Jump to:
Regulatroy Management Training
Neurologist Training for 1 year Exam
Good Clinical Practice (GCP) Training
Human Subjects Protections (HSP) Training
Research Coordinator Meeting Archive
December 2022 - Screen Failures
March 2023 - Withdrawal of Consent
May 30, 2023 - Clinical Standardization Guidelines for RCs
June 2023 - Arctic Sun Overview
July 2023 - Scheduling the 1 Year Follow Up KKI Call and Neurologic Exam
August 2023 - P-ICECAP Monitoring
October 2023 - P-ICECAP Refresher for Low/No Enrollment Sites
Documents
Regulatory Parameters Document
This document shows the regulatory requirements (including training) for each role in the study. Use this to understand what training you need to complete.
Procedures for Outcomes Data Collection
Training Videos and Slides
Protocol Training
Required for all team members
The Protocol training consists of the following THREE requirements:
1. Review the Protocol.
2. Watch the protocol introduction (one video) and P-ICECAP protocol game (two videos) from the Investigators Kick-Off meeting
P-ICECAP Protocol Overview - Dr. Frank Moler
Slides (PowerPoint)
Protocol and Standardization Game - Kahoot! - Dr. William Meurer
Protocol and Standardization Game - Kahoot! Part II - Dr. William Meurer
3. Complete the protocol training certification.
NOTE: Upon completion of all three requirements save the attestation and send it to your Study Coordinator to upload to WebDCU. There is no expiration for this certification.
WebDCU Trainings
Data Training
Required for all team members
Complete the Training Certificate after the video is viewed and upload it to WebDCU.
WebDCU for Everyone - Sara Butler
WebDCU Data Training Certificate
Regulatory Document Management Training
Required for regulatory staff as named in the EDOA
Complete the Training Certificate after the two videos are viewed and upload it to WebDCU.
1) DOA Log Training - How to Update Your Site's DOA Log
2) Regulatory Document Module Training
*Specific to only the regulatory document module in WebDCU
WebDCU Regulatory Training Certificate
WebDCU Optional Training:
WebDCU General Overview
There is no certification for this training
Adverse Event Training
Adverse Event Reporting - Dr. Robert Silbergleit
Slides (PowerPoint)
SAE Reporting Tidbits and Pearls 3-1-22
Presenter: Robert Silbergleit, MD
E-Consent Training
7/26/2022 E-Consent Training with Moni Weber
Randomization Training with Sara Butler
Neurologist Training for 1 year Exam
Neurologist Training with Faye Silverstein, MD
Good Clinical Practice (GCP)
A free option for GCP training is available at the National Institute of Allergy and Infectious Diseases (NIAID). Click here to access the NIAID training.
NOTE: Effective January 1, 2017 – NIH expects all NIH-funded clinical investigators and clinical trial staff who are involved in the design, conduct, oversight, or management of clinical trials to be trained in Good Clinical Practice (GCP). Recipients of GCP training are expected to retain documentation of their training. GCP training should be refreshed at least every three years in order to stay up to date with regulations, standards, and guidelines.
https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm
Human Subjects Protection (HSP)
Attention: You only need to complete the training module below if your institution does NOT provide HSP training.
Collaborative Institutional Training Initiative (CITI)
Research Coordinator Meeting Archive
May 25, 2022 - Outcomes Training for Sites
Slides (PowerPoint)
December 9, 2022 - Screen Failures
January 30, 2023 - Study Payments
March 29, 2023 - Withdrawal Best Practices
June 20, 2023 - Arctic Sun Overview
This meeting was not recorded
July 18, 2023 - Scheduling the 1 Year Follow Up KKI Call and Neurologic Exam
August 15, 2023 - P-ICECAP Monitoring
October 3, 2023 - P-ICECAP Refresher for Low/No Enrollment Sites