Participants

When you wish to participate in any of our clinical trial, our site staff will be at your help and support and will guide you through the process and help you feel comfortable and appreciated as a research trial participant. Out site Investigator or any designee will brief you about your voluntary participation and informed consent process before starting any trial related activity. Once you have signed the inform consent form our site investigator (doctor) or other members of the study team will take you for health assessments, physical exams, laboratory tests, or other procedures required by the study protocol. At any point of the time during the study process if you have any question or concern feel free to contact us for any assistance or clarification.

A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents (ICH GCP).

Study protocol vary from study to study but there are common steps for all the trials. For a better understanding of the common steps of clinical trial participation, kindly go the below mentioned steps. Although each trial is different, there are many similar processes and steps to ensure your comfort and safety, and to ensure we are collecting the best information for the trial Sponsor.

This is your first interaction with our team member via in person visit or telephonic conversation to know about the study in which you can participate. Our team will brief you about all the processes and you will get ample opportunity to ask questions to get better clarity about you benefits of participation in a trial.

Once you are voluntarily looking to participate in clinical trial. Study investigator or designee will brief you about your rights and obligations as a participant of the study. You will get the copy Inform consent document in language of your choice to understand it fully. You can take as much of time as you need. You can also consult your family doctor or family member and can discuss it with them. Once you voluntarily decided to participate in the trial you will be requested to sign Inform consent form and this form will also be signed by study investigator. One photo copy of signed inform consent form will be given to you for you reference and original copy will be with be with study investigator for his records.

Once you have signed your inform consent form for voluntary participation in clinical trial. The study investigator or designee will go for your clinical examination and other laboratory investigations to check whether you meet the basic study requirements?.

After evaluation of all your screening parameters and meeting all study inclusion criteria’s and none of the exclusion criteria’s. You are assigned to a treatment course, which could be either new investigational drug or standard of care/placebo. In most of the studies (double blind) You and your doctor may not know what you receive.

The number of study visits varies from study to study and these may be days, weeks, or months apart. In your inform consent document there will be brief details about each visit, such as labs, physical exam, questionnaires, or other tests/procedures.

This visit may be telephonic or in person visit to assess how you are doing after ending study treatment.

If you completed all the visits as per protocol then your participation in the study has successfully ended.

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