1 (Can refer to the grant proposal.) Introduction Provide background and rationale for developing a registry/repository including information about the disease or condition, the target population and the unmet need and value of the desired information /specimen for future research. Potential future use of registry/repository Any cooperating investigators or groups that will utilize the registry/repository 1.2 Relevant Literature and Data Include literature and data that provide background for the study and established validity for scales and evaluation tools. STUDY OBJECTIVE Example: purpose of the registry/repository is to provide a mechanism to store, data, “The specimens, etc. to support the conduct of future research about…..” Primary Objective Secondary Objective (brief overview of registry/repository design ) Description Include a general description of the participating (if applicable), nature of the data and specimens and mechanisms for protection. Data/Specimen Collection Provide an overview of the methods that will be used for the data/specimen collection (database, interviews, physical examination, existing specimen sources, blood draws, biopsies, etc.) Study Duration, Enrollment and Number of Subjects Study Population -Inclusion and Exclusion Criteria
1 (Can refer to the grant proposal.) Introduction Provide background and rationale for developing a registry/repository including information about the disease or condition, the target population and the unmet need and value of the desired information /specimen for future research. Potential future use of registry/repository Any cooperating investigators or groups that will utilize the registry/repository 1.2 Relevant Literature and Data Include literature and data that provide background for the study and established validity for scales and evaluation tools. STUDY OBJECTIVE Example: “The purpose of the registry/repository is to provide a mechanism to store, data, specimens, etc. to support the conduct of future research about…..” Primary Objective Secondary Objective (brief overview of registry/repository design ) Description Include a general description of the participating (if applicable), nature of the data and specimens and mechanisms for protection. Data/Specimen Collection Provide an overview of the methods that will be used for the data/specimen collection (database, interviews, physical examination, existing specimen sources, blood draws, biopsies, etc.) Study Duration, Enrollment and Number of Subjects Study Population -Inclusion and Exclusion Criteria
registry_repository_protocol_template_unc_ch.docx