Informed Consent for Clinical Trials Form

Provide clinical trial subjects with enough information to allow for an informed decision about the subject's participation in the clinical trial. Use this template to facilitate the potential subject's understanding of the study, provide an opportunity for the potential subject to ask questions and to consider whether to participate, obtain the potential subject's voluntary agreement to take part in the clinical trial, and continue to provide information as the clinical investigation moves forward.

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Related Content

• HIPAA Authorization to Use and Disclose PHI in Clinical Research
  Use this authorization template when a clinician or researcher anticipates disclosing an individual's protected health information (PHI) in the course of conducting research or as a result of collecting such data during clinical research.
• Clinical Research Support Agreement
  Begin your negotiation and drafting process for an agreement between a drug manufacturer (sponsor) and an institution taking on responsibility for conducting clinical research on behalf of the sponsor with this template clinical research support agreement. Prepare an agreement that contemplates the sponsor providing financial support (funding for direct and indirect costs) or material support (samples of the study drug), or both, to the institution.
• Informed Consent for Clinical Trials for People with Disabilities
  Complement your general informed consent form with this template, which can be used with clinical trial subjects with disabilities. Use this form when enrolling subjects with physical challenges (e.g., subjects unable to speak or write, subjects with hearing and/or vision loss). Also use this form when enrolling subjects with impaired consent capacity. Give subjects the ability to understand the information presented to them relevant to their making an informed decision about whether to participate.

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