MS Project: Study Protocol for a Clinical Trial
The typical length of a MS project is 10 pages double-spaced, with the following elements.
- ABSTRACT: A brief summary (100 - 250 words ) of the design appears at the front. This should state the purpose of research and its main design elements.
- BACKGROUND OF STUDY: Contains scientific information on why disease is important and why the treatment might work
- OBJECTIVES: Documents what the study proponents hope to achieve. Detail includes:
- PRIMARY QUESTION/RESPONSE VARIABLE
- SECONDARY QUESTION/RESPONSE VARIABLES
- SUBGROUP HYPOTHESES
- STUDY POPULATION: Describe the individuals to whom the treatment will be given in practice. Details should include:
- INCLUSION/EXCLUSION CRITERIA
- SAMPLE SIZE / POWER ESTIMATES This Section Required for a MS project.
- ENROLLMENT OF SUBJECTS: Describe how subjects will be identified, screened and enrolled. Include descriptions of
- INFORMED CONSENT
- ASSESSMENT OF ELIGIBILITY
- BASELINE INFORMATION
- RANDOMIZATION SCHEME This Section Required for a MS project.
- INTERVENTION: Describe the intervention and delivery as it will be given in practice, including the following elements:
- DESCRIPTION AND SCHEDULE
- MEASURES OF COMPLIANCE
- FOLLOW-UP VISIT DESCRIPTION AND SCHEDULE - Describe how all needed information will be obtained and how loss to follow up will be minimized.
- ASCERTAINMENT OF RESPONSE VARIABLES: Please provide details on the following areas:
- DATA COLLECTION
- DATA MONITORING AND QUALITY CONTROL
- DATA ANALYSIS: Give the specific approaches that will be used for adjusted and unadjusted analysis of data, and in particular for the primary outcome of interest. This Section Required for a MS project.
- TERMINATION POLICY
- ORGANIZATION: This section is very important, since a great deal of the success of a protocol depends on management. Please include these elements:
- PARTICIPATING INVESTIGATORS: Verify that the appropriate people are doing the appropriate things.
- STUDY ADMINISTRATION, with committees and subcommittees, including the policy and data monitoring committee.
- CITED REFERENCES: Cite all articles and sources where background and other information was obtained.
NOTE: Protocols for studies that are not clinical trials may have slightly different formats.
Statistics MS Project
The Statistics MS project is designed to demonstrated the ability to undertake planning and conducting statistical research, and communicating plans and results in writing.
The Masters project should be completed in one of the classes the student takes. Several core Statistics and Biostatistics MS classes give data analysis or study planning assignments which require writing a report that (depending on how well the student does) fulfills the Masters project requirements. Student should check with teachers of the course on whether a particular assignment of that class meets these requirements.
The format of a report depends on the type of statistical research, design, or analysis that is done for the project. Most Masters projects will fall into one of the following three categories.
- Statistical Analysis of Data Using statistical methods to analyze data for a focused problem of interest and communicating findings in a manner to advance the substantive field. The student is also expected to also write the programs used to analyze the data.
LINK TO TYPICAL FORMAT FOR STATISTICAL ANALYSIS OF DATA
- Protocols for Statistical Research (Typically Clinical Trials) Development of study plans or draft study designs to be used to obtain approval or funding or to undertake applied statistical research. The student is also expected to use statistical software (or otherwise) to obtain power / sample size estimates.
LINK TO TYPICAL FORMAT FOR STUDY PROTOCOL
- Development of Statistical Methods or New Applications Development of new statistical methods or application of current statistical methods to a new area. The student is expected to contribute substantially to the development and/or the application. [As this may be more challenging than the other two types of projects, it is not expected that many Masters Projects would involve this].
LINK TO TYPICAL FORMAT FOR NEW STATISTICAL METHOD/APPLICATION
The formats described above for each of these Types of Masters projects are suggestions, not strict requirements. The teacher of a class (in consultation with other faculty) has discretion on whether a written report fulfills the Masters Report requirement and Masters Projects that do not fall exactly into the above formats are possible. Still, any Masters Project should require students to undertake statistical research or planning and written communication at equivalent levels to these formats.