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Outline of DSMB Report


The NINDS recommends that DSMB reports be divided into Open Session Reports and Closed Session Reports. Open Session reports can be shared with investigators and provide general information about study progress and safety. Information in Closed Session Reports is limited to DSMB members and includes a summary of the closed report findings and tables by treatment data. Unless the DSMB is unmasked to treatment, use coded treatment group names (e.g. Treatment A, Treatment B.)

OPEN SESSION REPORT

Title page

  • Study name, date of report, date of data cut-off, author of report (e.g., Statistical Data Center, not specific names) and “OPEN SESSION REPORT”

Table of contents

  • All pages should be numbered and include “Open  Session Report” in header or footer.

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.

Introductory material (see sample template for single page summary)

  • Study organization, list of participating centers and key personnel
  • Purpose of study
  • Summary of protocol and procedures or study synopsis, including treatment arms; outcomes; study schema; screening, enrollment and follow-up; study flow chart; 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
  • Response to previous DSMB report if applicable
  • List of protocol changes
  • Status of any Ancillary Studies (if not presented in the report itself)

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

Main sections

  • Accrual
    • Summary of accrual data
    • Accrual by month
    • Accrual by center
    • Cumulative overall
    • Cumulative compared with projected graph  over full enrollment period
    • 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
    • Quality of data

  • Baseline characteristics
    • Gender and ethnicity data by site
  • Distributions of demographic and key clinical features overall
  • Safety data - adverse events
    • Summary of safety and adverse event data
    • Treatment duration
    • Premature withdrawals from study, discontinuation of treatment; reasons
    • Deaths by center
    • Serious adverse events by center and subject
    • Adverse events grouped by body system overall and by center
    • Out-of-range laboratory values
    • Frequency of specific symptoms

 

CLOSED SESSION REPORT

Title page

  • Study name, date of report, date of data cut-off, author of report (e.g., Statistical Data Center, not specific names) and “CLOSED SESSION REPORT”

Table of contents

  • All pages should be numbered and include “Closed Session Report” in header or footer.

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 (prepared by the blinded study statistician)

  • Overview of report, including list of abbreviations, sources of data, conventions used in the report
  • Summary of significant findings or highlights
  • Copy of statistical report

Main sections

  • Accrual
    • CONSORT Participant Flow Diagram (reference: CONSORT Statement)
    • Accrual by treatment group
    • Cumulative by treatment group
  • Data availability
    • Adherence measures by treatment group
  • Baseline characteristics
    • Distributions of demographic and key clinical features by treatment group
  • Safety data - adverse events
    • Cumulative dose by treatment group
    • Premature withdrawals from study, discontinuation of treatment; reasons by treatment group
    • Time to discontinuation and withdrawal by treatment group
    • Deaths by center and by treatment group
    • Serious adverse events by treatment group
    • Adverse events grouped by body system by treatment group
  • Primary outcome analysis (ONLY INCLUDE FOR INTERIM ANALYSIS REPORT)
    • 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 (ONLY INCLUDE FOR INTERIM ANALYSIS REPORT)
    • Overall and by treatment

 

STUDY SYNOPSIS: [Name of Study]

OBJECTIVE: Enter overall aim of trial

ORGANIZATION:
PI: [Enter Name]
Study Leaders: [Names Steering Committee]
Data Center: [Enter Names of Mgr and Statisticians]
Medical Monitor: [Enter Name]
NINDS Staff: [Enter Names]
DSMB Members: [Enter Names]

 

DESIGN:
General design info, # weeks, single/double blind, Treatment arms

Inclusion: List major inclusion criteria

Exclusion: List major exclusion criteria

Sample Size: N=

Randomization: [Stratification variables]

Statistical Methods: [ITT or other approach]

Interim Analysis: When planned, how many
SCHEDULED EVALUTIONS
Visit Frequency: Identify Clinic Visits (Wk X,Y, etc) and Telephone Visits

Screen Assessments: List primary assessments at visit

Baseline Assessments: List primary assessments at visit

Primary Outcome: Measure - list when collected (Wk 6, 12, etc)

Secondary Outcomes: Measures- list when collected (Wk 6, 12, etc)

Safety Assessments:Measures- list when collected (Wk 6, 12, etc)

STUDY TREATMENTS
For each treatment including control -list treatment name, dose/frequency

OUTCOME MEASURES
Primary Outcome: Measure, when
Secondary Outcomes: List measures

SAFETY:
SAEs: When reported to DSMB

DSMB Reporting: Report frequency

IND: Y/N Exemption #

TIMETABLE: Enrollment Period: Expected Start-End Dates/ expected #/mo.
First Interim Analysis: Date expected
Study Completion: Expected Last visit date
Any additional key time points

DATE UPDATED:

Last updated January 29, 2010