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Why Staff Training Problems are a liability for Your Clinical Trial site

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Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.

Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.

In one notable case, PIs were prosecuted due to inadequate training and oversight of research staff. Study coordinators, often without relevant research experience and from low-wage backgrounds, were left to manage studies without proper guidance. This lack of training led to errors and potential fraud, highlighting a crucial gap in compliance.

Ensuring that all research staff are properly trained is essential for the integrity of clinical trials. If you need help developing a robust clinical research program, reach out to me.

Support the show

  continue reading

159 episoade

Artwork
iconDistribuie
 
Manage episode 450166091 series 3506216
Content provided by Darshan Kulkarni. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by Darshan Kulkarni or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ro.player.fm/legal.

Training your research site staff is critical. Despite regulations requiring Principal Investigators (PIs) to ensure proper training for research staff, recent cases reveal significant lapses. PIs are responsible for certifying that all associates, colleagues, and employees involved in the research are adequately trained and informed. However, instances have emerged where this responsibility was neglected.

In one notable case, PIs were prosecuted due to inadequate training and oversight of research staff. Study coordinators, often without relevant research experience and from low-wage backgrounds, were left to manage studies without proper guidance. This lack of training led to errors and potential fraud, highlighting a crucial gap in compliance.

Ensuring that all research staff are properly trained is essential for the integrity of clinical trials. If you need help developing a robust clinical research program, reach out to me.

Support the show

  continue reading

159 episoade

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