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
Glasgow Outcome Scale - Extended - Updated 2/23/2022
Supplemental Training (optional)
The Protocol training consists of the following THREE requirements:
1. Review the Protocol v.7.
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.
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
Optional Training:
WebDCU General Overview
DOA Log Training - How to Update Your Site's DOA Log
Regulatory Document Module Training Video (specific to only the regulatory document module in WebDCU)
EFIC Module Training Video (NEW 11-27-19)
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.
*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.
Additional GOSE Resources:
Preventing Lost to Follow-Up Timeline (New 4/12/24)
Preventing Lost to Follow-Up (New 4/12/24)
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)
Supplemental Training (optional)
HOBIT Quick Training Video (3 minutes)
Quarterly GOSE Meetings
December 2019: (New 12-17-19)
September 2019: