Acarbose Cardiovascular Evaluation : Ancillary Studies

Acarbose Cardiovascular Evaluation

Ancillary studies
Ancillary Study Proposals The Steering Committee for the Acarbose Cardiovascular Evaluation (ACE) trial 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 the ACE trial. We define an ancillary study as an investigation that is distinct from the ACE main protocol, but uses information from ACE participants, data, or samples collected by ACE. Such studies may involve the acquisition of data not obtained as part of the ACE study procedures, and may utilize information from some or all of the ACE participants. Ancillary studies require external funding which must include provision for any ancillary study costs. In order to protect the integrity of the ACE, ancillary studies must be reviewed by the ACE Ancillary Studies Committee and approved by the ACE Steering Committee prior to submission for funding. Studies that propose to analyze ACE data for novel study questions not included under the scientific aims of ACE can also be considered as ancillary studies. Please note the following specifications as you consider the submission of an ancillary study proposal: All ACE ancillary studies will require outside funding, as the ACE trial cannot finance additional investigations. At least one ACE investigator must be involved in each proposed study, either as an initiating investigator or a collaborator. Proposed studies must not have a deleterious impact on the main study, particularly with respect to interventions which might confound the main study objectives. Ancillary studies should not significantly increase the time and effort required of patients or site personnel. This may preclude studies involving detailed data collection, unless they involve only a small number of sites. Primary ACE data will not be available to investigators of ancillary studies prior to the completion of the study. In addition, treatment group assignment will not be unblinded until completion of the main trial. All received ancillary study proposals will undergo an initial review by the Ancillary Studies Committee which may recommend advancement of the proposal to the Steering Committee for further evaluation; request revisions of the proposed study; or reject the submission. Please refer to the ACE Ancillary Studies Policy for details. To submit an ancillary study proposal, please complete an Ancillary Study Application Form. Participation of the specified ACE 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 the ACE Study, and look forward to receiving your proposal.


ACE Study, Diabetes Trials Unit, OCDEM, Churchill Hospital, Old Road, Headington, Oxford, OX3 7LJ Tel: +44 (0)1865 857257 Fax: +44 (0)1865 857256 Email: ace@dtu.ox.ac.uk Home \| Freedom of Information \| Privacy Policy \| Copyright \| Accessibility \| OCDEM \| NDM \| Oxford University

Ancillary studies

Ancillary Study Proposals