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Investigator Responsibilities - Drug and Biological Therapies

An investigator's responsibilities in conducting clinical investigations of drugs or biological therapeutics are stated in 21 CFR 312.

Most of these responsibilities are included in Form 1572 (discussed in 21 CFR 312.53). Additional requirements are also contained in 21 CFR 50 (Informed Consent Process), and 21 CFR 56 (IRB regulations), and sections of 21 CFR 312.

The responsibilities included in the Form 1572 are:

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