Exposure as Collected

In the SDTMIG, the Exposure (EX) domain is used to represent exposure to study treatment as described in the protocol. The CDASHIG EC domain is used to represent data as collected on the CRF, and is used in a study when the SDTMIG EX domain cannot be directly populated with the data collected on the CRF.

CDASHIG EC is used when:

  1. An alias for the actual treatment name is used (e.g., the study is masked) rather than the actual treatment name (e.g., the study is open label).
  2. Exposure data are collected in non-protocol-specified units (e.g., tablets).
  3. Scheduled and/or missed doses are collected.
  4. Planned doses (e.g., a calculation based on body weight) are collected in addition to actual doses given.

A sponsor may choose to always collect exposure data using the CDASHIG EC domain.

Extensive discussion of the use of the EC and EX domains, including examples of data collection, is available in the SDTMIG. 

Commonly collected variables and codes have been included; however, this CRF would require customization to meet the needs of each protocol specified study treatment. Codelists may be updated to add or remove additional values from controlled terminology. Additionally, some variables such as Units or Route of Administration may be preprinted on the CRF, if only one option applies. Start/End Time was not included but may be added based on the data collection scenario.

Form EC - Exposure as Collected
EC - Exposure as Collected
What is the[study treatment/dose] label identifier?
* What was the ([intended/planned/actual]) ([study treatment/dose]) (start) date?
 01 Jan 2000
What was the ([intended/planned/actual]) ([study treatment/dose]) (end) date?
 01 Jan 2000
What was the dose (per administration) (of [study treatment/dose])?
What were the units for the dose?
What was the frequency of [study treatment/dose] dosing?
What was the route of administration (of the [study treatment/dose])?
Was the dose adjusted? No  Yes  
What was the reason the dose was adjusted?
Was the study treatment interrupted? No  Yes  
What was the duration of the treatment interruption?
What was the interruption duration unit? Minutes  Hours  Days  
Did the subject complete the full course of study treatment? No  Yes  
* Mandatory field

EC eCRF Package