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Ancillary Studies: Data Issues

The release of any Teen-LABS data from the DCC to an ancillary study investigator is subject to the rules regarding release and use of data defined in the Teen-LABS publications and presentations policy.

In general, all data collected by the ancillary study must be provided to the Teen-LABS DCC electronically and in a timely fashion for integrating into the main database and analysis by the DCC. In return, ancillary study investigators will receive an analysis file containing both their data and approved relevant data from the main study. The ancillary study PI will be given the first opportunity to analyze, present and publish data collected for the specific aims of the ancillary study. After a reasonable time (in general, 18 months after the ancillary study PI has received the cleaned data), the ancillary study data will be made available for additional uses by Teen-LABS investigators, in collaboration with the ancillary study investigators. It is the responsibility of the ancillary study PI to state to the Steering Committee in writing in advance of the analysis any special circumstances that would make these guidelines for data sharing impossible or undesirable. Reasonable and justified requests for limiting Steering Committee use of the data will be considered. In addition, the acquisition or analysis of specialized data sets, such as high-throughput genotyping or microarray data, by the Coordinating Center may be negotiated between the PI of the ancillary study and the Coordinating Center prior to the Steering Committee granting final permission to proceed with the study.

If core Teen-LABS data are to be used as part of an ancillary study, any additional data or samples collected for the ancillary study will become part of the Teen-LABS archive, and management and statistical analysis of the Teen-LABS component of the data will, in general, be performed by the Teen-LABS DCC. However, as indicated above, in the case of specialized methods or those requiring unique forms of analysis, the Coordinating Center will consider requests that delegate such analyses to the ancillary studies’ investigators.

Additional data requests for funded ancillaries: Funded ancillary studies seeking to receive data from the main Teen-LABS study that were not requested in the original proposal must submit a written request through the ancillary subcommittee. The request must include a precise description of the data requested, a justification for the receipt of such data, an explanation of the use and preliminary plans for analyzing and reporting the additional data. The ancillary study PI is responsible for working with the DCC to determine any impact that the additional data might have on DCC operations, and for covering the costs incurred by the DCC in providing the requested data. The ancillary subcommittee will review the proposal to determine whether or not it should be recommended to the Steering Committee for final approval.