Full AAHRPP Accreditation June 15, 2007

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.

August 2009

The Reportable Events Copy button is here! At last with the upgrade done 8/28/2009 there is a copy button on Reportble Events. After you complete a Reportable Event you will have a button that says Copy This Reportable Event. When you press this button the pop up page will ask you to name the event and then ask What Studies you want to Copy this event to click the Add button and all the Studies on which you are listed will appear and you can click the ones you want to copy the adverse event to. In the History it will tell you not only the ID for the new event but also confirm that the reportable event was copied to Study (Title) (IRB00-XXXX). This was technically difficult to do and therefore it has taken alot of time and testing to be sure it is correct.

The upgrade also addressed the remaining issues with the Consent Form Stamping. Please use only the current templates on the IRB website whenever you create or revise Consent forms. This will cause fewer requests by the IRB for revisions. Please understand these are not static documents changes in regulations and MetroHealth's interpertation of them require the IRB to update the templates with some frequency. The language provided by your sponsor is not always acceptable to the IRB do not just cut and paste into the blank consent form the language given to you by your sponsor. The HIPAA language has been changed as of 8/26/2009 please consult the templates for the new language.

The final system upgrades will take place the week of August 17th. With this last upgrade there will be a change in the Reportable Events forms that will allow the reporting of a single event on multiple studies. The Time and Effort System has been moved over to the eIRB System. An email with instructions was sent to all users however if for some reason you failed to receieve these instructions please look in the Time and Effort Reporting Information Folder on the IRB Home Page. 

Please Note that as of 8/23/2009 all consent forms will be required to have new language in the section: Whom do I call if I have questions or problems? This language states that subjects can make complaints either to the Principal Investigator or to the IRB. This is per our SOPs page 126. The IRB Staff will be looking for this language staring 8/24/2009. 

JULY 2009

The IRB patching was completed on July 10th. The IRB is now stamping documents from sections 13.7, 14.6, 16.2, 17.16, 23.2, 24.3, 25.2, and 27.1. Click supports conversion of .doc,.docx,.xls,.xlsx,.pdf and image files to .pdf files. We currently do not support conversion of .pub files. HTML files are converted by Aspose only if they don't contain any css and malformed html. To save yourself delays and frustration please convert all documents to be stamped to either .doc, .docx, .xls, .xlsx, or .pdf before you submit them to the IRB.

JUNE 2009

The week of June 8th the IRB Staff and Click Commerce will be working on two upgrades to the MHS eIRB System. First we are testing a new consent form stamping procedure. This will enable the IRB staff to stamp from several places in the application not just 17.16. We will move away from the word mail merge templates. This means the IRB staff will create new templates for you to use going forward. The second upgrade is behind the scenes, it is a snapshot of all approved studies, amendments (modified studies) and continuing reviews taken at the time of approval. This will allow everyone to see what questions were on these project types at the time of approval. It will also permit IRB staff and users to more easily access orginial versions.

After these upgrades the Reportable event copy button is going to be tested and then deployed onto the site. Click is working on that currently. Sometime in July the CRU will convert over to the Click system. This should be seamlees for users. Now when you say Yes you will use the CRU there will be four new pages of CRU questions that you will need to complete and when the entire application is done it will go to the CRU for review as it does currently. The CRU, however, will now have the ability to request changes conduct a Science Review meeting and send notices just like the IRB does. We will keep you updated about this implementation.

Time and Effort: There are currently 500 outstanding Time and Effort reports from 2008. The Lawson system has some "issues" and we are unable to allow you to complete these reports in the old Lawson system. Once Lawson is upraded on June 20th. All Time and Effort users with outstanding effort reports will be asked to come to the IRB office and we will open a special version of Lawson for you so that you can complete your reports. On July 1, 2009 all Time and Effort reports for Jan-June 2009 will appear in your IRB inbox for you to complete. Instructions on how to do this will be sent to you soon. There will also be online instructions.

MAY 2009

There are now two new submission types: Suspension of Enrollment by Sponsor, Investigator, or Regulatory agency and Emergency Action Letters from Sponsor. The MHS IRB SOPs require that all suspensions by Sponsors, Investigators or Regulatory Agencies (i.e. FDA) be reported IRB promptly. This has brought about some confusion for Investigators so this is an effort to clarify what defines "promptly" and how that reporting is to be accomplished.  "Promptly" means within 24 hours of your learning of or making a decision to suspend a study. This is to be done via a phone call to either the IRB office or thr IRB Chair. Following this phone call or simultaneously with this phone call you also need to report the suspension using the Reportable Event forms designated for this purpose Section 18.0 Suspension of Enrollment by Sponsor, Investigator, or Regulatory agency. If your sopnsor issues and Emergency Action Letter the same requirements apply. Call the IRB Office or Chair within 24 hours. Following this phone call or simultaneously with this phone call you also need to report the reasons why this Emergency Action Letter was issued and your plans to distribute it to subjects. 

Please review the General Information for Investigators folder on the IRB Home Page. On this page you will find information frequently asked for by sponsors and/or funding agencies. Investigators will also find document templates they can use to organize study files. Many of these forms are required as part of Good Clinical Practices and will reviewed as part of any IRB Audit.

The FDA and OHRP have recently ruled that IRBs must review all advertisements in the Media form in which they will be presented to subjects. This means the IRB can no long review transcripts of video or audio. The Investigator will need to provide the IRB with audio and video files that can be loaded into the eIRB system.