What if I wish to add extra sites or studies to my project?

Sites: Adding extra sites to a project may be beneficial for various reasons. Additional sites offer the opportunity to increase enrollment and may provide access to specific, desirable populations. Speak with your Program Director about how additional sites may be added and the appropriate process for doing this.

Studies: An ancillary study entails the collection from study participants of data and/or specimens, or the conduct of additional analyses of existing materials or samples that are outside the specific scientific objectives of a parent study. Ancillary studies must undergo review with respect to their effect on additional burden on the participants and the need for an additional consent form. Your Program Director will work with you to evaluate the proposal prior to submitting an application for an ancillary study.

Ancillary study investigators should discuss policies concerning ownership of data with the parent study investigators or Steering Committee (SC)before initiation of an ancillary study. Study management requirements should be negotiated on a case-by-case basis by the parent study Steering Committee and ancillary study investigators. For contract supported studies, the NHLBI Contracting Officer may need to be included in the negotiations if contract terms or conditions are likely to be affected.

The DSMB/OSMB of the parent study should:

• Monitor the progress of all ancillary studies.
• Determine which, if any, ancillary study data should be monitored and how they will be reviewed.
• Consider adding ad hoc members if monitoring of an ancillary study requires additional expertise beyond that on the Board.