Clinical Trials Community

مجتمع الدراسات السريرية

Arabic

 Clinical Trials Approval Process

Before initiating any clinical trial, there are several official approvals that the study team must be obtained to evaluate the study from scientific, ethical, social and financial point of view.

Scientific Approval:

it includes evaluating the study's scientific value and whether or not it's repetitive or novel, and does it add to the scientific community? It also includes evaluating the data from previous phases of the clinical trials (like animal studies and pre-clinical data) by experts in the field.

Ethical Approval:

it includes reviewing the ethics part of the trial to ensure that all risk and benefit are disclosed and measure were taken to protect the clinical trial participants and evaluate the risk and benefit ratio, the committee pay special attention to trials involving vulnerable groups like elderly, pregnant women and children.

Regulatory Approval:

After obtaining ethical approval, the study file will be submitted to the regulatory authorities (Food and Drug Authorities) to ask for permission to conduct the trial and register it the local clinical trials registry, the regulatory authority conduct deeper review to the trial's investigational product and risks and benefits. The study file includes all documents to be reviewed like study protocol, informed consent form, case report form, investigators brochure etc.