Investigator's Responsibilities

What do I agree to when I sign a 1572?

• I agree to conduct the study(ies) in accordance with the relevant, current protocol(s) and will only make changes in a protocol after notifying the sponsor, except when necessary to protect the safety, rights, or welfare of subject.
• I agree to personally conduct or supervise the described investigation(s).
• I agree to inform any patients, or any persons used as controls, that the drugs are being used for investigational purposes and I will ensure that the requirements relating to obtaining informed consent in 21 CFR Part 50 and institutional review board (IRB) review and approval in 21 CFR Part 56 are met.
• I agree to report to the sponsor adverse experiences that occur in the course of the investigation(s) in accordance with 21 CFR 312.64
• I have read and understand the information in the investigator's brochure, including the potential risks and side effects of the drug.
• I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the study(ies) are informed about their obligations in meeting the above commitments.
• I agree to maintain adequate and accurate records in accordance with 21 CFR 312.62 and to make those records available for inspection in accordance with 21 CFR 312.68
• I will ensure that an IRB complies with the requirements of 21 CFR Part 56 will be responsible for the initial and continuing review and approval of the clinical investigation.  I also agree to promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to human subjects or others.  Additionally, I will not make any changes in the research without IRB approval, except where necessary to eliminate apparent immediate hazards to human subjects.
• I agree to comply with all other requirements regarding the obligations of clinical investigators and all other pertinent requirements in 21 CFR Part 312.

Note: This is FDA language taken from the form 1572 and not a KUMCRI product.

• Good Clinical Practice in FDA Regulated Clinical Trials
• Code of Federal Regulations (CFR)
  
  a.  Investigational New Drugs - 21 CFR Part 312
  b.  Investigational New Drug Responsibilities of Investigators - 21 CFR Part 312.60-312.70
  c.  Financial Disclosure by Clinical Investigators - 21 CFR Part 54
  d.  Investigational Device Exemptions - 21 CFR Part 812
  e.  Protection of Human Subjects - 21 CFR Part 50
• Common Rule, Protection of Human Subjects, Federal Register 45 Part 46
• FDA Information Sheets