Has anyone had to draft a data safety monitoring plan for behavioral or epidemiologic research?  I am looking for model language to put in grant applications and submissions to IRBs that requires a data safety monitoring plan for these kinds of low risk studies.  Study participants are generally cancer patients involved in a behavioral intervention to improve quality of life, underserved populations at high risk for cancer who will be involved in behavioral interventions aimed at prevention and studies that take blood or mouth wash samples for DNA and involve a questionnaire to determine relationship of such things as diet, family history etc with cancer.  I understand these kinds of studies do not have to be reviewed by a data safety monitoring board, but do require a data safety monitoring plan.  Thanks