Are the coordinating centers expected to produce and appropriately document ancillary study data or should this be the responsibility of the ancillary study investigator?
The parent study will need to consider how it should implement the policy. Since the coordinating centers are more familiar with the guidelines, it may be advantageous for the coordinating center to review and, if necessary, revise the ancillary data (based on NHLBI guidelines) and add the ancillary study data to the parent study database. The coordinating center would need to request that the ancillary study investigator provide appropriate documentation. The coordinating center should require appropriate compensation either through the ancillary study award or directly as part of the study s contract or grant award.
Related Questions
- Are the coordinating centers expected to produce and appropriately document ancillary study data or should this be the responsibility of the ancillary study investigator?
- If an NHLBI funded parent study has an ancillary study funded by another NIH institute or some other entity, is a data set from the ancillary study still expected?
- What is the Coordinating Centers role in data analysis, as distinguished from the Study Investigators role?
