Below you will find all IRB-approved documents and forms related to the UChart implementation. Should you have any questions regarding these, please do not hesitate to contact us.
- Investigator Guidance
- UM IRB UChart Determination Letter
- Mail the Subject Notification Letter to all currently enrolled subjects by January 30, 2011
- All currently enrolled participants (in active treatment) must sign these two documents at their next regularly scheduled research encounter:
- Addendum - Informed Consent
- HIPAA Form B
- Submit an Amendment adding the Subject Notification Letter, the ICF Addendum, revised ICF and HIPAA Form B to your study by April 30, 2011:
- See HIPAA Form B links above (also available on the HIPAA page)
- See Consent Templates page for Addendum to be submitted with your amendment.