%0 Journal Article %1 Chan2013 %A Chan, An-Wen %A Tetzlaff, Jennifer M %A Gøtzsche, Peter C %A Altman, Douglas G %A Mann, Howard %A Berlin, Jesse A %A Dickersin, Kay %A Hróbjartsson, Asbjørn %A Schulz, Kenneth F %A Parulekar, Wendy R %A Krleza-Jeric, Karmela %A Laupacis, Andreas %A Moher, David %D 2013 %J BMJ (Clinical research ed.) %K Checklist ClinicalProtocols ClinicalProtocols:standards ClinicalTrialsDataMonitoringCommittees ClinicalTrialsasTopic ClinicalTrialsasTopic:methods ClinicalTrialsasTopic:standards ClinicalTrialsasTopic:statistics&numericald ComputerSecurity DataCollection DataCollection:methods Ethics Humans Medical MedicalAudit PatientSelection PracticeGuidelinesasTopic ProfessionalRole QualityControl RandomAllocation ResearchDesign ResearchPersonnel ResearchSupportasTopic SampleSize SocialResponsibility StatisticsasTopic TimeFactors TreatmentOutcome %P e7586 %R 10.1136/bmj.e7586 %T SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. %U http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3541470&tool=pmcentrez&rendertype=abstract %V 346 %X High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. %@ 1756-1833; 0959-535X

@article{Chan2013, abstract = {High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.}, added-at = {2023-02-03T11:44:35.000+0100}, author = {Chan, An-Wen and Tetzlaff, Jennifer M and Gøtzsche, Peter C and Altman, Douglas G and Mann, Howard and Berlin, Jesse A and Dickersin, Kay and Hróbjartsson, Asbjørn and Schulz, Kenneth F and Parulekar, Wendy R and Krleza-Jeric, Karmela and Laupacis, Andreas and Moher, David}, biburl = {https://www.bibsonomy.org/bibtex/2342abd3c766956b65369410562e254f8/jepcastel}, city = {Women's College Research Institute at Women's College Hospital, Department of Medicine, University of Toronto, Toronto, Canada, M5G 1N8.}, doi = {10.1136/bmj.e7586}, interhash = {5fc7ec863a19ea32564b39b2ddecbd4a}, intrahash = {342abd3c766956b65369410562e254f8}, isbn = {1756-1833; 0959-535X}, issn = {1756-1833}, journal = {BMJ (Clinical research ed.)}, keywords = {Checklist ClinicalProtocols ClinicalProtocols:standards ClinicalTrialsDataMonitoringCommittees ClinicalTrialsasTopic ClinicalTrialsasTopic:methods ClinicalTrialsasTopic:standards ClinicalTrialsasTopic:statistics&numericald ComputerSecurity DataCollection DataCollection:methods Ethics Humans Medical MedicalAudit PatientSelection PracticeGuidelinesasTopic ProfessionalRole QualityControl RandomAllocation ResearchDesign ResearchPersonnel ResearchSupportasTopic SampleSize SocialResponsibility StatisticsasTopic TimeFactors TreatmentOutcome}, month = {1}, note = {7139<m:linebreak></m:linebreak>JID: 8900488; OID: NLM: PMC3541470; epublish;<m:linebreak></m:linebreak>Protocol; RCT}, pages = {e7586}, pmid = {23303884}, timestamp = {2023-02-03T11:44:35.000+0100}, title = {SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.}, url = {http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=3541470&tool=pmcentrez&rendertype=abstract}, volume = 346, year = 2013 }