After completion and acceptance of an Application of Intent (AOI), investigators are asked to prepare a brief summary (Analysis Concept Form) of their proposal for review by the CCSS Publications Committee. Completion of the form is necessary in order to ensure that the resources available are appropriately utilized and that the statisticians involved in carrying out the analysis are sufficiently well-informed to provide optimal input.
Investigators are encouraged to submit analysis concept proposals, regardless of their direct involvement in the CCSS. Prior to submitting the proposal, investigators are required to receive approval for the proposed analysis plan with the CCSS Principal Investigator, the appropriate Working Group Chair(s), and the CCSS Statistical Center. The submitted analysis concept proposal should address the following six items:
- Study title: Please provide a working title for the proposed manuscript. This should be as descriptive so that the objective and scope are clearly stated.
- Working group and investigators: Indicate the CCSS Working Group most relevant to the proposal. List those investigators who have been involved in the development of the concept analysis or 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/fax numbers) to whom contacts from the CCSS Publications Committee and Statistical Center should be addressed.
- Background and rationale: Prepare a concise overview and framework to justify the analysis, to educate the biostatisticians, and to 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: Provide variables that may prove to be important or should be taken into consideration in analyzing the data (i.e., confounders and effect modifiers).
- Investigators are asked to provide examples of specific tables and figures that will illustrate important relationships and that may or may not be part of the final manuscript.
- Special consideration: Provide any additional information that you consider important in considering the proposed analysis.
The completed Analysis Concept Form should be mailed to CCSS@stjude.org. The CCSS Publications Committee meets monthly on the third Monday of each month. In order to be considered for review the concept should be received by the second Monday of the month
If you have questions, please contact Dr. Aaron McDonald, CCSS Project Director at Aaron.McDonald@stjude.org.