Developing a plan for reporting Adverse Event
Adverse Event is essential to maintaining Good Clinical Practices ( GCP ) and ensuring safety of participants in clinical studies. Your data monitoring plan should describe the mechanism for reporting adverse events to your IRB
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An adverse event (also referred to as an adverse experience) can also be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. An adverse event can arise from any use of a drug (e.g., off label use, use in combination with another drug) and from any route of administration, formulation or dose, including overdose.
Institutional Review Board (IRB) , the DSMB
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
Data and Safety Monitoring Board (DSMB) , the FDA
an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC).
Food and Drug Administration (FDA) and other parties responsible for receiving and reviewing them.
is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage
National Heart, Lung, Blood Institute (NHLBI) is concerned about patient safety in Clinical Trial. Reports of all Serious Adverse Events ( SAE
National Institutes of Health (NIH)
the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers
that conduct and support biomedical and behavioral research. NIH Homepage
Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage
Serious Adverse Event (SAE) ) which are expected or unexpected
- An adverse event or suspected
Suspected (Adverse Event)
any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND safety reporting, ‘reasonable possibility’ means there is evidence to suggest a causal relationship between the drug and the adverse event. As suspected adverse reaction implies a lesser degree of certainty about causality than adverse reaction, which means any adverse event caused by a drug.
adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse reaction, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Unexpected (Adverse Event) must be sent to your NHLBI Program Director
An adverse event or suspected adverse reaction is considered "unexpected" if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, of an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. "Unexpected" as used in this definition, also refers to adverse events or suspected adverse reactions that are mentioned in the investigator brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specifically mentioned as occurring with the particular drug under investigation.
Program Director or Clinical Trials Specialist
staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Official.
Clinical Trials Specialist (CTS) as outlined in a Policy for Reporting Clinical Study Serious Adverse Events.
individual who works as part of the program staff on clinical research projects, managing and overseeing clinical and operational activities of the project.
You may wish to view or use the FDA adverse event reporting form called MedWatch. These forms may be a useful starting point for you if you do not have study-specific forms developed already.
Related Documents Concerning FDA IND
Investigational New Drug (IND) Reporting Requirements:
an application, filed by a drug sponsor with FDA (Form FDA 1571
) to conduct clinical trials. It includes detailed descriptions of all trial phases, protocols, IRB members, and investigators
FDA Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
Guidance for Industry and Investigators: FDA Safety Reporting Requirements for INDs and BA/BE Studies
Page Last Updated: September 2011
Content Manager: ClinicalResearchPolicyManager@nhlbi.nih.gov