Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT04784208
Eligibility Criteria:
Inclusion Criteria:
* The criteria based on which, subjects in each Arm will be chosen to take part in the survey. Arm 1: Subjects from the general population who are naïve to their hypothyroid status.
* Male and female subjects between the age of 18 years and 65 years
* Willing to sign the Subject Authorization Form (SAF) Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve\*.
* Male and female subjects between the ages 18 years and 65 years.
* Subjects who had symptoms of hypothyroidism, were seen by a physician and diagnosed with hypothyroidism after laboratory testing of TSH \> 4.5 mIU/L within 2 weeks from the date of survey
* Willing to sign the SAF
* Willing to provide their Thyroid Function Test report that was used to diagnose Hypothyroidism. \* Treatment naive diagnosed on basis lab and clinical diagnosis within last 2 weeks
Exclusion Criteria:
* Arm 1: Subjects from the general population who are naïve to their hypothyroid status
* Individuals less than 18 years of age and more than 65 years of age.
* Pregnant or lactating females
* Subjects previously diagnosed with and received treatment for thyroid diseases.
* Subjects not willing to sign the SAF. Arm 2: Subjects who are newly diagnosed patients of Hypothyroidism and are treatment naïve
* Individuals less than 18 years of age and more than 65 years of age.
* Pregnant or lactating females
* Subjects previously diagnosed with and received treatment for thyroid diseases.
* Patients on treatment for Thyroid diseases Subjects not willing to sign the SAF.
The above-mentioned criteria will be applicable to both Face validation and Pilot survey.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04784208
Study Brief:
Protocol Section:
NCT04784208