TRAQ DSS form Hospital-based Research Checklist

1. Give your project a title
2. Do not enter the start & end date IF your research funds will be held in Queen’s. If your research funds will be held in the hospital/hospital research institute OR if there is no funding associated with the project, then enter start and end dates
3. If your project has an international dimension (your project is occurring in the United States or another foreign country), note the name of the country(ies) in the Keywords textbox
4. Click Search under Related Certifications to link your certifications (human ethics/biohazards/animal care) to your project – if certification is already active, or in progress/under review 
5. Click Add New under Related Certifications to make note of any required human ethics/biohazards/ animal care certification not yet submitted to a review committee 

• For researchers with cross-appointments: using the Affiliation drop-down menu select the department/research centre where the project will be taking place
• To transfer the role of PI, click Change PI, search for PI, click Select once PI is identified
• To add team members, scroll down, click Add New under Other Project Team Members*, click Search Profiles, search for team members, click Select once a team member is identified

* Project Team Members that are external to Queen’s, may be added in the Comments box (under PI information). However, any team members who should have access to the TRAQ DSS Form through the Researcher Portal should be added to the Investigator Database and added to the file under Other Project Team Members. To add an external user to the Investigator Database, please email the TRAQ Help Desk.

** Team members who create a TRAQ DSS FORM on behalf of the PI MUST list themselves as a team member before the TRAQ DSS FORM is submitted for approvals. 

1. Click Add New to add sponsor 
2. Click Agency and search for agency’s name. When found, click Select 
3. Choose program name from Program drop down menu
4. For Hospital-based Research where there is no funding and no contracts involved, click Agency and search for [enter hospital/hospital research institute name here], click Select. Select “No Funds, No Contract Reviewed” from Program drop down menu 
5. Use calendar icon to enter Competition Date: [enter competition date, if applicable, here] 
6. Use calendar icon to enter anticipated project Start and End Date. Click GENERATE, this will create  disbursement table. Please populate Total Requested Cash ONLY in the first disbursement row. 

General

• Question 1.1: Identify the location where your research funds will be held
  • If one or more of the three hospitals/hospital research institutes is chosen, please remember to also select the appropriate RESEARCH DIRECTOR(s) on the “Approvals” tab (i.e. KHSC-HDH - Vic Sahai; KHSC-KGH – Vic Sahai PC - Kathleen Fitzpatrick), and the hospital operations directors of any hospital departments affected by your research
• Question 1.2: YES/NO answer. Check YES only if you require space in addition to your existing research space assigned
• Question 1.3, 1.4, and 1.5: select the option that applies
• Question 1.6: YES/NO answer. If your research meets ANY of the following criteria, check “YES” to Question 1.6 within the TRAQ DSS FORM:
  • Research occurs in a hospital setting
  • Research utilizes or requires hospital staff, space, services and/or other resources
  • Research offices for yourself and/or your research staff/students/trainees are located in a hospital setting OR your research lab, unit, centre, space, and/or equipment is located in a hospital setting, even if your research project is occurring off-site
  • Research involves obtaining or retrieving patient biological samples/specimens from patients seen (or samples stored) at one of the hospitals for lab projects and transported to your research lab located within OR outside of the hospital (i.e. Bottere l Hall, CRI)
  • Research involves extracting patient data from hospital medical records
  • Research involves purchasing supplies or equipment at/through the hospitals
  • Research involves the use of hospital services and payment to hospital departments
  • Research funds will be held within one of the hospitals/hospital research institutes 

Appropriate Hospital Operational Directors and Research Directors

If your answer is “YES” to Question 1.6 in the TRAQ DSS FORM, you MUST select the appropriate Research Director(s) to approve based on which hospital(s) are impacted and selected under Questions 3.1-3.3.

Research Directors are as follows: 

• Kingston Health Sciences Centre (KHSC) - Hôtel Dieu Hospital (HDH) or Kingston General Hospital (KGH) site - RESEARCH – Steven Smith
• Providence Care (PC) – RESEARCH - Allison Philpot

You MUST also identify ALL hospital departments that will be impacted by your research on the "Other Approvals" under the APPROVALS tab. You must check off the hospital department even if you or your research staff/students/trainees are the ones accessing the space (versus Hospital staff) and carrying out the research activities OR if the study involves usual care/standard of care. The hospital departments need to be made aware of any impact to the flow of patient operations even if hospital staff and resources are not used.

Overhead 

• Question 2.1 and 2.2: select the option that applies. If you select OTHER, please provide a justification in the text box provided (e.g. ‘Other’ -> the funding agency does not fund overhead expenses [link to program guidelines]). 

