While it is best to begin working with CTSI in the pre-award phase of your study, it is possible to tailor services to fit the available budget after an award is received.
Clinical research includes patient-oriented research, epidemiological and behavioral studies, and outcomes and health services research, all of which may or may not involve clinic use. See NIH definition of clinical research. Clinical trials are a subset of clinical research and are studies in which participants are assigned to one or more interventions with evaluation of the effects of the interventions on health-related biomedical or behavioral outcomes. See NIH definition of a clinical trial.
Please refer to the following links:
Per Vanderbilt, "REDCap is a secure web application for building and managing online surveys and databases. While REDCap can be used to collect virtually any type of data in any environment (including compliance with 21 CFR Part 11, FISMA, HIPAA, and GDPR), it is specifically geared to support online and offline data capture for research studies and operations. The REDCap Consortium, a vast support network of collaborators, is composed of thousands of active institutional partners in over one hundred countries who utilize and support their own individual REDCap systems."
REDCap projects can be created for MSU faculty, staff, and graduate students with a faculty advisor. Clinical and adjunct MSU faculty are included in this group. Accounts can be created for any individual involved with a REDCap project, regardless of their affiliation with MSU.
Yes. REDCap provides various ways to export projects and data from other installations and to import them to the MSU service. These migrations preserve most study data, but the audit history of the project is not included. To retain this information, the entire log history for a project should be exported and saved at MSU.
CTSI currently supports over 100 active projects. Our data managers are designing and changing projects every day. They have the experience of seeing how study design decisions impact the entire future of a study. However, we are also invested in building the data management skills of faculty and graduate students. We offer project specific training, email and phone support, open helpdesk hours, and training sessions to support your team if you choose to configure your own project.
The intake of existing data varies based on the future needs of a project, but there are common approaches that can be used depending on the structure of the data. For tabular data (CSV or XLS), we may import it into a REDCap project to gain features such as data quality, audit history, de-identification, and shared reporting. For large file-based data (image, video, DNA or Genome sequencing), a controlled storage location would be more appropriate. We support risk assessments and governance processes supporting storage on top of standard university services.
We support projects with all phases of data sharing including creating new data structures and data elements, translating instruments, add data on to existing data elements, GUID creation, and submitted data packages. We can provide this as a full service to a project or create the structure and train study staff to take over the operation.
CTSI offers this service. Contact CTSI for a consultation to assess your research needs.