Research Study Procedures
The procedures for research studies from start to finish
Background Info
The research infrastructure in the Seaman Family MR Centre (SFMRC) is available for a variety of imaging research studies. Generally, access is provided on a cost-recovery basis with rates determined in conjunction with Diagnostic Imaging at Alberta Health Services.
All requests for access to resources are vetted via our Scientific Review Committee. This committee oversees requests for both the SFMRC and the Child and Adolescent Imaging Research (CAIR) Program.
Requirements
- A completed online Application for 3T Research Time form.
- A brief project description.
This form is only available from the U of C network (including the U of C VPN) or the AHS network.
This paperwork is to be submitted prior to submitting an approval request to research ethics. Applications are reviewed for scientific validity and for administrative issues. Please provide the most accurate information on study duration, number of patients, etc.
Once the application is submitted, the investigator(s) must:
- Secure the appropriate research ethics board or animal care approvals from the appropriate local board, and
- Provide a copy of these certifications via email to the Scientific Review Committee (3Treview@ucalgary.ca) prior to study commencement.
Pilot Scans
Limited time for imaging pilot studies is also available. These exploratory studies are typically small, unfunded projects of ≤10 scanning sessions. They are intended to help secure preliminary data for subsequent grant applications. Investigators (and their Department Head) requesting pilot study time are required to certify that no funding is available using this form. Pilot support is not intended to extend funded studies.
Types of Scans
- Low risk studies are designated such by the Centre during the Scientific Review Process and include normal control subjects and a limited number of healthy out-patient studies (as approved by the Medical Director). All other studies are considered high risk. Please note that every low-risk patient requires completion by the study PI and submission to the Centre of this form.
- Urgent studies are designated by the Centre and include imaging studies that need to occur within 48 h because of research study requirements. The Centre has very limited capacity to accommodate urgent studies. All other studies are considered non-urgent.
- Clinical-research studies are done on high risk patients and include components that are used for clinical care and for research. They require REB-approval and can be either urgent or non-urgent.
- Research-only studies are done on low- and high-risk patients and are only done for research purposes. They require REB-approval and can be either urgent or non-urgent.
Letters of Support
Upon receipt of approval from the Scientific Review Committee and an administrative assessment, Jeff Hardie (jeff.hardie@albertahealthservices.ca) can provide a Letter of Support suitable for submission to a granting agency. Please allow sufficient time for scientific review prior to the grant submission deadline.
Questions? Please contact the Chair of the Scientific Review Committee, Dr. Brad Goodyear, at 3treview@ucalgary.ca.
Once your study is Approved and the imaging and data transfer protocols are finalized, please contact Paul Romo to arrange for a Kick Off meeting. Please bring to this meeting your study coordinator(s) and any other relevant research personnel or trainees. Paul will arrange for key Centre staff (reception, technologist, IT) to be present.
At the Kick Off Meeting, we will review the process of booking your subjects and address any special circumstance or concerns. Once any remaining issues are resolved, your study will become Active and you will be able to book subjects.
Questions? Please contact Dr. Brad Goodyear at goodyear@ucalgary.ca.
To cancel a subject, please contact Paul Romo with your cancellation request and details. Scans cancelled with less than 24 h notice may be billed to the investigator.
To modify a booked subject, please cancel the existing scan (see above) and then make a new booking (see step #4 below).
Questions? Please contact Paul Romo at paul.romo@albertahealthservices.ca or 403-944-1800.
Scanner Availability
The 3 T MR scanner is typically available for research studies from 8h00 to 17h30 weekdays, effective 17 April 2017). We ask that researchers with low risk studies (defined here under "Request a New Study") and appropriately trained personnel attempt to utilize slots outside of these times as this often the only time that high risk studies (defined here under "Request a New Study") can be conducted. We also operate on one Saturday per month (see below).
When scanning outside of 8h00-15h30 weekdays, and on weekends, the study team needs to provide a Level 1 trained person.
Special arrangements for specific operational needs are to be discussed with Jeff Hardie (jeff.hardie@albertahealthservices.ca) or Brad Goodyear (goodyear@ucalgary.ca).
Booking Subject Appointments
- Please use the on-line form. Note that the form is only available from the U of C network (including the U of C VPN) and the AHS network.
- b. For clinical-research studies, provide in addition a clinical requisition to Paul Romo by fax at 403-944-3622.
- A copy of the subject screening sheet and signed consent (signature page only) need to be faxed to Paul at time of booking at 403-944-3622. Please ensure that the Research Subject Name and Research Study ID (per the on-line booking form) are included on these documents. The on-line form is only accessible from an AHS or U of C network (if you are offsite you can access through a VPN connection).
The Intra-operative MR scanner is scheduled through Surgical Services.
Scan Timeslots
Early Morning Scans (8h-9h)
This slot is intended for some urgent studies (defined under "1. Request a New Study") but is also available for booking of other subjects. When booking in this slot, please be aware that there is a chance that your subject might be bumped for an urgent research study. We estimate this occurs about 10%-20% of the time. We will do our best to accommodate your subject, but there may be occasions where they will need to be rescheduled.
Urgent Scans (15h-16h)
This slot is reserved for examinations that are approved as urgent studies (defined under "1. Request a New Study"). This is necessary since a number of approved studies have 24 h or less notice of the need to image a subject. To book one of these studies, please use the on-line book form and call Paul Romo to request times on these days.
Weekend Research Scanning Sessions
[UPDATE WEEKEND SCANNING SCHEDULE FOR 2019 HERE]
The 3 T Diagnostic Scanner is available for research studies on the following Saturdays. Please use the on-line book form to request times on these days. Note that investigators will need to ensure that a Level 1 or higher trained person accompanies the subject.
Questions about the online form? See the FAQ.
Other questions? Please contact Paul Romo at paul.romo@albertahealthservices.ca or 403-944-1800.
When a study is finished please inform the Scientific Review Committee by email. The Center will change your study status when you exceed the number of subjects approved by your ethics approval.
To extend the number of subjects past the ethics approval, an ethics amendment followed by a study modification is required.
Questions? Please contact Dr. Brad Goodyear at goodyear@ucalgary.ca.
When images from a Finished study are no longer being actively imaged, your research study needs to be Closed. Please inform the Scientific Review Committee by email to make arrangements for long-term archival of your data.
After 12 months of inactivity the Center may close a study.
Please note the Center can not guarantee the storage of image data from Closed studies.
Questions? Please contact Dr. Brad Goodyear at goodyear@ucalgary.ca.