Unstained section available 3a. Please specify required sample storage conditions: Are you proposing use of limited biospecimens? YES GO TO Question 4a, Next Page NO GO TO Question 5, Next Page Justification for the request of limited and irreplaceable biomaterials: Discuss how the proposed project will take advantage of the depth of larger NEPTUNE clinical data set and it should make the case clearly that the proposed study will have significant scientific impact. Provide preliminary data to support the proposal’s hypothesis and technical feasibility. The ancillary studies committee may consider the use of NEPTUNE biosamples to develop preliminary data in an iterative fashion in some cases. In this case, explain why alternative samples cannot be obtained from other sources. Provide consideration of the source and condition of requested biospecimens, such as how they were collected, prepared and stored if this might affect the proposed analysis. Describe assay details and methodology including: amounts and type of samples (applicants should request the minimum volume required for their assays), anticipated assay variability, quality control (assay "robustness") assessment. Will you need a statistician or data analyst from the DACC for you proposed ancillary study? YES The DACC will contact you to set up a time to discuss the details of the biostatistical support and will generate a cost estimate NO Please provide a description of the biostatistical expertise that will be available from your team for this proposed study Does your proposed involve additional study visits, additional procedures or specimen acquisition beyond the core NEPTUNE protocol? END YES NO 6a. Describe the rationale for additional procedures, specimens or visits.
Unstained section available 3a. Please specify required sample storage conditions: Are you proposing use of limited biospecimens? YES GO TO Question 4a, Next Page NO GO TO Question 5, Next Page Justification for the request of limited and irreplaceable biomaterials: Discuss how the proposed project will take advantage of the depth of larger NEPTUNE clinical data set and it should make the case clearly that the proposed study will have significant scientific impact. Provide preliminary data to support the proposal’s hypothesis and technical feasibility. The ancillary studies committee may consider the use of NEPTUNE biosamples to develop preliminary data in an iterative fashion in some cases. In this case, explain why alternative samples cannot be obtained from other sources. Provide consideration of the source and condition of requested biospecimens, such as how they were collected, prepared and stored if this might affect the proposed analysis. Describe assay details and methodology including: amounts and type of samples (applicants should request the minimum volume required for their assays), anticipated assay variability, quality control (assay "robustness") assessment. Will you need a statistician or data analyst from the DACC for you proposed ancillary study? YES The DACC will contact you to set up a time to discuss the details of the biostatistical support and will generate a cost estimate NO Please provide a description of the biostatistical expertise that will be available from your team for this proposed study Does your proposed involve additional study visits, additional procedures or specimen acquisition beyond the core NEPTUNE protocol? YES NO END 6a. Describe the rationale for additional procedures, specimens or visits.
App_D%20Application%20Form%2001-09-17.docx