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Nov 5, 2014

 
FDA GCP Training
The FDA conducts GCP training on site, but also provides on-line training and a whole training program

Yes, the Food and Drug Administration (FDA) conducts GCP training. As described below, the agency conducts some GCP training on site, but also partners with other federal agencies and organizations across the United States to conduct additional training. FDA also has recently made GCP training available online.

In the fall of 2009, FDA's Critical Path Initiative launched a Clinical Investigator Training Course targeted at medical professionals who participate in FDA-regulated clinical trials. This 3-day course includes lectures given by senior FDA experts and guest lecturers from industry and academia. It provides FDA's perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research, and acceptable scientific and analytic standards in clinical study design and conduct. See FDA's Clinical Investigator Training Course for further information.

Throughout the year, FDA district offices co-sponsor two-day workshops with the Society of Clinical Research Associates (SoCRA). These conferences are entitled, “FDA Clinical Trial Requirements, Regulations, Compliance, and GCP Conference.” FDA personnel from both the co-sponsoring district office and headquarters participate in these workshops. Locations and dates for future workshops are available at the SoCRA website. FDA personnel, from both headquarters and the district offices, also regularly present at meetings of various professional organizations. In addition to SoCRA, these include the Drug Information Association (DIA), Public Responsibility in Medicine and Research (PRIM&R), the Association of Clinical Research Professionals (ACRP), the Regulatory Affairs Professionals Society (RAPS), and others.

FDA routinely collaborates with the Office for Human Research Protections and the Department of Veterans Affairs on regional programs focused on human subject protection in regulated research. Information about these programs is available at:

Both the Center for Drug Evaluation (CDER) and the Center for Devices and Radiological Health (CDRH) provide online training relevant to clinical trials on their respective websites. These training programs are accessible at CDERLearn and CDRH Learn respectively.

Other agencies in the Department of Health and Human Services do provide training in this area:

Finally, there are numerous references related to good clinical practice (GCP) and human subject protection (HSP), available on FDA's website, including:

FDA Clinical Investigator Training Course (pdf)



New Data Dashboard Tool Shares FDA’s Inspection, Compliance and Recall Data
As part of FDAs commitment to transparency, FDA is pleased to announce that they have released a new online tool to provide insight into their compliance, inspection, and recall activities.

This new dynamic tool represents a departure from the downloadable spreadsheet-based datasets that FDA have posted in the past. Instead, the FDA data dashboard presents information in an easy-to-read graphical format. It also provides access to the underlying data allowing anyone interested to see related data and trends.

FDAs new dashboard provides data for FY 2009 to FY 2013, and allows access to data on:

  • Inspections;
  • Warning letters;
  • Seizures and injunctions;
  • And statistics, specifically for recalls.

They plan to update the data semi-annually.

The dashboard is staged in a cloud environment, and it allows you to:

  • Download information for additional analysis;
  • Manipulate what you see by selecting filters;
  • Rearrange the format of datasets and the way columns are sorted;
  • Drill down into data; and
  • Export charts and source information for further review.

FDA developed this new dashboard after President Obama issued a Presidential Memorandum on Regulatory Compliance in January 2011.

The President directed federal agencies to make publicly available compliance information easily accessible, downloadable and searchable online, to the extent feasible and permitted by law. FDA formed internal working groups that same year to develop recommendations for enhancing the transparency of our operations and decision-making processes. These working groups identified an online tool as a way to present compliance and enforcement data in a user-friendly manner. The dashboard represents the latest example of our commitment to compiling and posting a wealth of FDA data for public review and feedback.

FDA works within a global environment and is carrying out more inspections around the world. FDA collaborates with regulatory authorities across the globe to protect public health. The data dashboard provides information about inspections in this global environment, and makes this information more readily accessible to the public. Now you can use the dashboard to see this kind of inspection-related information to better understand our regulatory decisions.

A “feedback mechanism” is available so you can send comments, questions or concerns directly to FDA at FDADataDashboard@fda.hhs.gov.

This rollout effort is part of FDA’s continuing commitment to share inspection, compliance, and recall data. FDA will continue to update the data dashboard and provide public access to this timely and important information.



 

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