FOCAS TRIAL Enrolling Site Resources

FOCAS Trial
FOCAS Trial: Focal Cerebral Arteriopathy Steroids (FOCAS)

ENROLLMENT RESOURCES, TRAININGS, STUDY TEAM MEETINGS and NEWLETTERS

ENROLLMENT RESOURCES

Essentials For Acute Enrollment

Hotline Phone Numbers
Protocol v1.4
Manual of Procedures (MOP) v1.3
Inclusion/Exclusion Criteria V1
Daily Inpatient To-Do List v1.4 Word | PDF
Daily Inpatient Checklist v1.0 Word | PDF
Appendix 2 - Neuroradiology Guidelines v1.2
Appendix 3 - Neuroimaging Guidelines v1.2
Appendix 4 - FCA Clinical Guidelines v1.2
Appendix 5 - Laboratory Manual v1.1
Appendix 6 – Data Collection Guidelines v1

Study Team Tools

Hotline Phone Numbers
WebDCU™ Login Page
Study Team Tools Table of Contents (September 20, 2024)
Site Readiness Review List v1.2
Schedule of Events v1
Frequently Asked Questions v1.2
Daily Inpatient To-Do List v1.4 Word | PDF
Daily Inpatient Checklist v1.0 Word | PDF
Nurse Specimen Collection Guidelines v1
Subject Binder Template V1
Site Monitoring QA Checklist V1
FOCAS ClinicalTrials.gov

Slide Decks

Payment Schedule / Statement of Work

Payment Schedule / Statement of Work (8/17/23)

Site Packet

Canadian Sites: Contact us for the Canadian version of the FOCAS site packet, including the protocol and informed consent documents

Site Packet Table of Contents (Aug 14, 2024)
Protocol v1.4
Protocol Signature Page v1.4
Site Summary v1
Manual of Procedures (MOP) v1.3
Appendix 1 - Pharmacy Guidelines v1
Appendix 2 - Neuroradiology Guidelines v1.2
Appendix 3 - Neuroimaging Guidelines v1.2
Appendix 4 - FCA Clinical Guidelines v1.2
Appendix 5 - Laboratory Manual v1.1
Appendix 6 – Data Collection Guidelines v1
Baseline Interview v1.1
Study Drug Diary: English | Spanish
Tolerability Questionnaire v1
Recovery and Recurrence Questionnaire (RRQ v1
Pediatric Stroke Outcome Measure (PSOM) v1
Pediatric NIH Stroke Scale (PedNIHSS) v1
Pediatric NIH Stroke Scale (PedNIHSS) Short Form v1
Training Attestation Form v6
(Note: Depending on your browser's PDF viewer, you may need Download/Save to computer to Sign)
Individual COI Form v1
Birthday Card Templates v1
Reminder Cards English v1
Reminder Card - Fillable Template: English | Spanish
Site Training Log v1
PCP Notification Letter v1

Protocol Training

WebDCU & Advarra Guidelines

Study Team Training

Open Office Hours

FOCAS Office Hours will be held on the 4th Wednesday of every month at 1pm PT / 4pm ET

August 28, 2024
September 25, 2024
October 23, 2024
November 27, 2024

Additional Training

E-consent User Guidelines
Neuroradiology training: Slides | Video
Peds NIHSS Training
WebDCU Regulatory Database Webinar (7-19-23)
Study Overview & Budget Webinar (6-5-2023)
REDCap E-Consent Training : Webinar | Slides
REDCap "Recap" E-Consent Training : Webinar

Upcoming Meeting Dates

FOCAS Investigator & Study Team Meetings will be held on the 1st Friday of every other month (the even numbered months) at 11am PT / 2pm ET Via Zoom. We will host ad-hoc meetings or trainings as needed via Zoom or in-person, which are also listed below. A calendar invite will be sent in advance with the meeting details.

Monday, November 11^th, 2024, Time: 4:10pm PT/ 7:10pm ET Child Neurology Society, San Diego, California (In-person & Via Zoom)
Friday, December 6, 2024 11am PT / 2pm ET

Past Investigator Meetings

Date	Description	Content
10/25/24	Investigator & Study Team Meeting	Webinar \| Slides
8/9/24	Investigator & Study Team Meeting	Webinar \| Slides
6/7/24	Investigator & Study Team Meeting	Webinar \| Slides
5/3/24	Investigator & Study Team Meeting	Webinar \| Slides
2/26/24	Investigators & Study Team Meeting	Webinar \| Slides
2/6/24	Investigator & Study Team Meeting, ISC	Webinar \| Slides
10/4/23	Investigator & Study Team Meeting, CNS	Webinar \| Slides
2/7/23	Investigator & Study Team Meeting, ISC	Webinar \| Slides
2/3/23	Investigator & Study Team Meeting	Webinar \| Slides