Newsletter - September 3, 2015
GCP Inspectors Need to be Highly Qualified, Says EMA
The European Commission (EC) released an opinion article last week highlighting its expectations on the minimum standards of qualification of GCP inspectors, in particular regarding their education and training. Per the EC, an inspector must have university level education in medicine, pharmacy, pharmacology, toxicology or other fields relevant to Good Clinical Practice principles. In addition, the inspector must be appropriately trained in inspection processes, both theoretical and practical, and periodically assessed for his/her preparedness. Familiarity with the rules and practices of GCP, how trials are practically conducted, and risk assessment are also expected. The document goes into further details of how inspections should be done, documented and reviewed. Read More...
Electronic Informed Consent in Clinical Trials: Opportunity or Liability
In a news release today, it was announced that England approved its first electronic informed consent. There has been quite a lot of discussion regarding use of electronic or computer-based informed consent in clinical trials. The challenges of these I terms of added cost and time for creating one have not been fully addressed. FDA published a guidance document in March of this year on the topic detailing what it expects to see in computer-based informed consent. On the face value electronic informed consent (E-IC) seems quite promising as unlike paper informed consent forms (ICFs) which contain a “dry” description of a given trial, an E-IC can contains images, audio, video, and interactive tools allowing a better description of a given trial. Read More...
GCP Inspectors Need to be Highly Qualified, Says EMA
The European Commission (EC) released an opinion article last week highlighting its expectations on the minimum standards of qualification of GCP inspectors, in particular regarding their education and training. Per the EC, an inspector must have university level education in medicine, pharmacy, pharmacology, toxicology or other fields relevant to Good Clinical Practice principles. In addition, the inspector must be appropriately trained in inspection processes, both theoretical and practical, and periodically assessed for his/her preparedness. Familiarity with the rules and practices of GCP, how trials are practically conducted, and risk assessment are also expected. The document goes into further details of how inspections should be done, documented and reviewed. Read More...
Electronic Informed Consent in Clinical Trials: Opportunity or Liability
In a news release today, it was announced that England approved its first electronic informed consent. There has been quite a lot of discussion regarding use of electronic or computer-based informed consent in clinical trials. The challenges of these I terms of added cost and time for creating one have not been fully addressed. FDA published a guidance document in March of this year on the topic detailing what it expects to see in computer-based informed consent. On the face value electronic informed consent (E-IC) seems quite promising as unlike paper informed consent forms (ICFs) which contain a “dry” description of a given trial, an E-IC can contains images, audio, video, and interactive tools allowing a better description of a given trial. Read More...
