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June 2016

NIAMS Data and Safety Monitoring (DSM) Report Template for Multi-site Studies —Closed Session—

DSM Report Template: Instruction Sheet

The following report template is intended to act as guidance and a reference document for investigators, study staff, data managers, study statisticians and others involved in submitting periodic reports to a Monitoring Body (e.g., Data and Safety Monitoring Board, Safety Officer). The proposed structure should be customized according to the individual study needs. Additional or fewer reports may be appropriate, but the template serves as a starting point.

Prior to the first Monitoring Body report, study team members should review this template and customize it to the specific needs of the protocol. During the introductory call, the designated study team member who is responsible for preparing these reports (i.e., statistician, data manager) should present the customized table shells to the NIAMS and the Monitoring Body. The final format of the reports, tables, and listings will be approved by the Monitoring Body and the NIAMS. This process will ensure the appropriate study data are presented to the Monitoring Body and will promote efficiency in the creation of future safety reports.

The design, scope and nature of a study will impact how data are presented. Outlined below are a few issues that should be considered as this document is tailored:

  • For studies in which there are masked treatment groups, the Monitoring Body, at its discretion, may request and review unmasked data in the closed session materials. The decision to present results in an unmasked fashion should be discussed with the NIAMS and the Monitoring Body.
  • It is recommended that data stratified by treatment group be masked (i.e., Treatment A versus Treatment B).
  • As a general rule, interim results should not be presented unless interim analyses are described in the protocol or the Monitoring Body has requested an interim analysis to assess a safety concern or study futility. The decision whether or not to present interim or final results in this report should be discussed with the Monitoring Body and the NIAMS.
Template Recommendations:
  • In the following templates, the instructions, explanatory text, and examples are indicated by blue text. Be sure to replace examples with protocol-specific details.
  • Instructional text will also be enclosed in {braces} to signify this text for screen-readers used by the visually impaired.
  • Delete template-specific instructional text and this Instruction Sheet during the report development process.
  • Report Cover Page

    Protocol Title/number: <Insert title of the protocol>
    Grant Number: <Insert grant number>
    Principal Investigator (PI): <Name of PI
    PIís Title
    Institution
    Address>
    Meeting date: <Insert date of the scheduled meeting, if applicable>
    Date of Report: <Insert date that the report is being issued>
    Data as of: <Insert the date of the data snapshot for the analyses in this report>
    Prepared by: <Name of person who prepared the report
    Personís Title
    Place of employment
    Address>

     

    TABLE OF CONTENTS

    Report Cover Page
    Note: the Protocol Synopsis and Executive Summary are included in the Open Session Report.
    Study Administration
    Recruitment and Participant Status
    Figures and Tables
    Table 1: Participant Enrollment Status by Site and Masked Treatment Group
    Table 2: Demographics by Site and Masked Treatment Group
    Table 3: Key Baseline Characteristics by Site and Masked Treatment Group
    Table 4: Study Duration for All Participants by Masked Treatment Group
    Data Quality Table
    Table 5: Summary of Missed Visits by Site and Masked Treatment Group
    Safety Assessments for All Participants
    Table 6: Incidence of Adverse Events by Body System and Preferred Term and Masked Treatment Group
    Table 7: Severity of Adverse Events by Preferred Term and Masked Treatment Group
    Listing 1: Adverse Events by Site and Masked Treatment Group
    Listing 2: Serious Adverse Events by Site and Masked Treatment Group
    Listing 3: Deaths by Site and Masked Treatment Group
    Table 8: Laboratory Test Results Summary by Masked Treatment Group
    Table 9a—9i: Laboratory Test Results Summary by Site and Masked Treatment Group
    Listing 4: Clinically Significant Abnormal Lab Values by Site and Masked Treatment Group
    Listing 5: Unanticipated Problems by Masked Treatment Group
    Listing 6: Protocol Deviations by Masked Treatment Group

     

    Study Administration

    Recruitment and Participant Status:

    Figures and Tables

    Table 1: Participant Enrollment Status by Site and Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group ____ (N=) Masked Treatment Group ____ (N=)
      Site 1 Site 2 Total Site 1 Site 2 Total
      N %* N %* N %* N %* N %* N %*
    Enrolled   100   100   100   100   100   100
    Active                        
    Completed Protocol                         
      N %** N %** N %** N %** N %** N %**
    Discontinued from Treatment/Follow-up Ongoing   100   100   100   100   100   100
    Reason 1 ****                        
    Reason 2                        
      N %*** N %*** N %*** N %*** N %*** N %***
    Discontinued from Treatment/Follow-up Completed   100   100   100   100   100   100
    Reason 1                        
    Reason 2                        
      N %*** N %*** N %*** N %*** N %*** N %***
    Discontinued from Study/Follow-up Not Ongoing   100   100   100   100   100   100
    Reason 1                        
    Reason 2                        

     

    For some protocols, it is important to distinguish between participants who withdrew early from the study and those who discontinued treatment but may or may not still be followed.

