IRB/HRPP Auditing and Monitoring

Prepping for Auditing and Monitoring
ensures a project compliance

Compliance Corner

We assist with preparation for IRB Office of Human Research Protections (OHRP), Federal Drug Administration (FDA) or Good Clinical Practice (GCP) auditing of regulatory requirements, a risk assessment and assessment of clinical components are met. You can schedule time with us to determine the level of review that may be needed for your clinical research studies. We can help to ensure proper IRB decisions based on the regulatory requirements. Contact Us for a determination of the level of audit necessary for your organization.

IRB Services US is pleased to offer Good Clinical Practices (GCP), auditing and monitoring for clinical research professionals. We also offer an initial risk assessment for GCP as well as many years of experience and expertise in GCP auditing & Monitoring, education and training. Contact us for more details on our rigorous risk assessment process in the area of GCP compliance

The GCP training and risk assessment process, researchers can assess:

• The regulations and their implications for practice

• Demonstrated proficiency in the practical application of GCPs

• GCP competency

Auditing & Monitoring

• HRPP development

• HRPP auditing

• IRB preparatory for audit

• Develop a monitoring plan

• Monitoring strategy

• Monitoring methods

• Monitoring of critical data and processes

• Routine monitoring

• HRPP Training

Audit Prep Documents

Educational Resources for Researchers

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