Internal auditing of clinical research policy. 3364-70-28

Policy Class: Research
Policy Action: New policy proposal
Purpose of Policy: The primary purpose of the internal audit process is to ensure the protection of human subjects, verify the validity and accuracy of data collection, identify non-compliance, and take corrective action when necessary.  The audit process involves verifying subject eligibility, protocol adherence, and regulatory compliance according to FDA, ICH Good Clinical Practice, University policies, and all other applicable regulations.  The internal auditing of clinical trials will promote continuous improvement opportunities by providing an increased awareness of University policies to researchers and staff as well as education of best practices to ensure the University is conducting consistent high quality research.
This policy supersedes: n/a, Keywords: internal audit, monitoring procedures, regulatory compliance, protocol adherence
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Abstract/Description: Policy Class: Research

Policy Action: New policy proposal

Purpose of Policy: The primary purpose of the internal audit process is to ensure the protection of human subjects, verify the validity and accuracy of data collection, identify non-compliance, and take corrective action when necessary. The audit process involves verifying subject eligibility, protocol adherence, and regulatory compliance according to FDA, ICH Good Clinical Practice, University policies, and all other applicable regulations. The internal auditing of clinical trials will promote continuous improvement opportunities by providing an increased awareness of University policies to researchers and staff as well as education of best practices to ensure the University is conducting consistent high quality research.

This policy supersedes: n/a
Subject(s): Research
Alumni/Friends of UT
Staff
Students