    * % of participants who are enrolled. ** % of participants who have discontinued treatment, but continued to be followed as part of the study.

    *** % of participants who have discontinued the study and are no longer being followed. **** Reasons should be customized with items relevant to the study protocol.

     

    Table 2: Demographics by Site and Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group ____ (N=____) Masked Treatment Group ____ (N=____)
    Characteristics Site 1
    N%
    Site 2
    N%
    Site i
    N%
    Total N (%) Site 1
    N%
    Site 2
    N%
    Site i
    N%
    Total N (%)
    Total Enrolled:                
    Gender Male                
    Female                
    Ethnicity Hispanic or Latino                
    Not Hispanic or Latino                
    Missing                
    Race American Indian/Alaska Native                
    Asian                
    Black or African American                
    Native Hawaiian or Other Pacific Islander                
    White                
    More than one race                
    Missing                
    Education Grade School                
    High School or equivalent                
    Some college, no degree                
    College degree                
    Graduate degree                
    Doctoral                
    Age Mean                
    Standard Deviation                
    Median                
    Minimum                
    Maximum                

    * Categories should be customized with items relevant to the study protocol; the items listed are only examples.

     

    Table 3: Key Baseline Characteristics by Site and Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group ____ (N=____) Masked Treatment Group ____ (N=____)
    Characteristics* Site 1 Site 2 Site i TOTAL Site 1 Site 2 Site i TOTAL
    N (%) N (%) N (%) N (%) N (%) N (%) N (%) N (%)
    Body Mass Index Below 18.5                
    18.5 — 24.9                
    25.0 — 29.9                
    30.0 and Above                
    Western Ontario and McMaster Universities  Arthritis Index (WOMAC) Total Score Mean                
    Standard Deviation                
    Median                
    Minimum                
    Maximum                

    * Characteristics should be customized with items relevant to the study protocol (e.g., stratification variables); the items listed are only examples.

     

    Table 4: Study Duration for All Participants by Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group ____ (N=____) Masked Treatment Group ____ (N=____)
    Time in Study* Expected** Actual*** Expected** Actual***
    Total N= N (%) N (%) N (%) N (%)
    Visit 1        
    Visit 2        
    Visit 3        
    Visit 4        
    Completed Study        

    * Should be customized to visit schedule and can be shown by visits, days, weeks, months, or treatment periods.

    ** Number of participants expected to complete each study milestone.

    *** Number of participants who completed each study milestone.

    Study Administration

    Data Quality Table

    Table 5: Summary of Missed Visits by Site and Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group ____ (N=____) Masked Treatment Group ____ (N=____)
    Missed Visits Site 1 Site 2 Total Site 1 Site 2 Total
    N (%) N (%) N (%) N (%) N (%) N (%)
    Number of Completed Participants            
    Number of Participants Missing Visits            
    Number of Missed Visits            
    Average Number of Missed Visits for Completed Participants            
                 
    Number of Active Participants            
    Number of Participants Missing Visits            
    Number of Missed Visits            
    Average Number of Missed Visits for Active Participants            

    {This table should display the number of participants missing visits and the number of actual missed visits divided by those who are currently active on the protocol and those who completed.}

    Safety Assessments for All Participants:

    Tables and Listings

    Table 6: Incidence of Adverse Events by Body System and Preferred Term and Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group ____ (N=____) Masked Treatment Group ____ (N=____)
    Body System and Preferred Term* Total N= Total N=
    n** (%)*** Events**** n** (%)*** Events****
    Overall            
    Body System 1*****            
    Preferred Term 1            
    Preferred Term 2            
    etc.            
                 
    Body System 2            
    Preferred Term 1            
    Preferred Term 2            
    etc.            
                 
    Body System 3            
    etc.            

    {Standard medical terminology should be used when recording AEs. Furthermore, it is recommended that studies that plan to submit data to regulatory authorities should code their AE data using an electronic coding system such as the Medical Dictionary for Regulatory Activities (MedDRA) or the Common Terminology Criteria for Adverse Events (CTCAE).

