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.
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November 2008
Reminder of Important Determination to be made by study staff when submitting Reportable Events Chapter 13 page 107 of the MHS IRB SOPs
B. Reportable Events Requiring Report to the MHS IRB:
Please Note: If an MHS investigator is notified about an adverse event that occurred at another site in a study related to, but not the same as, the MHS protocol, and the adverse event results in a change in the MHS protocol,consent form, or the risk/benefit ratio, the adverse event must bereported within (10) working days of learning of the event using theReportable Event Form attached to each approved study in the eIRBSystem, and the protocol changes must be made and submitted to the IRB by the principal investigator as soon as possible. The same rule applies if the change in the MHS protocol is due to publication of the adverse events results from another study which has an impact on the MHS protocol. Adverse events which occur in another study (including fatal events) and which do not result in a change in the protocol, consent form, or the risk/benefit ratio for the MHS study, do not need to be reported to theIRB but should be kept on file by the investigator.
October 2008
Section 22-00 Clinical Trials Registration in new. All subsequent sections have been re-numbered.
NEW: IRB suggested formatting of Risks for Informed Consent documents:
When writing the Risk section of the Informed Consent the IRB will now require use of the Comprehensive Adverse Event and Potential Risks list (CAEPR) system for Informed Consent Forms with multi drug regimens. CAEPR provides a single list of reported and/or potential adverse events (AE) associated with an agent using a uniform presentation of events by body system.
This format will be optional for agents that have less than 4 body systems affected and/or less than 12-15 risks associated with the study drug(s).
Sample of how to format CAPER Risks:
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Risks associated with ……..put drug Name here……
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Likely (>20%)
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Less Likely (<20%)
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Rare but serious (<3%)
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Allergy/Immunology
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Allergic reaction/hypersensitivity
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Blood/Bone Marrow
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Hemoglobin
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Leukocytes (total WBC)
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Platelets
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September 2008
Use of combined ICF/HIPAA forms must be pre approved by the IRB Office and can only be used for Minimal Risk Studies.
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.
