DF/HCC DATA AND SAFETY MONITORING REPORT

DSMB meeting date:

Protocol #:

Protocol Title:

Overall PI:

Site PI(s):

Study Status:

Date Activated:

Statistician:

Clinical Research Coordinator:

Phase of Study:

Disease Program:

Patient population:

Drug(s) & Intervention(s):

Participants: DFCI, MGH, BWH, BIDMC, Other:______

IMPORTANT: In preparing this report or requesting data from Data Management, be mindful of the study design and blinding requirements. Typically, all studies reviewed by the DSMB require pre-approval from the Board to release data for analysis, abstracts, presentations, manuscripts, etc.

  1. SUMMARY:

Please provide a narrative summary of study conduct to date including a brief description of any previous DSMB reviews and recommendations.

II. HISTORY:

III.DESIGN SUMMARY:

This is a randomized phase ___ protocol. There are ___ arms. The main elements of the design are summarized below:

A. Schema:

B. Objectives of the Protocol/Endpoints:

C. Eligibility:

D. Target differences:

E. Power and sample size:

F. Interim analyses:

IV.ADMINISTRATIVE STATUS OF THE STUDY:

A. Accrual table:

Target accrual
Actual accrual
Protocol activation
Rate (# pts/month)
Expected stop date
Target accrual rate

In addition, please provide a table detailing number of accruals by site.

B. CONSORT Diagram

Please refer to Appendix 1 for a CONSORT Diagram template. For more information on CONSORT Diagrams, please go to only include an “Analysis” section of template as appropriate.

C. Case Report Form Status:

Include a summary table for each site with the number and percentage of missing forms by type of form. This table must be from a Missing Forms Report (MFR) run no more than 2 weeks prior to the DSMB submission deadline and include the date the report was run. Pleasefollow these instructionsto generate a summary detail MFR, or see the FAQs section ofthe ODQ Data Management pagefor more information.

Example:

This report reflects data entered as of 09/18/18.
Site 1
Form Type / # Missing Forms / # Expected Forms / % Missing Forms
Baseline / 0 / 60 / 0.0%
Follow-up / 1 / 9 / 11.11%
Toxicity / 0 / 76 / 0.0%
Treatment / 0 / 284 / 0.0%
Total / 1 / 439 / 0.23%
Site 2
Form Type / # Missing Forms / # Expected Forms / % Missing Forms
Baseline / 0 / 72 / 0.0%
Follow-up / 3 / 18 / 16.67%
Toxicity / 0 / 101 / 0.0%
Treatment / 0 / 369 / 0.0%
Total / 3 / 572 / 0.52%

D. Eligibility status:

V.TOXICITY

Table and narrative

VI.OUTCOME DATA:

Outcome Table if applicable Survival and/or Response – Narrative

Ask the study statistician if there are any unique features to the study design that would help the DSMB better understand how the trial is intended to be conducted.

Appendix 1: The Consort E-Flowchart Aug. 2005