11. Who takes responsibility for reporting adverse events from the Network sites to IRB, sponsor, and other regulatory agencies?


The site investigator notifies the principal investigator (PI) of any event meeting expedited reporting requirements as soon as possible. Event reporting to sponsor will first be completed by the principal investigator or site investigator. The PI will determine this reporting responsibility at the onset of a study, and also report to the JHM IRB, and other regulatory agencies as required.

10. How does the principal investigator oversee study conduct at JHCRN sites?


The Johns Hopkins principal investigator and lead site investigator(s) communicate regularly about all study activities to ensure quality and integrity of each study.

16. Who ensures research staff at JHCRN sites are appropriately trained in the conduct of human subjects’ research?


The Johns Hopkins Medicine IRB requires human subjects research compliance training, both initial and continuing, be completed by each investigator and other study team member(s).

15. Where does monitoring take place and where are regulatory documents kept?


Routine study monitoring occurs at both the main Johns Hopkins central site as well as at each participating JHCRN site. The sponsor’s monitor arranges visits with individual sites on mutually convenient dates. Regulatory documents are maintained by the PI’s team at Johns Hopkins for all participating JHCRN sites.

14. Do sponsors or CROs pay the JHCRN sites directly for their study participation?


No. Payment to affiliate sites is managed by JHU.