Author: Cimino JJ
April 1, 2013 The NIH Intramural Research Program’s Protocol Navigation Training Program presents:
Meeting Data Access and Reporting Requirements with the NIH’s Biomedical Translational Research Information System (BTRIS).
James J. Cimino, M.D., Chief of the Laboratory for Clinical Informatics Development at the NIH Clinical Center and Senior Scientist within the Lister Hill Center for Biomedical Communications at the National Library of Medicine. The NIH Biomedical Translational Research Information System (BTRIS) is a repository of clinical research data collected from across the NIH intramural research program. BTRIS allows investigators engaged in clinical research to access current and historical data on subjects in their research protocols and allows all NIH researchers to retrieve de-identified data sets to support hypothesis generation and data re-use. BTRIS provides a single, unified database that integrates data from six different clinical and research record systems, as well as many ancillary clinical systems at the NIH Clinical Center, with continuous data sets reaching back to 1976 or earlier. BTRIS users can formulate and execute their own queries to obtain data sets in “spreadsheet” form for download, analysis and reporting.
In this seminar, Dr. Cimino:
- describes the kinds of data included in BTRIS,
- demonstrates how to initiate queries in BTRIS for the retrieval of both identified and de-identified data sets, and
- demonstrates how to use BTRIS to meet reporting requirements for Institutional Review Boards and ClinicalTrials.gov.
Author: Williams RJ
The NIH Intramural Research Program Protocol Navigation Training Program presents Rebecca J. Williams, Pharm.D., MPH, Lister Hill National Center for Biomedical Communications, National Library of Medicine
“ClinicalTrials.gov: Registration and Results Submission Requirements”
January 7, 2013 More than five years have passed since the FDA Amendments Act of 2007 (FDAAA) expanded the requirements for clinical trial registration to include the submission of summary results to ClinicalTrials.gov. Is your clinical protocol subject to the law and are you prepared to comply? In this seminar, Dr. Williams outlines FDAAA requirements and medical journal policies that require clinical trial registration as a condition of publication. She also provides practical tips and examples for registering protocol information and submitting results to ClinicalTrials.gov.
Author: Callaghan FM
“Biostatistics 101: Introduction to Power and Sample Size”
November 5, 2012
The NIH Intramural Research Program Protocol Navigation Training Program presents Fiona Callaghan, Ph.D., National Library of Medicine
One of the hardest aspects of study design is determining appropriate power and sample size. Insufficient sampling may result in the inability to disprove the primary hypothesis, wasting time and resources and creating the potential for misleading results. This seminar covers the fundamental concepts underlying classical hypothesis testing and presents examples for analyzing basic one- and two-sample experiments.