Education and Training

P-ICECAP

Education and Training

Welcome to the P-ICECAP Education and Training page! Here you will find essential training and certification requirements for P-ICECAP study team members. It includes mandatory protocol training, WebDCU navigation, regulatory compliance education, and the research coordinator meeting archive, with additional optional resources for continued learning. Please click through the options below to explore the available trainings.

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

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

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.

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 Reporting – Dr. Robert Silbergleit

Slides (PowerPoint)

SAE Reporting Tidbits and Pearls 3-1-22 

Presenter: Robert Silbergleit, MD

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 with Sara Butler

Neurologist Training with Faye Silverstein, MD

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

Attention: You only need to complete the training module below if your institution does NOT provide HSP training.

Collaborative Institutional Training Initiative (CITI)

May 25, 2022 – Outcomes Training for Sites

Slides

December 9, 2022 – Screen Failures
 January 30, 2023 – Study Payments
March 29, 2023 – Withdrawal Best Practices
May 30, 2023 – CSG for RCs
June 20, 2023 – Arctic Sun Overview

This meeting was not recorded

Slides

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
January 16, 2024 – P-ICECAP Resources
July 16, 2024 – Obtaining Run Sheets
January 13, 2025 – Common Data Pitfalls

This presentation was not recorded

Slides

February 4, 2025 – Introduction to Motivational Interviewing for Research Coordinators

Slides