RAMPART: A Coordinator’s Perspective Greater Philadelphia-Southern New Jersey NETT Network Katherine Lamond, Project Manager University of Pennsylvania January 6, 2010

GPSNJ-NETT RAMPART Sites Participating Spoke Hospital Hub University of Pennsylvania (Philadelphia, PA) York Hospital (York, PA) PI: Jill Baren, MD, MBE SC: Katie Lamond PI: Dan Bledsoe, MD SC: Barbie Stahlman, MS Jen Sullivan, PharmD Medic 97 (based at York Hospital) Participating EMS Dept. EMS Coordinator: Dan Bledsoe, MD

GPSNJ-NETT Sites UPenn * † CHOP * † Pennsylvania * St. Luke’s § † Abington § St. Mary’s § Cooper * † Shore Memorial § * Academic § Community † Level 1 Trauma Lourdes § Holy Redeemer § York * §

Challenges Geographic distance –Considerations: EFIC activities Distribution of study supplies and study drug to Spoke Day-to-day coordination Site Verification Visits

Solutions EFIC activities –Conducted group CC activities rather than one-on-one activities –Limited Hub personnel travel to Spoke to 4 days for CC: Recruitment 3 Focus Group sessions 1 Community Meeting –Additional EFIC coordination provided remotely via telephone, fax, and , including summary of CC results. –Spoke team coordinates PD activities with assistance from Hub

Solutions Distribution of study supplies & study drug –Central Pharmacy ships study drug directly to Spoke –Study supplies shipped or ed from Hub to Spoke –Spoke team distributes study boxes to EMS units Day-to-day coordination –Spoke SC is primary SC –Hub Project Manager provides secondary coordination remotely Sends check list after each enrollment Keeps track of expiring regulatory documents Follows up with Spoke team about DCRs, etc.

Solutions Site Verification Visits –Site Initiation Visit / Mock Enrollment (on-site July 2009) –Prepare for or follow up from Site Monitoring Visits & FDA audits; As needed –Flexibility in plan to allow for on-site visit or remote verification (conference calls, check for completeness of data in WebDCU) –Site Verification forms: Subject check list Study check list

Strengths Spoke team Small, highly-dedicated, easily managed study team Handles day-to-day coordination of study well Frequent, often daily communication with Hub team Dedicated paramedics based at Spoke Hospital with a strong interest in RAMPART

Strengths Hub team Secondary coordination from Hub helps Spoke through changes in study personnel (e.g. primary Spoke SC) Provides regulatory support –Drafts IRB submissions –Uploading documents into WebDCU Provides additional resources as needed, for example: –EFIC presentation for IRB members –RAMPART FAQs for Medical Command Physicians

Questions?