MEMORANDUM OF UNDERSTANDING BETWEEN EASTERN ASSOCIATION FOR THE SURGERY OF TRAUMA (EAST) AND THE PRINCIPAL INVESTIGATOR OF AN EAST SPONSORED MULTICENTER TRIAL

The Eastern Association for the Surgery of Trauma (EAST) congratulates you on the approval of your multicenter research study application by the EAST Multicenter Trials (MCT) Committee.  The intent of an EAST Multicenter Trial is to successfully conduct and publish a multicenter trial assembling data from five or more centers which seeks to answer an important and novel question in the practice of trauma, acute care surgery or surgical critical care which will change or significantly affect the care of injured or critically ill patients.

As the Principal Investigator (PI) for this study, you will be primarily responsible for overseeing data collection, data security and data integrity. 

As the PI of this study, you agree to the following requirements of an EAST-MCT:

  1. The PI agrees to retain control of the data and agrees to establish appropriate administrative, technical, and physical safeguards to prevent unauthorized use of or access to the data.
  2. EAST will consider the study active once the protocol is approved by the primary site's Institutional Review Board (IRB). The PI will maintain active IRB approval throughout the study and notify EAST and participating centers within one month if IRB approval lapses.
  3. Biannual enrollment updates must be submitted to the EAST MCT Chair or upon request by EAST administrative staff.
  4. Failure to respond to two consecutive biannual enrollment updates will result in the inactivation of the study.  The second notice will include a warning that failure to respond will result in termination of the study.
  5. Residents or Fellows must have a faculty investigator as a Co-PI on the study. If the fellow or resident leaves the coordinating center during trial enrollment, the original institution will remain as the coordinating center with the faculty member as the lead PI on the study.  
  6. The PI agrees to notify EAST once the study is no longer recruiting or has been terminated prematurely for any reason.
  7. Data from the MCT are encouraged to be submitted in abstract form to the EAST Annual Scientific Assembly and submitted for potential publication to the Journal of Trauma and Acute Care Surgery.
  8. All manuscripts produced as a result of EAST MCTs should acknowledge that the data were generated from an EAST Multicenter Trial in the methods section.
  9. If a study reaches publication, PIs are strongly encouraged to have the words “EAST Multicenter Trial” in the title or subtitle of the manuscript.
  10. If a study reaches publication, PIs will be expected to submit a Visual Abstract for their EAST MCTs to EAST. EAST will promote the study on social media and place the visual abstract on the EAST website with study information. 
  11. The expectation is for two authors per center to be included on the authorship list for abstracts and manuscripts, assuming those authors have met the minimum requirement for authorship. The lead authors of the study should be listed as either first and second author, or first and last author at the discretion of the PI.  The remaining authors from participating centers should be listed in the order of highest center enrollment for this study. All authors that do not fit on the title line of the manuscript per journal limitations should be listed at the conclusion of the manuscript as members of the “EAST XXXX Study Group”.
Any issues that may arise during the length of this EAST MCT should be brought forth promptly to the EAST MCT Chair.  By signing below, you agree to adhere to the above requirements of an EAST sponsored MCT.

Signed:

Name: John Cull, MD, FACS
Title: Chair, EAST Multicenter Trials Committee
Eastern Association for the Surgery of Trauma (EAST)


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