Manual of procedures

s, Public Presentations, Electronic Postings General Abstracts, public presentations of study data and electronic postings of study data must follow the same processes outlined for primary publications as noted above, but do not require the same levels of scrutiny and are handled expeditiously. The Publications Committee Chairs, or at the Chairs’ discretion, the Publications Committee, may approve requests pending NHLBI Program Office approval for abstract submission, public data presentation or electronic data posting. The DCC has the right to review and prioritize approvals based upon the availability of required resources. Abstracts All abstract authors must have made substantive contributions to the study. Acknowledgments of funding sources are not required in the abstract text but must be included in the presentation slides or poster materials, if the abstract is accepted.s All abstract authors must have made substantive contributions to the study. Acknowledgments of funding sources are not required in the abstract text but must be included in the presentation slides or poster materials, if the abstract is accepted. Proposals for abstract submissions should be initiated well in advance of the abstract submission deadline. The Publications Committee prioritizes their review process in the following way: peerreviewed publications receive higher priority than abstracts, public presentations and electronic postings. Public Presentations and Electronic Postings of Study Data In general, a complete set of summary slides is prepared by the Lead and Senior Author and Protocol Statistician upon completion and analysis of each BMT CTN study. Individual investigators who wish to prepare additional slides for public presentation must utilize data from the final Data Analysis Report. Such presentations must also be submitted to the DCC for submission to the Publications Committee Chairs, their designee, or at the Chairs’ discretion, the entire Committee, for review and approval. Each such presentation must also acknowledge the BMT CTN Administrative MOP Version 13.0 September 25, 2018 8-6 authors, funding agencies, contributors and the participating Core and Affiliate Centers. Electronic posting of study data must not occur prior to publication of the study’s primary manuscript in a peer-reviewed journal. Secondary Manuscripts Manuscripts arising from the study outside the primary endpoints are considered secondary manuscripts. These include: • Reports of secondary analyses pre-specified in a protocol • Reports of other secondary analyses from one or more BMT CTN trials • Ancillary studies • Laboratory studies • Methodological papers • Position papers • Other technical reports All secondary manuscripts must follow the same review process as a primary results manuscript as detailed in Section 8.4. Authorship Guidelines Authorship guidelines are based on fairness, inclusion and stimulation of participation and compliance. Author rewards focus on intellectual input and effort extended during the lifecycle of the trial. The Publications Committee is responsible for the development and modification of guidelines for determining authorship. Authorship guidelines are ratified by the Steering Committee prior to implementation. Authorship on BMT CTN publications is a privilege commensurate with both personal and center contribution to the research being presented and the Network as a whole. The primary requirement for authorship of a BMT CTN publication is a substantive contribution to the research effort and is a reward for many aspects of contribution including: (1) membership and active participation in the Protocol Team; (2) active accrual to the protocol; (3) timely and accurate reporting of data; and, (4) active participation in Steering Committee activities. These activities may include participation in the following areas: hypothesis generation, concept development, protocol development, study implementation, subject enrollment, data collection, data analysis, and manuscript preparation and finalization. In most instances, contributions in several areas must occur, and in every instance, authors are expected to contribute to manuscript preparation and finalization. The fundamental premise of authorship designation is the reward for overall effort. The success of the Network depends on many people and authorship is used to reward participation in Network activities. First and senior authorship positions on the primary and secondary manuscripts should be broadly shared. First and senior authorship on the primary paper does not imply the same BMT CTN Administrative MOP Version 13.0 September 25, 2018 8-7 privilege on any subsequent manuscripts resulting from the same completed protocol or related ancillary studies. Authorship Eligibility Requirements Each member of the Protocol Team has eligibility for authorship on the final primary manuscript from the study. In addition, each Clinical Center Principal