Research Data Requests
To request data for research purposes, please fill out the submission form below and follow the standard operating procedure.
Send all requests for data access to ANESMHRAC-L@lists.ufl.edu for consideration.
Standard Operating Policy & Procedure for Data Access & Reporting
These policies and procedures apply to NAMHR, its employees, subcontractors and others who manage, oversee and conduct research regulated by the FDA.
Applicable Regulations and Guidelines
- 21 CFR 312.50 – General Responsibility of Sponsors
- 21 CFR 312.56 – Review of Ongoing Investigations
- ICH E6, 1.2.5 – Definition of Data Monitoring Committee
- ICH E6, 5.2.5 – Establishing an independent data-monitoring committee
- ICH E9, 4.6 – Establishing an independent data-monitoring committee
- FDA – Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data-Monitoring Committees
Policy for Registry Database Access
|1.||Internal Researcher & External Researcher||
The NAMHR encourages qualified medical scientists to work with the Registry staff to obtain epidemiologic and other data from the database.
An internal researcher is a member of the NAMHR home institution (UF), previous home institution (University of Pittsburgh), MHAUS board member, or the Registry Advisory Committee.
An external researcher is defined as a researcher who is not a member of the NAMHR home institution (UF), previous home institution (University of Pittsburgh), MHAUS board member, or the Registry Advisory Committee.
Internal and external researchers will be permitted access to the Registry data only after meeting the following requirements:
|2.||Registry Advisory Committee Registry Manager||
During the approval process, preference will be given to applications, which do not overlap with research in progress.
The registry will not reveal the names of patients registered in the registry to researchers.
Additionally, if a grant is applied for using the data from the Registry Database, the Registry Advisory Committee (MHAUS) will need to review and approve prior to grant submission and should be sent to the NAMHR listserv for review.
If external researchers need to contact individuals patients (e.g., to draw blood samples), then the following procedures will be available.