A brief summary of the status of each study. Specify which 12 months are covered by your report such as reporting period for this submission is from June 1, 2010 to May 31, 2011. “the General Note: Maintain all headings throughout this document. If a particular section doesn’t apply to your state so! – The summary is required to include the following information for each study: Title of Study The of the study (with appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient populations, and a statement as to whether the study is completed. It may look something like the list below. Also, you can add a table here to list other study sites. Title of Study: title Study Design: open label, closed label, randomized etc. Purpose: This study will…. . Patient Population: disease state, healthy, age, etc. Study Status: Open, closed, enrolling, completed etc. Enrollment Update The total number of subjects initially planned for inclusion in the study; the number entered into the study to date, tabulated by age group, gender, and race; the number whose participation in the study was completed as planned; and the number who dropped out of the study for any reason. Examples of tables that might be appropriate for your study are below. Use if appropriate or change to suit your needs. There should also be some verbiage summarizing things. Table 1.1.2-1 Subject Enrollment by Site Total First Enrollment Site Last Enrollment Date Enrolled Date University of Somewhere Somewhere else University State Hopsital Total sites country: site Other country: site Total non-US sites
A brief summary of the status of each study. Specify which 12 months are covered by your report such as “the reporting period for this submission is from June 1, 2010 to May 31, 2011. General Note: Maintain all headings throughout this document. If a particular section doesn’t apply to your – state so! The summary is required to include the following information for each study: Title of Study The of the study (with appropriate study identifiers such as protocol number), its purpose, a brief statement identifying the patient populations, and a statement as to whether the study is completed. It may look something like the list below. Also, you can add a table here to list other study sites. Title of Study: title Study Design: open label, closed label, randomized etc. Purpose: This study will…. . Patient Population: disease state, healthy, age, etc. Study Status: Open, closed, enrolling, completed etc. Enrollment Update The total number of subjects initially planned for inclusion in the study; the number entered into the study to date, tabulated by age group, gender, and race; the number whose participation in the study was completed as planned; and the number who dropped out of the study for any reason. Examples of tables that might be appropriate for your study are below. Use if appropriate or change to suit your needs. There should also be some verbiage summarizing things. Table 1.1.2-1 Subject Enrollment by Site Site Total Enrolled First Enrollment Date Last Enrollment Date University of Somewhere Somewhere else University State Hopsital Total sites country: site Other country: site Total non-US sites