nett-workings · minnesota 15 45 6 7 nyp 16 10 not active 2 ... there is a lot going on here at the...

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University of California, SF J. Claude Hemphill, III, MD University of Kentucky Roger Humphries, MD University of Cincinnati Arthur Pancioli, MD University of Maryland Barney J. Stern, MD University of Minnesota Michelle Biros, MD, MS University of Pennsylvania Jill Baren, MD, MBE University of Texas Elizabeth Jones, MD Virginia Commonwealth University Joseph P. Ornato, MD Wayne State University Robert Welch, MD Emory University David Wright, MD Henry Ford Health System Christopher Lewandowski, MD Medical College of Wisconsin Tom Aufderheide, MD New York Presbyterian Hospital Stephan Mayer, MD Oregon Health & Science University Robert Lowe, MD, MPH Stanford University James V. Quinn, MD Temple University Nina Gentile, MD University of Arizona Kurt Denninghoff, MD CLINICAL COORDINATING CENTER (CCC) University of Michigan William Barsan, MD National Institute of Neurological Disorders and Stroke (NINDS) Clinical Trial Group Robin Conwit, MD and Scott Janis, PhD STATISTICAL & DATA MANAGEMENT CENTER (SDMC) Medical University of South Carolina Yuko Palesh, PhD PARTICIPATING HUBS AND INVESTIGATORS Enrollment Update: ALIAS RAMPART ProTECT POINT Arizona 4 55 6 0 Cincinna 18 125 19 3 Emory 18 73 19 1 HFH 8 62 3 12 Kentucky 18 29 2 4 Maryland 5 2 Not Acve 4 Minnesota 15 45 6 7 NYP 16 10 Not Acve 2 Oregon Legacy 24 4 0 Stanford 8 61 9 7 Temple 16 8 5 3 Texas 20 77 16 4 UCSF 13 121 2 2 UPenn 20 24 12 9 VCU 6 56 Not Acve 1 Wayne State 12 170 0 9 Wisconsin 6 44 28 3 TOTAL 203 986 131 71 as of 12/17/10 at 12pm

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NETT-WorkiNgs NEurological EmErgENciEs TrEaTmENT Trials (NETT) NETWork

DEcEmbEr 2010

University of California, SFJ. Claude Hemphill, III, MD

University of KentuckyRoger Humphries, MDUniversity of Cincinnati

Arthur Pancioli, MDUniversity of Maryland

Barney J. Stern, MD University of MinnesotaMichelle Biros, MD, MS

University of PennsylvaniaJill Baren, MD, MBEUniversity of Texas

Elizabeth Jones, MDVirginia Commonwealth University

Joseph P. Ornato, MDWayne State University

Robert Welch, MD

Emory UniversityDavid Wright, MDHenry Ford Health System Christopher Lewandowski, MDMedical College of Wisconsin Tom Aufderheide, MDNew York Presbyterian HospitalStephan Mayer, MDOregon Health & Science UniversityRobert Lowe, MD, MPHStanford University James V. Quinn, MDTemple University Nina Gentile, MDUniversity of Arizona Kurt Denninghoff, MD

cliNical coorDiNaTiNg cENTEr (ccc) University of MichiganWilliam Barsan, MD

National Institute of Neurological Disorders and Stroke (NINDS)

Clinical Trial GroupRobin Conwit, MD and Scott Janis, PhD

sTaTisTical & DaTa maNagEmENT cENTEr (sDmc) Medical University of South Carolina

Yuko Palesh, PhD

ParTiciPaTiNg Hubs aND iNvEsTigaTors

Enrollment Update: ALIAS RAMPART ProTECT POINT

Arizona 4 55 6 0

Cincinnati 18 125 19 3

Emory 18 73 19 1

HFH 8 62 3 12

Kentucky 18 29 2 4

Maryland 5 2 Not Active 4

Minnesota 15 45 6 7

NYP 16 10 Not Active 2

Oregon Legacy 24 4 0

Stanford 8 61 9 7

Temple 16 8 5 3

Texas 20 77 16 4

UCSF 13 121 2 2

UPenn 20 24 12 9

VCU 6 56 Not Active 1

Wayne State 12 170 0 9

Wisconsin 6 44 28 3

TOTAL 203 986 131 71

as of 12/17/10 at 12pm

Pleased to meet you...

Cassidy ConnerPOINT and ProTECT Data ManagerMedical University of South CarolinaCassidy is a Data Manager at the Medical University of South Carolina’s Data Coordination Unit (DCU) where he manages the WebDCU™ POINT and ProTECT trial databases. He handles database design, functionality, and QA, and provides assistance to study team members across all NETT sites that need help using WebDCU™’s POINT and ProTECT databases. Cassidy received an M.S. in applied sociology from Clemson University with a focus in research methods and survey design, and this background has been especially helpful in research database development and case report form design. Outside of work, Cassidy enjoys spending his free time with his girlfriend, Jaime, and golden retriever, Colette.

Catherine Dillon, CCRPProgram ManagerMedical University of South CarolinaCatherine Dillon graduated from the College of Charleston and started her career as a marine biologist at the South Carolina Department of Natural Resources. When she wasn’t shark fishing or scuba diving, she created and maintained databases for the Office of Fisheries Management. After a career change in 2002, Catherine joined the Medical University of South Carolina as a study coordinator within the Institute of Psychiatry. She joined the Data Coordination Unit (DCU) in 2003 and has been there ever since. During her time with DCU, she has been responsible for a broad range of project and data management activities for over 40 protocols including multi-site, international, industry and federally-funded, acute and exception from informed consent trials. She is married to her husband Dan. Together they have a 12-year-old son named Joseph, a 3-year-old daughter named Sophia, and a puppy named Dusty.

