Investigative Site
Conduct Standards
C1 – The Organization has written operating procedures and demonstrates practices for assessing and minimizing the risks involved in proposed human research.
C2 – The Organization has written operating procedures and demonstrates practices to establish the delegated responsibilities of individuals subject to the HRPP and individuals outside the HRPP as they relate to each human research study.
C3 – The Organization has written operating procedures and demonstrates practices for the development of Clinical Trial Agreements with Investigators of human research.
C4 – The Organization has written operating procedures and demonstrates practices for the development of Informed Consent Forms and for the process of obtaining informed consent from research participants.
C5 – The Organization has written operating procedures and demonstrates practices for the recruitment of potential research participants.
C6 – The Organization has written operating procedures and demonstrates practices for the compensation of research participants.
C7 – The Organization has written operating procedures and demonstrates practices for monitoring human research.
C8 – The Organization has written operating procedures and demonstrates practices for the management and processing of deviations from the IRB/REB-approved human research.
C9 – The Organization has written operating procedures and demonstrates practices for the proper handling, storage and transfer of biological samples and investigational products.
C10 – The Organization has written operating procedures and demonstrates practices for reporting to the IRB/REB.
C11 – The Organization has written operating procedures and demonstrates practices for ethically conducting research in which confinement of the research participants is required.
