Clinical Trial Approval Process : Proposed Online Model

The DCGI is planning to shift the process of approving clinical trial applications online. Each trial will be assigned a unique identity number. Pharma companies, ethics committees, doctors/investigators responsible for trials would regularly update information on the online database. It is expected to put the details of the patients, severe side effects they may suffer and compensation paid to them. A regulator may seek additional details.

The details about the indications for the drug, the disease it seeks to cure will have to be uploaded.

The details of the investigator or doctor conducting the trial, the details of his team, the site of the trial and whether such trials are being conducted in other parts of the world will be given.

The details of the targeted patients group will be given. It is to be informed whether any vulnerable groups such as children,pregnant women, nursing mothers are participating in the trial.

There should be a disclosure regarding the composition of the ethics committee, their meetings and proceedings.

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