This is a reminder of the University’s policy for clinical research subject enrollment. UM tracks all subjects involved in clinical research protocols that test a drug, device, or biologic and/or involve procedures, lab tests, and/or interventions on a patient. According to the policy, a principal investigator (or their designee) must submit a research subject enrollment/disenrollment form within 24 hours of subject consent or disenrollment from a study (for any reason other than the end of the study). You can submit the form on the Clinical Research Initiation Services (CRIS) Web site or by entering the subject’s enrollment status in Velos. For more information, visit the enrollment policy or browse the FAQs.

Notification of the CRIS office or the Jackson Health System Clinical Trials Office (JHS-CTO) of subject enrollment at UM or JHS does not relieve investigators of their responsibility to notify the Institutional Review Board (IRB) of subject enrollment at the time of the protocol’s continuing report submission per IRB policy. If subjects are enrolled at or participate in studies at a JHS facility, investigators are also responsible for notifying the JHS-CTO within 24 hours, as required per JHS policy.

More information:

• CRIS subject enrollment policy
• Velos login
• FAQs on the CRIS subject enrollment policy
• IRB policy
• JHS policy

Dr. Jay Sosenko speaks on “Medical Practices and Procedures in the Research Setting” on Tuesday,  January 26 at 12 p.m. in the Mailman Center for Child Development, room 3023, at the Miller School campus. To register, log on to ULearn or contact the Office of Research Education and Training at 305-243-5092.

The HIV and Women Scientific Program, University of Miami DCFAR, is hosting a Breakfast Presentation and Discussion Meeting: “HIV and Women – Infants and Children” on Thursday, January 21 from 8:30 to 10:30 a.m. at the Clinical Research Building, room 1080.  Gwen Scott, from the Division of Pediatric Infectious Disease and Immunology, and Tracie Miller, from the Department of Pediatrics, will present on HIV in infants and children from the perspective of HIV issues for women. The aims of the presentation and discussion meeting are to discuss research opportunities, network and collaborate with other UM investigators on research applications, identify investigators from other CFARs for collaboration, and nominate scientists for the spring conference “HIV in Adolescents and Young Adults” as part of the DCFAR Scientific Program initiative to expand grants that support research on HIV and women. To participate, RSVP by e-mailing svamos@med.miami.edu or calling 305-243-2103.

This is a reminder of the University’s policy for clinical research subject enrollment. We track all subjects involved in clinical research protocols that test a drug, device or biologic and/or involve procedures, lab tests, and/or interventions on a patient. According to the policy, a principal investigator (or their designee) must submit a research subject enrollment/disenrollment form within 24 hours of subject consent or disenrollment from a study (for any reason other than the end of the study). You can submit the form on the Clinical Research Initiation Services (CRIS) Web site or by entering the subject’s enrollment status in Velos. For more information, visit the enrollment policy or browse the FAQs.

Notification of the CRIS office or the Jackson Health System Clinical Trials Office (JHS-CTO) of subject enrollment at UM or JHS does not relieve investigators of their responsibility to notify the Institutional Review Board (IRB) of subject enrollment at the time of the protocol’s continuing report submission per IRB policy. If subjects are enrolled at or participate in studies at a JHS facility, investigators are also responsible for notifying the JHS-CTO within 24 hours, as required per JHS policy.

More information:

• CRIS subject enrollment policy
• Velos login
• FAQs on the CRIS subject enrollment policy
• IRB policy
• JHS policy

The National Institutes of Health (NIH) is implementing major changes to all competing applications with due dates on or after January 25, 2010. To help clarify these changes, the University of Miami’s Office of Research has launched a new site with information for our research community.

Visit the Office of Research Web site (www.miami.edu/research) and select the link under “New NIH Formats” to read about:

• restructured application forms with new instructions that will affect your research plan and biosketch, and shorter page limits;
• upcoming workshops at UM (December 10 from 12 to 1 p.m. at the Medical Training Simulation Lab), including helpful training materials to download;
• using InfoEd with the new formats; and
• NIH sites with more information and sample templates.

For more information, e-mail your campus contact:

• Coral Gables: Sandy Blanco (resadmin.cg@miami.edu)
• Miller School: Jill Tincher or Tom Gill (mra@med.miami.edu)
• Rosenstiel: Soraida Diaz (aida.diaz@miami.edu)