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 EC STUDYID Study Identifier Char Identifier Req Unique identifier for a study.
2 EC DOMAIN Domain Abbreviation Char Identifier Req Two-character abbreviation for the domain.
3 EC 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 EC ECSEQ Sequence Number Num Identifier Req Sequence Number given to ensure uniqueness of subject records within a domain. May be any valid number.
5 EC ECGRPID Group ID Char Identifier Perm Used to tie together a block of related records in a single domain for a subject.
6 EC ECREFID Reference ID Char Identifier Perm Internal or external identifier (e.g., kit number, bottle label, vial identifier).
7 EC ECSPID 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 Page.
8 EC ECLNKID Link ID Char Identifier Perm Identifier used to link related records across domains.
9 EC ECLNKGRP Link Group ID Char Identifier Perm Identifier used to link related, grouped records across domains.
10 EC ECTRT Name of Treatment Char Topic Req Name of the intervention treatment known to the subject and/or administrator.
11 EC ECMOOD Mood Char C125923 Record Qualifier Perm Mode or condition of the record specifying whether the intervention (activity) is intended to happen or has happened. Values align with BRIDG pillars (e.g., scheduled context, performed context) and HL7 activity moods (e.g., intent, event). Examples: "SCHEDULED", "PERFORMED".
12 EC ECCAT Category of Treatment Char Grouping Qualifier Perm Used to define a category of related ECTRT values.
13 EC ECSCAT Subcategory of Treatment Char Grouping Qualifier Perm A further categorization of ECCAT values.
14 EC ECPRESP Pre-Specified Char C66742 Variable Qualifier Perm Used when a specific intervention is pre-specified. Values should be "Y" or null.
15 EC ECOCCUR Occurrence Char C66742 Record Qualifier Perm Used to indicate whether a treatment occurred when information about the occurrence is solicited. ECOCCUR = "N" when a treatment was not taken, not given, or missed.
16 EC ECDOSE Dose Num Record Qualifier Exp Amount of ECTRT when numeric. Not populated when ECDOSTXT is populated.
17 EC ECDOSTXT Dose Description Char Record Qualifier Perm Amount of ECTRT when non-numeric. Dosing amounts or a range of dosing information collected in text form. Example: "200-400". Not populated when ECDOSE is populated.
18 EC ECDOSU Dose Units Char C71620 Variable Qualifier Exp Units for ECDOSE, ECDOSTOT, or ECDOSTXT.
19 EC ECDOSFRM Dose Form Char C66726 Variable Qualifier Exp Dose form for ECTRT. Examples: "TABLET", "LOTION".
20 EC ECDOSFRQ Dosing Frequency per Interval Char C71113 Variable Qualifier Perm Usually expressed as the number of repeated administrations of ECDOSE within a specific time period. Examples: "Q2H", "QD", "BID".
21 EC ECDOSTOT Total Daily Dose Num Record Qualifier Perm Total daily dose of ECTRT using the units in ECDOSU. Used when dosing is collected as Total Daily Dose.
22 EC ECDOSRGM Intended Dose Regimen Char Variable Qualifier Perm Text description of the intended schedule or regimen for the Intervention. Example: "TWO WEEKS ON", "TWO WEEKS OFF".
23 EC ECROUTE Route of Administration Char C66729 Variable Qualifier Perm Route of administration for the intervention. Examples: "ORAL", "INTRAVENOUS".
24 EC ECLOT Lot Number Char Record Qualifier Perm Lot Number of the ECTRT product.
25 EC ECLOC Location of Dose Administration Char C74456 Record Qualifier Perm Specifies location of administration. Example: "ARM", "LIP".
26 EC ECLAT Laterality Char C99073 Variable Qualifier Perm Qualifier for anatomical location further detailing laterality of the intervention administration. Examples: "LEFT", "RIGHT".
27 EC ECDIR Directionality Char C99074 Variable Qualifier Perm Qualifier for anatomical location further detailing directionality. Examples: "ANTERIOR", "LOWER", "PROXIMAL", "UPPER".
28 EC ECPORTOT Portion or Totality Char C99075 Variable Qualifier Perm Qualifier for anatomical location further detailing distribution, which means arrangement of, apportioning of. Examples: "ENTIRE", "SINGLE", "SEGMENT".
29 EC ECFAST Fasting Status Char C66742 Record Qualifier Perm Indicator used to identify fasting status. Examples: "Y", "N".
30 EC ECPSTRG Pharmaceutical Strength Num Record Qualifier Perm Amount of an active ingredient expressed quantitatively per dosage unit, per unit of volume, or per unit of weight, according to the pharmaceutical dose form.
31 EC ECPSTRGU Pharmaceutical Strength Units Char Variable Qualifier Perm Unit for ECPSTRG. Examples: "mg/TABLET", "mg/mL".
32 EC ECADJ Reason for Dose Adjustment Char Record Qualifier Perm Describes reason or explanation of why a dose is adjusted.
33 EC TAETORD Planned Order of Element within Arm Num Timing Perm Number that gives the planned order of the Element within the Arm.
34 EC EPOCH Epoch Char C99079 Timing Perm Trial Epoch of the exposure as collected record. Examples: "RUN-IN", "TREATMENT".
35 EC ECSTDTC Start Date/Time of Treatment Char ISO 8601 Timing Exp The date/time when administration of the treatment indicated by ECTRT and ECDOSE began.
36 EC ECENDTC End Date/Time of Treatment Char ISO 8601 Timing Exp The date/time when administration of the treatment indicated by ECTRT and ECDOSE ended. For administrations considered given at a point in time (e.g., oral tablet, pre-filled syringe injection), where only an administration date/time is collected, ECSTDTC should be copied to ECENDTC as the standard representation.
37 EC ECSTDY Study Day of Start of Treatment Num Timing Perm Study day of ECSTDTC relative to the sponsor-defined DM.RFSTDTC.
38 EC ECENDY Study Day of End of Treatment Num Timing Perm Study day of ECENDTC relative to the sponsor-defined DM.RFSTDTC.
39 EC ECDUR Duration of Treatment Char ISO 8601 Timing Perm Collected duration of administration. Used only if collected on the CRF and not derived from start and end date/times.
40 EC ECTPT Planned Time Point Name Char Timing Perm Text Description of time when administration should occur. This may be represented as an elapsed time relative to a fixed reference point, such as time of last dose. See ECTPTNUM and ECTPTREF.
41 EC ECTPTNUM Planned Time Point Number Num Timing Perm Numerical version of ECTPT to aid in sorting.
42 EC ECELTM Planned Elapsed Time from Time Point Ref Char ISO 8601 Timing Perm Planned elapsed time relative to the planned fixed reference (ECTPTREF). This variable is useful where there are repetitive measures. Not a clock time.
43 EC ECTPTREF Time Point Reference Char Timing Perm Name of the fixed reference point referred to by ECELTM, ECTPTNUM, and ECTPT. Examples: PREVIOUS DOSE, PREVIOUS MEAL.
44 EC ECRFTDTC Date/Time of Reference Time Point Char ISO 8601 Timing Perm Date/time for a fixed reference time point defined by ECTPTREF.