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EXenatide Study of Cardiovascular Event Lowering



Ancillary Study Proposals

The Executive Committee for the EXenatide Study of Cardiovascular Event Lowering (EXSCEL) will accept ancillary study proposals for review. Ancillary studies may provide valuable information beyond that explored in the context of the main trial, and will promote continued academic interest in EXSCEL. We define an ancillary study as an investigation that is distinct from the EXSCEL main protocol, but uses information from EXSCEL participants, data, or samples collected by EXSCEL. Such studies may involve the acquisition of data not obtained as part of the EXSCEL study procedures, and may utilize information from some or all of the EXSCEL participants.

Please note the following specifications as you consider the submission of an ancillary study proposal:

All received ancillary study proposals will undergo an initial review by the EXSCEL Ancillary Studies Committee. That committee may recommend advancement of the proposal to the Executive Committee for further evaluation; request revisions of the proposed study; or reject the submission.

All ancillary studies must be reviewed and approved by the EXSCEL Executive Committee prior to initiation. Studies which request access to the biomarker/future use blood samples will require additional review and approval by the Biomarker Committee.

To submit an ancillary study proposal, please complete this Ancillary Study Application Form and email your completed form to exscel@dtu.ox.ac.uk

Participation of the specified EXSCEL investigator will be confirmed prior to official review. Please be certain that your contact information is correct, as additional information may be requested of you during the review process. We appreciate your interest in EXSCEL, and look forward to receiving your proposal.