Clinical Trial Compliance

Ensuring local, federal, and international regulatory compliance of your clinical study.

Numerous laws and regulations govern clinical research practices on regional, national, and international levels, and complying with these guidelines is a fundamental yet complex building block of all activities involved in clinical research. Maintaining compliance with these laws and regulations will ensure that:

Do you want to learn more about how to navigate the various regulatory requirements for your research program?

In order to ensure that all clinical experts and personnel involved in the clinical trial process understand the importance of meeting regulatory standards, it is important to select a biotech CRO that possesses a comprehensive Human Research Protection Program (HRPP).

Beyond safeguarding the rights and welfare of research participants, the HRPP aims to educate investigators, sponsors, research staff, and IRB members on the ethical durability of all research activities and what measures must be taken to maintain compliance.

Our Human Research Protection Program

ethica CRO’s HRPP oversees all our research activities to ensure that our research programs constantly conform to all applicable laws and regulations. These duties include—and are not limited to—internal monitoring of research activities, vendor selection processes, and the implementation of a comprehensive unanticipated problem reporting and management system.

To learn more about our HRPP, please visit our Human Research Protection Program page.

Our Approach to Regulatory Compliance for Clinical Research

At ethica CRO, compliance is an integral component of our participant-centric approach to clinical research. Above all, we are committed to protecting the rights and welfare of all research participants in all of our research activities.

Our Compliance with Regional, National, and International Guidelines

At ethica CRO, we are proud to be the first accredited CRO in the world. Thanks to our robust SOPs and comprehensive HRPP, we have successfully maintained our accreditation for nearly fifteen years.

ethica CRO’s clinical research activities and HRPP adhere to all applicable international, American and Canadian principles, laws, and regulations, including:

International Guidelines

UNESCO Universal Declaration on Bioethics and Human Rights
World Medical Association (WMA), Ethical Principles for Medical Research Involving Human Subjects (Declaration of Helsinki)
International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Good Clinical Practice: Consolidated Guideline (GCP)
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-Related Research Involving Human Subjects

Canadian Acts, Regulations and Guidelines

Personal Information Protection and Electronic Documents Act (PIPEDA)

Food and Drug Regulations of Health Canada – Part C
- Division 2 – GMP Guidelines
- Division 5 – Drug for Clinical Trials Involving Human Subjects
Natural Health Products Regulations of Health Canada – Part 4 – Clinical Trials Involving Human Subjects
Medical Device Regulations from Government of Canada Medical – Part 3 – “Medical Devices for Investigational Testing Involving Human Subjects”
Cannabis Act and Regulations
Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada, Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)

US Acts, Regulations and Guidelines

Health Insurance Portability and Accountability Act (HIPAA) and Regulations
21 CRF Part 11 – Electronic Records; Electronic Signatures
21 CRF Part 50 – Protection of Human Subjects
21 CRF Part 54 – Financial Disclosure by Clinical Investigators
21 CRF Part 56 – Institutional Review Boards
21 CRF Part 210 – cGMP in Manufacturing, Processing, Packing, or Holding of Drugs
21 CRF Part 211 – cGMP for Finished Pharmaceuticals
21 CRF Part 312 – Investigational New Drug application
21 CRF Part 812 – Investigational Device Exemptions
45 CRF Part 46 – Protection of Human Subjects
Section 801 – Food and Drug Administration Amendments Act (FDAAA 801)
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report)