Table 2.

Recommendations for reporting of DSMBs in publications of RCTs

Minimum reporting recommendations
Report whether or not a DMC/DSMB was used in peer-reviewed publications and on ClinicalTrials.gov (or a comparable well-established clinical trial registration website)
If a DMC/DSMB was used:
• Report the following in the text of the article:
• Brief description of major responsibilities, including monitoring participant safety, benefit:risk assessment, recruitment, data quality, and study integrity, as well as any involvement in interim analyses  • Any DMC/DSMB recommendations that significantly modified the protocol after study initiation or an indication that no such recommendations occurred  • Names and affiliations of DMC/DSMB members  • Frequency of DMC/DSMB meetings  • Whether the data presented to the DSMB were unblinded, separated by treatment group but blinded to treatment assignments (i.e., “blinded assignments”), or not separated by treatment group (i.e., aggregate sample data only)
• Report the following in supplemental material (if not included in a publicly-available charter):
• Whether or not investigators and sponsors were blinded to DMC/DSMB deliberations involving unblinded data and any other DMC/DSMB activities that should generally not be revealed to investigators or sponsors  • Whether or not the DMC/DSMB members were evaluated for conflicts of interest  • Who was responsible for preparing the reports for the DMC/DSMB (e.g., independent statistical group, unblinded statistician from the organization conducting the trial, or study sponsor personnel)  • DMC/DSMB charter with any amendments indicated

^*Possible sections in which this information can be included in the article text include: (1) the Methods section, (2) Acknowledgements, (3) separate section before the References, (4) list of contributors, or (5) in a footnote. This placement will likely depend on journal policy.