Monitoring and Accountability
SPORR partners with Stanford researchers and other key stakeholders to develop resources and tools for the Stanford community that support monitoring and accountability.
SPORR Projects:
- Focus Groups and Stanford-Wide Survey on Data Sharing and Management Practices
- CTSA Institutional Survey on R&R Activities
- Registration and reporting of clinical trials affiliated with California universities
- Analyzing Protocol, Code, and Data Sharing of Stanford Researchers
- Monitoring the Publication and Reporting of IRB Approved Stanford Research
Focus Groups and Stanford-Wide Survey on Data Sharing and Management Practices
Stanford Program for Rigor and Reproducibility (SPORR) in collaboration with Stanford’s Lane Library aimed to understand data sharing and management practices of Stanford early career researchers, as well as support they might need to follow the 2023 National Institutes of Health (NIH) Data Management and Sharing policy.
We conducted 4 focus groups with a total of 16 participants from 14 different departments across Stanford’s School of Medicine.
Results
Participants stated that writing data management plans was done only when required by IRB or funding applications. Similarly they shared data only when required by the funders or journals. Most participants had not received education, nor had departmental or lab templates or guides on how to manage data. Currently, most use cloud-based services to store their research data, and to share it with collaborators or statisticians, but they expressed uncertainty in the security and best methods of doing this. Participants emphasized that it takes a lot of effort to prepare and store the data properly, and that without dedicated funding, incentives, or mandates to make these practices required or being implemented by all equally, they fear that currently investing the time in data management might leave them at a disadvantage for the career advancement. Their wish for web resources are presented in the Figure on the left.
The results obtained were used to help develop a survey that will soon be sent to all of Stanford School of Medicine.
CTSA Institutional Survey on R&R Activities
The goal of this project was to determine the degree to which Clinical and Translational Science Awards (CTSA) funded institutions incorporated R&R activities into their translational research infrastructure.
Results were published in the Journal of Clinical and Translational Science (JCTS).
The resources shared by institutions and discovered by search of institutional websites are also available in our data repository.
We INVITE institutions that did not respond to our initial survey as well as non-CTSA institutions to share their R&R activities with us by filling out the Activities Form. Shared resources will be available on our website.
Media Coverage:
The article announcing our project was published in the Spectrum News.
Registration and Reporting of Clinical Trials Affiliated with California Universities
Study doi: https://doi.org/10.1186/s13063-025-09270-2
Based on our protocol, we analysed prospective registration, results reporting, trial registration number reporting, and publication accessibility status for trials with primary completion dates from 2014 to 2017 affiliated with seven California universities. Almost all of these trials preceded the FDAAA mandate.
Under FDA and NIH regulations only one university, i.e., commonly the university whose Protocol Registration and Results System (PRS) trial account is used to register the study, holds the legal and contractual responsibility for trial registration and results reporting in the public registry, and is listed as the lead sponsor of the study in ClinicalTrials.gov registry.
However, in our study, a University is affiliated with a trial, if any of its investigators, sponsors, or responsible parties were associated with the trial. According to the FDAAA Trials Tracker, only 92 (8%) of trials in our study are subject to the FDAAA mandate.
In summary, out of 1091 trials with primary completion dates from 2014 to 2017 one fifth (19%) lacked any kind of results dissemination (e.g., summary results in registry, journal article, poster or abstract) 5 years after their primary completion date.