September 2013
HUMAN SUBJECTS RESEARCH - Back

Revised Investigational Drug Data Sheet

An updated version of the Investigational Drug Data Sheet (Revised 2/13) has been posted on the IRB website http://www.hopkinsmedicine.org/institutional_review_board/
forms/
. All new and revised drug data sheets are required to be submitted on the updated template as of May 1, 2013. Investigational Drug Data Sheets received after May 1, 2013 on an outdated template will be returned and the application will not be processed until the correct drug data sheets are submitted. Please note that a separate IDDS must now be submitted for each site (HCGH, Sibley Memorial, Suburban, JHBMC) at which the IND will be dispensed.


eIRB 2 Launch and Information Sessions

The JHM IRB electronic research application system, eIRB, is being replaced by eIRB 2. eIRB is almost ten years old, and has become increasingly problematic with slow processing, error messages and time outs. eIRB 2 is built on the same software platform, but incorporates newer and more advanced technology.

eIRB2 will be launched in late September. Prior to the launch eIRB will be taken off line for a few days to migrate data to eIRB2. Migration will occur over a weekend to minimize the impact on workflow. Users will be updated on the exact dates and times as testing for the new system is completed.

For more information about the changes in eIRB 2 see http://www.hopkinsmedicine.org/
institutional_review_board/about/eIRB/eirb2_launch.html
.

To help ease the transition three information sessions are scheduled prior to the eIRB2 launch date:

  • Wednesday, September 25th 3:00-4:00 p.m., Tilghman Auditorium (located off the Turner Concourse)
  • Thursday, September 26th 1:00-2:30 p.m., Bayview Campus Asthma and Allergy Center, Carroll Auditorium
  • Friday, September 27th 10:00-11:00 a.m., Tilghman Auditorium (located off the Turner Concourse)


eIRB 101 Enrollment is Now Available Through myLearning

"eIRB 101: Prepare and Submit an Application and Post Submission Actions" is an in-person training session offered on the 1st Monday and 3rd Friday of every month in Reed Hall B-102. Registration is required to attend an eIRB technical training class.

Registration for eIRB 101 Training is now available through myLearning https://lms4.learnshare.com/catalog/display.resource.aspx?resourceid=358053.


eIRB Non-JHED User Self-Registration

Non Hopkins affiliated users (Non JHED users) will now need to contact the eIRB Help Desk at jhmeirb@jhmi.edu for assistance in creating their eIRB account.


Compliance Monitoring Program Information Session

The Compliance Monitoring Specialists in the Office of Human Subjects Research will present a session entitled "The Office of Human Subjects Research Compliance Monitoring Program Presents: The New eIRB 2 and Clinicaltrials.gov Requirements - Information and Procedures for Maintaining Compliance." The Monitors will provide practical direction and recommendations relevant to some important changes in eIRB 2 and the requirements for protocol registration and reporting. Time will also be available at the end of the session for any compliance related questions you may have. The sessions are open to all and we hope that you will be able to attend one of them.

  • East Baltimore campus: Friday, September 13, 2013, from 10:00 - 11:00 a.m. in the Miller Research Building rooms G01 - G03
  • JHBMC campus on: Monday, September 16th, from 10:00 a.m. - 11:00a.m., in the Carroll Auditorium



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September 2013 articles:
Revised Investigational Drug Data Sheet
eIRB 2 Launch and Information Sessions
eIRB 101 Enrollment is Now Available Through myLearning
eIRB Non-JHED User Self-Registration
Compliance Monitoring Program Information Session
 
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