Re-Training Sessions Aug. 3 and 5, 2020 (All Sites)
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.
WebDCU
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)
The Outcomes training consists of the following FOUR requirements:
1. Review the MoP Outcomes Section
2. Review the Slideset
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.
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)
Data Training and Attestation (see above)
3. ICU Nurses review the following:
Instructional Videos for CNS Monitor and CarePath
5) Blinding
Tips for using CNS Monitor and CarePath (from Study Coordinator Educational Spotlight 2-4-20)
How to Collect Additional Information from CNS Monitor (from Study Coordinator Educational Spotlight 2-4-20)
4. PI sign Attestation and upload to WebDCU
Re-Training Education Sessions August 3 and 5, 2020
Slides (Enrollment, Protocol and Clinical Training)
Slides (Moberg Tips)