Privacy Notice for Study Screening

About this notice

Innovative Wellness Pty Ltd trading as Clinical Research Australia (we, us or our) conducts screening questionnaires to assess whether people may be eligible to participate in clinical research studies.

This notice explains how we collect, use, store and disclose personal information provided during study screening. It applies to our online screening questionnaires generally. Additional information may be provided for an individual study where necessary.

Information we collect

Depending on the study, we may collect:

• Your name and contact details
• Your age, sex, location, height and weight
• Information about your physical and mental health
• Information about medications, supplements and treatments
• Pregnancy or breastfeeding information
• Information about alcohol, tobacco or other substance use
• Your responses to study-eligibility questions
• Technical information generated when you use the questionnaire, such as your IP address, browser or device information

Health information is sensitive information under Australian privacy law.

Why we collect this information

We collect this information to:

• Assess whether you may meet the eligibility requirements for a study
• Identify matters requiring clarification or safety review
• Contact you about a telephone interview or other screening steps
• Manage recruitment and screening records
• Meet applicable ethical, regulatory, legal and study-management requirements

Completing a screening questionnaire is voluntary. You may stop at any time. However, if you do not provide the requested information, we may be unable to assess your eligibility.

Completing a screening questionnaire does not enrol you in a study or guarantee that you will be eligible. If you progress, you will receive the relevant study information and be asked to provide separate informed consent before participating in the study.

We will not add you to a marketing or general study-notification list unless you provide separate consent.

Who may access your information

Your information may be accessed only where reasonably necessary by:

• Authorised Clinical Research Australia personnel
• The study investigator or an appropriately qualified health professional
• The study sponsor, monitor or auditor, where authorised
• A Human Research Ethics Committee
• Regulatory or government authorities where required
• Service providers that assist us with questionnaire administration, data storage, communications or information technology

These persons and organisations are required to handle information securely and confidentially.

We may also use or disclose information where required or authorised by law, or where necessary to lessen or prevent a serious threat to a person’s life, health or safety.

Online questionnaires and overseas storage

Our online screening questionnaires are administered using Alchemer.

Information submitted through Alchemer is stored and processed using Alchemer’s US-based infrastructure. This means that your screening information may be stored or processed in the United States.

Alchemer acts as a service provider to Clinical Research Australia. We take reasonable steps to ensure that service providers handling screening information maintain appropriate privacy and security protections.

Storage and security

We take reasonable steps to protect personal information against misuse, interference, loss, unauthorised access, modification and disclosure.

Access to screening information is restricted to authorised persons who require it for screening, study administration, oversight or regulatory purposes.

No method of transmitting or storing information electronically is completely secure. You should contact us before completing the questionnaire if you have concerns about submitting your information online.

What happens to your screening information?

If you enrol in a study, relevant screening information may become part of your study record and will be retained in accordance with the study information and consent documents, the approved protocol and applicable requirements.

If you do not enrol, your screening information will be retained, de-identified or destroyed in accordance with the approved study requirements, our record-management procedures and applicable legal, ethical and regulatory obligations.

We may retain limited de-identified information about screening outcomes, such as the screening date, outcome and general reason for ineligibility, for recruitment management, study reporting or audit purposes.

Accessing or correcting your information

You may request access to personal information we hold about you or ask us to correct information that is inaccurate, incomplete or out of date. Some exceptions may apply under Australian law or research-record requirements.

Questions or complaints

If you have questions about this notice, would like to access or correct your information, or wish to make a privacy complaint, please contact:

Email

admin@clinicalresearch.com.au

Telephone

+61 8 9448 7376

We will review and respond to privacy complaints within a reasonable period. If you are not satisfied with our response, you may contact the Office of the Australian Information Commissioner at www.oaic.gov.au.

For further information, please read Clinical Research Australia’s Privacy Policy.