most investigator call - nih strokenet
TRANSCRIPT
3/16/2021
1
MOST Investigator Call2/22/2021
• MOST trial updates• Enrollment
• ICD and HIPAA• eConsent• Outcomes and reminders from Investigator Meeting on 1/12/2021
• Rankin Focused Assessment
• COVID Impact Survey
• Data Management
Agenda
3/16/2021
2
Randomization Emails
• Enrollments: 133 • Sites with Enrollments since 1/12/2021
Barnes Jewish Hospital: Dr. Peter Panagos and Jenny Babka (2)
Abington Memorial Hospital: Dr. Hana Choe and Ashley DePalmo (4)
Wake Forest Baptist Medical Center: Dr. Cheryl Bushnell and Karin Haski (8)
M Health Fairview Southdale Hospital: Dr. Oladi Bentho and Megan Tessmer (13)
SUNY Upstate Medical University: Dr. Julius Gene Latorre and Lena Deb (4)
University of Utah Healthcare: Dr. Adam DeHavenon and Mike Dela Cruz (1)*
Sarasota Memorial Hospital: Dr. Mauricio Concha and Jeanette Wilson (10)
University of Michigan Hospital: Dr. Cemal Sozener and Amanda Melvin (4)
• Sites Released with at least one enrollment: 37
Congratulations to the M Health Fairview Southdale team for enrolling the first patient to receive tenecteplase in MOST!
* Site first enrollment
Enrollment Updates
3/16/2021
3
Randomized by Site
DHR Health
Ochsner Medical Center ‐Main Campus
Jackson Memorial Hospital
University of Mississippi Medical Center
Akron General Medical Center
Mount Sinai Beth Israel
Cedars‐Sinai Medical Center
Mercy Health West Hospital
UPMC Presbyterian Hospital
UPMC Mercy Hospital
Rush University Medical Center
University of Wisconsin University Hospital
Beth Israel Deaconess Medical Center
Miami Valley Hospital
UCSD Health La Jolla
University of New Mexico Hospital
UF Health Shands Hospital
WVU Healthcare Ruby Memorial Hospital
Tampa General Hospital
Loyola University Medical Center
Massachusetts General Hospital
Ronald Reagan UCLA Medical Center
UMASS Memorial Medical Center
Swedish Medical Center
Mercy Hospital Anderson
The Mount Sinai Hospital
University of Louisville Hospital
NYP Weill Cornell Medical Center
Stanford University Medical Center
St. Luke's University Hospital ‐ Bethlehem Campus
San Francisco General Hospital
UCSF Medical Center
Henry Ford Hospital
Grady Memorial Hospital
Sites Pending First Enrollment
3/16/2021
4
Randomized by Month
133 subjects behind target
Cumulative Randomized by Month
3/16/2021
5
• Study Drug Administration Retraining Attestation signed by PI and uploaded to “Attestation of Study Drug Administration Retraining” placeholder under Site Documents
• Protocol v5.1 Principal Investigator Training Attestation signed by PI and uploaded to PI’s “Protocol Training” placeholder under People Documents
• Local Tenecteplase Protocol You may waive this document and the reason waived should state that your site will not be treating subjects with tenecteplase. If you intend to use tenecteplase, documentation uploaded to the “Local Tenecteplase Protocol” placeholder under Site Documents should include the following information:• The date that your site switched to tenecteplase
• The tenecteplase dosage used, including max dose
• Include if alteplase will still be used for acute stroke treatment and the indication for when it will be used
• Your institution’s acute stroke treatment decision algorithm or protocol
• Please refer to the MOST Regulatory Document Parameter Guidelines for WebDCUTM in the Toolbox
Regulatory Document Reminders
• All sites will be required to upload the signed informed consent document and the signed standalone HIPAA document for remote monitoring by the NDMC for all enrolled subjects. The two signed documents must be uploaded into WebDCUTM as a single PDF file.
• Reminder that the informed consent process for MOST involves three separate documents:1. Informed Consent
2. Standalone HIPAA Authorization
3. Participant Study Information Sheet
• Informed consent document will be updated before the end of April to change the sponsor information from University of Cincinnati to Washington University in St. Louis
Informed Consent and HIPAA
3/16/2021
6
Old version asked if participant/LAR would like to receive a PDF copy after completing each form (ICD, HIPAA etc.).
eConsent Updates
Test link: https://redcap.research.cchmc.org/surveys/?s=4YKLJC7AYY
Old version asked if participant/LAR would like to receive a PDF copy after completing each form (ICD, HIPAA etc.).
New version asks for participant/LAR email after all forms are completed instead of asking if they would like to receive PDFs.
All PDFs now sent in one email to participant/LAR, and one email to study team.
eConsent Updates
3/16/2021
7
Updated Randomization Verification Form
Study Drug Administration Best Practice 1. Site pharmacies should withdraw the bolus into a syringe before dispensing to
the bedside.
