Regulatory Focus™ > News Articles > National Cancer Institute Calls for Reevaluation of its Regulatory Reporting Requirements

National Cancer Institute Calls for Reevaluation of its Regulatory Reporting Requirements

Posted 21 September 2012 | By

The National Cancer Institute (NCI) is calling for comments on how it collects-and whether it's necessary to collect-information on clinical studies that it oversees on behalf of US regulatory officials.

Though the US Food and Drug Administration (FDA) is responsible for ensuring clinical trial regulations are upheld in the course of research, it regularly delegates this authority to other government agencies when those agencies conduct their own research.

NCI, a department of the National Institutes of Health (NIH), is one such agency, and is supposed to collect information about the clinical investigators participating in the trials and safety measures put into place to protect patients.

This collected information, known as the Drug Accountability Record, is generally used for compliance purposes, but is also used in support information distributed to patients enrolled in trials.

"The information collected is used to identify qualified investigators and to facilitate the submission and distribution of important information relative to the investigational drug and the response of the patient to that drug," NCI explained in its Federal Register posting.

NCI said the information is collected from investigators as many as 16 times per year from nearly 4,000 respondents. Other information, including the Statement of Investigator, Supplemental Investigator and Financial Disclosure documents, are collected from more than 20,000 respondents each year.

Now, NCI wants to know if it's collecting too much information, the right types of information or not enough information. Comments are due by 20 November 2012.

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