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 registering, 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.
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July 2010
Change in Policy: All "keys" used to maintain de-identified data are now going to have to be electronic and stored in the Redcap database. The exception will be industry sponsored clinical trials. This is at the request of the Assistant General Counsel and goes along with increased security measures being taken across the MetroHealth enterprise. The Redcap database is secure and there is a dedicated IT Professional who can assist researchers to quickly set up a secure file for their key. If you are setting up a new study or have an exisiting study with a "key" Please contact Charles Sarbach at 216-778-3330. Mr. Sarbach can also assist researchers in setting up other types of secure databases in Redcap. These resources are provided for researchers under the CASE CTSC.
Reminders:
Security Audits are now in progress, they will run through August. These audits are being done at the request of Mark Moran, President and CEO of MetroHealth. Please cooperate with the auditors in scheduling your audits. The audits are not time consuming and can usually be preformed in 30 minutes.
Any report or letter from the Sponsor, CRO, or monitoring entity is to be submitted to the IRB within 10 days of the receipt of the letter. To report all monitoring letters use the Reportable Event forms and select Miscellaneous Report as the submission type.
Storing PHI on portable devices is not permitted per MHS Policy. All data with PHI needs to be stored on a secure network drive. Please consult with IT and arrange to transfer any exisitng data stored on a portable devices (CD, Floppy disc., Laptop etc.) to a secure drive. There is a specific process for destroying any CDs, DVDs, Floppy discs or other portable electronic storage media. This is because there are specific EPA Regulations to which MetroHealth must adhere. If you have any such media you wish to destroy please contact Ron Wallace in Enviromental Services.
