Education and Training

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Training Documents

Training Videos and Slides

Protocol Training

WebDCU Training

Data Training

Regulatroy Management Training

Optional WebDCU Training

Adverse Event Training

Consent Training

E-Consent Training

Randomization Training

Neurologist Training for 1 year Exam

Good Clinical Practice (GCP) Training

Human Subjects Protections (HSP) Training

Research Coordinator Meeting Archive

May 2022 - Outcomes

December 2022 - Screen Failures

January 2023 - Study Payments

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

January 2024 - Resources

July 2024 - Obtaining Run Sheets

 


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.

SIREN WebDCU User Manual

Procedures for Outcomes Data Collection

Esophageal Probe Placement

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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.

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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

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Adverse Event Training

Adverse Event Reporting - Dr. Robert Silbergleit

Slides (PowerPoint)

 

SAE Reporting Tidbits and Pearls 3-1-22 

Presenter: Robert Silbergleit, MD

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Consent Training

5/10/2023 Mock Consent with Dr. Matt Kirschen and Moni Weber


 

E-Consent Training

7/26/2022 E-Consent Training with Moni Weber

 

Randomization Training

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

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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)

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Research Coordinator Meeting Archive

May 25, 2022 - Outcomes Training for Sites

Slides (PowerPoint)

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December 9, 2022 - Screen Failures

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 January 30, 2023 - Study Payments

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March 29, 2023 - Withdrawal Best Practices

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May 30, 2023 - CSG for RCs

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June 20, 2023 - Arctic Sun Overview

This meeting was not recorded

Slides

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July 18, 2023 - Scheduling the 1 Year Follow Up KKI Call and Neurologic Exam

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August 15, 2023 - P-ICECAP Monitoring

 

October 3, 2023 - P-ICECAP Refresher for Low/No Enrollment Sites

 

January 16, 2024 - P-ICECAP Resources

 

July 16, 2024 - Obtaining Run Sheets