• Abstract and introduction
• Study participants
• Study design and controls measuring study results
• Data management problems
• Describing the data
• Presenting the results
• Interpreting the results
• Establishing causality
• Determining importance and generalizability of results

This program is designed for professionals involved in:

• Medical affairs
• Medical communications
• Medical information
• Medical writing
• Field-based medical affairs support (i.e., medical science liaison)
• Medical call center environment
• Regulatory affairs
• Clinical research
• Professional education, training, and development
• Document management/eSubmissions

Upon completion of this module, learners should be able to:

• Determine whether participants in a study are appropriately selected, and are representative of the patients who receive the interventions being investigated
• Identify the purpose, key features, and possible bias of a published study abstract and introduction sections
• Analyze the efficacy, safety, and effectiveness outcomes of a study
• Recognize how tables and graphs can be used effectively, but may also misrepresent data
• Evaluate the internal validity of a study
• Identify when data is missing and the significance of the Intention to Treat analysis
• Determine the importance of critically evaluating scientific literature, as well as the possible sources of bias within a published clinical study
• Evaluate whether study results are objectively interpreted
• Define causal and non-causal relationships, and criteria for causality
• Categorize how data is described in a study
• Recognize the role that population size, cause, strength, randomization, and generalizability play in determining the importance of a study