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Policy 1: Research Source Documents


The Center for MR Research understands the need for security and confidentiality of research source documents. All data storage devices (paper, diskettes, CD, Optical Disks, etc.) are kept in a locked cabinet to which only Center for MR Research Staff has access.

PROCEDURE

1. A file will be established for each human research subject (patient/healthy volunteer). This file will contain the Center for MR Research Safety Screening Questionnaire, the original Informed Consent Form, subject identification information for demographic database purposes, medical history available, TIF copies, dictated report hardcopy, payment vouchers if applicable, tracking sheet for each visit, and copies of any correspondence or notes on communication.

2. The files will be kept in a locked cabinet to which only the MR Research Staff has access. Files removed from the cabinet will be tracked by the Clinical Research Coordinator such that all files may be located at any given time.

3. A database of all research subjects will be maintained and kept secured by the Clinical Research Coordinator.

4. None of the source documents will be removed from the Center for MR Research at any time without the written consent of the Director of the Center or the IRB.

Sponsor: Director
Date: 8/01

Policy 2: Confidentiality of Research Data


The Center for MR Research provides a service for many individual investigators. Since some of these investigators may be involved in similar research, the confidentiality of the individual investigators research data must be secured such that it cannot be used by anyone but the investigator or his/her designates.

PROCEDURE

The Center for MR Research staff will be responsible for moving data from the scanner to other storage devices on completion of the scans performed by the Center for MR Research staff in a timely fashion. The Staff will also be responsible for the security of any data storage media consistent with Good Clinical Practices.

If the Investigator or his/her designate performs the scan involved in their research, the Investigator or his/her designate is responsible for removing the information from the scanner workstation as soon as the scan is complete. The Center for MR Research will not be responsible for the confidentiality of the information left on the scanner after completion of the study.

Sponsor: Director
Date: 8/01

Policy 3: Medical Records: Release of Information


The Center for MR Research restricts the release of medical information and medical records. (see HMP IM 4.03 Medical Records: Release of Information).

PROCEDURE

1. All requests for medical information must be in written form and accompanied by a properly executed Release of Medical Information Form signed by the Patient/Subject or their legally-authorized representative specifying the medical records to be released.
2. No medical information originating outside the Center for MR Research which may be contained in the Center for MR Research files may be released for any reason. The requester should be referred to original source.
3. If the requested information is contained in the Patient/Subject's Medical Record at UICMC, the request and release should be forwarded to the Medical Records Department for response.

Sponsor: Director
Date: 03/02

Policy 4: Subject: Internet Protocol (IP) Address


It is the policy of the Center for MR Research to secure all Patient/Subject information such that unauthorized access is not possible.

PROCEDURE

An Internet Protocol Address may not be added or given to staff not specifically allowed access to Patient/Subject data as part of their normal duties.

A non-Center employee may not have an IP address established without the written permission of the Director of the Center. A copy of the authorization with dates will be kept on file by the Network Analyst and Clinical Research Coordinator, responsible for Subject records.

Sponsor: Director
Date: 03/02

Policy 5: Creating paradigm files for SCS


It is the policy of the Center for MR Research to facilitate the successful utilization of all functional data producing equipment. Consistency in the methodology used to create the data promotes this success.

PROCEDURE

1. All paradigms should be movie files, consisting of a series of frames to be played sequentially.
2. The resolution of the files should be standard VGA, that is, 640 pixels wide and 480 pixels high.
3. All movies should play at 30 frames per second, regardless of the rapidity of motion (or lack thereof) in them.
4. If color is used, the bit depth should be adjusted to 24 bits, providing 8 bits of resolution each in the red, green and blue channels. For paradigms without color, 2 bit or 8 bit grayscale may be used. Please choose 8 bit if possible, since anti-aliasing cannot be done at 2 bit depth.
5. Any software can be used to produce the movie files, however, we recommend Adobe Premiere.
6. If the movie files contain accompanying audio information, the maximum resolution permitted for audio is two channels at 16 bits and a sampling rate of 44.1 kHz.
7. Video Signal Encoding: this must be MPEG-2 only. No other encoding methods are acceptable. You may enclose the files in an AVI wrapper, proving that MPEG-2 was used as the encoding method. We recommend the MPEG-2 encoder included with Pinnacle DV500 Plus.
8. Audio Signal Encoding: this must be mp3 compatible. Variable or constant bit rates may be used, but the data stream should not average more than 64 kbits/s.
9. We recommend anti-aliasing if motion is present in the paradigm.
10. Microsoft Media Player is used to play the movie files in the SCS. However, Media Player can use many codecs, which may or may not be installed on our system. The fact that the movie plays in Media Player on your computer is no guarantee that it will play on the SCS. Please test your paradigm on the SCS at least a day or two before using it on a subject.

Sponsor: Director
Date: 8/02

Policy 6: The limit for the disk space usage.


It is the policy of the Center for MR Research to limit the usage of free disk space on the CMRR Data Server for External Users.

Procedure

Every effort is made to provide external users with as much disk space as they require. However, the total amount of disk space will always be limited and investigators should try to use only what is necessary.

The following quota has been set by the Center for MR Research:

External user accounts for each investigator: 10 Gigabytes

If you reach your quota you will not be able to create or extend files.

Investigators who require a larger quota should contact Ian Atkinson (ian@uic.edu) to request a larger quota.

Sponsor: Director
Date: 10/05

Policy 7: Inventory Tracking


It is the policy of the Center for MR Research to maintain an inventory of significant items.

Procedure

When an item is received it shall be entered into the database. The database is located on the server and the network path is \\128.248.211.3\inventory which can be accessed by typing in the path in your internet browser.

Sponsor: Director
Date: 3/06

Policy 8: Notification of maintenance to shared computing resources


Notification of maintenance to shared computing resources will be made to all affected users prior to performing maintenance.

Procedure

1) Notification of planned maintenance that may affect availability of a shared computing resource (e.g., data server, network printer, computing cluster, license server, shared workstation, etc.) will be made to the entire department via email at least 48 hours prior to beginning maintenance. This notification will be repeated 1 hour before beginning maintenance. The notification will describe the maintenance to be performed, the need for the maintenance, the expected time to complete the maintenance, and the availability of the computing resource during maintenance.

2) Notification of unplanned (emergency) maintenance that may affect availability of a shared computing resource (e.g., data server, network printer, computing cluster, license server, shared workstation, etc.) will be made to the entire department via email at least 10 minutes prior to performing maintenance. The notification will describe the maintenance to be performed, the need for the maintenance, the expected time to complete the maintenance, and the availability of the computing resource during maintenance. If data availability will be affected, a verbal notification will also be made to the entire department to minimize the risk of data loss.

Sponsor: Director
Date: 06/06