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Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

Reporting guideline provided for?
(i.e. exactly what the authors state in the paper)
Reporting of statistical analysis plans (SAPs) for clinical trials.


Statistical Analysis Plan (SAP) Checklist (Word)

Full bibliographic reference Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the Content of Statistical Analysis Plans in Clinical Trials. JAMA. 2017;318(23):2337-2343.
Language English
PubMed ID 29260229
Relevant URLs
(full-text if available)
The full-text of this guideline is freely available at: https://jamanetwork.com/journals/jama/fullarticle/2666509
Explanation and elaboration papers
Relevant more generic / specialised reporting guidelines
(i.e. main generic guideline or extension to a generic guideline)
Early phase clinical trial statistical analysis plans: Homer V, Yap C, Bond S, Holmes J, Stocken D, Walker K, Robinson EJ, Wheeler G, Brown S, Hinsley S, Schipper M, Weir CJ, Rantell K, Prior T, Yu LM, Kirkpatrick J, Bedding A, Gamble C, Gaunt P. Early phase clinical trials extension to guidelines for the content of statistical analysis plans. BMJ. 2022;376:e068177. PMID: 35131744

Reporting guideline website URL http://lctc.org.uk/SAP-Statement
Study design Clinical trials, Experimental studies
Applies to the whole report or to individual sections of the report? Statistical analysis plan-whole report
Record last updated on February 14, 2022


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