DAERS (DAIDS Adverse Event Reporting System) Training

Who takes DAERS Training?

DAERS Training is provided to sites who are prioritized for enrollment based on criteria set forth by DAIDS:

• High EAE Generator; Network Sites (by Region); Non Network Sites (by Region)
• If the CRS fits the prioritized criteria, the RCC will contact the CRS with an invitation e-mail requesting information from the site and will be given instructions to complete DAERS training which is provided via Webcast.

How to sign up for DAERS training:

Send an email to daids‐essupport@niaid.nih.gov and include the information below for each person needing training. Forms can be found on RCC’s website: http://rcc.tech-res.com/faqs_DAERS.aspx

• User Information Sheet ‐ Used by the sites to provide a list of authorized staff that will need access to DAERS. You will be needed to provide the Names, Contact Information, Roles (Submitter or Reporter) and applicable protocols for each user of the DAERS application. RCC will verify the study physicians (Investigators) listed on the User Information Sheet against the 1572/IoR document. RCC also verifies the CRS is protocol registered to all the protocols listed on the User Information Sheet.
• Attestation and Agreement for Electronic Signatures form – A required document for any study physician who will ultimately submit and electronically sign EAE reports via the DAERS (for compliance with 21CFR Part 11). You must e‐mail/fax the Electronic Signature Attestations (ESAs) for the study physicians listed on the User Information Sheet and then mail the original signed ESAs to RCC. The Study Physician (Submitter) attests that their electronic signature equates to their written signature.

1. Submit the completed forms as an email attachment to the RCC at RCCSafetyOffice@tech‐res.com for processing.

2. Once the forms have been accepted, the DAERS Training support staff will contact the staff listed on the User Information sheet and provide a link to the DAERS central training registration website.

3. CRS staff selects a training session that they can accommodate in their schedule, complete the online registration form and submit.

4. CRS staff will then receive an email confirmation message stating the time and date of the training. Web and teleconference details will be emailed at least 3 days prior to the training date.

Click Here to access the FAQ on DAERS Training and Access

CSM (Clinical Site Monitoring) Training

Who takes CSM Training?

CRSs that were monitored in Q1 2009 were selected to use the CSM system.

Each subsequent quarter, CRSs being monitored (and who have not been trained previously) will be selected and invited for training.

• CRSs are sent an introductory email explaining the CSM system and providing registration details for the training approximately 2-4 weeks prior to the monitoring visit.
• CRSs are required to register for training sessions.
• CSM trainings are offered most Tuesdays and Thursdays of each month via web/teleconference.
• All training requests should be sent to DAIDS-ESSupport@niaid.nih.gov  
• CRSs may attend as many trainings as desired. Some CRS staff have reported that attending the session again after using the CSM system has been quite beneficial.
• CRS staff with responsibility for more than one CRS need only attend CSM training once.

How to sign up for CSM training:

Send an e‐mail to DAIDS‐ES Support at daids‐essupport@niaid.nih.gov to request training.

• The ES Support team will send the training registration link for the current month.
• CRS staff selects a training session that they can accommodate in their schedule, complete the online registration form and submit.
• They will then receive an e‐mail confirmation message stating with the web and teleconference details.

Click Here to access the FAQ on CSM Training and Access

DAIDS Protocol Registration System (DPRS)

What is the DAIDS Protocol Registration System (DPRS)?

The DAIDS Protocol Registration System (DPRS) is an internet-based system for DAIDS Clinical Research Sites (CRS) to submit protocol registration documents to the DAIDS Protocol Registration Office (PRO). The DPRS will ensure a more efficient and timely registration process as well as create a centralized location for accessing protocol registration information.

The DPRS is the official source of information for all protocol registrations performed by the DAIDS PRO.

Click Here for more information on PRO Module