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Clinical Trial Protocol Deviation Document

Known as: Protocol Violation, Protocol Deviation Report, Protocol Deviations 
Records that detail any non-compliance or deviations from a clinical study's protocol.
National Institutes of Health

Papers overview

Semantic Scholar uses AI to extract papers important to this topic.
2018
2018
A perioperative surgeon-controlled open-lung approach versus conventional protective ventilation with low positive end-expiratory pressure in cardiac surgery with cardiopulmonary bypass (PROVECS…
BackgroundPostoperative pulmonary complications (PPCs) are frequent after on-pump cardiac surgery. Cardiac surgery results in a… 
2017
2017
Ranpirnase Eradicates Human Papillomavirus in Cultured Cells and Heals Anogenital Warts in a Phase I Study
Background Human papillomaviruses (HPV), the causative agents of anogenital warts, are the most prevalent sexually transmitted… 
Review
2013
Review
2013
Prostate radiotherapy clinical trial quality assurance: how real should real time review be? (A TROG-OCOG Intergroup Project).
2008
2008
Reliability of Japanese clinical trials estimated from GCP audit findings.
To describe the reliability of Japanese clinical trials, we compared the results of a Good Clinical Practice (GCP) audit… 
2004
2004
Recent Changes in Quality in Japanese Clinical Trials
BACKGROUND: Japanese clinical trials have some unique characteristics in both design and conduct. We have studied recent changes… 
Review
2002
Review
2002
Quality assurance in the EORTC 22921 trial on preoperative radiotherapy with or without chemotherapy for resectable rectal cancer: evaluation of the individual case review procedure.
Review
2002
Review
2002
Radiotherapy quality assurance of gynecologic oncology group (GOG) protocol 165, a cooperative group study of carcinoma of the cervix
1997
1997
Intention‐to‐Treat Analysis in Randomized Trials: Who Gets Counted?
This article discusses the rationale and implications associated with the selection and use of analysis strategies for randomized… 
Review
1997
Review
1997
Quality assurance of the EORTC trial 22881/10882: Boost versus no boost in breast conserving therapy
BackgroundThe initial quality assurance programme of the EORTC Radiotherapy Cooperative Group in trial 22881/10882 is described… 
Review
1993
Review
1993
Quality control review for radiotherapy of small breast cancer: analysis of 708 patients in the GBSG I trial. German Breast Study Group (GBSG).
Within six years between November 1983 and December 1989 the German Breast Cancer Study Group (GBSG) conducted a prospective… 
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