Regulatory Documentation IRB
The divisions should work with Staford IRB group. Some of the regulations to be aware of:
45 CFR 46.103(b) 5: Prompt reporting of any unanticipated problems involving risks to subjects or others.
21CFR312,21 CFR 812: Holds sponsors and investigators responsible for ensuring research is conducted according to investigational plan.
21 CFR 312.64: Promptly reporting to the sponsor any adverse effect that may reasonably te regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, report the adverse effect immediately.
21 CRR 812.150(a): Submit to the sponsor and to the reviewing IRB a report of any unaticipated adverse drug effect...as soon as possible, but in no event less than 10 working days after the investigator first learns of the effect.
45 CFR 46.103B(5): Prompt reporting of any unanticipated problems involving risks to any subjects or others.
45 CFR46.113: Authorizes the IRB to suspend or terminate approval of research not being conducted in accordance with IRB requirements.
45 CFR46.103b(5): Mandates the IRB to report any serious or continuing noncompliance with 45 CFR 46 or the requirements or determinations of the IRB.
21 CFR812.3(s): Unanticipated adverse device effect: any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identifified in nature, severity, or degree of incidence in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.
21CFR312.32(a): Serious adverse drug experience: any adverse drug experience occuring at any dose that results in or requires medical or surgical intervention to prevent any of the following outcomes: death, a life-threatening adverse drug experience, in patient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect.
21 CFR 312.32c(1) A: Notify FDA and all paticipaint investigators in a written report of any adverse experience associated with the use of the drug that is both serious and unexpected.
21 CFR 312.32c(2): Notify FDA by phone or fax of any unexpected fatal or life-threatening experience associated with the use of the drug as soon as possible but in no event later than 7 calendar days after the sponsor's initial receipt of the information.
21 CFR812.150a: Requires investigator to notify sponsor and IRB of any deviation from the investigational plan when change is implemented in an emergency-expect in an emergency, prior approval by the sponsor is requird for any deviation from the investigational plan. Prior FDA and ARB approval may be required when proposed deviations may affect the scientific soundness of the investigatonal plan or the rights, safety, and welfare of subjects.
21 CFR 812.150b(1): Submit results of evaluation of unanticipated adverse devise effects to the FDA, all reviewing IRBs and participating investigators within 10 working days after the sponsor first receives notice of the effect.
ICH Guideline 4.5: Investigator should not implement any deviation from or changes of the protocal without prior review and documented approval from the IRB excpet where it is necessary to eliminate an immediate hazard(s) to a study or when the change(s) involve only logistical or administrative aspects of the study.
