Final call before we close subscription!
Subscription to input data and programs (including SAS and R) for all the lessons is now offered at 7,500 INR for a few days.
Click here for more details.
Variable_order Dataset_name Variable_name Variable_label Type Codelist Role Core CDISC_notes
1 DV STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 DV DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 DV 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 DV DVSEQ Sequence Number Num Identifier Req Sequence number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 DV DVREFID Reference ID Char Identifier Perm Internal or external identifier.
6 DV DVSPID Sponsor-Defined Identifier Char Identifier Perm Sponsor-defined reference number. May be preprinted on the CRF as an explicit line identifier or defined in the sponsor's operational database. Example: Line number on a CRF page.
7 DV DVTERM Protocol Deviation Term Char Topic Req Verbatim name of the protocol deviation criterion. Example: "IVRS PROCESS DEVIATION - NO DOSE CALL PERFORMED". DVTERM values will map to the controlled terminology in DVDECOD (e.g., "TREATMENT DEVIATION").
8 DV DVDECOD Protocol Deviation Coded Term Char Synonym Qualifier Perm Controlled terminology for the name of the protocol deviation. Examples: "SUBJECT NOT WITHDRAWN AS PER PROTOCOL", "SELECTION CRITERIA NOT MET", "EXCLUDED CONCOMITANT MEDICATION", "TREATMENT DEVIATION".
9 DV DVCAT Category for Protocol Deviation Char Grouping Qualifier Perm Category of the protocol deviation criterion.
10 DV DVSCAT Subcategory for Protocol Deviation Char Grouping Qualifier Perm A further categorization of the protocol deviation.
11 DV TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the element within the arm.
12 DV EPOCH Epoch Char C99079 Timing Perm Epoch associated with the start date/time of the deviation. Examples: "TREATMENT", "SCREENING", "FOLLOW-UP".
13 DV DVSTDTC Start Date/Time of Deviation Char ISO 8601 datetime or interval Timing Perm Start date/time of deviation represented in ISO 8601 character format.
14 DV DVENDTC End Date/Time of Deviation Char ISO 8601 datetime or interval Timing Perm End date/time of deviation represented in ISO 8601 character format.
15 DV DVSTDY Study Day of Start of Deviation Event Num Timing Perm Study day of start of event relative to the sponsor-defined RFSTDTC.
16 DV DVENDY Study Day of End of Deviation Event Num Timing Perm Study day of end of event relative to the sponsor-defined RFSTDTC.