char		Identifier	Perm	Internal or external Reproductive System Findings record identifier.
7	RP	RPSPID	Sponsor-Defined Identifier	Char		Identifier	Perm	Sponsor-defined identifier. Perhaps pre-printed on the CRF as an explicit line identifier or defined in the sponsor's operational database.
8	RP	RPTESTCD	Repro System Findings Test Short Name	Char	C106479	Topic	Req	Short name of the measurement, test, or examination described in RPTEST. It can be used as a column name when converting a dataset from a vertical to a horizontal format. The value in RPTESTCD cannot be longer than 8 characters, nor can it start with a number (e.g."1TEST"). RPTESTCD cannot contain characters other than letters, numbers, or underscores. Examples: NUMLIV, NUMPREG, BCMETHOD, etc.
9	RP	RPTEST	Reproductive System Findings Test Name	Char	C106478	Synonym Qualifier	Req	Verbatim name of the test or examination used to obtain the measurement or finding. The value in RPTEST cannot be longer than 40 characters. Examples: Number of Live Births, Number of Pregnancies, Birth Control Method, etc.
10	RP	RPCAT	Category for Repro System Findings	Char		Grouping Qualifier	Perm	Used to define a category of related records.
11	RP	RPSCAT	Subcategory for Repro System Findings	Char		Grouping Qualifier	Perm	A further categorization of RP records.
12	RP	RPORRES	Result or Finding in Original Units	Char		Result Qualifier	Exp	Result of the Reproductive System Findings test as originally received or collected.
13	RP	RPORRESU	Original Units	Char	C71620	Variable Qualifier	Exp	Original units in which the data were collected. The unit for RPORRES. Examples: YEARS.
14	RP	RPSTRESC	Character Result/Finding in Std. Format	Char		Result Qualifier	Exp	Contains the result value for all findings, copied or derived from RPORRES in a standard format or standard units. RPSTRESC should store all results or findings in character format; if results are numeric, they should also be stored in numeric format in RPSTRESN. For example, if a test has results "NONE", "NEG", and "NEGATIVE" in RPORRES and these results effectively have the same meaning; they could be represented in standard format in RPSTRESC as "NEGATIVE".
15	RP	RPSTRESN	Numeric Result/Finding in Standard Units	Num		Result Qualifier	Exp	Used for continuous or numeric results or findings in standard format; copied in numeric format from RPSTRESC. RPSTRESN should store all numeric test results or findings.
16	RP	RPSTRESU	Standard Units	Char	C71620	Variable Qualifier	Exp	Standardized unit used for RPSTRESC and RPSTRESN.
17	RP	RPSTAT	Completion Status	Char	C66789	Record Qualifier	Perm	Used to indicate that a Reproductive System Findings test was not done. Should be null if a result exists in RPORRES.
18	RP	RPREASND	Reason Not Performed	Char		Record Qualifier	Perm	Describes why a measurement or test was not performed. Examples: BROKEN EQUIPMENT or SUBJECT REFUSED. Used in conjunction with RPSTAT when value is NOT DONE.
19	RP	RPBLFL	Baseline Flag	Char	C66742	Record Qualifier	Perm	Indicator used to identify a baseline value. The value should be "Y" or null.
20	RP	RPDRVFL	Derived Flag	Char	C66742	Record Qualifier	Perm	Used to indicate a derived record. The value should be Y or null. Records which represent the average of other records or which do not come from the CRF are examples of records that would be derived for the submission datasets. If RPDRVFL=Y, then RPORRES may be null, with RPSTRESC and (if numeric) RPSTRESN having the derived value.
21	RP	VISITNUM	Visit Number	Num		Timing	Perm	1. Clinical encounter number. 2. Numeric version of VISIT, used for sorting.
22	RP	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	RP	VISITDY	Planned Study Day of Visit	Num		Timing	Perm	Planned study day of the visit based upon RFSTDTC in Demographics.
24	RP	RPDTC	Date/Time of Measurements	Char	ISO 8601	Timing	Exp	Date of Reproductive System Finding.
25	RP	RPDY	Study Day of Repro System Findings	Num		Timing	Perm	1. Study day of Reproductive System Findings observation, measured as integer days. 2. Algorithm for calculations must be relative to the sponsor-defined RFSTDTC variable in Demographics.