By Philip Cola, Aviva Grosbard, Carol Fedor

Coordinators are an critical component of the medical learn staff, and are necessary to the effective operating of medical trials. but, the enter of coordinators is usually unacknowledged and studying and coaching possibilities will be scarce. "Responsible study: A advisor for Coordinators" presents a entire source for coordinators (both skilled and new), screens, and different research web site execs. The booklet supplies useful details at the many actions and duties which are undertaken by means of the trendy coordinator. The overseas authorship guarantees that the content material is appropriate to the worldwide physique of study coordinators.

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SOPs play a vital role in ensuring that research studies are performed in compliance with the guidelines and regulations; they act as a systematic set of procedures that ensure that the quality of every aspect of the study is maintained. qxd 29/9/05 15:03 Page 34 Responsible Research • Chapter 2 By being aware of the major guidelines and regulations, and by understanding how they should be implemented, you can ensure that your clinical research is safe and efficient. References 1. 2. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans 1998 (with 2000, 2002 updates).

It defines three important ethical human rights: respect, beneficence, and justice. Also referred to as the Common Code, The “Belmont Report” embodies the fundamental ethical principles on which US federal legislation on clinical research is based. 600 men were studied between 1932 and 1972, including 201 ‘controls’ (those without syphilis). The HSP problems were two-fold: • Participants in the study were misinformed regarding the reasons for conducting the study. • Appropriate medical care was withheld simply in the interest of understanding the natural progression of the disease.

Canadian Institutes of Health Research, Personal Information Protection and Electronic Documents Act: Questions and Answers for Health Researchers. Ottawa, ON: Public Works and Government Services Canada, 2001. 7. Fedor CA. The coordinator’s forum: follow-up to the effect of HIPAA. Clinical Researcher 2003;3(7):24–6. 8. Research Repositories, Databases, and the HIPAA Privacy Rule. NIH Publication Number 04-5489, 2004. pdf. Accessed February 18, 2005. 9. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data.

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