Hospital Research

• Question 3.1, 3.2, and 3.3: select the options that apply. Please identify all hospital departments impacted by your research on the “Approvals” tab, including the appropriate RESEARCH DIRECTOR(s). At a minimum if you said YES to Question 1.6, you must select the appropriate RESEARCH DIRECTOR(s) to approve your Hospital-based Research (i.e. KHSC-HDH - Vic Sahai; KHSC-KGH – Vic Sahai; PC = Kathleen Fitzpatrick)
• Question 3.4 and 3.5: select the option that applies
• Questions 3.6, 3.7, and 3.8: select the option that applies. This question MUST be answered for all clinical trials. For Question 3.8, “industry-led” is usually pharmaceutical studies whereas “investigator-led” is usually academic studies.
• Questions 3.9, 3.10, and 3.11: complete the free-form boxes

Checklist

• Questions 4.1 and 4.2: select the option that applies. At a minimum, a draft or final research proposal/study protocol AND budget/budget justification (if applicable) should be attached to the TRAQ DSS FORM so that the appropriate HOSPITAL OPERATIONAL DIRECTOR(s)/RESEARCH DIRECTOR(s)/Department Head can review for approval.
• Question 4.3, 4.4, 4.5, 4.6, and 4.7: select the option that applies.
• Question 4.8: select the option that applies. A Hospital Departmental Impact & Information Form MUST be attached for all Hospital-based Research. 

• For Hospital-based Research projects, researchers MUST attach the following documents with their TRAQ DSS FORM application prior to submission:
  • Research proposal or study protocol (draft version accepted)
  • Budget and budget justification (if applicable, draft version accepted)
  • Hospital Departmental Impact & Information Form**
  • KHSC Laboratory Services Study Request Form** if using KHSC lab services for ANY biological samples/specimens for your research project (standard of care  AND/OR above standard of care)
  • KHSC Pharmacy Services Study Request Form** if using KHSC pharmacy services for ANY drug monitoring, storage, mixing or blinding for your research (standard of care  AND/OR above standard of care)
  • KHSC Clinical Engineering Services Study Request Form if using ANY medical equipment (hospital- owned, researcher owned, and/or industry-owned (vendor)) in KHSC (KGH Site and/or HDH Site) for your research project 
     
• Other important documents to upload, if applicable: 
  • For research projects involving an Informed Consent Form, please upload if available
  • For research projects working with industry or other academic partners outside of Queen’s and/or local hospital(s)/hospital research institute(s) that require legal review of an agreement/contract, please upload the Study Agreement so that the contract review process can commence by Queen’s
    • Future Study Agreement Amendments: Please log into TRAQ and under your Applications (post review), add an event to your TRAQ DSS FORM file.  Click on EVENTS tab and select the AMENDMENT FORM link. Complete the Amendment Form and upload an electronic version of the Amendment contract and submit.  This will initiate the review of the amendment by Queen’s.
  • Investigator Brochure or Product Monograph, if available (industry-sponsored clinical drug trials)
  • HSREB, CTO and/or OCREB certification approval letter*, if already obtained
  • Overhead Waiver Form, if applicable (http://www.queensu.ca/secretariat/policies/research/indirect.html) 
     
• Click Add Attachment to attach your document(s). 

* If HSREB, CTO and/or OCREB certification application has not yet been approved, you will be required to provide a copy of the approval letter at a later date by submitting an Amendment Form.

** These forms are available for download at the following links: http://www.queensu.ca/traq/awards-grants- contracts/supportive-documents or http://www.kgh.on.ca/research/researchers-staff-trainees. Once completed, please attach to your TRAQ DSS FORM prior to submission. 

• If your answer to Question 1.6 is YES, you MUST select the appropriate RESEARCH DIRECTOR(s) and HOSPITAL OPERATIONAL DIRECTOR(s) to approve your Hospital-based Research ( i.e. KHSC-HDH - Vic Sahai; KHSC-KGH – Vic Sahai; PC = Kathleen Fitzpatrick). Please identify ALL hospital departments that could be impacted by your research. This includes for example:
  • any inpatient/outpatient clinic(s) and/or surgery space that will be accessed to recruit, obtain consent, gather information or biological samples/specimens from a patient for research purposes, or
  • medical records if accessing/extracting patient data from medical charts for research project.
• For all hospital departments, you must check off the hospital department even if a researcher/research staff/student/trainee is the individual accessing the hospital space and carrying out the research activities (i.e. Hospital staff are not carrying out the research) AND/OR if the study involves usual care/standard of care. The hospital departments need to be made aware of any impact to their flow of patient operations, even if hospital staff and resources are not being used to assist the research project.
• The Hospitals cannot absorb any costs (i.e. staffing, facilities, diagnostic and lab tests, etc.) associated with Hospital-based Research that are above and beyond usual care/standard of care. Research budgets must include a recovery of costs where hospital departments are impacted.