Registry clinical trials design
(PDF) document. Describes review criteria for study records submitted to the registry (Draft, August 2010)
(PDF) document. Describes review criteria for each scientific module in the results section of the study record submitted to the results database (Draft, September 2009)
(PDF). Abbreviated overview of review criteria for avoiding common data entry errors made during results submission (Draft, May 2011)
(PDF). Tips on entering results data, including three examples of common study models (parallel design, crossover design, and diagnostic accuracy studies), and measure types.
(PDF). An overview of common errors identified in submitted records with results.
(PDF). Tri-fold brochure providing an overview of key information on registering and submitting the results of clinical trials to ClinicalTrials.gov.
U.S. Laws, Regulations, and Guidance
(PDF). Full text of the Food and Drug Administration Amendments Act (FDAAA); (PDF) expanded the requirements for the ClinicalTrials.gov database (September 2007)
(PDF). The National Institutes of Health's (NIH) interpretation of the terms "responsible party" and "applicable clinical trial, " as used in FDAAA (Draft, March 2009)
(PDF), which must accompany drug, biological product, and device applications or submissions. For more information, see .
Clustering in Bioinformatics and Drug Discovery (Chapman & Hall/CRC Mathematical & Computational Biology)
Book (CRC Press)
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.