CMRR Subject Tracking Requirements

Standard forms and processes related to subject tracking

The IRB has determined that 3T scans conducted at CMRR are except from the CMRR subject tracking requirement. The forms and processes below are effective as of  July 1, 2014. Scans completed on or after this date should use the most recent version of the forms and adhere to current policies.

Field Strength CMRR MR Subject Safety Screening Form

CMRR Facility Research Visit Information Form

CMRR Exit Questionnaire
3T Required Not Required Optional
4T Required Required Optional
7T Required Required Optional
10.5T Required Required Required

Form Requirements

  1. All studies must use the most recent version of the CMRR MR Subject Safety Screening Form.
    1. The Screening Form has been reorganized, enhanced and reformatted
    2. A new Magnet Safety FAQ is available to provide additional insight into why items on the Screening Form are important. It is CMRR’s goal to keep enhancing this FAQ, so please check back often for the most up-to-date version.
    3. The Form should be kept with all other subject forms and is subject to periodic audit from CMRR.
  2. The revised CMRR Facility Research Visit Information Form (formerly called the CMRR Subject Information Form) will be used to record subject data for studies conducted on systems above 3T.
    1. Researchers should scan this Form at the conclusion of the study using the established document scanning procedures.
    2. CMRR Research Administrator will enter the subject information into REDCAP
  3. The CMRR Exit Questionnaire is no longer required except for subjects scanned on a systems with an Investigational Device Exemption (9.4T and 10.5T).

Consent Language Changes

Data for subjects scanned at 3T will no longer be entered into the subject tracking database. Therefore, studies using only the CMRR 3T should change the wording in the "Significant New Findings" section of the Consent Form to read

"You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study."

  1. Revised consent form with changes tracked and a "clean" version should be sent along with Change in Protocol form, template attached, to irb@umn.edu and cc Felicia Mroczkowski (kensl001@umn.edu).
  2. This should be done as soon as possible, but does not have to be completed prior to adopting the new forms and adhering to the new procedures.