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 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  • FDA  –  Draft Guidance for Clinical Trial Sponsors on the Establishment and Operation of Clinical Trial Data-Monitoring Committees

Process Overview

Policy for Registry Database Access

Roles and Duties

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:
    • Submits his/her application to NAMHR with draft protocol for review by the Registry Advisory Committee. (see attachment DR 1001-A)
    • The researcher provides a data dictionary of the variables to be studied.
    • Submits request to the NAMHR listserv which will include the NAMHR Staff and Research Advisory Committee members.

Registry Advisory Committee Registry Manager

  • During the approval process, preference will be given to applications, which do not overlap with research in progress.
    • Application is received by the NAMHR office.
    • Submission sent to The Registry Advisory Committee for review/comments/approval or disapproval.
    • If approved contract and data use agreement will be sent to the researcher.
      • Once contract, data use agreement, IRB approval, and NAMHR fee are received, data will be released.
      • The research utilization fee shall be $1000.00 for external researchers inclusive of overhead but subject to change based on The Research Advisory Committee’s review and recommendations.
    • If not approved, researcher will be notified and explanation provided.
  • 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.
    • Registry personnel will identify the appropriate subjects for the study (e.g., those who have consented to be contacted).
    • The NAMHR staff will contact the subjects with information about the study including to inquire about the interest in participating in the study. If they are interested they will be given the external researcher’s contact information.
    • The NAMHR library of papers will be made available to researchers when they have paid the initial fee, as subject to copyright laws.
    • Any publications will need to be reviewed by the NAMHR office prior to publications.
    • Any publications resulting from use of the Registry data will cite the North American Malignant Hyperthermia Registry (NAMHR) of MHAUS as a source of data.