|Study Phase & Step||Items to Consider|
|Defining the Research Question||
o Have consensus recommendations/guidelines for simulation research been reviewed?|
o Has a review of the published literature (within and outside of simulation / healthcare) been conducted?
o Is the question feasible, interesting, novel, ethical and relevant?
|Identifying Outcome Measures||
o Is it possible to measure a clinically relevant outcome?|
o If simulation outcomes are being collected -- have the measurement tool(s) been previously validated? Can you establish a causal link to clinically relevant outcomes?
o If technology is being used to collect data, is the data known to be reliable and accurate?
o Have you conducted/do you plan to conduct a pilot study?|
o Is a multicenter study needed to answer the question? If so why - for generalizability, sample size?
o If the pilot study is complete, have you documented lessons learned and iteratively adapted your work for protocol development of multicenter study?
|Project Development Phase|
o Does your research team have expertise in all relevant areas?|
o Have you considered inviting trainees or junior faculty as collaborators?
o Have you considered inviting collaborators and/or content experts from outside the simulation community?
o Do you have a clear role for each collaborator?
o Have all members of your research team had opportunity to contribute to protocol development?|
o Have external experts and/or peers reviewed your protocol and provided feedback?
o Have you reached consensus before finalizing the protocol?
|Research Operations Manual||
o Does your research operations manual contain all the key elements: consent and recruitment strategy, study team members, study flow, inclusion and exclusion criteria, study methods and data management procedures?|
o Have you described in detail how to standardize the simulation environment (and intervention if applicable) across sties?
o Have you conducted training sessions for other sites (either in person or remotely)?
o Is it possible to complete your multicenter study without grant funding?|
o Have you maximized opportunities for matching/in-kind support?
o Have you identified appropriate funding agencies and opportunities that align with your research objectives?
o Have you appropriately prioritized high value items in your budget?
|Ethical Approval and Subsite Contracts||
o Has the lead study site obtained ethics approval?|
o Has a copy of the approved ethics submission been circulated to collaborators?
o Has feedback from prior ethics board reviews been circulated to collaborators?
o Has work to execute subsite contracts been initiated early to prevent delays in research?
o Have you created a timeline for ethics review for participating sites?
|Clinical Trial Registration||o Has the study been registered in a clinical trial registry?|
|Manuscript Oversight Committee||
o Has a manuscript oversight committee been established?|
o Has the manuscript oversight committee developed a document outlining planned publications with proposed writing teams and target journals?
o Have all collaborators received a copy of this document?
o Have all sites conducted feasibility testing?|
o Have lessons learned from feasibility testing been shared across sites?
|Study Execution Phase|
|Recruitment and Enrollment||
o Is the consent process standardized across sites?|
o For randomized controlled trials, does the randomization process ensure equal allocation of study groups within sites?
|Communication and Decision Making||
o Has a plan for frequent, planned communications amongst investigators been established?|
o Has a clear organizational structure been established and communicated with all collaborators?
o Has a research steering committee been established?
o Do all sites have a research operations committee?
o Is there a strategy to foster collaborative spirit and to build team cohesion?
o Is there a plan to use motivational strategies (eg. dashboards)?
o Is there a quality assurance plan?|
o Will there be centralized monitoring and intermittent review of data?
o Will there be site visits by the principal investigator or core study team members?
|Data Abstraction and Analysis||
o When assessment tools are being used, is there a plan to do rater orientation training?|
o When assessment tools are being used, is there a plan to do rater booster training?
o When video review is being used, to avoid bias, can raters be assigned participants that are not from their own site?
o Has missing data been analyzed to determine if systematic biases exist?
|Presentation and Publication||
o Have abstracts been submitted for presentation at relevant conferences?|
o Has the research team taken advantage of all potential opportunities for publication?
o Has the main study been submitted and published prior to other sub-studies?
o Does the research team have a media dissemination strategy?|
o Has the research team considered opportunities for dissemination through traditional media, social media and online forums?
|Translation to Practice||
o Have relevant stakeholders been engaged in efforts to translate results to practice?|
o Have the results been shared with colleagues within existing networks and societies?
|Future work||o Has the team discussed next steps for this research group/question?|