Clinical Research Support Agreement

Whether representing a healthcare institution leading a clinical trial or the pharmaceutical manufacturer (sponsor) whose medication is the focus of that trial, don’t start from scratch when negotiating and drafting agreements between the parties to support the study of the sponsor’s medication. This template, which includes guidance and drafting notes, contemplates the sponsor providing both financial support (e.g., funding for direct and indirect costs) and material support (e.g., samples of the study medication) to the institution.

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• HIPAA Authorization to Use and Disclose PHI in Clinical Research
  Use this template to obtain participant authorization when the provider anticipates disclosing participant protected health information (PHI) as part of, or after completion of, clinical research. HIPAA requires that providers obtain this authorization for use and disclosure of PHI not otherwise allowed by the Privacy Rule.
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  Learn how HIPAA, the federal Common Rule, and Food and Drug Administration regulations set the standards for maintaining the privacy and confidentiality of data obtained from participants in clinical trials.
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  Incorporate this template into your practice and use with your covered entity clients (like group health plans) to facilitate patient and plan participant requests to limit access to their information, as allowed by HIPAA.

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