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Title page

• Study name, date of report, author of report (e.g., Statistical Data Center, not specific names)

Table of contents

• Separate reports or sections for open-session and closed-session data
• All pages should be numbered

List of tables and figures

• Note: each table and figure should show date of data cut-off for inclusion. Totals, denominators should match where appropriate. Tables and figures should be clearly labeled and self-explanatory. If randomization is stratified, tables and figures may need to be presented by strata.

Summary of report (generally prepared by the study Principal Investigator)

• Current status of study
• Discussion of issues or problems
• Overview of report, including list of abbreviations, sources of data, conventions used in the report.

Introductory material

• Study organization, list of participating centers and key personnel
• Purpose of study
• Summary of protocol and procedures, including treatment arms; outcomes; study schema; screening, enrollment and follow-up procedures; flow of data; dosing protocol. Highlight any important changes since previous report.
• Interim monitoring guidelines (stopping guidelines)
• Summary of procedures for identifying and reporting adverse events
• Summary of procedures for verifying/adjudicating outcome measures
• Projected timetable for study milestones
• List of previous DSMB meeting dates/reports

Main sections

• Accrual
  • Summary of accrual data
  • Accrual by month
  • Accrual by center and treatment
  • Cumulative overall and by treatment
  • Cumulative compared with projected, over time and by center
  • Subject status: number screened, number eligible, ineligible, refused
  • Reasons for ineligibility or refusal, overall and by center
  
  
• Data availability
  • Summary of data availability and quality
  • Completeness of reporting of baseline and follow-up data
  • Timeliness of receipt of data
  • Error resolution timeliness and completeness
  • Protocol deviations/violations
  • Adherence measures, overall and by treatment group*
  • Quality of data
  
  
• Baseline characteristics
  • Gender and ethnicity data by site
  • Distributions of demographic and key clinical features overall and by treatment group*
  
  
• Safety data - adverse events*
  • Summary of safety and adverse event data
  • Treatment duration
  • Cumulative dose by treatment group
  • Premature withdrawals from study, discontinuation of treatment; reasons
  • Time to discontinuation and withdrawal by treatment group
  • Deaths by center, treatment group
  • Adverse events and serious adverse events by center and subject
  • Adverse events grouped by body system
  • Out-of-range laboratory values
  • Frequency of specific symptoms
  • Distributions of adverse events and serious adverse events by treatment group
  
  
• Primary outcome analysis*†
  • Completeness of reporting
  • Number of events overall and by treatment group
  • Events by time and treatment group; subgrouped by age or other key characteristics
  • Interim monitoring boundary
  
  
• Other outcomes*†
  • Overall and by treatment

*All treatment group-specific and outcome analyses should be presented in closed-session report
†More detailed report may be required at time of formal interim analysis

 

Last updated April 20, 2007