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Volunteer F.A.Q.
What is a clinical trial?
A clinical trial is basically a scientific study that involves people. The aim of clinical trials is to investigate
whether a product is reliable, safe and effective.  Clinical trials allow researchers to measure the extent of the product effect, so they can predict with some confidence how much it will benefit people, and whether there are any potential side effects of the product. Clinical trials differ according to various studies and also in what they require of a subject/ volunteer.
Why should I participate in a clinical trial?
It's a way to help you and to help others. It provides an opportunity for you to help increase knowledge by helping researchers find out if a particular Product is safe and effective.
What do volunteers have to do to participate in a clinical trial?
  • Fill in the registration form.
  • Volunteer then have to undergo a brief medical physical examination. This depends on specific research goals of each trial. Volunteer must meet the requirements of the trial
  • After the medical investigator approves the volunteer, he/she must make a commitment in time and be willing to follow the directions and instructions of the research team.
  • Periodic routine checks generally take ½ hour to two hours. The number of visits and the length of the visits depend on the type of trial.
  • No surgery or invasive method is involved for most of the clinical trials being undertaken by “C.L.A.I.M.S.” as of date.
What does informed consent mean?
Volunteer must be fully informed, and consent to participate in a clinical trial. Informed consent involves a discussion between Volunteer and the investigator or research team member about what is involved in the trial, its purpose, risks, procedures, conveyance, and who volunteer should contact if they have questions.

Volunteer are encouraged to ask questions during the discussion so as understand what they are signing. Informed consent also requires Volunteer to sign and date the consent form.
Are there benefits to participating in a clinical trial?
Yes!! Each Volunteer is provided with reimbursement per visit as conveyance for study related travel. The Volunteer is not required to bear any cost for participation in study. The test product and doctor’s consultation will be provided free of charge
What are the risks or discomfort in study?
The product details are thoroughly scrutinized before use. However, since we do not have any a complete medical history of the volunteer, there are possible risks, such as adverse events or side effects to be considered when participating in any clinical trial. Participants are informed of known risks or side effects before starting the trial. Risks also are explained in the informed consent document.

Volunteers have to make sure to fully understand them. There is always the possibility of unknown risk. If any new side effects or risks are discovered during the trial volunteers are informed.

Volunteers, who intend to become pregnant, are pregnant or breast feeding cannot participate in study.
Is there any compensation for study related injury for Volunteer?
C.L.A.I.M.S. Pvt Ltd has limited insurance for covering study related expenses. Anyone whose health suffers as a result of participation in the trial will be compensated as per insurance coverage if considered appropriate and is reported within the stated period.
Is Volunteer information kept confidential?
All study reports /records will be kept confidential at all times .Volunteer identity will not be revealed except as required by law. The result of their treatment (details: clinical evaluation, self evaluation etc) may be published for scientific reasons. Volunteer identity will not be revealed in those publications.
Can a volunteer withdraw from an ongoing study?
Participation in study is entirely voluntary. During the studies there is often new information coming in about the product being tested. Sometimes because of this information, you might want to drop out of the study. Volunteers may not take part and can leave the study at any time. If left voluntarily, you may not be reimbursed.
How long do clinical trials run?
It depends on the trial; they can vary from days to a number of months, or even years. Volunteer will be told the expected length of the trial before beginning the trail. This information is discussed with the Volunteer during the informed consent process.