简谈Define中变量的属性:Origin

2020-07-14  本文已影响0人  野藤_

一、Origin的定义

Origin是Define,XML中数据集变量的一个元数据属性(Metadata Attribute),这个属性用于说明数据的来源。在Define文件中,所有变量的Origin都应该有值。如果一个变量定义了Value Level Metadata (VLM), 那么Origin属性要么在变量层面(Variable Level)定义,要么在值层面(Value Level)定义。

关于Origin的标准属于,在SDTMIG中有详细的介绍(v3.2, 4.1.1.8节),这里简单描述一下:

  • CRF: Data collected on CRF.
  • eDT: Data receied via external data transfer.
  • Derived: Defived data are not directly collected on the CRF but are calculated by an algorithm or reproducible rule, which is dependent upon other data values.
  • Assigned: A value that is determined by individual judgement rather than collected as part of the CRF.
  • Protocol: A value only specified in protocol and not appear on a CRF.

二、Origin的使用规则

具体的使用规则如下:

Rule Origin
Collected on the CRF (CRF上收集) CRF
Collected as a pre-printed value on CRF (作为CRF上预印值 收集) CRF
Mapped from a look-up (从查找表中映射) Assigned
Mapped to complete a record (映射以完成一条记录) Assigned
Mapped from external data sources (从外部数据源映射) eDT
Defined in protocol (方案中定义) Protocol
Derived data (派生出的数据) Derived

三、相关规则说明及举例

1. Data collected on the CRF,Origin = CRF

对于从CRF上具体Form直接收集的变量,其Orgin是CRF。如果CRF上直接收集的变量的长度超过200,从主变量中拆分的子变量的Origin也是CRF

CRF 1.1 CRF 1.2

2. Data collected as a pre-printed value on CRF,Origin = CRF

有一些CRF收集的变量信息已经有预设值了,这些变量的Origin也是CRF。如下图的情况,CRF收集入组前60天受试者酒精饮料的摄入情况,这时候SUEVLINT(Evaluation Interval, 评价区间)的值“-P60D”是提前指定的,变量SUEVLINT的Origin为“CRF”。

CRF 2.1

3. Data mapped from look-up,Origin = Assigned

4. Data mapped to complete a record,Origin = Assigned

5. Data mapped from external data source, Origin = eDT

eDT 1.1

6. Data from Protocol, Origin = Protocol

7. Derived Data, Origin = Derived

Derive的数据不是直接从CRF上收集的,而是通过某种算法或可重复性规则计算得来的。

四、对于Origin,需要具体变量具体分析

1. EPOCH

EPOCH 2

2. VISIT

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