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3.3.2-sample-description.rst

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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: