during the visit.

The report should state the problems uncovered during the

visit and describe recommendations to correct them. A timeline should be
agreed upon and included in the report to ensure that followup of the issues is
completed and implemented into the study’s procedures.
In this section of the MOP, please describe the monitoring plan, including a
planned monitoring timeline.
3.23 Reports
Once a study begins, routine reports prepared by the Coordinating Center or
study statistician are an important quality control tool. Monthly reports may
describe target and actual enrollment by site and in aggregate, individuals
screened with reasons for screen failure, and participant disposition (enrolled;
active, completed, and discontinued treatment; and lost to followup). Monthly
reports can also list or summarize AEs and SAEs. Administrative reports can
list the forms completed, entered, and missing and/or erroneous data and
forms. DSMB/independent monitor(s) and NCCIH will specify the type and
frequency of reports they wish to receive. Other reporting requirements (e.g.,
to local IRBs and other regulatory bodies) should also be described.
In this section of the MOP, please discuss the types and frequency of the
reports that will be prepared, and the members of the study team who are
responsible for their completion.
3.24 Data and Safety Monitoring Activities
The roles and responsibilities of the entities