Investigator whose center enrolls at least one subject in the study is eligible for authorship. Additional authors may be invited at the discretion of the Protocol Chair(s), in consultation with the Protocol Team, with approval of the Publications Committee Chairs or full Committee, if needed. Eligibility for authorship does not guarantee authorship. Eligible authors must still make substantive contributions, including careful review and contributions to the draft manuscript. Establishing the Order of Authorship for Primary Results Manuscript For each manuscript, the Protocol Chair(s) will recommend the co-authors and the order of authorship based on the Administrative MOP parameters and provides the authorship list to the DCC for approval. Any potential additional authors proposed outside the scope of the Administrative MOP should be reviewed and approved by the Publications Committee with documented reasoning.The DCC will review the authorship list to confirm if authorship is warranted, and request rationale from Chairs if needed. The DCC will also assess Protocol Chair authorship order based on accrual and participation metric posted on the SharePoint website, and get approval/adjudication from the Executive or Publications Committee if needed. If there are multiple Protocol Chairs, two Chairs share first authorship, provided they meet the below requirements and the journal allows this practice. The Publications Committee will adjudicate any disputes, and may also recommend additional authors after review of accrual tables and based on definitive and justifiable, well-documented reasoning. Approved requirements for author order are as follows: • SENIOR (last) AUTHOR REQUIREMENTS − PI of Core Center or DCC or Center that proposed or led the trial − Protocol Team member − Attended majority of Protocol Team Calls − Attended majority of Steering Committee Meetings − Author’s center actively participated in the trial − Author’s center showed commendable protocol compliance and data submission • FIRST AUTHOR REQUIREMENTS − Protocol Team member (preferably Chair or Co-Chair) − Attended majority of Protocol Team Calls − Writes the first draft of the manuscript − Author’s center actively participated in the trial • AUTHORSHIP BASED ON PROTOCOL TEAM AND ENDPOINT REVIEW COMMITTEE (ERC) PARTICIPATION − The second and third authors will be the Protocol Officer or Statistician. The order will be determined by the Protocol Chairs. BMT CTN Administrative MOP Version 13.0 September 25, 2018 8-8 − Each Protocol Team/ERC member will be an author, in order of accrual, if the following criteria are met:  Attended the majority of Protocol Team/ERC calls  Author’s center actively participated in the trial  Author’s center had satisfactory protocol compliance and data submission − If the Protocol Team/ERC member is already represented as first or Last Author, an additional Second Author from that center will be added − If a center has more than one member represented on the Protocol Team/ERC, only one member is eligible to be an author under this criterion. The other Protocol Team member(s) may be eligible for authorship if they meet any of the additional authorship criteria. • AUTHORSHIP BASED ON CENTER PARTICIPATION IN ORDER OF ACCRUAL − The top five accruing centers will have a single author in order of accrual − If one of these centers is the First or Last Author, a Second Author from that center will be added − Author identity may be determined by center PI − Author’s center must have also had satisfactory protocol compliance and data submission • BMT CTN PUBLICATIONS LIST ALL CENTERS THAT PARTICIPATED − Any center that has enrolled at least one patient will be acknowledged in the publication • CONSIDERATIONS FOR ADDITIONAL AUTHORS − A physician from an Affiliate Center can be named in acknowledgement of overall effort, exceptional accrual and/or supportive input throughout the lifecycle of the study − An additional physician author from a same center mentioned above can be named if he/she has shown exceptional accrual or intellectual input − These can be non-physicians from any center  Nurses  Study coordinators  Pharmacists  Statisticians • IF THE JOURNAL OR ABSTRACT GUIDELINES LIMIT THE NUMBER OF AUTHORS, AUTHORS WILL BE DELETED IN THE FOLLOWING ORDER: − Remove authors in reverse order of center accrual − Remove Protocol Team members and top accruing centers in reverse order of center accrual − Remove Secondary Statistician − Minimum author assignments will be First, Last, Protocol Officer and Primary Statistician Establishing the Order of Authorship for Secondary Results or Ancillary Study Manuscripts Secondary results manuscripts will follow similar authorship guidelines as described above for primary results manuscripts. However, special recognition is given to those who were not BMT CTN Administrative MOP Version 13.0 September 25, 2018 8-9 considered for First and Senior Authors on the primary paper. Consideration as added