    *The Preferred Term is a distinct descriptor (single medical concept) for a symptom, sign, disease, diagnosis, therapeutic indication, investigation, surgical, or medical procedure, and medical, social, or family history characteristics

    ** Number of participants experiencing an AE (participant is to be counted only once for each adverse event).

    *** % of total number of participants in the study.

    **** Number of events for Body System and Preferred Term.

    ***** Body Systems may include: Blood and lymphatic system disorders; Cardiac disorders; Congenital, familial and genetic disorders; Ear and labyrinth disorders; Endocrine disorders; Eye disorders; Gastrointestinal disorders; General disorders and administration site conditions; Hepatobiliary disorders; Immune system disorders; Infections and infestations; Injury, poisoning and procedural complications; Investigations; Metabolism and nutrition disorders; Musculoskeletal and connective tissue disorders; Neoplasms benign, malignant and unspecified (incl cysts and polyps); Nervous system disorders; Pregnancy, puerperium and perinatal conditions; Psychiatric disorders; Renal and urinary disorders; Reproductive system and breast disorders; Respiratory, thoracic and mediastinal disorders; Skin and subcutaneous tissue disorders; Social circumstances; Surgical and medical procedures; Vascular disorders.

     

    Table 7: Severity of Adverse Events by Preferred Term and Masked Treatment Group

    Data as of:
    Date of report:

      Masked Treatment Group
    ____ Total N=
    Masked Treatment Group
    ____ Total N=
    Preferred Term* Mild Moderate Severe Mild Moderate Severe
    n** (%)*** n (%) n (%) n** (%)*** n (%) n (%)
    Preferred Term 1            
    Preferred Term 2            

    *For each preferred term, sort by most common event in descending order of incidence.

    **Number of participants experiencing a certain severity of an adverse event where each participant is counted only once at highest level of severity.

    ***% of participants experiencing a certain severity of an adverse event.

     

    Listing 1: Adverse Events by Site and Masked Treatment Group

    Data as of:
    Date of report:

    Site Participant ID Masked Treatment Group Age Gender Event Term AE Onset Date AE Stop Date Study Intervention Start Date Study Intervention Stop Date Relationship* Participant discontinued from intervention? Expected (Y/N) Severity** Outcome*** Serious (Y/N)
                                   
                                   
                                   
                                   
                                   
                                   
                                   
                                   
                                   

    * Relationship should be specifically defined for each study (i.e., Relationship to intervention, Relationship to study drug, etc.) The following are commonly used categories: Definitely, Probably/Possibly, Not Related

    ** The following are commonly used categories: Mild, Moderate, Severe.

    *** Outcome:
    Recovered, without treatment
    Recovered, with treatment
    Still Present, no treatment
    Still Present, being treated
    Residual effect(s) present-no treatment
    Residual effect(s) present-being treated
    Subject died

     

    Listing 2: Serious Adverse Events by Site and Masked Treatment Group*

    Data as of:
    Date of report:

    Site Participant ID Masked Treatment Group Age Gender Event Term Study Intervention Duration** Study Intervention Start Date Study Intervention Stop Date SAE Onset Date SAE Stop Date or Ongoing Relationship to Study*** Expected? (Yes/No) Outcome **** Unanticipated Problem?***** (y/n)
                                 
                                 
                                 

    * This listing can be sorted by SAE Description or by Participant ID.

    ** The number of days on study treatment at the onset of the SAE.

    *** Relationship should be specifically defined for each study (i.e., Relationship to intervention, Relationship to study drug, etc.) The following are commonly used categories: Definitely, Probably/Possibly, Not Related.

    **** Outcome:
    Recovered, without treatment
    Recovered, with treatment
    Still Present, no treatment
    Still Present, being treated
    Residual effect(s) present—no treatment
    Residual effect(s) present—being treated
    Subject died

    *****The incident must meet the following criteria to qualify as an Unanticipated Problem:

    • was unexpected in terms of nature, severity, or frequency
    • is definitely or possibly related to participation in the research
    • suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized

    NOTE: All AEs in Listing 1 that have been designated as an SAE ("Y") should be also listed on this Listing.

     

    Listing 3: Deaths by Site and Masked Treatment Group

    Data as of:
    Date of report:

    Site Participant ID* Masked Treatment Group Gender Age Date Enrolled Date of Death Study Intervention Start Date Study Intervention Stop Date Cause of Death Relationship **
                         
                         
                         
                         
                         
                         
                         
                         
                         
                         

    * It is expected that individuals will be listed on Listing 1: Adverse Events, Listing 2: Serious Adverse Events and the more detailed Listing 3: Deaths by Site.

