Ancillary study proposals are defined as projects that involve the collection of new data directly from patients or from clinical investigators, or new biologic samples. Analysis of existing data, existing biological samples, and the resulting publications are the purview of the Working Groups and the Publications Committee, and can be requested using the process of preparing and submitting an analysis concept proposal (see Analysis Concept Proposals).
- Criteria for Use of the Cohort
- Who Can Use the Cohort?
- Process for Submitting an Ancillary Study to CCSS
- Review of Proposals
- Standard Operating Procedures for Conduct of Ancillary Studies
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 the cohort with low-priority requests. The overall objective is to achieve an appropriate balance between future demands made upon the cohort members and feasibility research needs.
All proposals for ancillary studies must fulfill four overarching criteria:
- the proposed research addresses a key question on the etiology, therapy, follow-up, survival, etc. in childhood cancer or on the health of offspring of survivors;
- this is a unique opportunity - i.e. a question that is either only answerable, or best answered, using the CCSS cohort;
- the proposed methodologies must be state-of-the-art; and
- the proposed research team has outstanding qualifications to conduct the research to address the hypotheses of the proposed study.
Proposals to utilize the CCSS cohort can be submitted by any investigator, regardless of their direct involvement in the CCSS. The objective is to ensure that the most scientifically important hypotheses are addressed, by the most qualified investigators. Prior to submitting a proposal, investigators will be encouraged to discuss their research plan with the CCSS Principal Investigator, appropriate Working Group Chair(s), and the CCSS Statistical Center.
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 ultimate question.
As a first step an investigator should submit an Application of Intent (AOI). The CCSS Steering Committee will review the AOI and determine the appropriate Working Group assignment.
Investigators proposing an ancillary study will need to be teamed up with a member of relevant Working Group or other CCSS investigator for input on both science and CCSS process. The full proposal will be written and submitted to the Steering Committee via the CCSS Principal Investigator or other route. The opinion of the chair of the relevant Working Group will be sought. S/he will consult with other WG members with appropriate expertise and they will render a joint recommendation that will take into account:
- 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 ultimate question.
The following procedure will be employed for review of proposals:
- An initial 3-page brief proposal, describing the study and identifying why the proposal fulfills the overarching criteria, will be submitted to Dr. Armstrong (include Aims, Hypothesis, Methods and Relative Background).
- The proposal will be reviewed by the CCSS Executive Committee and ad hoc reviewers with specific expertise relevant to the grant if needed.
- The outcome of this initial review will be either "Rejected" or "Preliminarily Approved". The CCSS Principal Investigator will report its decision to the applicant.
- Proposals that receive preliminary approval will then need to be expanded into a NIH-style proposal.
- These final proposals will always include:
- 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.
- The detailed (NIH-style) proposals will be reviewed at a teleconference by the Steering Committee.
A decision will be rendered on the proposal as follows:
- approved following specified modifications
- not approved but with agreement to reconsider a revision
- not approved
- Approved proposals that are then submitted to a funding agency will be accompanied by a letter guaranteeing access to CCSS cohort members. In situations where funding has not been secured, approval will be re-reviewed on an annual basis and the project either renewed or discontinued.
The following procedures relate to the conduct of approved ancillary projects. (Printable Word Document)
Exceptions to the procedures listed below may be made upon approval of the CCSS Principal Investigator.
1. Grant Proposals
CCSS representation as co-investigators on grants associated with ancillary projects will be negotiated on a project-by-project basis, but in general will be in accordance with the following guidelines:
|Coordinating Center||Typically the Project Director||If data are to be collected, documents prepared, or participants recruited by the CCSS Coordinating Center|
|Data and Statistics Center||Typically the CCSS Biostatistician||If data preparation, manipulation, and/or analyses are to be conducted by the CCSS DSC|
|Radiation Physics Center||Center Director||If radiation dosimetry is required beyond that in the current database|
|Biorepository||Center Director||If biospecimens are to be utilized as part of the research|
|Biopathology Center||Center Director||If pathology material will be utilized, or if additional pathology collection/review is needed|
|Working Group Chair(s)||Working Group Chair||If the working group chair will have a substantial scientific role in facilitating/conducting the research scope of the ancillary study|
CCSS co-investigators will be directly involved in grant preparation (initial submissions, as well as resubmissions) and must sign-off on all applications prior to submission to the funding agency.
When applicable, and justifiable, funding for CCSS co-investigators and resource center staff should be included in grant submissions. The extent of support for CCSS-associated investigators, staff, and activities (telephone, postage, travel, etc.) will be negotiated on a project-by-project basis.
2. Study Conduct
Before data and/or biological samples are sent to ancillary study investigators: (1) documentation of IRB approval from all performance sites for the ancillary study must be received, and (2) a material transfer agreement (MTA) must be executed.
Contact and recruitment of subjects to participate in ancillary studies will only be performed by the CCSS Coordinating Center staff.
Data collection and interventions will be carried out by CCSS Coordinating Center staff, except in situations where the Coordinating Center does not have and cannot acquire the appropriate expertise or capacity.
Contact and interactions with CCSS participants by individuals outside of the CCSS Coordinating Center will be limited and structured in a fashion that ensures coordination/interaction with the CCSS Coordinating Center (e.g., shared contact logs, routine conference calls, etc.).
All data, and corresponding documentation, collected as part of the ancillary study will be provided to the CCSS Data and Statistics Center in an organized fashion, upon completion and publication of the primary aim(s) of the ancillary study.
After data collection/intervention delivery has been completed, all paper and electronic sources of personal health information (e.g., names, contact information, dates of birth and diagnosis, etc.) will be destroyed/removed. Subjects will be linked through a project-specific ID that can only be linked back to the subjects by the CCSS Coordinating Center.
Approval to directly contact CCSS cohort members will only include the procedures of the approved ancillary study protocol. No subsequent contact of study participants will be allowed without approval from the CCSS Executive Committee.
3. Reporting/Publication of Results
All abstract submissions and publications emanating from the ancillary study, whether or not related to the primary aims of the ancillary study, must follow CCSS publication procedures and policies regarding authorship and approval by CCSS investigators. Any proposed publications not directly related to the ancillary study aims, should be submitted to the CCSS Publications Committee for review and approval.