Data Integrity in Global Clinical Trials: Discussions From Joint US Food and Drug Administration and UK Medicines and Healthcare Products Regulatory Agency Good Clinical Practice Workshop

2020 ◽  
Vol 108 (5) ◽  
pp. 949-963
Author(s):  
Ni A. Khin ◽  
Gail Francis ◽  
Jean Mulinde ◽  
Cheryl Grandinetti ◽  
Rachel Skeete ◽  
...  
2013 ◽  
Vol 35 (8) ◽  
pp. e9
Author(s):  
A. Prakash ◽  
B. Medhi ◽  
S. Kaur ◽  
S. Kumari ◽  
P. Sarotra

2017 ◽  
Vol 4 (4) ◽  
pp. 166
Author(s):  
Salem D. Al Suwaidan ◽  
Aseel S. Alsuwaidan

<p class="abstract"><strong>Background:</strong> Conducting clinical research in accordance with the standards of regulatory authorities and within the guidelines of the good clinical practice (GCP) is a matter of concern.  It has been noticed that some increment in the conduction of clinical trials outside USA and European countries in the last two decades. The main objective of this study is to identify the magnitude of some obstacles that affect the conduction of clinical trials in accordance with the GCP.</p><p class="abstract"><strong>Methods:</strong> Developing questionnaire in accordance with the criteria of the GCP would make assessment on how to buildup infrastructure including policy and procedures of the research institution. Recommendation of the study is to perform this questionnaire every other year to assess the progress and development of the research institution.</p><p><strong>Conclusions:</strong> To identify good clinical researchers, what sort of obstacle(s) regarding conducting clinical trials, and from these obstacles how to resolve it and build up infrastructure for the research institution and also to establish the strategic plan for the research institution.</p>


2010 ◽  
Vol 20 (6) ◽  
pp. 1125-1131 ◽  
Author(s):  
Werner Brannath ◽  
Hans Ulrich Burger ◽  
Ekkehard Glimm ◽  
Nigel Stallard ◽  
Marc Vandemeulebroecke ◽  
...  

2020 ◽  
Vol 173 (4) ◽  
pp. 320-322 ◽  
Author(s):  
Samer Al Hadidi ◽  
Martha Mims ◽  
Courtney Nicole Miller-Chism ◽  
Rammurti Kamble

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