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Zdrowie i gospodarka · 29.01.2010

Submission for OMB Review; Comment Request Clinical Trials Reporting Program (CTRP) Database (NCI)

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute (NCI), the National Institutes of Health (NIH), has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 9, 2009, (Vol. 74, No. 215, p. 57684) and allowed 60-days for public comment. Two public comments were received. The first comment, received November 11, 2009, questioned the purpose and safety of clinical trials conducted outside of the United States. An e-mail response was sent on January 6, 2010, acknowledging the commenter's concern. The response noted that the NCI's Clinical Trials Reporting Program is an information collection activity intended to assist the NCI in management of the NCI's clinical trials portfolio, which is global in nature. The response further stated that while CTRP is not directly related to the conduct of a clinical trial, the NCI hopes to use the information to facilitate routine review of safety, efficacy, and administrative data reported from on-going cancer trials.

Source: Federal Register — Health and Human ServicesOpen original release →