How to Submit an Ancillary Study

The CCSS cohort is a unique resource to be used widely to facilitate the conduct of high-quality research. Concurrently, we recognize the importance of protecting the integrity of the cohort and the need to avoid excessive contact of participants. The overall objective of the ancillary study process is to achieve an appropriate balance between demands made upon the cohort members and utilizing the CCSS as a platform to conduct important survivorship research.

There are two kinds of proposals a) pilot studies with funding in hand, and b) larger studies for which funding will be sought. In both cases, CCSS must be the most appropriate resource for the proposed question.

As a first step, an investigator should submit an Application of Intent (AOI). The CCSS Executive Committee will review the AOI with emphasis on Working Group assignment and making sure there is no overlap with existing CCSS projects. After the AOI is approved, the next step is for the investigator to submit a 3–4 page summary of the proposed project (see Review of Proposals below). 

Investigators proposing an ancillary study will need to be teamed up with a member of a relevant Working Group for input on both the science and CCSS process. Front-end involvement of the applicable Working Group is very important to facilitate a successful proposal. 

The following procedure will be employed for review of proposals:

• After approval of an AOI, the investigator will submit an initial 3-4 page proposal describing the study (include Relative Background, Aims, Hypotheses, and Methods).
  • The brief proposal should be submitted to Vikki Nolan, CCSS Project Director (vikki.nolan2@stjude.org)
• The proposal will be reviewed by the CCSS Executive Committee and ad hoc reviewers with specific expertise relevant to the proposal if needed. The Executive Committee will consider:
  • quality of the ultimate scientific question and methods,
    
  • impact on cohort members,
  • impact on CCSS resources,
  • uniqueness of the capacity of CCSS to answer the proposed questions.
• The outcome of this initial review will be either “Rejected” or “Preliminarily Approved”. The CCSS Principal Investigator or Project Director will report the decision to the applicant.
  
• Proposals that receive preliminary approval can then be prepared and submitted to the funding agency.  If desired, a letter of support from the CCSS PI can be provided.
• Please note that the proposal to the funding agency generally includes:
  • a clear description of how the additional data or samples will be collected (usually via the CCSS Coordinating Center - and, if not via the Coordinating Center, a clear rationale for a different approach);
  • a clear description of how the Statistical Center will be involved in the proposed ancillary study including involvement of the senior statistician; and
  • a budget that covers these ancillary study-specific costs.
• If the proposal is ultimately funded, then the investigator will need to submit a concept proposal after funding and before any publications from the project are submitted.