Item 5a: Names, affiliations, and roles of protocol contributors.
“R.T.L.*x, E.J.M. x, A.K.x . . .
RTL conceived of the study. AK, EN, SB, PR, WJ, JH, and MC initiated the study design and JK and LG helped with implementation. RTL, JK, LG, and FP are grant holders. LT and EM provided statistical expertise in clinical trial design and RN is conducting the primary statistical analysis. All authors contributed to refinement of the study protocol and approved the final manuscript.” 47
Individuals who contribute substantively to protocol development and drafting should have their contributions reported. As with authorship of journal articles48 listing the protocol contributors, their affiliations, and their roles in the protocol development process provides due recognition, accountability, and transparency. Naming of contributors can also help to identify competing interests and reduce ghost authorship (Items 28 and 31b).9;10 If professional medical writers are employed to draft the protocol, then this should be acknowledged as well.
Naming of authors and statements of contributorship are standard for protocols published in journals such as Trials49 but are uncommon for unpublished protocols. Only five of 44 industry-initiated protocols approved in 1994-95 by a Danish research ethics committee explicitly identified the protocol authors.9
|4: Funding||5b: Sponsor contact information|