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Guidelines for Establishing and Operating a Data and Safety Monitoring Board - Appendix 1
Funding
- Funding Opportunities
- Clinical Research
- Regulations, Policies, and Guidance
- Guidelines for Developing a Data and Safety Monitoring Plan
- Draft Guidelines for Establishing and Operating a Data and Safety Monitoring Board
- NACDA Guidelines for Administration of Drugs to Human Subjects
- NACDA Guidelines for Substance Abuse Research Involving Children and Adolescents
- Bioethics
- More Clinical Trials Information
- Post-Award Concerns
- General Information
- Grant & Contract Application Process
- Funding Priorities
- Research Training
Initial Protocol Review
Outline of protocol items to be reviewed
Statement of protocol design (e.g., blinding, control group)
Characteristics of study data collection site(s)
Inclusion/exclusion criteria
Randomization/stratification plan
Definition of participants (e.g., screened, enrolled, randomized, training, treated, drop out, lost to follow-up)
Intervention definition
- Dosage and frequency
- Manual (specification for behavioral studies)
Reasons to discontinue participation
- Safety rules
- Behavioral rules
- Missed assessments rules
Reasons to change treatment regimen
Outcome measures
- Primary
- Secondary
Sample size
- Calculation
- Definition of subjects used for calculation (usually those randomized)
Key adherence variables
Key safety variables (e.g., BP, pulse, liver function tests)
Data analysis plan
Interim analysis plan
This page was last updated March 16, 2004.
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