Frequently Asked Questions
What is a clinical study?
A clinical study is a carefully designed investigation to find treatment of a material or method on a disease state conducted according to a formal study plan.
Why should I volunteer?
Volunteering in a clinical study is an important decision to better understand diseases, improved treatment methods and provide alternative therapies for patients.
How long will the study last?
Each study has different requirements. Some studies are a single visit while others can involve more visits lasting over several weeks.
What are the possible benefits?
Benefits to you as a participant include expert medical care for the condition being studied, opportunities to try medications to help your disease and help others by contributing to medical research and treatment advances. Compensation is often provided to those who qualify.
What is Informed Consent?
Informed Consent is a document used to record a subject's willingness to participate in a clinical trial. The subject or legal representative signs and dates the form after receiving an in-depth explanation about the risks, responsibilities, and possible benefits associated with the research study.
How much does it cost?
Costs that are covered can vary by study. In most clinical studies, qualified participants will receive study medication, testing and education at no charge.
What if I want to stop the study?
Your participation is voluntary and you may choose not to participate at any time. Refusal to participate will involve no penalty or loss of benefits to which you would otherwise be entitled.
How is my medical information protected?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) went into effect in April 2003. This federal regulation was passed to protect the privacy of an individual’s medical information. Certified Clinical Research shares the same concerns regarding your medical information and is in complete compliance with this act.
Who looks out for my interests?
Safety is the number one concern for human volunteers in clinical trials. As such, there are strict federal regulations (FDA) and international guidelines in place to assure this. Each research site is also overseen by an Institutional Review Board (IRB) to ensure that the study is being conducted according to the protocol and that the safety and rights of the volunteer are being protected. In addition, throughout the trial, the sponsor pharmaceutical company assigns a representative to monitor the study at each trial site. If at any point during the study the investigation medication proves to be unsafe or ineffective the study may be terminated.
Who do I call with questions?
We have only addressed a few of the many questions you might have about clinical research, but it is of paramount importance to mediSpect that you are knowledgeable and completely comfortable about your decision to participate in a drug study. We welcome any additional questions you may have to help you decide if participating in a clinical trial is right for you. Please feel free to contact us by e-mail (research@medispect.net) or by telephone (828)264-7760 with any questions you may have.
A clinical study is a carefully designed investigation to find treatment of a material or method on a disease state conducted according to a formal study plan.
Why should I volunteer?
Volunteering in a clinical study is an important decision to better understand diseases, improved treatment methods and provide alternative therapies for patients.
How long will the study last?
Each study has different requirements. Some studies are a single visit while others can involve more visits lasting over several weeks.
What are the possible benefits?
Benefits to you as a participant include expert medical care for the condition being studied, opportunities to try medications to help your disease and help others by contributing to medical research and treatment advances. Compensation is often provided to those who qualify.
What is Informed Consent?
Informed Consent is a document used to record a subject's willingness to participate in a clinical trial. The subject or legal representative signs and dates the form after receiving an in-depth explanation about the risks, responsibilities, and possible benefits associated with the research study.
How much does it cost?
Costs that are covered can vary by study. In most clinical studies, qualified participants will receive study medication, testing and education at no charge.
What if I want to stop the study?
Your participation is voluntary and you may choose not to participate at any time. Refusal to participate will involve no penalty or loss of benefits to which you would otherwise be entitled.
How is my medical information protected?
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) went into effect in April 2003. This federal regulation was passed to protect the privacy of an individual’s medical information. Certified Clinical Research shares the same concerns regarding your medical information and is in complete compliance with this act.
Who looks out for my interests?
Safety is the number one concern for human volunteers in clinical trials. As such, there are strict federal regulations (FDA) and international guidelines in place to assure this. Each research site is also overseen by an Institutional Review Board (IRB) to ensure that the study is being conducted according to the protocol and that the safety and rights of the volunteer are being protected. In addition, throughout the trial, the sponsor pharmaceutical company assigns a representative to monitor the study at each trial site. If at any point during the study the investigation medication proves to be unsafe or ineffective the study may be terminated.
Who do I call with questions?
We have only addressed a few of the many questions you might have about clinical research, but it is of paramount importance to mediSpect that you are knowledgeable and completely comfortable about your decision to participate in a drug study. We welcome any additional questions you may have to help you decide if participating in a clinical trial is right for you. Please feel free to contact us by e-mail (research@medispect.net) or by telephone (828)264-7760 with any questions you may have.