2. Study team members should perform a timeout after the bolus is administered to ensure the appropriate rate for 0‐2 hour dose is programmed.‐ The weight‐based dose including bolus volume, dosing rates and dosing duration according to the Randomization Verification Form MUST be confirmed in the orders entered in the EMR.
3. Study team members MUST communicate with the bedside nurse before 2‐12 hour dose is initiated to facilitate proper transition from 0‐2 hour dose to 2‐12 hour dose.
We ask that all teams abide by these guidelines.
3/16/2021
8
Summary of Protocol v5.1 ChangesInclusion/Exclusion
• Treated with 0.9mg/kg IV rt‐PA or 0.25mg/kg IV TNK within 3 hours of stroke onset or time last known well
• Any surgery, or a biopsy of parenchymal organ in the past 30 days
• Positive urine or serum pregnancy test for women of child bearing potential
• Elevated pre‐thrombolysis PTT above laboratory upper limit of normal
Summary of Protocol v5.1 Changes (cont’d)• All study medications must be stopped at 12 hours from the initial bolus of study medication regardless of interruptions to the infusion.
• An aPTT will be assessed at 2 hours and 6 hours, according to the WebDCUTM
generated instructions, in argatroban arm subjects.
• Between 24 hours and hospital discharge, a brief survey of the consent experience will be obtained from the subject or surrogate who signed the ICD. If the survey cannot be administered before discharge, it can be collected up to the Day 30 visit.
• All adverse events (AEs)*, all Serious AEs, and all safety outcomes will be reported from randomization through Day 3 or Discharge, whichever comes first. After Day 3/Discharge, all serious AEs and all safety outcomes will be reported.*Removed requirement for non‐serious AEs to be study drug‐related
3/16/2021
9
Background: DSMB recommendation to increase compliance with blinded 30 and 90‐day mRS assessments and implement a structured mRS interview tool.
• The RFA takes 3–5 minutes to apply and provides clear, operationalized criteria to distinguish the 7 assignable global disability levels.1
• There is flexibility to adhere to usual interview flow while ensuring all information fields on the RFA are completed.
• Should be applied for the 30‐ and 90‐day mRS assessment, and at baseline, if applicable, to confirm the mRS assessment.
Rankin Focused Assessment
1. Saver JL, Filip B, Hamilton S, et al. Improving the Reliability of Stroke Disability Grading in Clinical Trials and Clinical Practice: The Rankin Focused Assessment (RFA). Stroke. 2010 May; 41(5): 992–995.
Rankin Focused Assessment
3/16/2021
10
Rankin Focused Assessment
Data Reminders• General Reminders
• CRF Collection
• Baseline F143
• F126 – Rule Violation
• Consenting and Monitoring
3/16/2021
11
General Reminders
• Please do NOT open WebDCUTM in multiple tabs or windows!
• Please remember to enter screen failures
• CRF data must be submitted within 5 days of collection• Exceptions:
• Adverse Events must be submitted within 5 days of knowledge of the event
• Death must be reported within 24 hours of knowledge of the event
• DCRs should be responded to within 5 days • Please remember to respond to the DCR after updates have been made and be sure to submit the CRF so that we can close the query.
CRF Collection
• Every subject must be moved to the End of Study visit.
• All CRFs must be completed, even if in completing them you are indicate that the data is not collected.
• All rules must be dismissed. You can dismiss a rule by selecting the pencil icon below the rule violation ( )
• Need documentation as to why a visit is out of window. • Add to General Comments
3/16/2021
12
Baseline F143 • Please remember that the NIH score on F143 at the baseline visit should be the same one used to randomize a subject on F102.
• The NIH assessment should be completed before rt‐PA administration
• If we have queried you to update F143 because it does not match the one on F102, remember to update the entire form and not just the score at the end.
F126 – Rule Violation
• This means that subject has an adverse event reported on F104 where Q07 Outcome = ‘Continuing, follow‐up is required’.
• Since the subject is at end of study and we cannot do any more study related activities, Q07 will need to be updated.
• Once F104 is updated, you will need to go back and resubmit F126.
3/16/2021
13
Consenting and Monitoring Updates• Informed Consent Form
• Reminder – Please make sure to upload the ICF and HIPAA form as one document to WebDCU for review. This request is for ALL randomized subjects.• IF the HIPAA form was not used, please reach out to Iris Deeds, Melissa Hoffman, and Katie Trosclair ASAP.
• Please make sure to check and respond to any open DCRs• If using eConsent, please make sure to upload the Attestation Form along with the signed ICF for review
• If a NTF is requested, please remember to upload NTF along with original ICF for review (in one upload)
• Site Reports • Early April
• Monitoring visits • In process
• Virtual site check‐in• In process
NDMC Contacts
Jocelyn Anderson ‐ Data [email protected]
Katie Stever‐ Data [email protected]
When to contact: Any WebDCU‐related, data entry, Aspera, user accounts, or CRF questions
Katherine Trosclair – Site Monitoring Manager
When to contact:
If you have WebDCU‐related DOA/regulatory database questions, Informed Consent Remote Monitoring questions, or Site Monitoring questions
