3.3.2 Sample description
Required |
Repeatable |
---|---|
Yes |
Yes |
Definition:
ANZCTR Step 5 - Eligibility - Key inclusion criteria
Occurrences: 1
Input type: Text
Example input:
Minimum Age : 12 years Maximum Age: 25 years Sex: F
Minimum Age : 0 years Maximum Age: 3 years Sex: M
Controlled vocabulary source: Nil
Notes:
Please note that the ANZCTR metadata describes the sample for the whole trial; individual datasets produced by the trial may be derived from subsets of the whole sample.
The sample description for individual datasets should appear in 3.2 Dataset description.
ANZCTR Step 5 - Eligibility - Minimum age
Occurrences: 1
Input type: Number and option from provided list
Example input:
Controlled vocabulary source:
Years
Months
Weeks
Days
Hours
Notes:
ANZCTR Step 5 - Eligibility - Maximum age
Occurrences: 1
Input type: Number and option from provided list
Example input:
Controlled vocabulary source:
Years
Months
Weeks
Days
Hours
Notes:
ANZCTR Step 5 - Eligibility - Gender
Occurrences: 1-3
Input type: Text from list
Example input:
Males
Females
Both males and females
Controlled vocabulary source:
Males
Females
Both males and females
Notes:
ANZCTR Step 5 - Eligibility - Can healthy volunteers participate?
Occurrences: 1
Input type: Text from list
Example input:
Controlled vocabulary source:
Yes
No
Notes:
ANZCTR Step 5 - Eligibility - Key exclusion criteria
Occurrences: 1
Input type: Text
Example input:
Diagnosis of sleep apnea or any other chronic respiratory disease
Any acute or chronic condition that would limit the ability of the patient to participate in the study
Refusal to give informed consent
Controlled vocabulary source: Nil
Notes: