On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
HHS Seeks Comments on Transfer of IRB Oversight Draft Guidances
The guidance documents address the following topics:
- Regulatory background for research project transfer;
- Transfer of oversight of a research project from an internal IRB to an external IRB, or an external IRB to another external IRB, when the project remains at the same institution;
- Transfer of oversight of a research project from one internal IRB to another internal IRB; and
- Transfer of oversight of a research project when the project is transferred to a newly engaged institution.
Both draft guidance documents recommend that the transfer process use a written agreement between the original and receiving IRBs that covers a number of specific items, such as the date of transfer, record retention, and whether consent forms need revision.
Comments are due by August 13, 2012. FDA and OHRP intend to work together in developing final guidances to ensure harmonization.
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017