Checklist for a New Research Study

Study Title:
LPI:
PI:
Co-Is:
Residents:
Students:
  1. Develop your research question and study idea
/ Consider a meeting with Drs. Paul, Thabane, Buckley, Busse, Shanthanna, Reddy, or Youssef to discuss your proposed research question. If this is a residency project be sure to consult the Minimum Requirements for Researchbefore choosing your topic. In developing your research question be sure to draw inspiration from your clinical experience and focus on areas where you feel that practice can be improved. A tough case that causes you to reflect on your management and question your diagnosis or treatment decisions is a great seed for a research project. Please note that getting the right question is the most important part of doing research—because the research questions drives the design, the architecture and the necessary collaborations for the study. Thabane L, Thomas T, Ye C, Paul J. (2009) Posing the research question: not so simple. CJA (2009) 56, 71–79
  1. Review the literature
/ Search the literature for background articles on your topic and ensure that your research question hasn’t been answered definitively so that your project has the potential of generating something novel. Rachel Couban, a research assistant in the National Pain Centre, can assist you with the search if you like.
  1. Find a mentor
/ If this is a residency project find a staff person to assist you with your project and serve as a mentor. Any staff can assist you, you just need to find one who shares interest in your topic. The following link shows the research interests of some of the anesthesia staff: Anesthesia staff research profiles.
  1. Develop the study methodology and analysis plan
/ Consider meeting with Drs. Thabane and/or Paul to discuss the proposed research methods for your project. It is important for your mentor to attend these meetings.
  1. Write up your research protocol
/ Write the introduction, research question, proposed methodology, and reference sections for your project. Be sure to stipulate your primary and secondary outcomes and the rationale for the proposed sample size. Depending on the methodology (systematic review, retrospective review, questionnaire, etc.) be sure to consult the applicable reporting guideline[LT1]for your study proposal. The goal should be to write the document so it serves as the plan for your study and serves as the first half of a manuscript if you choose to submit your study for publication.
  1. Write up your Reference list
/ Be sure to use a reference database like EndNote to cite references in your study document and to create your Reference section. Toni Tidy can provide you a link to download EndNote if you require a copy.
  1. Discuss your project at a Monthly Research Dinner Meeting
/ Get some initial feedback at this meeting which occurs the first Wednesday of each month. Contact Toni Tidy () to request to be put on the schedule for the next meeting to present your project.
  1. Presentation to Research Interest Group
/ Present your research proposal at one of the Research Interest Group dinner meetings to get feedback from the department research group. Use the feedback from this meeting to fine tune your research proposal.
  1. Finalize research protocol
/ Most journals now publish protocols for different types of studies. We encourage you to consider submitting your protocol for publication in a peer-reviewed journal. Here is a list of examples of published protocols.[LT2]
  1. TRUST Trial
  2. Pulse radiofrequency of Dorsal root ganglion RCT study
  3. Lumbar transversus abdominis plane block pilot study
  4. Opioid substitution and antagonist therapy systematic review
  • Check out the Trials Journal site: &
  • Pilot & Feasibility Journal site:
*Please note that you will need final REB approval (Step 13 below) before submission for publication.
  1. Apply for funding (if necessary)
/ If your project requires any supplies (e.g. drugs or equipment) or research assistant help for patient recruitment or data collection be sure to apply for funding. The department doesn’t have funding to provide research supplies and coordinators for unfunded studies. For residency research projects the RMA has a fund to support this studies.
Funding is an essential element for many studies and this should be considered early as it takes time to apply for research grants.
  1. Prepare REB submission
[Note: retrospective chart reviews; databases; prospective chart reviews; case reports may not need all documentation listed]
Note:
  • All individuals (students, residents, fellows, and research assistants) who participate in clinical trials involving human research are required to complete the Good Clinical Practice (GCP) training.
  • For researchers doing retrospective reviews, only the Chart Review Tutorial (CRT) is required.
  • Systematic reviews do not require either the GCP or CRT training.
/ The following will be needed:
  • eREB account set-up
  • Pick LPI/ Co-investigators for each site [HHS & SJHH]
  • Finalize the protocol after getting feedback from necessary departments/faculty/staff
  • Participant consent form
  • Case report form (CRF)
  • Any type of patient contact information, for example questionnaires, scales, telephone script
  • Get quote from lab/pharmacy if required
  • Prepare budget if required
  • All necessary approvals prior (via email) to e-signature requests, for example surgeons, clinical managers, charge nurses, chiefs of department, health records, pharmacy etc.

  1. REB Conditional Approval received
/ Respond to all questions/concerns via eREB site.
  1. Final REB Approval received
/ The study can only begin once final REB approval has been received.
  1. Set up a REDCap database for data collection
/ REDCap is a Research Electronic Data Capture tool which enables secure online data collection which is encrypted, password protected and backed up. REDCap is gives the researcher tools to develop data collection forms for the study such that demographics and the primary and secondary outcomes can be collected. Toni Tidy can assist with setting up this database as we have developed several templates from previous studies for patient demographics, past medical history, anesthesia and surgery details and medication lists. The data collection forms have to mirror what is stipulated in the REB approved study document. If any modifications are required then a REB amendment request needs to be submitted.
Please ask your mentor and Drs. Thabane & Paul to review your case report forms to ensure that you are collecting all required data to address your study objectives.
  1. If your project is a chart review contact Decision Support Services (DSS) to get the list of patients of interest
/ DSS will need REB final approval and all the data points as approved by the REB
  1. If your project is a clinical trial set up in-services with allnursing groups involved and notify affected department heads of the study as applicable
/ For your study to succeed the nurses and clinicians that are impacted by your study need to be informed about the study before it is launched. This is always a critical step, especially when you ask clinical staff to take part in the study in terms of the study intervention or data collection. For example, if your study will be recruiting elective surgical patients then the Pre-op Clinic manager and staff need to be notified about the study.
  1. If it is a pain study in the Pain Clinictrial, set up in-services withthe nurses in that department.
/ Contact the Michael G. DeGroote Pain Clinic’s Clinical Manager – Carrie-Lynn Meyer at

  1. Monthly Research Meeting *Attendance Required
/ While your study is ongoing, your attendance is required at our Monthly Research Meetings which are held every second Wednesday of the Month at 4-5pm in the Pain Institute Conference Room MDCL 2106.
  1. Collect data on your required sample
/ Be sure to communicate regularly with research assistants assisting you so you can help to manage any issues that arise.
  1. Analyze the data and develop your study tables and figures
/ Meet with the Department biostatistician and plan the necessary analyses for your data. You will be asked to create mock-up tables of how you would like the results of the analyses to be reported. We can provide you with examples to show you how to do this task.[LT3]
  1. Write up the Results and Discussion sections
/ Be sure to reference the necessary reporting guideline again and the Instructions for Authors for the journal you plan to submit to.
  1. Present your project at Resident Exchange Day
/ Your research requirement is complete!
  1. Consider submitting your project as an abstract to a national meeting.
/ Canadian Anesthesiologists’ Society Annual Meetings
  1. Consider submitting your work for publication
/ It is important that you follow the relevant reporting guideline for your study design[LT4]

[LT1]We should also connect this to Equator Network:

[LT2]Here we can list some examples, and I would be glad to provide them

[LT3]This is a very important step to ensure that the analyses are geared towards what will be presented in a manuscript. We have examples that we can provide to people to use

[LT4]Again, we can link to Equator Network