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Home » Topics » Clinical Trials » Inspections and Audits

Inspections and Audits
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MHRA Cites Data Management and Integrity in GCP Inspections

June 14, 2018
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More

MHRA Cites Data Management, Integrity Issues in GCP Inspections

June 4, 2018
Problems with inaccessible trial master files and confusing questionnaires are among the nonconforming practices cited in the latest GCP inspection report from the UK Medicines and Healthcare Products. Read More

ANSM Creates New Unit to Handle Early Stage Clinical Trials

January 18, 2018
France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials. Read More

ANSM Creates New Unit to Handle Early Stage Clinical Trials

December 27, 2017
ANSM’s plans come in response to a fatally flawed Phase 1 French trial that left one patient dead and five injured in 2016. Read More

ANSM Creates New Unit to Handle Early Stage Clinical Trials

December 12, 2017
France’s Agency for the Safety of Health Products has established a unit dedicated to overseeing early phase clinical trials. Read More

Clinical Investigator Lands Warning Letter for Enrolling Pregnant Subject

March 10, 2016
The FDA has dinged a clinical investigator in a warning letter for failing to conduct an investigation, according to the investigational plan. Read More

FDA Raises Alarm Over Unauthorized Clinical Trial

December 14, 2015
In a rare move, the FDA is censuring a Newport Beach-based laser eye surgery center for a clinical trial it conducted beginning in 2012. Read More

Report Outlines Strategies for Risk-Based Monitoring

October 8, 2015
As centralized risk-based clinical trial monitoring becomes the norm, sponsors are gaining access to broad overview data on research and compliance trends that can help them identify both real and potential problems across their trial locations. Read More

Trial Investigator Warned Over Lack of SOP Documentation

September 10, 2015
A San Diego, Calif.-based clinical researcher received an FDA warning letter over its lack of documentation of standard operating procedures for overseeing studies and details of in-service protocol and specimen handling training in a Form 483 response. Read More

Device Trials Program Overhaul Aims for Speed, Consistency: FDA

June 11, 2015
The U.S. FDA’s device center is taking steps to improve the predictability of IDE reviews with the establishment of a new director-level position to oversee the clinical trials in the Office of Device Evaluation, a center official says. Read More

21st Century Cures Act Sails Through House Committee

June 11, 2015
The ayes had it with the House Energy & Commerce Committee May 21, with all 51 members voting to pass the latest version of the 21st Century Cures Act. Read More

Expert Advises on Risk-Based Monitoring in Clinical Trials

May 7, 2015
Sponsors should decrease their use of on-site monitoring in clinical trials in favor of more centralized, risk-based methods that can be largely conducted remotely, an expert says. Read More
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