ISPCTN Communication
As a reminder, a weekly checklist comes out each Friday highlighting action items and brief updates for clinical sites. The ECHO ISPCTN monthly bulletin comes out on the first Tuesday of each month.
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ECHO ISPCTN Steering Committee
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ECHO ISPCTN Outcomes Working Group Charter
Action Requested
The revised ECHO ISPCTN Outcomes Working Group Charter was sent via email to ISPCTN Steering Committee principal investigators/representatives on Friday, May 1. Please submit your vote to endorse (or not) this charter by COB on Friday, May 8. After the charter has been endorsed, the DCOC will start forming working groups. Send your endorsement to Jessica Snowden.
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Virtual F2F ISPCTN
Steering Committee Meeting
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May 12: 2:00 - 5:30 p.m.
May 13: 2:00 - 5:30 p.m.
(Eastern Times)
Action Requested
Breakout Session Registration
At the upcoming May 12-13 virtual meeting, you will have the opportunity to attend one of four breakout sessions. Please use this link Breakout Signups to register for a breakout session each day of the virtual meeting. Breakout registration will close on Friday, May 8. The DCOC will assign attendees to breakout rooms on a first-come, first-served basis, so sign up early.
Please share the Virtual Meeting Agenda and Breakout Signups with those on your team who will be attending the meeting. A pre-meeting information email complete with a Virtual Meeting Guide will be shared with all registered attendees by Friday, May 8.
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The VDORA1 revised protocol was approved by the central IRB on May 4. The revisions include a minor adjustment to allow the 5 remaining phase 1 participants to submit their final pharmacokinetic samples up to a year after starting their study drug and the planned dosing changes for phase 2 of the study. The DCOC is working to update each site’s informed consent forms (ICF) by adding local context information to the revised ICF.
Action Requested
The DCOC has also sent VDORA1 site team draft budgets for the next phase of the study. Please work with your VDORA1 team to complete their budget and IRB documents as soon as possible so we’re ready to reactivate sites for phase 2.
The study team is closely monitoring the research restrictions in place at our VDORA1 sites as well as the data about COVID-19 and asthma so that we can plan for a safe resumption of study activities.
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Revised Protocol - Next Steps
The revised iAmHealthy feasibility pilot protocol revisions include a transition to remote consent and at-home measurements so that the study can resume without face-to-face encounters. This protocol was approved by the central IRB on May 4 and will follow a similar process of updating the budgets and local ICFs. We will continue to provide updates on both protocols as they move through these approval steps.The DCOC will send the approved version with IRB approval letter to sites.The study is on track to start virtual consent and enrollment on June 1, 2020.
The DCOC sent an updated contact list that includes the new diet-recall team members. They have begun contacting consented participants who have not completed their diet recall. The diet recall team will contact sites if they have problems contacting participants.
Study Supplies Ordering
As sites are working through the logistics of remote consent and baseline measurements, let DeAnn Hubberd or Lora Lawrence know if you need the DCOC to provide your sites with any supplies (e.g., hard copies of documents, extra activity monitors, etc.).
iAmHealthy Site Readiness Questionnaire
All sites need to complete the iAmHealthy Site Readiness Questionnaire by COB Wednesday, May 6.
Site Readiness Questionnaire
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ACT NOW ESC
Currently 20 sites have been added to the central IRB approved protocol for ACT NOW-ESC. Please contact ACTNOWESC@dm.duke.edu with any questions about ESC site activation. Last week, the ACT NOW ESC newsletter launched. This newsletter will be delivered to sites every other week.
ACT NOW ESC NEWSLETTER
ACT NOW Weaning
Ten sites have been added to the SMART IRB instance for the ACT NOW Weaning study, which will allow these sites to cede and start the IRB addition process.
This week, there are two ACT NOW Weaning Pharmacy training sessions. If you are an ACT NOW Weaning site, please be sure a member of your site’s pharmacy team attends at least one of the sessions next week. If you need more information about either of these sessions, email ACTNowSupport@rti.org
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To access the latest ECHO ISPCTN Publications updates, click here:
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To access the ECHO ISPCTN Manuscripts Author Roster, click here:
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ECHO ISPCTN Face-to-face Steering Committee
Save the Date & Register Your Team - August 11-12, 2020
Action Requested
The DCOC has secured a date and venue for the final Steering Committee meeting for ECHO ISPCTN Cycle 1. This meeting's main focus will be looking back at lessons learned from Cycle 1 as well as celebrating the entire Network's successes.
Please save the dates and register below to attend the meeting and reserve your hotel.
Meeting Registration:
REGISTER
Hotel Reservations: Rate: $259 Deadline: July 10, 2020
BOOK YOUR ROOM
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Professional Development Opportunity
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Clinical Trials in the Era of COVID-19
Weekly Webinar Series
The weekly webinar series by WCG Institute includes particular considerations for rural areas which may be helpful as we as a Network prepare for our virtual meeting next week.
WEEKLY WEBINAR SERIES
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Share the Good News from your Site!
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If you have good news that you would like to share in the ECHO ISPCTN Monthly Bulletin please email AskDCOC@uams.edu
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Check out the updated ECHO Website
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