Full AAHRPP Accreditation June 15, 2007
Welcome, this site enables an Institutional Review Board (IRB) to capture the entire IRB regulatory process, monitor the flow of information and the associated activities and tasks for all participants, delivering a complete electronic document based solution for Human Research Subject Protections and Regulation.
Click on the Login link above if you are a registered user. If you are not a registered user you will need to click on Registration. In order for your registration to be processed you must enter all requested information. After registrating, you will be notified (by email) of your user name, password and site security policies within 24-48 hours. This is not an automatic registration process, you will not receive an instant response.
Did you forget your username or password? If yes, go to the login screen and use the links "Forgot password?" or "Forgot Username?".
eIRB Help Times: Mondays (2:30-4:30); Wednesdays (1-3); Fridays (9-12) Alternative times by appointment.
Scanner Times: Monday - Friday 8-4:30
eIRB Availability: The eIRB is not available from 12:00AM to 12:30AM when it backs up all stored data.
Recommended Browsers: See IRB-General Information
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September 2008
Changes on the Continuing Review form page one. New Questions for expired studies only.
State of the Parent Study: Read only
If this study has expired you must answer this question: If your study is expired please assure the IRB that no activity has taken place on this study and that no new subjects have been enrolled. True False
If you have enrolled new subjects or continued to work on this study please explain in the comment box
below:
The IRB per Federal Regulations must have a method or means to gather the above information so rather than ask each investigator for this information as a separate assurance we are incorporating it into the Continuing review form. If your study is not expired you go directly to question 1.1.
Reminder: Please check the dates stamped on your Consent Forms and HIPAA Authorization Forms before asking subject to sign them. If you find any discrepancies please call the IRB Office.
August 2008
Please use only approved consent templates and do not alter the area of the template designated for IRB Use Only.
THIS SIDE — IRB OFFICE USE ONLY
Revisions have been made in Section 20.01 Drug Information. At the request of the Research Pharmacy two new questions have been added at 20.4 asking about dosing information.
July 2008
There has been a change in the HIPAA Authorization language effective 7/22/2008:
Old language HIPAA section: If I give permission now for use of my PHI, can I withdraw my permission in the future?
You have a right to withdraw your permission/authorization, in writing, at any time. All of the PHI that has already been collected about you as part of the study will continue to be used. No new PHI about you will be collected for study purposes unless the PHI concerns an adverse event (bad effect) related to the study.
New Language HIPAA section: If I give permission now for use of my PHI, can I withdraw my permission in the future?
You have a right to withdraw your permission/authorization, in writing, at any time. No new PHI about you will be collected for study purposes unless the PHI concerns an adverse event (bad effect) related to the study.
July 18, 2008 Click Commerce is working today on Updates to the Consent Form stamping function. In the future all Consent Forms when stamped will convert to PDF documents with a Water Mark in the center of each page. Once these changes have been made the IRB templates will be revised to remove the old mail merge fields from the footer.
New servers have been approved and should be pruchased and installed over the next month. The new servers will add increased speed to the eIRB system. Users should notice an immediate change in the time it takes to move throughout the system. During the upgrade some archived studies will be moved to a backup server and may no longer be directly accesible to investigators or their staff. This will effect all studies closed in the electronic system before 1/1/2006. If you need to access a study closed before 1/1/2006 you will need to submit a request to the IRB Staff who will then provide access to the archived file.
The weekend of July 12-13 Click Commerce will be working on updates to the eIRB system.
Change in eIRB application Question 19.8 has been combined with Question 19.9 and they are now one question with 2 parts.
June 2008
The Continuing Review forms have been revised. There are changes in Sections 2, 3, 4, 6, 7, 8, 9, 10, and 15. The funding questions in Sections 3 and 4 have been reduced to 1 page. There is now new content in Section 4 which is about Data Security. On pages 2, 4, 6, 7, 8, and 10 information has been pulled over from the approved protocol application and this information is "read only". If there are differences between what is in the approved protocol and the way you are conducting your study then you will need to submit an Amendment to reconcile these differences.
Click Commerce will be doing some upgrades to our system Friday June 27th and Monday June 30th. They are working on correcting consent form stamping problems. You may encounter internal server errors during this time.
You have the right to withdraw your permission/authorization, at any time. No new PHI about you will be collected for study purposes unless the PHI concerns an adverse event (bad effect) related to the study.
