Are you interested in conducting clinical research?
Thank you for contacting us about your desire to perform research. We have an active research program and are excited about reviewing your protocol. Our Clinical Research Team carefully reviews all proposals, but prior to our evaluation we require that the submission contain the following information. We will notify you promptly concerning our decision about whether to fund your proposal. All proposals become the property of Arizant Healthcare.
Clinical Research Proposal
Research hypothesis – Every study must have at least one basic hypothesis that can be tested as described in the methodology and statistical analysis sections.
Literature review – A complete review of the relevant source literature must be provided. The review must include a list of citations.
Proposed methodology – The proposed plan for testing the research hypothesis must include a detailed protocol. The protocol must describe the proposed study design, randomization scheme, inclusion/exclusion criteria, recruitment plan, data acquisition plan, a list of potential intercurrent or adverse events, and case report forms.
HIPAA compliance – The proposal must include a review of the current HIPAA policy at the institution(s) participating in the proposed study. Please include information on whether study sponsors have access to source documents.
Statistical analysis plan – A description of how the data will be analyzed, including justification for intention-to-treat analysis or on-treatment analysis must be included. A power analysis, sample size estimate, and a discussion of how type I and II errors will be minimized must be included.
Ethics review – A description of potential ethical problems and how they will be avoided. A draft of an Institutional Review Board (IRB) or Independent Ethics Committee (IEC) submission document must be included.
Publication plan – The investigator is responsible for producing a final report of the study. Irrespective of the study results, the final report must include a discussion section that explains the research findings.
Investigator’s Curriculum Vitae or resume
Cost estimate – An itemized breakdown of study costs must be included in the submission package. Are there sources of supplementary funding?
Duration estimate – The investigator must include an estimate of the amount of calendar time the study will last.
Please send your submission via the following:
By mail: Arizant Healthcare Inc.
attn: Al Van Duren, Director of Clinical Affairs
10393 West 70th Street
Eden Prairie, MN 55344
By fax: 952-918-5247, attn: Al Van Duren, Director of Clinical Affairs
