Who volunteers for clinical trials?
Volunteers for bioequivalence studies are generally healthy adults aged between 18 and 55 years.

Phase I and II clinical trials require healthy volunteers, however, in some cases patients with specific diseases or disorders may also be recruited.

Who conducts the clinical trial?
The study is conducted by Q-Pharm, on behalf of a company sponsoring the research.

Why is the clinical trial being done?
Pharmaceutical products contain an active ingredient (a chemical compound that produces an effect when taken), and a formulation (the additional chemical constituents that are required for stability, or solubility, or even for easier administration of the active ingredient). Bioequivalence studies are designed to determine if a newly formulated drug is equivalent to the drug currently available as the market leader.

Phase I clinical trials are typically first-in-human trials of new agents. They are conducted to assess safety and tolerability of new drug candidates.

Where is the clinical trial being performed?
The clinical trial is performed in Q-Pharm facilities located within the Royal Brisbane and Women's Hospital campus, Brisbane, Australia.

How Many volunteers take part in the clinical trial?
The number of volunteers generally ranges from 10 to 100 plus.

What if I change my mind about volunteering for the clinical trial?
Participation in the clinical trial is voluntary, and you may withdraw at any time.

How do I know if the clinical trial is ethical?
Prior to initiating the clinical trial Q-Pharm receives ethical approval from the Human Research Ethics Committee of the Queensland Institute of Medical Research.

What information am I given prior to commencing a clinical trial?
Q-Pharm will provide you with detailed information on:

• The recruitment process;
• Any pre-clinical trial screening tests required;
• The name, nature and type of drug being studied, and any side effects you may experience;
• Any risks involved as a result of your participating in the clinical trial;
• The length of the clinical trial; and
• The time and nature of confinements to the wards during the clinical trial.

Do I have to be part of the clinical trial?
You are free to choose to take part in a clinical trial, or not. You may withdraw from a clinical trial at any time.

What payment will I receive for participating in this clinical trial?
Payment for participation in studies is calculated from a formula which provides for the reimbursement of time, the number of visits, travel expenses, parking, inconvenience and any minor discomfort. No deductions for any taxes will be made and volunteers are solely responsible for reporting any such payment on their tax return and for the payment of any taxes due for receipt of these payments.

Who collects and views my personal information?
All personal data is collected by Q-Pharm staff, and will be held on file. The medical investigator and Q-Pharm staff record information relating to your health during the clinical trial.

You will be required to provide Photo ID ( Drivers licence, passport or proof of ID card) to verify your identity each time you visit the clinic.    

Your personal information may be viewed by Q-Pharm staff and representatives of:

• The company sponsoring the clinical trial;
• The Human Research Ethics Committee of the Queensland Institute of medical Research; and
• Government regulatory agencies (including the Australian Therapeutic Goods Administration).

However, for the purpose of reporting the results of the clinical trial, as a volunteer you are identified using only a clinical trial identification number, your initials, and sometimes your gender and age.

Q-Pharm undertakes to hold all your personal information in confidence.

Am I able to access the information kept about me?
Q-Pharm keeps all forms where your personal information is recorded and you may ask Q-Pharm staff to show them to you. This information is not forwarded to the company sponsoring the clinical trial. You may contact the sponsor company if you wish to ascertain the information they hold in relation to studies you participate in. Please see also "Privacy Guidelines" document. Q-Pharm will supply the sponsor company name to you, and contact details, as you require.

Q-Pharm is a clinical trials company that collects personal information in order to conduct clinical studies and satisfy requirements of relevant (pharmaceutical) regulators. Q-Pharm is committed to compliance with the Privacy Act 1988, the National Privacy Principles and the NH&MRC National Statement on Ethical Conduct in Research Involving Humans (1999) in the collection, use, storage and disposal of that information. Information is only collected with the consent of subjects. Q-Pharm’s Privacy Policy is available to study subjects and members of the public on request.

Are there any consequences to me of not providing all or part of the information requested?
Participation in a clinical trial is voluntary and you may withdraw at any time. If you do not wish to provide the required personal information, you will not be able to participate in the trial.

Can I tell my friends and family about the clinical trial?
Since this study is being conducted by Q-Pharm on a confidential basis you are requested not to discuss the study more broadly than any consultation you require in deciding whether or not to participate.

What is expected of me when I am on a clinical Trial?
Please refer to our "Code Of Conduct" document

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