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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 | The explanation and elaboration content for the SAP Statement (PDF) is freely available. |
| Relevant more generic / specialised reporting guidelines (i.e. main generic guideline or extension to a generic guideline) |
Specialised 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 |