MS Project: Study Protocol for a Clinical Trial

The typical length of a MS project is 10 pages double-spaced, with the following elements.

  1. 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.
  2. BACKGROUND OF STUDY: Contains scientific information on why disease is important and why the treatment might work
  3. OBJECTIVES: Documents what the study proponents hope to achieve. Detail includes:
    1. PRIMARY QUESTION/RESPONSE VARIABLE
    2. SECONDARY QUESTION/RESPONSE VARIABLES
    3. SUBGROUP HYPOTHESES
  4. STUDY POPULATION: Describe the individuals to whom the treatment will be given in practice. Details should include:
    1. INCLUSION/EXCLUSION CRITERIA
    2. SAMPLE SIZE / POWER ESTIMATES This Section Required for a MS project.
  5. ENROLLMENT OF SUBJECTS: Describe how subjects will be identified, screened and enrolled. Include descriptions of
    1. INFORMED CONSENT
    2. ASSESSMENT OF ELIGIBILITY
    3. BASELINE INFORMATION
    4. RANDOMIZATION SCHEME This Section Required for a MS project.
  6. INTERVENTION: Describe the intervention and delivery as it will be given in practice, including the following elements:
    1. DESCRIPTION AND SCHEDULE
    2. MEASURES OF COMPLIANCE
  7. FOLLOW-UP VISIT DESCRIPTION AND SCHEDULE - Describe how all needed information will be obtained and how loss to follow up will be minimized.
  8. ASCERTAINMENT OF RESPONSE VARIABLES: Please provide details on the following areas:
    1. TRAINING
    2. DATA COLLECTION
    3. DATA MONITORING AND QUALITY CONTROL
    4. 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.
    5. TERMINATION POLICY
  9. ORGANIZATION: This section is very important, since a great deal of the success of a protocol depends on management. Please include these elements:
    1. PARTICIPATING INVESTIGATORS: Verify that the appropriate people are doing the appropriate things.
    2. STUDY ADMINISTRATION, with committees and subcommittees, including the policy and data monitoring committee.
    3. 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.