Risk Management


Risks of Clinical Research

DIGEST NO 3 FOR WEB Anne M. Menke, RN, PhD, OMIC Risk Manager, and Kimberly Wynkoop, OMIC Legal Counsel Clinical research is closely tied to the practice of medicine, and many physicians either participate in studies as investigators or refer patients for enrollment. While traditionally research was linked to academic institutions, it is increasingly being conducted in the offices of physicians who may work directly with pharmaceutical companies or device manufacturers. The Office for Human Research Protection (OHRP) has raised concerns that an increasingly commercialized and competitive research environment may erode informed consent and put research subjects at risk.1 OMIC has had only two lawsuits related to clinical trials. This small...
SEMINARS:

Jan
17
Sat
all-day Cataract Surgery: Telling It Lik... @ Ritz-Carlton, Sarasota
Cataract Surgery: Telling It Lik... @ Ritz-Carlton, Sarasota
Jan 17 all-day
Cataract Surgery: Telling It Like It Is! January 15-18, 2015 @ Ritz-Carlton, Sarasota | Sarasota | Florida | United States
Join us in Sarasota on January 15-18, 2015, for this very popular event! This meeting sells out every year. The OMIC session is being offered on Saturday, January 17th, at 1:15 p.m. Also please take[...]
all-day Hawaiian Eye 2015 at Grand Waile... @ Grand Wailea
Hawaiian Eye 2015 at Grand Waile... @ Grand Wailea
Jan 17 all-day
Hawaiian Eye 2015 at Grand Wailea, Maui on January 17, 2015 @ Grand Wailea | Kihei | Hawaii | United States
The Grand Wailea in Maui is the site for the popular 2015 Hawaiian Eye Meeting. OMIC’s Chair of the Board, Tamara R. Fountain, MD, will speak at three events during this meeting. Date of Event:[...]
Jan
17
Sat
all-day Cataract Surgery: Telling It Lik... @ Ritz-Carlton, Sarasota
Cataract Surgery: Telling It Lik... @ Ritz-Carlton, Sarasota
Jan 17 all-day
Cataract Surgery: Telling It Like It Is! January 15-18, 2015 @ Ritz-Carlton, Sarasota | Sarasota | Florida | United States
Join us in Sarasota on January 15-18, 2015, for this very popular event! This meeting sells out every year. The OMIC session is being offered on Saturday, January 17th, at 1:15 p.m. Also please take[...]
all-day Hawaiian Eye 2015 at Grand Waile... @ Grand Wailea
Hawaiian Eye 2015 at Grand Waile... @ Grand Wailea
Jan 17 all-day
Hawaiian Eye 2015 at Grand Wailea, Maui on January 17, 2015 @ Grand Wailea | Kihei | Hawaii | United States
The Grand Wailea in Maui is the site for the popular 2015 Hawaiian Eye Meeting. OMIC’s Chair of the Board, Tamara R. Fountain, MD, will speak at three events during this meeting. Date of Event:[...]


CASE STUDY:

Fraudulent Enrollment of Patient in Clinical Trial

Ryan Bucsi, OMIC Senior Litigation Analyst

Allegation

Manipulating screening data for study eligibility, failure to supervise technician, and abandonment.

Disposition

Case settled for $250,000.

Case summary

An OMIC insured was the principal site investigator (PSI) at an OMIC-insured research center during a clinical trial comparing the effectiveness of an anti-VEGF drug, focal laser photocoagulation, and steroids for the treatment of...

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Adverse Events in Clinical Research

Anne M. Menke, RN, PhD, OMIC Risk Manager Just as with care provided outside of research, subjects who participate in clinical trials can experience complications from the study intervention. Federal regulations use the term “adverse events” to describe these outcomes and define them in intentionally broad terms. In drug trials, for example, an adverse event would include any adverse change from the patient’s baseline condition, including any abnormal clinical laboratory test value, which occurs during the course of the study, whether related to the study medication or not. Management of...





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