What is the Clinical trial?
Any investigation in human subjects intended to discover or verify the safety and efficacy of the product.
Are you eligible to participate?
Anybody can participate in the clinical trial. Each clinical trial defines who is eligible to take part in the study. If you are eligible your Physician will approach and explain further on the clinical trial schedule.
All of the records and data from your participation will be kept confidential. The results of your participation in this study may be used for publication or for scientific purposes, but neither your name nor your identity will be disclosed unless you give separate specific consent to this, or unless required by law. The research records for this study may be reviewed by some agencies.
What are the risks and benefit ?
There are both benefits and risks associated with clinical trials. By participating in a clinical trial, you may benefit by:
- gaining access to new treatments that are not yet available to the public
- obtaining expert medical care at a leading health care facility
- playing an active role in your own health care
- helping others by contributing to medical research
- there may be unpleasant, serious side effects from treatment
- treatment may not be effective for some individuals
- the study may require a lot of time for traveling to the study site, receiving treatments, or hospital stays
Reimbursed based on the subjects’ anticipated expenses incurred during participation in a study (e.g., parking, meals, travel).
There is no direct compensation if you are participate in the study, however if you experienced any side effect or serious side effect direct from the investigational product which need further treatment there is insurance coverage secured by the sponsor provided you are comply with the instruction given.
Your participation is strictly voluntary. Refusal to participate will not involve any penalty, loss of benefits, or reduction in the quality of medical care.
You are free to withdraw at any time for any reason, this will not affect in any way the quality of health care you will receive.
If you desire or want any further information regarding your rights as a research patient, you may contact Institut Jantung Negara Ethics Committee (IJNEC) at 03 2617 8266/8264
If you desire or want any further information on clinical trial, you may contact the physician who has enrol you in the study at 03 2617 8200.