.. _3.3.2:

3.3.2 Sample description
==============================

======== ==========
Required Repeatable
======== ==========
Yes      Yes
======== ==========

**Definition:**

.. _step5:

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.

.. _step5:

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:**

.. _step5:

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:**

.. _step5:

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:**

.. _step5:

ANZCTR Step 5 - Eligibility - Can healthy volunteers participate?
~~~~~~~~~~~~~~~~~~~

**Occurrences:** 1

**Input type:** Text from list

**Example input:**

**Controlled vocabulary source:**

* Yes
* No

**Notes:**

.. _step5:

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:**