What are the regulations governing the clinical trials of drugs?
In New Hampshire, the regulations governing the clinical trials of drugs are outlined in the State of New Hampshire Department of Health and Human Services (DHHS) Division of Public Health Services (DPHS) Administrative Rule Saf-C 5020. The rule states that clinical trials conducted in New Hampshire must be approved by the DHHS Institutional Review Board (IRB). The IRB is responsible for the review and approval of all clinical trials conducted in the state. Clinical trials must be conducted in accordance with Good Clinical Practice (GCP) guidelines. The GCP guidelines ensure the safety of the participants and the integrity of the data collected. The protocol for the clinical trial must be approved by the IRB prior to initiation. The IRB must also review and approve any modifications made to the protocol prior to implementation. The IRB is responsible for conducting ongoing reviews of all clinical trials. This includes reviewing the safety of the participants, the ethical administration of the clinical trial, and the accuracy of the data collected. The IRB is responsible for reporting serious adverse events to the DHHS. The DHHS has the authority to suspend or terminate a clinical trial if any safety issues are identified or if the quality or integrity of the data is found to be compromised. Additionally, any regulations, rule changes, or guidance documents that are relevant to clinical trials must be reviewed, approved, and adhered to by the IRB prior to their implementation.
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