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Why are Investigative Site Clinical Research SOPs so important?
ey establish standards for
responsibilities that regulatory authorities have attributed to the Investigator. Well-written and
well-managed GCP SOPs provide an offi
cial and standard way to consistently execute required
research-related activities. In addition, they can improve communication among staff
dependence on individuals with institutional knowledge, and improve effi
ciency of staff
Are Clinical Research Investigator Site SOPs required by law/regulations?
? ICH GCP 2.13 states that ?Systems with procedures that assure the quality of every aspect of
the trial should be implemented.?
? 21 CFR 312.53 states that the Investigator will ?ensure that all associates, colleagues, and
employees assisting in the conduct of the study(ies) are informed of their obligations in
meeting the above commitments.?
? FDA guidances and regulations infer Investigator responsibility.
? ISO 14155:2011 (6.8.1) states that ?the Investigator shall assure the accuracy, completeness,
legibility and timeliness of the data reported to the Sponsor...?
? ISO 14155:2011 (6.11) states that ?Audits...may be conducted...to evaluate compliance
with the CIP, written procedures, the International Standard and the applicable regulatory
? PhRMA Principle on Conduct of Clinical Trials (2009:2.i.) Quality Assurance. Procedures
are followed to ensure that trials are conducted in accordance with GCPs and that data
are generated, documented and reported accurately and in compliance with all applicable
e investigative clinical research site that operates under Clinical Research SOPs demonstrates
it has a commitment to research and that consistent processes for research activities are in place
Dr. Gizelle Baker and Dr. Wilkerson have complementary and integrated expertise, forming an extremely
powerful and knowledgeable research leadership team. Both have extensive experience in US and global
product development for drugs, biologics and devices. Additionally, both have led clinical project/programs and/
or departments and served as project advisors on numerous project teams, and have been responsible for the
strategic planning of development programs for drugs, biologics, and devices in a variety of therapeutic areas.
They have published more than 20 articles in reputed journals. Dr. Wilkerson holds her PhD in Biochemistry
from the Stanford University School of Medicine, where she was a National Science Foundation Pre-Doctoral
Fellow. Dr. Baker holds her PhD in Biometry and Epidemiology from the Medical University of South Carolina
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