An article posted on clindev.eu shares that the European Medicines Agency (EMA) has announced a three month public consultation of a draft transparency policy regarding clinical trial information. EMA is hoping to launch the policy in early 2014. Potential threats to the timeline would be resolved court cases challenging the 2010 open access to documents policy and ongoing legislation to replace the European Directive. The draft policy itself though contains three categories aimed to release as much information possible while keeping personal patient information secure. The EMA urges the public to upload comments to the draft policy using the submission form and they must be sent by September 30, 2013 to ctdatapolicy@ema.europa.eu. To read the full article click here.
Single IRB – A Guide to the Common Rule sIRB Mandate
The sIRB requirement is active. Is your study affected?
Clinical Research Accelerated
You need high quality, timely board reviews so that you can get your study in the clinic.
Recent Posts
Chevron, Natural Resources Defense Council, Loper Bright Enterprises, Raimondo, et al.
5 Common Errors in the Informed Consent Process
Pearl IRB 2024 Year-End Schedule
Snowball Sampling: Is it ethical to pay your study subjects to recruit participants on your behalf?
Improving Exempt Submissions: 7 Tips to Reduce Revision Requests