| |
|
|  |
|
|
- Belmont Report
The Belmont Report is the “Ethical Principles and Guidelines for the Protection of Human Subjects of Research”. Finalized on April 18, 1979 by The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, this document identifies 3 primary ethical principles: Respect for Persons, Beneficence, and Justice.
- Association of Clinical Research Organizations (ACRO)
The Association of Clinical Research Organizations (ACRO) provides presentations and testimony on behalf of CROs. An example of this was the statement regarding the adequacy of human subject protection in research presented to the Congressional Subcommittee on Public Health on April 23, 2002. ACRO's founding members were five major CROs: Covance, Kendle, PAREXEL, PPD, and Quintiles.
- Pharmaceutical Research and Manufacturers of America (PhRMA)
The Pharmaceutical Research and Manufacturers of America (PhRMA) represents the leading research-based pharmaceutical and biotechnology companies in the United States. PhRMA's mission is to conduct effective advocacy for public policies that encourage discovery of important new medicines for patients by pharmaceutical/biotechnology research companies. There are over 30 companies who are members of this organization and publications from this group are posted on the website.
- FDA Commissioner speech
Speech to Pharmaceutical Research Manufacturers of America by Mark B. McClellan, M.D., Ph.D. Commissioner, Food and Drug Administration given on March 28, 2003 regarding drug development.
- Monitoring
FDA Bioresearch Guidelines for the Monitoring of Investigators
- Working with an IRB; A Project Manager's Guide
Ask anyone who has managed a clinical trial from start to finish what the key is to a successful and positive experience and they will tell you, "Proper planning and communication." At Copernicus Group IRB, we consider ourselves to be an extension of your project team as we partner together to protect subjects and offer the following considerations as a guide for working effectively and efficiently with any IRB.
|
|
|
|
|
|
|
|
print