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.
Clinical Team Training (New 7-22-20)
Protocol Training
View the Protocol Training Slides and Video; then complete the Training Certificate and upload it to WebDCU.
C3PO Protocol Training Certificate
WebDCU Training
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)
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)
Clinical Team Training (New 7-22-20)
The following training materials should be used to train each site's clinical team. This training is expected to be completed prior to a site's readiness call.
Study Overview (Slides)
Intervention Administration Video
Blood Bank Webinar (Blood Bank Personnel)