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.

13. Do sponsors and CROs negotiate budgets and contracts with each JHCRN site?

No. There is one budget and one contract between sponsor and JHU that includes costs for the JHU principal investigator and JHCRN site(s). A JHU budget specialist develops and negotiates all study budgets for the JHCRN.

12. Who does the sponsor and CRO correspond with at the affiliate sites, the JHCRN network coordinator or research staff?

Prior to study start-up, the network coordinator will be the main point of contact to help research staff get started. The network coordinator may have some contact with the sponsor/CRO after start up, but it is preferred they correspond with the research staff directly.

6. What is the Network Coordinator role?

Each JHCRN site has an assigned network coordinator who liaisons between the Johns Hopkins investigator, JHCRN site investigator, and their respective research teams. Responsibilities include: • Facilitating the identification, prioritization, and implementation of clinical trials jointly approved by JH and network site investigators, • Developing and implementing effective workflow processes between JHU and the network site in opening research studies, and • Serving as a main point of contact for both institutions.

9. Does the JHCRN have a site management plan?

Yes. It is available upon request.

8. Does each JHCRN site have its own principal investigator?

There is one principal investigator for each study who is a Johns Hopkins employee. A lead site investigator is designated at each JHCRN site who is accountable for local study oversight under the direction of the Johns Hopkins principal investigator.

7. How do sponsors and CROs identify a principal investigator for a study?

A JHCRN network coordinator can help you identify a JHU principal investigator. Coordinator contact information can be found at: http://ictr.johnshopkins.edu/clinical/clinical-resources/human-subjects-research-core/jhcrn/jhcrn-network-coordinators/.