    ** The following are commonly used categories for relationship: Definitely, Probably/Possibly, Not Related.

     

    Table 8: Laboratory Test Results Summary by Masked Treatment Group*

    Data as of:
    Date of report:

    Laboratory Test Masked Treatment Group Study Visits   ---------------Change from Baseline--------------
          N Mean SD Median Min Max N Mean SD Median Min Max
    Test 1 ___ (n=) Screening                        
        Visit 1                        
        Visit 2                        
      ___ (n=) Screening                        
        Visit 1                        
        Visit 2                        
                                 
    Test 2 ___ (n=) Screening                        
        Visit 1                        
        Visit 2                        
      ___ (n=) Screening                        
        Visit 1                        
        Visit 2                        
                                 
    etc.…                            

    * Table may include lab test results that are clinically significant, as defined by the protocol, or ALL lab test results.

     

    Table 9a- 9i: Laboratory Test Results Summary by Site and by Masked Treatment Group*

    Data as of:
    Date of report:

    Laboratory Test Normal Range Masked Treatment Group Study Visits   --------Change from Baseline------
          N Mean SD Median Min Max N Mean SD Median Min Max
    Test 1   ___ (n=) Screening                        
          Visit 1                        
          Visit 2                        
        ___ (n=) Screening                        
          Visit 1                        
          Visit 2                        
                                   
    Test 2   ___ (n=) Screening                        
          Visit 1                        
          Visit 2                        
        ___ (n=) Screening                        
          Visit 1                        
          Visit 2                        
                                   
    etc.…                              

    * One table for each site.

    ** Table may include lab test results that are clinically significant, as defined by the protocol, or ALL lab test results.

     

    Listing 4: Clinically Significant Abnormal Lab Values by Site and Masked Treatment Group

    Data as of:
    Date of report:

    Site Participant ID Masked Treatment Group Study Visit Lab Test Baseline Result Current Result % Change from Baseline Normal Range
                     
                     
                     
                     
                     
                     
                     
                     

    {Lab tests that are deemed clinically significant as specified in the study protocol should be listed along with baseline result and normal range as stated by the study lab.}

     

    Listing 5: Unanticipated Problems by Masked Treatment Group

    Data as of:
    Date of report:

    Site Date UP Identified Date of UP incident UP Description* Subject ID (or describe group affected) Masked Treatment Group (if applicable)** Action taken*** (1-10, include all that apply) Action taken, specify SAE? (yes/no) Reported to the IRB? (yes/no) IRB action required? If yes, describe response from IRB (attach correspondence, if necessary)
                         
                         
                         
                         

    {The incident must meet the following criteria to qualify as an Unanticipated Problem:

    • was unexpected in terms of nature, severity, or frequency
    • is definitely or possibly related to participation in the research
    • suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized}

    *Describe harm or potential harm that occurred to subject(s), whether the incident is resolved, and whether the subject(s) remains in the study. If the Unanticipated Problem is a serious adverse event, submit this form and complete the Serious Adverse Event form.

    **If the Unanticipated Problem affects a particular group in the study, please identify that group, i.e., subjects in Treatment Group A, subjects enrolled before January 1, 2014, etc. If a group of individuals affected is across more than one treatment group, it may not be possible to complete this field.

    ***Action taken with the study as a result of the Unanticipated Problem? (include all that apply):

    1 — No action
    2 — Revise protocol to eliminate apparent immediate hazards to subjects
    3 — Modification of inclusion or exclusion criteria to mitigate newly identified risks
    4 — Implementation of additional procedures for monitoring subjects
    5 — Suspension of enrollment of new subjects
    6 — Notify currently enrolled subjects

    7 — Suspension of research procedures in currently enrolled subjects
    8 — Modification of consent documents to include a description of newly recognized risks (site and/or study wide)
    9 — Provision of additional information about newly recognized risks to previously enrolled subjects
    10 — Other, specify

     

    Listing 6: Protocol Deviations by Masked Treatment Group

    Data as of:
    Date of report:

    Site Participant ID Masked Treatment Group Deviation Date Deviation Description* Deviation Category**
               
               
               
               
               

    *Deviation Description — record what occurred and why. For example, an expired drug was used by a new coordinator who did not check the expiration date. The description should also include remedies taken. In this case, the participant/subject was called to return the drug and was issued unexpired medication.

    **Deviation Category — provide a category of the protocol deviation description. Example deviation categories include: Randomization of ineligible participant; Failure to obtain consent; Participant seen outside window of follow-up; Not reporting serious adverse event.