Value added in using monitoring and training to improve the quality of clinical data from a clinical trial

Wednesday, October 26, 2011 — Poster Session III
10:00 a.m. – Noon	Natcher Conference Center	NIAID	CLIN/CULT/AGING/DISPREV-1

Authors

• A Adams
• B Baseler
• L Hoopengardner
• J Pierson
• S Simpson
• S Vogel

Abstract

The Regulatory Compliance and Human Subjects Protection Branch/Program (RCHSPB/P) provides services that facilitate the work of the investigators in the intramural community and those sponsored by the DIR/NIAID program to conduct clinical research of the highest quality, in accordance with applicable regulations, standards and guidelines. The Clinical Trials Management (CTM) group within RCHSPB/P monitors clinical trials to help ensure the protection of human subjects, validate the integrity of the data collection and recording process, and maintain compliance with all appropriate regulatory bodies, ICH/GCP Guidelines, and NIH/site policies. An analysis of the monitoring findings from these studies shows a direct correlation between the number of deviations and violations that occur and the amount of monitoring/training offered by the RCHSPB/P. The graphical analysis included supports the notion that the use of monitoring/training offered by RCHSPB/P improves the quality of the data that is produced by clinical trials, allows study staff to conduct trials more efficiently, and can help prepare study staff for an FDA audit. In conclusion, the services offered by RCHSPB/P are listed.

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