Review and publication of protocol submissions to Trials - what have we learned in 10 years?
- PMID: 28114958
- PMCID: PMC5256548
- DOI: 10.1186/s13063-016-1743-0
Review and publication of protocol submissions to Trials - what have we learned in 10 years?
Abstract
Trials has 10 years of experience in providing open access publication of protocols for randomised controlled trials. In this editorial, the senior editors and editors-in-chief of Trials discuss editorial issues regarding managing trial protocol submissions, including the content and format of the protocol, timing of submission, approaches to tracking protocol amendments, and the purpose of peer reviewing a protocol submission. With the clarification and guidance provided, we hope we can make the process of publishing trial protocols more efficient and useful to trial investigators and readers.
Comment on
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Increasing value and reducing waste: addressing inaccessible research.Lancet. 2014 Jan 18;383(9913):257-66. doi: 10.1016/S0140-6736(13)62296-5. Epub 2014 Jan 8. Lancet. 2014. PMID: 24411650 Free PMC article.
References
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- International Conference on Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 Good Clinical Practice: Consolidated Guidance, dated April 1996. http://www.fda.gov/downloads/Drugs/.../Guidances/ucm073122.pdf. Accessed 19 Dec 2016.
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