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ERegulatory & Legislative Brief Content Feb '10 2 10 10 - Fidelity

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What a Difference a Month Makes When last month s version of the eRegulatory and Legislative Brief went to press we fully expected to be bringing you word of a new health-care bill in this month s Brief* But then an election that got the attention of the nation happened in Massachusetts and now the near-term prospects of a new health-care bill of any sort appear dim* The IRS Issues Guidance on the Heroes Earnings Assistance and Relief Tax Act of 2008 In 2008 Congress passed the Heroes Earnings ...

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Who are the regulatory bodies in clinical trials?

The Drugs Controller General of India (DCGI) is an official of the CDSCO who is the final regulatory authority for the approval of clinical trials in the country.

What is eReg in clinical trials?

An Electronic Regulatory system, or eReg, is a digital platform used to store and track regulatory documents in the form of electronic regulatory binders throughout the life cycle of a clinical trial. eReg binders provide a way to efficiently manage a large number of documents while maintaining regulatory compliance.

What is regulatory clinical trial?

Regulations has been set to ensure integrity of the data collected from clinical trials which assure the safety, right and welfare of the subject.

What are some examples of regulatory agencies?

Regulatory Agencies: Federal, State and City Center for Disease Control. Environmental Protection Agency. Department of Transportation. Food and Drug Administration. National Institute of Health. Nuclear Regulatory Commission. Occupational Safety and Health Administration. National Institute of Occupational Safety and Health.

Is IRB a regulatory body?

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In ance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.

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