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Trials Participant - Hurricane Katrina

* CTEP has set up a central call number (301-496-5725) that will be in operation 24 x 7 (including the holiday weekend) that will take all calls related to trial issues and triage accordingly.

* CTEP will ship investigational drug to unapproved sites during the emergency, assist with sharing of drug supplies, and will provide protocols to physicians caring for patients in emergency situations

* OHRP is apparently relaxing some restrictions on IRB approval during the emergency, and CTEP will be able to assist physicians at unapproved sites

* The CTEP website will have information on many emergency policies (http://ctep.info.nih.gov)

* HIPAA rules have been suspended during the emergency - if CTEP can help physicians by supplying information about patient treatment on studies, we are happy to do so. However, we only have ID numbers and would need to contact the Group to obtain patient names. The CTSU may be able to assist as well in some cases.

* Finally, it would help to have a single contact person at each Group to handle HURRICANE-related issues. Can you please appoint someone and send me contact phone number and email. We will put the list on our web site and will try to coordinate activities, including drug-related issues, with this individual. Please also let us know if emergency coverage will be available over the holiday weekend.

Thanks for your help!