Timing for Release of Data to PharmGKB - Criteria for Tracking
The goal of this policy is to describe specific criteria for the timing of data depositions to PharmGKB, and to make clear the system by which timing of deposits are tracked. The intention is that the latest time that data sets should be submitted to PharmGKB is when a publication that results from pharmacogenetic research supported by the Network appears in PubMed.
Consistent with the goals of PharmGKB, deposition of individualized data is desirable, subject to institutional approval. The deposition of unpublished data is also strongly encouraged. If considered appropriate by the investigator (and concerned parties), quarterly depositions of data, as subjects and results are accumulated in long-term trials, are also encouraged.
The timing of data submissions to PharmGKB will be recorded and "published" by PharmGKB in the same way as the date of acceptance and the date of publication of an article are recorded in journal articles. To follow the progress of submission and to allow the Network to address roadblocks that impede the timeliness and effectiveness of the submission process, PharmGKB staff will record a series of "timestamps" for each data set submitted.
The tracking data recorded for each submission will include the following:
- The date of first submission to PharmGKB of a data set.
- Any and all dates of resubmission of modified versions of the same data to PharmGKB.
- The dates of return of data to the PI for modifications.
- The date of final acceptance by PharmGKB.
- The date of PI approval of the final PharmGKB data presentation.
- The date of appearance of the data to the public on PharmGKB.
- The date of acceptance of an article for publication.
In cases where investigators have concerns about issues relating to the submission of data from human subjects, they should contact the PharmGKB and/or their IRB to discuss appropriate alternatives to deposition of individual subject data.
Other versions of this policy are also available: