Education and Training

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.'

WebDCU User Account & Regulatory/Essential Document Process Guide 
This is a guide to accessing WebDCU and the submission and approval process for regulatory and/or essential documents for study team members.  


Training

Re-Training

 

 

Protocol 

The Protocol training consists of the following THREE requirements:

1. Review the Protocol v.5.  

2. Watch the Overview, Inclusion/Exclusion Criteria, Study Procedures, and Simulation videos.

Overview

Inclusion/Exclusion Criteria

Study Procedures

Simulation

3. Successfully complete the Certification Test

NOTE: Upon successful completion of the test you will receive an email with your Protocol Certification enclosed in the body of the email. Save this email and send it to your Study Coordinator to upload to WebDCU. There is no expiration for this certification.

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WebDCU

 Data Training

NOTE: Click on the arrows for full screen mode. 

Complete the Training Certificate after the video is viewed and upload it to WebDCU.

WebDCU Data Training Certificate

 

Regulatory Document Management Training 

NOTE: Click on the arrows for full screen mode. 

Complete the Training Certificate after the video is viewed and upload it to WebDCU.

WebDCU Regulatory Training Certificate

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Glasgow Outcome Scale - Extended (GOSE) Training and Certification

Training

You are required to watch the GOSE Training videos (Narration AND Examples), PRIOR to taking the certification test. Please make certain that you understand the content before you take this test. 

Narration:

 

Examples:

 

Certification:

NOTE: If you have not already downloaded the GOSE CRF do so at this time: GOSE CRF.  You will need to score 4 out of 5 interviews correctly in order to pass the test*. This test will take approximately 1 hour. Upon passing the test you will receive an email that will be your certificate to save and send to your Study Coordinator to upload to WebDCU.

GOSE Certification Link

*If you fail the GOSE Certification you will be contacted by a member of the HOBIT Outcomes team to discuss your responses and then will be given the link to take the GOSE Certification Re-Test. You will NOT be able to take the retest until you have been given permission.

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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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Re-Training

Attestation

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