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.

 

Study Team Training

Clinical Team Training (New 7-22-20)

 


 

Study Team Training

Protocol Training 

View the Protocol Training Slides and Video; then complete the Training Certificate and upload it to WebDCU. 

Slides 

C3PO Protocol Training Certificate

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WebDCU Training 

SIREN WebDCU User Manual v.4

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) 

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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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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)

Slides 

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