How to Submit a Concept Proposal

After completion and acceptance of an Application of Intent (AOI), investigators are asked to prepare a brief summary of their proposed research (Concept Proposal) for review by the CCSS Publications Committee. Submission of the concept proposal is necessary to ensure that resources are appropriately utilized and that the statisticians involved in carrying out the analysis are sufficiently informed to provide optimal input.

Prior to submitting the proposal for Publication Committee review, investigators are required to receive approval for the proposed plan from all co-investigators, the applicable Working Group Chairs, CCSS Principal Investigator, CCSS lead statistician, and when radiation therapy (RT) data are used, the head of the CCSS Radiation Dosimetry Center.  The concept proposal should address the following items:

Study title: Provide a working title for the proposed project. This should be as descriptive as possible so that the objective and scope are clearly stated.

Working group and investigators: Indicate the CCSS Working Group(s) most relevant to the proposal. These will be determined during the AOI submission and review. List investigators who have been involved in the development of the concept proposal and those who would bring specific required expertise to the analysis or interpretation of the data. These individuals may or may not be included in the final manuscript, depending on their contributions. Provide a list of investigators (names and email addresses) to whom questions from the CCSS Publications Committee and Statistical Center should be addressed.

Background and rationale: Prepare a concise overview and framework to justify the analysis, educate the biostatisticians and Publications Committee, and provide the foundation for the eventual manuscript.

Specific aims/objectives/research hypotheses: List the individual specific aims to be accomplished by the data analysis and the hypotheses being tested.

Analysis framework: The following specific aspects of the proposed analysis must be provided:

• Outcome(s) of interest: List each separately and provide a clear definition of each.
• Subject population to be included and, if appropriate, cases and controls: Provide explicit and detailed eligibility criteria for inclusion in the analysis.
• Exploratory variables: Describe variables that may prove to be important or should be taken into consideration in analyzing the data (i.e., confounders and effect modifiers).
• Draft tables/figures: Provide examples of specific tables and figures that will illustrate important associations that may or may not be included in the final manuscript.

Special consideration: Provide any additional information that you consider important in considering the proposed analysis.

The completed concept proposal should be e-mailed to Vikki Nolan, CCSS Project Director (Vikki.Nolan2@stjude.org). The CCSS Publications Committee meets monthly on the third Monday of each month.  To be considered for review, the concept proposal should be received by the second Monday of the month.

If you have questions, please contact Dr. Vikki Nolan, CCSS Project Director at Vikki.Nolan2@stjude.org.