PTS Multi-center Research Study Proposal 

The Panamerican Trauma Society (PTS) is proud to sponsor multi-center studies in order to facilitate the design and execution of multi-center projects.

The purpose of this initiative is to encourage researches from different centers to collaborate in studies of mutual interest. The collaborative projects must be initiated by the researchers, who will use their own resources to develop their proposals.

Those interested must follow the process listed below to develop and submit their research proposal.

PROCEDURES AND INSTRUCTIONS.

Phase I. DEVELOPMENT AND SUBMISSION OF PROPOSALS. Those interested must:

1.  Understand that the purpose of this group is to collaborate based on your trauma registries to better understand the epidemiology of trauma in Latin America. Consequently, it is very important to know if your trauma center has the following capacity:

          a. Electronic trauma record of your trauma hospital (# of years of registration?)                                                                                          b. Study Ethics Service (IRB)                                                                                                                                                                          c. Direct contact with the principal investigator                                                                                                                                           d. Direct contact with trauma assistant                                                                                                                                                          e. Name of the trauma center                                                                                                                                                                        f. How many trauma patients are registered each year?

It is important to know if your trauma center has all these requirement (a-f) to begin developing collaborations of multicenter studies.

2. Develop a research study proposal. Researchers should prepare a draft proposal including the following outline:

a.       Title of the research study
b.      Background (study gap)
c.       Main and secondary objectives
d.      Preliminary data (if it exists)
e.      Design and methods
f.        Power analysis (sample analysis)
g.       Risk and benefits analyses
h.      Expected results
i.        References

3.   Submit required documents. The draft proposal should include the following documents:

a.       PTS Multi-center research study proposal
b.      Defined variables
c.       Data collection tools
d.      The IRB approval by the institution (It is not mandatory when sending the proposal).

Note:  We recommend consulting with a statistician and possible co-investigators about the content of the proposal before submitting the proposal. The collaborators of the study must have a vision of consensus and commitment.

The proposal and required documents must be sent to gshanklin@vcu.edu along with this Application Form

Phase II. REVIEW AND APPROVAL OF STUDY. The PTS is committed to the following:

1. Accept proposals. The PTS will accept proposals the first week of every month.
   
2. Provide feedback to proposals. The reviewers will provide feedback and recommendations, require clarification from the  researchers, or suggest changes during the evaluation process prior to approval of study proposal.
   
3. Notify status of study proposal. The reviewers will notify the main researcher (contact person) via email about the status of approval of the proposal approximately 30 days after the proposal has been submitted.

Phase III. SUGGESTIONS FOR DATA COLLECTION AND ANALYSIS.

1. Establish the data collection process. If approved by the PTS, the researchers must establish a data collection procedure. Those interested can consider two options for data collection:

a.  Organize the collection of data by electronic means, as this will facilitate the analysis.
b.  Use an online tool for data collection, such as google docs, google forms, Dropbox or any other type. The instruments used should allow the collection and storage of electronic data as well as easy access to data and information in order to facilitate the analysis of data.

2.       Agreement (email) letter. The main researchers must prepare and distribute a letter of agreement or an email to potential co-investigators. This letter must include a copy of the following documents with the written agreement or email:

a. Study proposal
b. Data collection tools
c. Definition of variables

Note: In this phase it useful to:

3.       Work Schedule. It is recommended that the researchers develop a work schedule and distributes the schedule among the co-researchers.

4.       Study proposal updates. As your study advances, we recommend (not essential) submitting periodic updates via email by the co-investigators. Please be sure to include:

5.       Data analysis and development of research study. According to your work schedule, the researchers must download the final data collected from the electronic tools and proceed to analyze the data and prepare a draft of the study.

Phase IV. PRESENTATION AND PUBLICATION OF RESEARCH STUDY PROPOSAL

6.       Develop an abstract of the study. The researchers must write an abstract of the study and submit to the PTS for an oral presentation at the PTS Annual Congress. The abstract must be send via to e-mail gshanklin@vcu.edu.  The name of your electronic must include: Name of the main author – Multi-center Study. Sample: “Perico Perez – Multicenter Study”

7.       Publication of Research Study. The Panamerican Society is committed to helping the principal investigator publish the study either in the society's magazine or others depending on the impact of the study.