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. 2011 Mar;7(2):124-8.
doi: 10.1200/JOP.2010.000216.

Clinical investigator responsibilities

Allison R Baer  1 , Susan Devine, Chris David Beardmore, Robert Catalano
Affiliations

Clinical investigator responsibilities

Allison R Baer et al. J Oncol Pract. 2011 Mar.

Abstract

When conducting a clinical trial, it is important that clinical investigators successfully meet all research expectations, including regulatory requirements and the Guidelines for Good Clinical Practice.

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Figures

Figure 1.
Figure 1.
Investigator responsibilities throughout the life of a study. Copyright Hospital for Sick Children, Toronto, Ontario, Canada. Adapted with permission. IRB, institutional review board; CRF, case report form; AE, adverse event; SAE, severe adverse event.
Figure 2.
Figure 2.
Research team meeting agenda. Copyright Hospital for Sick Children, Toronto, Ontario, Canada. Adapted with permission.
See this image and copyright information in PMC

References

    1. International Conference on Harmonisation, Good Clinical Practice (ICH GCP). 1.34 Investigator. http://ichgcp.net/?page_id=377.
    1. Zon R, Meropol N, Catalano R, et al. American Society of Clinical Oncology statement on minimum standards and exemplary attributes of clinical trial sites. J Clin Oncol. 2008:2562–2567. - PubMed
    1. US Department of Health and Human Services, Office for Human Subjects Research. Belmont Report. Ethical Principles and Guidelines for the Protection of Human Subjects of Research. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html. - PubMed
    1. International Conference on Harmonization, Good Clinical Practice (ICH GCP). 1.36 investigator's brochure. http://ichgcp.net/?page_id=381.
    1. Society of Clinical Research Associates. Education. http://www.socra.org/html/education.htm.

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