Biotrial Pre-Screening Questionnaire

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This questionnaire includes questions about your child's health history and present condition. It will help us determine if you or your child qualify for a screening visit, during which eligibility for the study will be assessed.

The information you provide in this questionnaire is voluntary and confidential per US privacy laws. We will use it to update your or your child’s file in our recruitment database, send visit reminders, and contact you about upcoming studies. You are not required to answer any question you prefer not to.

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Study design: The study will consist of a physical examination and a one-time blood draw of a maximum of 16 mL for child participants and 46 mL for adult participants (exception 2x 46mL for adult participants enrolled for supine and upright cohorts).

Study participation and compensation: All study participants will receive financial compensation of up to $200.00, including a $50 payment for the screening visit and up to $125 for their travel expenses, calculated at the IRS Business mileage rate of $0.67 per mile for the round trip from their home to the Biotrial facility.

For participants aged 18 and older, the compensation will be loaded onto a virtual ClinCard. For participants under 18, the payment will be deposited into the ClinCard account of their legal guardian. The funds will be available within 2 business days after the end of participation.

The parents and legal guardians must bring legal documents to identify themselves as legal guardians of their minor children and sign the Informed Consent Form on behalf of their child.

Screening Visit: The screening visit will include a physical examination and other tests, such as venipuncture, vital signs, blood draw, and medical history. A medical doctor will assess the children's physical development. If the information you give us is accurate, you will be compensated for the screening visit.

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Do you understand and agree to answer all the questions accurately?* This field is required.

YESNO

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Are you answering this questionnaire for yourself or your minor child (less than 18 years)?* This field is required.

Myself

Minor child

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What is your first name and family name (or your minor child's first name and family name)?* This field is required.

First Name

Last Name

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What is your email address (parent's email address for a minor)?* This field is required.

example@example.com

Confirm Email

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What is your phone number (parent's phone number for a minor)?* This field is required.

Please enter a valid phone number.

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What is your zip code?* This field is required.#####

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For a volunteer 5 to 17 years: Can you bring to the screening visit the legal documents to prove you are your minor child’s legal guardian?* This field is required.• Child’s Birth Certificate or certified copy of the child’s birth certificate listing you as a parent. • School or medical records showing the child’s identity and listing you as the child’s parent or legal guardian. • A certified copy of an adoption decree listing you as a parent/legal guardian for an adopted child. • If divorced with a name change: - Documents proving your identity as a parent/legal guardian, such as a guardianship order, divorce decree or custody order, or joint custody agreement. - A letter dated and signed with their ID attached from the other parent or guardian that gives you the authority to consent for your child.

Yes

No

N/A

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For a volunteer 5 to 17 years: Can you bring the original of your child’s Social Security (SS) card at the screening visit?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A

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For a volunteer 18+: Can you bring a valid piece of ID (US passport, Permanent Resident Card, or State ID card with an expiration date) to the screening visit?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A

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If the volunteer is 18+: Can you bring the original of your Social Security (SS) card to the screening visit?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A

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What is your age (or your minor child's age)?* This field is required.

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What is your date of birth (or your minor child's date of birth)?* This field is required.

Date

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For a volunteers 20+ years: What is your weight (in lbs.)?Pregnant women, add your weight before your pregnancy.

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For a volunteer 20+ years: What is your height?Add your height in feet and inches.

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For volunteers 20+ years: Please, calculate your BMI here.

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For a volunteer 20+ years: Is your BMI within the 18.5-29.9 range?

YESNO

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For a legal guardian of a 5-17 child: Do you agree that your child from 5 to 17 years old will have a physical examination with a medical doctor to assess their body development?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A

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For a volunteer 18-21 years: Do you agree to a physical examination with a medical doctor to assess your body development?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A

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Can you (or your minor child) understand, speak, read, and write in English?* This field is required.

YESNO

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What is your language?

Spanish

Other

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Are you (or your minor child) a prisoner or legally institutionalized with rights restrictions?* This field is required.

YESNO

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Do you (or your minor child) agree to comply with the laboratory tests and follow the instructions given by the staff as outlined in the study protocol?* This field is required.

YESNO

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Are you (or your minor child) in good overall health, without acute or chronic illnesses such as diabetes or hypertension, and not on ongoing medication?* This field is required.

YESNO

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Do you have (or your minor child) any known psychiatric condition, such as depression, anxiety, or obsessive-compulsive disorder (OCD)?* This field is required.

YESNO

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Did you (or your minor child) use any prescription medications within 3 months before the study?* This field is required.

YESNO

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Have you (or your minor child) taken over 2000 IU/day of vitamin D supplements (over-the-counter or prescription) for the last 3 months?* This field is required.If the answer is Yes or No, the volunteer still qualifies.

YESNO

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Do you (or your minor child) agree to refrain from using painkillers and non-steroidal anti-inflammatory compounds within 1 week before the study?* This field is required.Such compounds are ibuprofen, naproxen, acetaminophen, aspirin, diclofenac, meloxicam, and any other painkillers. Gastro-oesophageal reflux and heartburn medication are permitted for pregnant women.

YESNO

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Do you (or your minor child) have a history of consumption, abuse, or addiction to drugs, psychotropic substances, or alcohol?* This field is required.

YESNO

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Did you (or your minor child) consume over 2 standard alcoholic drinks (>20g alcohol/day) on any day of the week before the blood draw?* This field is required.

YESNO

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Have you (or your minor child) done intense physical exercise for over 3 hours on any day of the last week before the blood draw?* This field is required.

YESNO

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Do you (or your minor child) have an unusual day/night lifestyle, such as night shift work?* This field is required.

YESNO

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Have you (or your minor child) been diagnosed with a sleep disorder?* This field is required.

YESNO

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Do you (or your minor child) have a history of eating disorders, namely anorexia nervosa and/or bulimia?* This field is required.

YESNO

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Did you (or your minor child) have any trauma, hospitalization, or surgery within the past 6 months?* This field is required.

YESNO

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Did you (or your minor child) have any infection within 3 months?* This field is required.Except for mild infections such as upper respiratory tract infections or mild urinary infections up to 1 month before blood collection.

YESNO

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Are you a male or a female?* This field is required.

I am a female

I am a male

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For females 22+: Are you menopausal, meaning with 12 consecutive months without menses and no other obvious pathological or physiological cause?* This field is required.The study requires healthy non menopausal and menopausal females. N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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For females 22+: Are you pregnant?* This field is required.The study requires healthy non-pregnant and pregnant females. N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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For females 22+:Are you breastfeeding?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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For females 22+: Do you have a regular menstrual cycle length of 28 +/- 7 days?* This field is required.The study requires healthy females at diverse phases of their menstrual cycle. N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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For females 22+: Do you have a history of any fertility disorder?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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For females 22+: Do you have a history of hyperandrogenism (androgen-secreting tumors)?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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For females 22+: Did you have surgery to remove your uterus (hysterectomy), ovary (unilateral oophorectomy), or ovaries (bilateral oophorectomy)?* This field is required.N/A stands for "Not applicable".

Yes

No

N/A, I am not 22+

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ADULTS, CHILDREN, AND LEGAL GUARDIANS MUST REGISTER ON OUR WEBSITE TO BE CONSIDERED FOR THIS CLINICAL TRIAL.

By submitting this form, you consent to Biotrial the right to collect, process, store, and use your personal contact and health information and assess your eligibility for the 1RO127 clinical trial.

After submitting, you will be redirected to sign up and also receive an email with a link to do so.

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