Keith Pauls, BSSenior Applications AnalystMedical University of South CarolinaKeith Pauls joined the Data Coordination Unit (DCU) over 6 years ago after receiving a BS in Computer Information Systems from Clemson University and a minor in Business Administration. As a Senior Applications Analyst he works on developing and maintaining the web-based clinical trial management system

(WebDCU™) created by the DCU. Keith enjoys his job because of the freedom to learn and develop new technologies that can be applied to the WebDCU™ system and the wonderful people he has an opportunity to work with. When not in front of a computer, Keith enjoys the outdoors and likes being at the beach and biking around the Charleston area. He also stays active by working out regularly (when motivated) and playing in competitive basketball and tennis leagues.

There is a lot going on here at the NETT-CCC preparing for RAMPART to begin and ALIAS to resume. We know that you have many things going on at your sites as well. In an effort to assist with anything sites

need during this time, Donna Harsh and Erin Zaleski will be reaching out to Study Coordinator(s) at each site to set up an informational phone call. We hope to hear how things are going at the Hub-Spoke complexes and answer any questions you may have. Please look for an email from Erin in the coming weeks to schedule a time for your site.

Platelet-Oriented Inhibition in New TIA TrialPrincipal Investigator: Clay Johnston, MD

ProTECT™ III Principal Investigator: David Wright, MDMark Your Calendars: The ProTECT Investigator Meeting is scheduled for April 28-29, 2011 in Atlanta, GA.Other Reminders: 1) Please provide documentation that Protocol Version 6.0 has been submitted to all IRBs. Remember you have 14 days to submit to your IRB from 12/8/10 when the protocol was made available. Documentation must be uploaded for each Spoke in WebDCU under: ProTECT Full Study v6 IRB Application Submittal. Once approval has been granted, please provide clear documentation from the IRB of the protocol version and approval period: ProTECT Protocol v6 IRB Approval. 2) All Hubs/Spokes need to submit a Revocation Form to IRBs for approval. The updated template is posted in the ProTECT Toolbox under Regulatory. If you have already received IRB approval for a Revoca-tion Form please revise that version to include the updated material provided in the template. Prior to submitting to your IRB, please provide a copy of the site-specific Revocation Form to NETT-CCC for review ([email protected]). After final approval is granted, please upload the form and documen-tation of IRB approval in WebDCU: ProTECT IRB Approved Revocation Form. 3) If there are updates to Informed Consent Forms, please provide a copy (using tracked changes) for NETT-CCC review as well ([email protected]). Current IRB-approved ICFs should be upload-ed in WebDCU: ProTECT IRB Approved Informed Consent Form. -Erin Zaleski ([email protected])

Thank you for your continued commitment to the POINT study! Here are a few important reminders:

1) A study team member must witness and record the loading dose!2) Please make sure the patient understands that the 8 tablet loading dose is ONLY for day one, and thereafter he/she should take only 1 tablet of study medication per day!3) Randomization must take place within 12 hours of the symptom onset.4) Screen Failure Logs are due the 10th day of the following month. -Tess Bonham ([email protected])

High-Dose Albumin Therapy For Neuroprotection In Acute Ischemic Stroke

Principal Investigator: Myron Ginsberg, MD

Mark Your Calendars: For selected sites the next Regional Meeting is scheduled for January 9-10, 2011 in Las Vegas, NV.Other Reminders: Passed Validation in ALIAS WebDCU is now Ready to Submit. Ready to Submit indicates the CRF is saved and has success-fully passed all validation rules which might have resulted in either a Rejection or Warning status, and from the viewpoint of the WebDCU

system is ready to be Submitted. -Sam Mawocha ([email protected])

NETT Network Contact Us: [email protected] (734) 232-2142 Website: http://nett.umich.edu

Publications Corner: OuR Investigators at WorkThe following were submitted for the Society for the Academic Emergency Medicine June 2011 meeting:Siewert N, Kade A, Pinawin A, Ring C, Zaleski E, Larson B, Reilly K, Raymond S, McKague DS, & Silbergleit R. Accuracy of EMS time of Arrival (TOA) measurement using an autonomous instrumented data logger designed for use in clinical trials. Pinawin A, McMullan J, Siewert N, and Silbergleit, R. Minimal Degradation of Midazolam and Loraz-epam in EMS Drug Kits Over 60 Days of STorage in Temperate and Hot Environments.

Look For Updates On

Enrollment In The

Monthly NETT NewsFlash

* Please submit patient enrollment data as soon as possible. This will help us provide the most up-to-date enrollment figures.

* Check the RAMPART website frequently! You can find the total enrollment there.

* If there are any specific requests for notification that enrollment has reached 1024, please forward to Erin Zaleski ([email protected]) as soon as possible.

* Ensure your local plan is in place for end of enrollment, including: * Training of study team about end of enrollment procedures and timelines * Ceasing enrollment and retrieval of study box/study drug within 24 hours of notification that enrollment has reached 1024 * Spreading the word to all medics and study team mem- bers that enrollment has ended * Retiring all study drug in the RAMPART Database within 5 days of end of enrollment Thanks to those who have already provided this informa- tion to NETT-CCC. If you have not yet provided informa- tion for your Hub, including a 24-hour contact list, please send to Erin Zaleski ([email protected]).

* Please respond to all DCRs and SAE requests. This will help make the final monitoring visit go much smoother!

RAMPART End of Enrollment - Important Reminders

A round of applause is in order...Congratulations to the Medical College of Wisconsin team for setting a new NETT record! Their team enrolled one patient in each of our four trials within 48-hours this month! We appreciate all the hard work and teamwork that it takes to pull this off. This is an incredible accomplishment!