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. Q-Pharm will supply the sponsor company name to you, and contact details, as you require.
The study is conducted by Q-Pharm on behalf of the organisation that is sponsoring the research. These may be commercial sponsors, contract research organisations, or research institutes/universities/hospitals.
Pharmaceutical and Biotechnology products contain an active ingredient (a chemical or biological compound that produces an effect when taken), and a formulation (the additional constituents that are required for stability, or solubility, or even for easier administration of the active ingredient).
Phase 1 clinical trials are typically first-in-human trials of new agents. They are conducted to assess safety and tolerability of new drug candidates.
Bioequivalence studies are designed to determine if a generic drug is equivalent to the drug currently available and marketed.
The clinical trial is performed in Q-Pharm facilities located within the Royal Brisbane and Women's Hospital campus in Brisbane, Australia.
The number of volunteers generally ranges from 10 to 100 per trial.
Participation in the clinical trial is entirely voluntary and you may withdraw at any time.
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 anticipated side effects you may experience
- Potential risks involved as a result of your participating in the clinical trial
- The length of the clinical trial
- The time and nature of confinements during the clinical trial.
Payment for participation in studies is calculated from a formula that 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.
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 or its delegate;
- Members of The Human Research Ethics Committee that reviews and approves the study; 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.
Phase 1 and 2 clinical trials require healthy adult volunteers, however, in some cases patients with specific diseases or disorders may also be recruited.
Volunteers for bioequivalence studies are generally healthy adults aged between 18 and 55 years.
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.