Publications & downloads

MAIN PUBLICATIONS

Chan A-W, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin J, Doré C, Parulekar W, Summerskill W, Groves T, Schulz K, Sox H, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 Statement: Defining standard protocol items for clinical trials. Ann Intern Med 2013;158:200-207.

Chan A-W, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin J, Dickersin K, Hróbjartsson A, Schulz KF, Parulekar WR, Krleža-Jerić K, Laupacis A, Moher D. SPIRIT 2013 Explanation and Elaboration: Guidance for protocols of clinical trials. BMJ 2013;346:e7586.

Translations

 

RELATED PUBLICATIONS

Dai L, Cheng CW, Tian R, Zhong LL, Li YP, Lyu AP, Chan A-W, Shang HC, Bian ZX. Standard Protocol Items for Clinical Trials with Traditional Chinese Medicine 2018: Recommendations, Explanation and Elaboration (SPIRIT-TCM Extension 2018). Chin J Integr Med. 2019; 25(1): 71-79.

Calvert M, Kyte D, Mercieca-Bebber R, Slade A, Chan A-W, King MT. Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension. Jama 2018;319(5):483–494.

Schulz KF, Grimes DA. Get in the spirit with SPIRIT 2013: Protocol content guideline for clinical trials. Contraception 2013;88:676-7.

Chan A-W, Tetzlaff J, Altman D, Dickersin K, Moher D. SPIRIT: New guidance for content of clinical trial protocols. Lancet 2013;381:91-2.

Tetzlaff JM, Chan A-W, Kitchen J, Sampson M, Tricco A, Moher D. Guidelines for randomized clinical trial protocol content: a systematic review. Syst Rev 2012;1:43.

Tetzlaff JM, Moher D, Chan A-W. Developing a guideline for clinical trial protocol content: Delphi consensus survey. Trials 2012;13:176.

The Lancet. Strengthening the credibility of clinical research. Lancet 375:1225.

BMJ Group. Elizabeth Loder on sharing SPIRIT. BMJ Group Blogs. November 3, 2010.

BMJ Group. Trish Groves: Let SPIRIT take you … towards much clearer trial protocols. BMJ Group Blogs. September 25, 2009.

DOWNLOADS

SPIRIT 2013 CHECKLIST (WORD | PDF)

SPIRIT 2013 FILLABLE CHECKLIST (WORD | PDF)

SPIRIT-Outcomes 2022 FILLABLE CHECKLIST (PDF)

SPIRIT-Outcomes 2022 FILLABLE CHECKLIST (Extension items only) (PDF)

FIGURE (WORD | PDF)