REGULATORY

Activities surrounding human clinical trials must follow regulations specified by governmental, quasi-governmental, and harmonization-oriented agencies. These regulations are put in place to protect current and future participants with respect to safety and privacy as well as to drive honest decision making based on the study results by preserving scientific integrity. The particular practice, interpretation, or implementation of these regulations is driven by the characterization of the intended population and by the intended use for the devices or pharmaceuticals.

Key guidance documents are put forth by two principal regulatory entities:

The United States Food and Drug Administration (hereafter referred to as the FDA) and the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals in Human Use (hereafter referred to as the ICH). Similar governmental and regulatory bodies in the international community, such as EMEA (European Medicines Agency) and PMDA (the Japanese Pharmaceuticals and Medical Devices Agency) oversee activities within their respective domains, but are heavily influenced by the standards promulgated by the FDA and ICH.

Adherence to the principles of good clinical practices (GCPs), including adequate human subject protection (HSP) is universally recognized as a critical requirement to the conduct of research involving human subjects. Many countries have adopted GCP principles as laws and/or regulations. The Food and Drug Administration’s (FDA’s) regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both GCP and HSP. These FDA regulations and guidance documents are accessible from this link:

http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ucm155713.htm

Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well- being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki, and that the clinical trial data are credible.

The objective of this ICH GCP guidance is to provide a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.

The guidance was developed with consideration of the current good clinical practices of the European Union, Japan, and the United States, as well as those of Australia, Canada, the Nordic countries, and the World Health Organization (WHO).

http://www.ich.org/products/guidelines.html


FOR MORE INFO :

http://www.hhs.gov/ohrp/humansubjects/index.html

http://www.fda.gov/regulatoryinformation/guidances/ucm122046.htm

http://ccts.osu.edu/education-and-training-programs/research-education-and-training-programs/clinical-research-coordinator-resources/regulatory-documents

http://www.icssc.org/Presentations/Capetown2007/16RegulatoryDocuments(Jones).pdf

http://www.bumc.bu.edu/crro/files/2010/03/Regulatory-binderFAQs-3-4-10.pdf


PATIENT REGISTRATION

Boca Raton Clinical Research follows HIPAA Guidelines and maintains patient confidentiality. Patient registration, medical history, family history and trial participation is stored in our patient database and is never shared or sold