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 (coming soon)
This is a guide to accessing WebDCU and the submission and approval process for regulatory and/or essential documents for study team members.
The Protocol training consists of the following THREE requirements:
1. Review the Protocol.
2. Watch the protocol introduction and P-ICECAP protocol game from the Investigators Kick-Off meeting (coming soon)
3. Complete the Attestation.
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.
SIREN WebDCU User Manual
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
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.
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)