December 2009 – The CenterWatch Monthly : PDF
Maine Revises Clinical Trial Transparency Rule
The revised regulations, which went into effect Nov. 2, are an attempt to clarify the Maine’s requirements for clinical trial registration and results reporting and to make them more compatible with federal reporting requirements under the FDA Amendments Act of 2007, which called for a federal system that expands public access to data from clinical trials.
FDA, OHRP Guidance on Unanticipated Problems and Serious Adverse Events
FDA and HHS regulations require that unanticipated problems encountered in clinical trials be reported. The FDA regulations require investigators to report unexpected, serious adverse events to the sponsor and the sponsor, in turn, shall report these events to the FDA in an expedited manner.
Debate Intensifies Over Future Shape of Safety Reporting
Europe’s system of safety reporting continues to be plagued by a host of inconsistencies, and no stakeholders appear happy with the current mechanisms for handling suspected unexpected serious adverse reactions (SUSARs).
Eye On: Lymphoma
Lymphoma, a form of blood cancer in which white blood cells known as lymphocytes proliferate more rapidly or have a longer than normal life span, may arise in the lymph nodes, spleen or other organs, bone marrow or blood.
Also in this issue:
- Month in Review
- In the Pipeline
- Opportunities Initiating