Education and Training

BOOST-3

Education and Training

Welcome to the BOOST-3 Education and Training Page! This page provides essential training materials and certification requirements for BOOST-3 study team members. Here, you’ll find protocol training, regulatory guidance, data management instructions, Human Subjects Protection (HSP), and Good Clinical Practice (GCP) resources. Click on the options below to explore the available trainings

The Protocol training consists of the following THREE requirements:

NOTE: You are exempt from this training if: a) You attended the in-person investigator kick-off meeting in Atlanta OR b) You attended a group protocol training session conducted by Trial Leadership.

1. Review the Protocol

2. Review the Protocol Training Slides.

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 as a PDF and send it to your Study Coordinator to upload to WebDCU. There is no expiration for this certification. If you do not receive your certificate upon completion of the certification test please reach out to the SIREN Education Coordinator, Courtney Miller.

SIREN WebDCU User Manual

Required Trainings

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 Trainings

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)

The Outcomes training consists of the following FOUR requirements:

1. Review the MoP Outcomes Section

2. Review the Slideset (this will take you to a dropbox file to download the slideshow)

NOTE: Download the slideset to your machine. Click on to hear the recording for each slide. You may have to increase your volume as well.

3. Watch the Video

NOTE: As you watch the video you will see the Local Outcome Examiner introduce the Central Examiner, but not actually make a call or have the Central Examiner complete the interview. Also, only 2 of the 3 psycho social questionnaires are presented in the video. Both the introduction and the number of questionnaires used in the video are simply examples of process.

4. Upload Practice Video

Practice administering the test battery with someone (co-worker/friend). When you are ready video record a mock administration of the test battery and submit the video AND source documents to OneDrive for review (each assessor will receive a link to OneDrive from the Outcomes Team).

Once the four requirements are complete and a member of the Outcomes Team has approved the submitted practice video a certification will be uploaded into WebDCU.

NOTE: Certification is maintained as long as an examiner completes a full in-person outcome evaluation at least once in a 6-month time span. If more than 6-months elapses then another video will be requested.

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)

1. In-service ED, ICU, Neurosurgery, Trauma, and other clinical site staff likely to interact with BOOST-3 subjects.

2. All Study Staff on eDOA Log review the following:

Protocol and Certification Test (see above)

MOP

CST Guidelines

Data Training and Attestation (see above)

3. ICU Nurses review the following:

Instructional Videos for CNS Monitor and CarePath

1) Initial setup