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2 We will begin the MaRISS Coordinator Call shortly Please place your phone line on mute. 8/26/2016 2

3 Overview Missing data Correct dates on Baseline NIHSS Form 24 hour window for consent CRF Forms What if Scenarios Answering GWTG-Stroke Clinical Trial question for MaRISS Patients MaRISS PRO Tool Recruitment update

4 Missing Data Primary outcome is Day 90 mrs, please make sure to account for this data for each patient on the follow-up form. For any missing data, please indicate NOT DOCUMENTED and enter an annotation in PMT to explain why data is missing. 8/26/2016 4

5 Enter Annotation for Missing data 8/26/ , American Heart Association 5

6 PMT Annotations Let us know any additional information data clarification we need to know, about a particular data element For example: A reason why a data element is missing, different from the norm 8/26/ , American Heart Association 6

7 PMT Annotations 8/26/ , American Heart Association 7

8 Baseline NIHSS Date on the form should be date of clinical assessment For example: If patient arrived on April 1, 2016 and consented on April 2, 2016, the date on the form should be April 1, Enter date of clinical assessment The Baseline NIHSS (at hospital arrival and/or at the time of treatment decision) are clinical assessments done as part of the stroke standard of care. The information should be collected AFTER the patient signed ICF but the date should show when the assessment was actually done.

9 24 hour consent window If it is standard of care at your hospital to conduct the 24 hourr NIHSS, then YES, the MaRISS protocol allows you to consent patients beyond 24 hours of hospital arrival If the NIHSS at 24 hours is NOT standard of care, then a potential MaRISS patient must be consented before 24 hours +/-4 hours, in order to obtain consent and enrollment before 24 hour assessment. MaRISS protocol requires NIHSS at 24 hours +/- 4 hours (from symptom onset) on ALL study subjects.

10 MaRISS Data Collection forms Please make sure the version of forms you are using are the MaRISS Data Collection Forms on the: MaRISS Patient Recruitment Page.

11 What if Scenario #1 Existing MaRISS patient had a stroke readmission. What are next steps? Should they be reconsented and re-entered into PMT? Answer: MaRISS ID should not be entered for second admission. If patient is still participating in the study, re-consent is not required, however the new stroke and hospital admission should be considered a Serious Adverse Event. If the patient received tpa in the initial admission when enrolled in MaRISS, the SAE must be reported to IRB and MaRISS via MaRISS Serious Adverse event form. If the patient did not receive TPA, SAE must be reported to IRB only. 8/26/

12 What if Scenario #2 What if a patient that is already in hospital for a non-stroke related reason presents with stroke like symptoms, would they qualify for MaRISS? Answer: Patients suffering a Mild or Rapidly Improving in-hospital strokes can be considered for screening/enrollment. Patient would be eligible if within 4.5 hours from the onset of symptoms the following conditions are met: He/she is evaluated by a neurologist and identified as suffering a mild (NIHSS 0-5) or Rapidly Improving Stroke Neurological symptoms cannot be attributed to any other concomitant condition A baseline NIHSS is performed as standard of care at the time of neurological evaluation and/or at the time of treatment decision The decision to treat or not to treat with thrombolytics is made within 4.5 h from the onset of symptoms. Note, patient must also meet all other inclusion criteria and none of the exclusion criteria to be 8/26/2016 eligible for MaRISS. 12

13 Answering GWTG-Stroke Clinical Trial question for MaRISS Patients If your hospital is participating in MaRISS and/or ARAMIS studies, please make sure your hospital s Get With The Guidelines -Stroke Abstractor is aware of how to answer the following question in the Get With The Guidelines Patient Management Tool: NOTE: Mild and Rapidly Improving Stroke Study (MaRISS) and Addressing Realworld Anticoagulant Management Issues in Stroke (ARAMIS) are both observational research studies with NO experimental design or intervention and are NOT Clinical Trials. For any MaRISS or ARAMIS Patients who are not enrolled in any other clinical trial, please answer NO for the above question. 8/26/

14 Identifying MaRISS PRO patients Day 1-Day 3 Consent Patient Conduct MaRISS assessments Confirm Eligibility for PRO For each eligible PRO patient MaRISS ID to mariss@heart.org Confirm Day 30, Day 90 process with patient before discharge Identify PRO Patient in PMT Reminders: You still need to do the Day 90 phone call with a PRO patient. The survey is active for 8 days from the time the patient is entered into the HealthCall web portal. Please remember to remind the patient to complete the survey before it expires. Please let us know if you have any questions about the PRO. 8/26/

15 MaRISS Recruitment Goals Overall Goal: 2650 Recruits 6 Recruits per Quarter 2 recruits per Month 100 hospitals recruit from May 2015 to 2017 Each hospital recruits 6 patients every 3 months Each hospital recruits 2 patients per month 15

16 MaRISS Enrollment Current: Participants Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Month

17 Q & A 8/26/

18 ROLL CALL Please to let us know you attended this coordinator call. MARK YOUR CALENDARS Next MaRISS Coordinator call: Monday September 19, 2016 at 12 pm PT / 2pm CT / 3 pm ET 8/26/