Ancillary studies that use resources of the D2d study are encouraged to harness the considerable potential of the parent study for obtaining new knowledge beyond its primary goals and objectives. Ancillary studies augment and promote the continued interest in the study of both participants and D2d investigators. To protect the integrity of the D2d study, ancillary study proposals must be reviewed and approved by the D2d Ancillary Studies Evaluation subcommittee, Steering Committee and Data and Safety Monitoring Board (DSMB) prior to implementation. In addition to meeting the standard for high scientific merit, the major criterion for approval of an ancillary study is that it does not negatively impact the conduct of the parent D2d study.
A D2d ancillary study is defined as research that (1) has not been previously described in the D2d study protocol or in ongoing ancillary study protocols; (2) derives new data through direct contact with D2d participants (via a procedure, questionnaire or observation) or through the use of stored biological specimens; (3) does not interfere with the goals and objectives of the parent study and (4) follows all policies and procedures of the D2d study.
Any qualified investigator may submit an ancillary study proposal, whether the investigator is internal (namely, a member of the D2d Study Group) or external to the D2d study. For detailed instructions on the D2d ancillary study application process, please click here.
To download the D2d Ancillary Study Letter of Intent document, please click here.