Why India?   Clinical Research Industry      Europe      Asia      Latin America      United States   Clinical Trials   Clinical Data Management   Central Reference Lab     CLINICAL TRIALS   01) What is a clinical trials?   A clinical trial is a research study in human volunteers to answer specific health questions. Observational trials address health issues in large groups of people/populations in natural settings.   02. Why participate in a clinical trial?   Participants in clinical trials can play a more active role in their own healthcare, gain access to new research treatments before they are widely available, and help others by contributing to medical research.   03. What happens during clinical trials?   The clinical trial process depends on the kind of trial being conducted. The team involving doctors and nurses as well as social workers and other healthcare professionals check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.   04. Who can participate in clinical trials?   The participation should be voluntary with no bias or force. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". Before joining a clinical trial , a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, whle others need healthy participants.   05. What is an informed consent?   Informed consent is the process of learning the key facts about a clinical trial before you decidewhether or not to participate. The research staff will give you informed consent documents that include the details about the study. If English is not your native language, you can ask for the consent documents in languages other than English. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision. It is a process that continues through the study. You should feel free to ask the research team questions before, during, and after the study.   06. How is the safety of the participant protected?   We have an Institutional Ethics Committee (IEC) that reviews and approves all types of research proposals involving human participants with a view to safeguard the dignity, rights, safety and well-being of all actual and potential research participants.The Ethical and Legal codes that govern medical practice also apply to clinical trials. The trial follows carefully controlled protocol, a study plan which details what researchers will do in the study. As a clinical trail progresses,researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants' names will remain secret and will not be mentioned in these reports.   07. Can a participant leave a clinical trial after it has begun?   Yes. A participant can leave a clinical trial, at anytime. While withdrawing from the trial, the participant should let the research team know about it, and the reasons for leaving the study.

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