subinvestigator

Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study.

Paxil Study 329 All Over Again? 2009

Or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the chief investigator (subinvestigator), are at significant risk for harming self.

Paxil Study 329 All Over Again? 2009

Promoted to Headline (H3) on 5/27/09: FDA Waved Through Asthma Drugs Despite Falsified Trials yahooBuzzArticleHeadline = 'FDA Waved Through Asthma Drugs Despite Falsified Trials'; yahooBuzzArticleSummary = 'Article: Trials of Singular, Serevent, Foradil, Flovent, Xolair, Accolate and Xopenex conducted at the Tucson, AZ facility of Vivra Asthma & Allergy were corrupted by protocol violations and outright falsifications says Robert Davidson, MD, a former clinical research subinvestigator at the facility.'

FDA Waved Through Asthma Drugs Despite Falsified Trials 2009

"On multiple occasions over the last 8 months the P.I. strongly counseled the S.I. [subinvestigator] to NOT mention potential risks of study participation to potential study subjects, (such as arrhythmia, drug-drug interaction, etc.) so as to not 'scare them away'," the FDA report reads elsewhere.

FDA Waved Through Asthma Drugs Despite Falsified Trials 2009

Trials of Singular, Serevent, Foradil, Flovent, Xolair, Accolate and Xopenex conducted at the Tucson, AZ facility of Vivra Asthma & Allergy were corrupted by protocol violations and outright falsifications says Robert Davidson, MD, a former clinical research subinvestigator at the facility.

FDA Waved Through Asthma Drugs Despite Falsified Trials 2009