Research Monitoring Plan Template - DOC

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					                                      Administrative and Operational
                                             Policies and Procedures
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                          Research Monitoring Plan Template

1. Does this study only involve use of existing data or specimens, anonymous
   surveys or behavioral observations?
      No – Complete the rest of this form and include with your IRB submission.
      Yes – Do not complete this form. This plan is not needed for your IRB submission.

2. Who will perform the safety monitoring?

        The study poses no more than minimal risk to subjects. The PI, external (i.e.,
        company-sponsored) Data Safety Monitoring Committee (DSMC) or other
        designee will perform the safety monitoring.
        (If selected, go to item 3)
        The study poses more than minimal risk to subjects. An internal (i.e.,
        Children’s) Data Safety Monitoring Committee (DSMC) will perform the safety
        monitoring. The DSMC is established (select one):
           within the division where the research is focused
           within the department where the research is focused
           within a Children’s affiliate, specifically: __________________________
        (If selected, go to item 4)
        The study poses more than minimal risk to subjects. An external Data Safety
        Monitoring Board (DSMB) will perform the safety monitoring. The DSMB is
        established (select one):
           by the protocol sponsor
           by the funding agency
        (If selected, go to item 5)

From this point forward, only complete the sections that are relevant to your
study monitoring plan and enter “N/A” in any irrelevant sections.

3. Who on the Children’s study team will perform safety assessments?
(Attach additional sheets as necessary.)


Name                           Role on Study                   Mailing Address, Telephone,
                                                               Pager and Email

                               Contact person and




4. What is the composition and responsibilities of the internal DSMC?
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                                             Policies and Procedures
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(DSMC voting members shall not have conflicts of interests with this study or with study
personnel. Any study personnel on the DSMC shall be non-voting members and shall not
serve as Chair. Attach additional sheets as necessary.)
 Name                   Role on DSMC          Title and               Mailing Address,
                                              Institution             Telephone, Pager and
                                              Affiliation             Email
                        Chair




5. What is the composition and responsibilities of the external DSMB?
(DSMB voting members shall not have conflicts with this study or with study personnel, and
the membership shall include an independent statistician. Any study personnel on the
DSMB shall be non-voting members and shall not serve as Chair. If DSMB members’ names
are unavailable at the time of submission they shall be added as an amendment as soon as
they are identified. If DSMB members’ names are confidential, justify this practice and
describe each member's role on the DSMB. Attach additional sheets as necessary.)

 Name                       Role on DSMB            Title and Institution /                Check
                                                    Company Affiliation                    Contact
                                                                                           Person
                            Chair
                                                    Mailing Address, Telephone,
                                                    Pager and Email:
                            Statistician




6. What are the safety monitoring methods and intervals?
(Monitoring intervals vary depending upon size, complexity, risk of study. Typically,
monitoring is more frequent for higher risk, complex studies. Below indicate the
interval/frequency of monitoring, i.e. number of months or number of subjects enrolled. If
monitoring frequency is complex and detailed, include a reference to the pages of the
protocol, investigator brochure or IRB application in which the interval/frequency of
evaluation is found.)
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                                                    Policies and Procedures
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 Data Evaluated (check all that apply)                        Interval/Frequency of Evaluation
      Age-specific intervention(s)
      Clinical test(s)
      Interview and/or other subject contact
      Physical exam and/or vital signs
      Symptoms and/or performance status
      Adverse events
      Other study parameter(s), specifically:


7. What scale is used to grade adverse events in this study?
In the table at the end of this section, identify what scale will be used to grade adverse
events (AEs) and indicate the assessment of the relationship between the adverse event
and the study procedures. Each study may have a unique approach to grading AEs and the
PI should consult the parent protocol and/or funding source for specific grading scales.
Below are suggested guidelines for the grading of AEs. In general, ad hoc scales are
discouraged.

Example A:    Cancer Therapy Evaluation Program (CTEP) Common Toxicity
              Criteria (CTC III)
              Available at: http://ctep.info.nih.gov. See “Reporting Guidelines, Common
              Toxicity Criteria.”

Example B:    Common Grading Scale
              0  No adverse event, within normal limits or not clinically significant
              1  Mild AE, did not require treatment
              2  Moderate AE, resolved with treatment
              3  Severe AE, resulted in inability to carry on normal activities and
                 required professional medical attention
              4  Life threatening or disabling AE
              5  Fatal AE

Example C:    FDA Scale
              Mild, Moderate, or Severe (i.e., death, life-threatening, necessitating or
              prolonging hospitalization.). Additional information available at:
              http://a257.g.akamaitech.net/7/257/2422/12feb20041500/edocket.access.gp
              o.gov/cfr_2004/aprqtr/21cfr312.32.htm.

             AEs   will   be   graded   according to CTEP Common Toxicity Criteria III (CTC III)
             AEs   will   be   graded   according to the Common 0-5 grading scale shown above
             AEs   will   be   graded   according to the FDA scale
             AEs   will   be   graded   using another system, specifically:
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8. What attribution scale is used in this study?
            The PI will determine the relationship of AEs to the study test procedures and/or
            agent as "not related," "possibly related," "related or probably related," or
            "unknown" using standard criteria for clinical trials.
            The PI will use an alternative attribution scale, specifically:

9. What is the adverse event reporting plan?
   Adverse events from this protocol need to be reported to the IRB and possibly other
   sponsoring agencies or regulatory bodies. Refer to the Research Adverse Event
   Reporting policy for guidelines on reporting adverse events (Policy # XX.XX) and
   indicate below all of those which apply.

              National Institutes of Health (NIH)
              Food and Drug Administration (FDA)
              Other agency or sponsor, specifically:


10. What are the decision-making criteria regarding continuation, modification
   or termination (including early termination rules) of the study?




11. What will interval statistical analysis entail?
   As applicable, describe interval statistical analysis used in deciding to continue, modify,
   or terminate the study. This description should include a brief description of the
   statistical methods used to decide continuation status of the study and should indicate if
   the statistician a participant in the study is independent.




12. What is the method for documenting DSMB meetings or discussions?
   As applicable, describe the method for documenting DSMB discussions and meeting
   minutes, as well as follow-up communications regarding the study. A summary and
   conclusions of the DSMB meeting need to be submitted to the IRB, but the detailed
   minutes do not, particularly for double-blind, randomized studies. Include in the
   description the timing of distribution of the DSMB report to the site investigator(s) and
   IRB(not to exceed 8 weeks). Also include information explaining how often the DSMB
   will meet.