Regulatory Parameters Document v.11.0 (Updated 1-27-17)
This document shows the regulatory requirements (including training) for each role in the study. Use this to understand what training you need to complete.
POINT Protocol Certification Training Modules
Please view the POINT Protocol Training Module (link below) before taking the Protocol Test, and view the POINT Training Module for ABCD² Score and TIA Mimics (link below) before taking the ABCD² and Enrollment Tests. There are 3 protocol certification tests to complete: Protocol, ABCD² and Enrollment. Upon successful completion of each test please send your certificate to your Study Coordinator.
1) Protocol Test: Passing this certification is required for the PI and primary Study Coordinator.
POINT Training Module for ABCD² Score and TIA Mimics (Click the PLAY icon to activate the sound for each slide).
2) ABCD² Test: Passing this certification test is required for those who will be completing the ABCD² assessment with subjects.
3) POINT Enrollment Test: Passing this certification test is required for the PI and primary Study Coordinator.
NIH Stroke Scale (NIHSS)
Instructions: Create an account, click on 'My Activities', then enroll in the appropriate NIHSS Certification.
(NOTE: The AHA and ASA professional education site is charging a fee for this certification; therefore, this link is redirected to a vendor that offers no fee. If you prefer to continue with the AHA/ASA for your certification and pay the fee click here).
This certification is required by those study team members who will be interacting with patients. You must re-certify by the expiration date stated on your certificate.
SIREN-NETT Modified Rankin Scale (mRS)
SIREN-NETT Modified Rankin Scale (NETT mRS) by Neurological Emergencies Treatment Trials (NETT) Network is licensed under a Creative Commons Attribution-ShareAlike 3.0 Unported License.
SIREN-NETT mRS Training
Please watch the mRS training video below, especially if you are unfamiliar with the mRS. Once you have viewed the training, proceed to take the Certification test. The Certification link is located below the video.
NETT mRS Certification Test*
*Once you have successfully passed the Certification Test you will receive an email with your certificate. Please save that email and forward it to your Study Coordinator to upload to WebDCU. The Certification is valid for 2 years.
WebDCU Regulatory Database and Data Training - Catherine Dillon
Please view the data training videos below appropriate for your role in the study and then complete the certificate at the link provided.
WebDCU User Manual (Version 19)
Study Coordinators and Investigators who will be doing data entry:
POINT Complete Data Training (19:25)
POINT Data Training Certificate (to be completed after viewing the data training)**
*Study team members who will be doing enrollment and randomization only are permitted to view the abbreviated training (POINT Abbreviated Data Training - Randomization Procedures). Primary Study Coordinators should watch either the POINT Complete Data Training or the POINT Abbreviated Data Training depending upon the experience level of the individual.
**Study team members who will be performing data entry must have a POINT Data Training Certificate uploaded into WebDCU before the user account will be issued. After viewing the appropriate POINT Data Training video, please complete the POINT Data Training Certificate and e-mail it to your Study Coordinator to be uploaded to WebDCU.
POINT Site Pharmacy Data Training Certificate (to be completed after viewing the data training)*
*Pharmacists who will be performing data entry must have a POINT Site Pharmacy Data Training Certificate uploaded into WebDCU before the user account will be issued. Please e-mail the certificate to your Study Coordinator to be uploaded to WebDCU.
Regulatory Document Coordinators: (Updated 10-28-16)
NOTE: Click on the HD icon at the bottom of the video for a clearer picture and the arrows for full screen mode.
POINT Regulatory Database Training Certificate (to be completed after viewing the data training)*
*Study team members who will be uploading regulatory documents must have a Regulatory Database Training Certificate uploaded to WebDCU before the user account will be issued. After viewing the Regulatory Database Training, please complete the Regulatory Database Training Certificate and e-mail it to your Study Coordinator to be uploaded to WebDCU.
Good Clinical Practice (GCP)
The SIREN-NETT GCP training module is currently being updated and will be available in the near future. Another free option for GCP training is available at the National Institute of Allergy and Infectious Diseases. Click here to access the NIAID training.
Health Insurance Portability and Accountability Act (HIPAA) (NOTE: When completing the online certificate please leave the "UMID" space blank if you are not affiliated with the University of Michigan).
Human Subjects Protection
iPad App for Informed Consent
Training Video (UPDATED 7-30-13)