We have completed through courses required through the CITI Program (Collaborative Institutional Training Initiative) for clinic human studies.
Getting accredited is an overwhelming endeavor. Just preparing and submitting the application is like a never ending project in its self. Once the application has been submitted running around trying to prepare for the inspection is nearly impossible. To comply with various accrediting bodies is practically unachievable even if you think everything is perfect they generally find something that you are not completely complaint with. Once you become compliant and receive your accreditation you are still not done. The meetings seem endless to make sure to stay in compliance not to mention trying to meet State and Federal laws. We help by providing our expertise in all aspects of accreditation.
Here’s how we can help:
• Preparing the application
• Submitting the application
• Preparation for Inspection
• Policies & Procedures
• Peer Review
• Quality Management and Improvement
• Risk Management
• Facility & Environment Issues
• Staffing Adequacy
• Fire & Emergency
• Infection Training
• Credentialing and Privileging
• Financial Management & Accountability
• Mission & Goals, Short & Long
• Organization Structure & Chain of Authority
• Legal & Ethical Matters
• Board Meetings
Our experience with the accreditation process has allowed for years of knowledge digging into each area of compliance. This has given us the opportunity to work with other clients for similar projects that might fit into one of these categories but not necessarily need to be accredited. Our administrative skills, project management, financial background, and State & Federal knowledge has made us key to solving your problems.
Our experiences include:
Animal Care and Use (ACU)
Animal Care and Use (ACU) materials cover general principles of ethical care and use of animals in research, training, and testing, as well as focusing on the care and use of particular species.
Biosafety and Biosecurity (BSS)
BSS content covers the principles of biosafety and biosecurity, including safe use and containment of biohazardous agents.
Clinical Research Coordinator (CRC)
CRC content provides a foundational training specifically focused on operational and regulatory elements necessary for the ethical conduct of clinical research, tailored to the needs of clinical research professionals.
Clinical Trial Billing Compliance (CTBC)
CTBC course focuses on developing the knowledge and skills necessary to maintain compliance and best practices associated with clinical research billing.
Conflicts of Interest (COI)
COI content covers the revised U.S. Public Health Service (PHS) regulations on financial conflicts of interest and an investigator’s responsibilities. A COI refresher course is available.
Disaster Planning for the Research Enterprise (DPRE)
DPRE content provides those responsible for research oversight at organizations with information about disaster planning and business continuity.
Essentials of Research Administration
Research Administration course provides an overview and explanation of research administration and professional positions within sponsored programs, as well as responsibilities for research administration.
Export Compliance (EC)
EC content provides an introduction to export compliance, as well as role and responsibility tailored training reflecting key individuals and departments across organizations that must adhere to export compliance regulations.
Good Clinical Practice (GCP)
GCP content includes distinct courses tailored to the different types of clinical research, suitable for research teams involved in clinical trials of drugs, biologics, and devices.
Good Laboratory Practice (GLP)
GLP content provides an overview of how nonclinical laboratory studies should be planned, performed, monitored, recorded, reported, and archived.
Healthcare Ethics Committee (HEC)
HEC course focuses on developing the knowledge and skill base necessary for being a successful HEC member.
Human Subjects Research (HSR)
HSR content includes two tracks, one with a biomedical focus, and another designed for the social, behavioral, and educational disciplines. Both tracks cover the historical development of human subjects protections, as well as current information on regulatory and ethical issues. Courses specific to institutional/signatory officials, IRB administrators, and IRB chairs are also available.
IRB Administration content provides members of an Institutional Review Boardâ€™s (IRB) administrative office and Human Research Protection Program (HRPP) with a comprehensive review of the critical areas associated with IRB and IRB office operations.
Information Privacy and Security (IPS)
IPS content covers the principles of data protection, focusing on the healthcare-related privacy and information security protections of the Health Insurance Portability and Accountability Act (HIPAA).
Responsible Conduct of Research (RCR)
RCR courses cover core norms, principles, regulations, and rules governing the practice of research.