FOCAS TRIAL Enrolling Site Resources

NIH STROKENET

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

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

WebDCU & Advarra Guidelines

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.

Friday, April 4th 2025
Friday, June 6th 2025
Friday, August 1st, 2025
Friday, October 3rd, 2025
Friday, December 5th, 2025

FOCAS CRC Meetings will be held on the 4th Wednesday of every other month at 1pm PT / 4pm ET via zoom. These are in replacement of the FOCAS office hours to highlight refresher sessions for the study team. A calendar invite will be sent in advance with meeting details”

Wednesday, May 28th, 2025
Wednesday, July 23rd, 2025
Wednesday, September 24th, 2025

Past CRC Meetings

Date	Description	Content
3/19/25	CRC Meeting	Webinar \| Slides

Past Investigator Meetings

Date	Description	Content
2/4/25	Investigator & Study Team Meeting, ISC	Webinar \| Slides
12/6/24	Investigator & Study Team Meeting	Webinar \| Slides
11/11/24	Investigator & Study Team Meeting, CNS	Webinar \| Slides
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

StrokeNet First Friday Update

NEWSLETTERS