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Faculty of Clinical Research and Drug Safety (FCRDS) An Autonomous Body Recognized by Ministry of Commerce & Industry, Government of India Conferred with QUALITY COUNCIL OF INDIA (QCI) D.L. SHAH NATIONAL
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01
Identify the purpose and objectives of the clinical trial.
02
Design the study protocol including the trial phases, inclusion/exclusion criteria, treatment interventions, and outcome measures.
03
Obtain necessary ethical approvals and permissions from regulatory authorities.
04
Recruit and screen potential participants who meet the eligibility criteria.
05
Randomize the participants into different treatment groups.
06
Administer the treatment interventions according to the study protocol.
07
Monitor and collect data on participants' health status and clinical outcomes.
08
Analyze and interpret the collected data.
09
Report the findings and conclusions of the clinical trial.
10
Publish the results in scientific journals or present them at conferences.

Who needs conducting clinical trials in?

01
Pharmaceutical companies developing new drugs or medical devices.
02
Academic researchers studying new treatments or interventions.
03
Government agencies assessing the safety and efficacy of healthcare interventions.
04
Healthcare professionals evaluating the effectiveness of existing treatments.
05
Patients or patient advocacy groups seeking access to innovative therapies.
06
Regulatory authorities requiring clinical evidence for approving new healthcare products or interventions.
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Conducting clinical trials involves the systematic investigation of a new drug, medical device, or treatment to evaluate its safety and efficacy in humans.
Researchers, sponsors, or organizations conducting clinical trials are required to file conducting clinical trials information.
Filling out conducting clinical trials involves providing detailed information about the trial's design, objectives, participant eligibility, and outcomes, typically through a standardized form or online submission system.
The purpose of conducting clinical trials is to generate data on the safety and effectiveness of new therapies or interventions before they are approved for public use.
Information that must be reported includes trial title, objectives, study design, participant demographics, intervention details, and outcome measures.
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