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Regulatroy Management Training
Good Clinical Practice (GCP) Training
Human Subjects Protections (HSP) Training
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
Outcomes Training
Outcomes Training for Sites - Moni Weber
Slides (PowerPoint)
E-Consent Training
7/26/2022 E-Consent Training with Moni Weber
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)