Definitions

Adverse Drug Experience is any unfavorable and unintended sign (including abnormal laboratory finding), symptom, or disease temporally associated with the use of medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure

Annual Reports  are a summary of the contents of both clinical and non-clinical information of the previous year which are related to either the IND or IDE.  Annual reports are due on the anniversary of the effective date of either the IND or IDE.  The IND/IDE Assistance Program has templates (annual report template) available to assist in the compliance of submitting the annual report in a timely manner.

Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), applicable to the prevention, treatment, or cure of a disease or condition of human beings.

Botanical drug are products intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans.  

• A botanical drug product consists of vegetable materials, which may include plant materials, algae, macroscopic fungi, or combinations thereof. 
• A botanical drug product may be available as (but not limited to) a solution (e.g., tea), powder, tablet, capsule, elixir, topical, or injection. 
• Botanical drug products often have unique features, for example, complex mixtures, lack of a distinct active ingredient, and substantial prior human use. Fermentation products and highly purified or chemically modified botanical substances are not considered botanical drug products.

Case Report Form (CRF) is a form used to collect various forms of data from your research.  The IND/IDE Assistance Program has set forth a template (Case Report Form template) showing the necessary information needed for case report froms.

Clinical Monitoring is one of the obligations of the sponsor of a clinical investigation. The monitoring functions may be delegated to a contract research organization.  Proper monitoring is necessary to ensure adequate protection of the rights of the human subjects and the safety of all subjects involved in clinical investigations and the quality and integrity of the resulting data submitted to the Food and Drug Administration.  The FDA has set forth Guidelines for the Monitoring of Clinical Investigations.

Clinical Investigation means any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.  An experiment is any use of a drug except for the use of a marketed drug in the course of standard medical practice.

Contract Research Organization (CRO) means a person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design of a protocol, selection or monitoring of investigations, evaluation of reports and preparation or materials to be submitted to the Food and Drug Administration.

Device means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is - (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Dietary supplements are products (other than tobacco) that is intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total daily intake, or a concentrate, metabolite, constituent, extract, or combinations of these ingredients.

• is intended for ingestion in pill, capsule, tablet, or liquid form.
• is not represented for use as a conventional food or as the sole item of a meal or diet.
• is labeled as a "dietary supplement."
• includes products such as an approved new drug, certified antibiotic, or licensed biologic that was marketed as a dietary supplement or food before approval, certification, or license (unless the Secretary of Health and Human Services waives this provision).

Drug means (A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and
(D) articles intended for use as a component of any article specified in clause (A), (B), or (C).

Effective Date is the date the IND or IDE study was permitted by the FDA to begin

Fatal Adverse Drug Experiences are any adverse drug experiences that cause the death of the subject.  The FDA has set forth Med Watch forms for the reporting of fatal or life threatening adverse drug experiences.  Fatal or life-threatening adverse drug experiences are to be reported to the FDA via phone or fax, no later than 7 calendar days after knowledge of the adverse event.

FDA means the Food and Drug administration.  The regulatory authority in the United States which oversees the pharmaceutical and medical device industries.  The FDA is responsible for ensuring that the drugs and medical device marketed in the US have a greater benefit than risk when used according to manufacturers’ directions.

FD&C Act means the Food, Drug and Cosmetic Act

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conduction, recording and reporting trials that involve the participation of human subjects.  The FDA has set forth, a Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance.  Compliance with this standard provides public assurance that the rights, safety, and wellbeing of the trial subjects are and the clinical trial data are credible.  Compliance with this standard also provides a unified standard for the European Union (EU), Japan, and the United States to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.  The IND/IDE Assistance Program has set forth a template (Good Clinical Practice Template) to aid in the compliance of these guidelines.

IAP means the IND/IDE Assistance Program

IDE means an investigational device exemption.

IDE exemption allows manufacturers of devices intended solely for investigational use to ship devices for use on human subjects (clinical evaluation), the FD&C Act authorized to exempt these devices from certain requirements of the Act that would apply to devices in commercial distribution.  Clinical evaluation of devices not cleared for marketing, unless exempt, requires an approved investigational device exemption (IDE) either by an institutional review board (IRB) or an IRB and FDA, informed consent for all patients, adequate monitoring and necessary records and reports.

 Studies exempt from the IDE regulation include:

1. A legally marketed device when used in accordance with its labeling
2. A diagnostic device if it complies with certain labeling requirement and if the testing:
        a.  is noninvasive
        b. does not require an invasive sampling procedure that presents significant risk;
        c. does not by design or intension induce energy into a subject;
        d. is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure.
3. Consumer preference testing, testing of a modification, or testing of a combination of devices if the device(s) are legally marketed device(s) AND if the testing is not for the purpose of determining safety or effectiveness and does not put subjects are risk;
4. A device intended solely for veterinary use.
5. A device shipped solely for research with laboratory animals and contains the labeling “CAUTION-Device for investigational use in laboratory animals or other tests that do not involve human subjects.

IND means an investigational new drug application.

IND exemption means that the study or research may be conducted without formal FDA oversight.  In order for a study to be exempt, the study drug must be lawfully marketed in the US and meet all of the following criteria:

1. The study is not intended to support FDA approval of a new Indication or a significant change in the product labeling.
2. The study is not intended to support a significant change in the advertising for the product.
3. The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increase the risks (or decreases the acceptability of the risks) associated with the use of the drug product.
4. The study is conducted with institutional review board (IRB) and informed consent regulations.
5.  The study is conducted in compliance with promotion and charging requirements for investigational drugs.

Investigational new drug means a new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.

Investigator means an individual who actually conducts a clinical investigation (i.e., under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team.  The FDA has set forth specifict responsibilities of the investigator.

Institiotional Review Board (IRB) is  board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights, safety, and welfare of human subjects.

Life-Threatening Adverse drug experiences are any adverse drug experience that places the subject at immediate risk of death from the reaction as it occurred.  The FDA has provided MedWatch forms for the reporting of life-threatening or fatal adverse drug experiences.  Life-threatening or fatal adverse drug experiences are to be reported to the FDA via phone or fax no later than 7 days after knowledge of the adverse event.

Nonsignificant Risk Devices are devices that do not pose a significant risk to the human subjects.  Examples include most daily-wear contact lenses and lens solutions, ultrasonic dental scalers, and foley catherters.

Protocol means a document describing the steps that will be carried our in order to perform the research study. It contains the drug or device name, intended use, objectives or hypothesis to be tested, duration of the trial, methodology to be used, description of the conduct of the trial, description of the statistical methods, inclusion and exclusion criteria case report forms, information demonstrating scientific soundness.

Serious Adverse Event (SAE) is any medical occurrence that at any dose results in death, is life-threatening, requires subject hospitalization/prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.  Important medical events that may not result in death, be life threatening, or require hospitalization may be considered SAE’s, when, based upon appropriate medical judgment, they may jeopardize the subject and may require medical/surgical intervention to prevent one of the outcomes listed above.  The FDA has available MedWatch forms for reporting serious or unexpected adverse drug experiences. and/or fatal or life-threatening adverse drug experience.  Serious or unexpected adverse drug experience is to be reported to the FDA no later than 15 calendar days after knowledge of the adverse event.

Sponsor means a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators.  The FDA has setforth specific responsibilities of the sponsor of a clinical investigation.

Sponsor-Investigator means an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator under this part include both those applicable to an investigator and a sponsor.  The sponsor-investigator must comply with the FDA's specific responsibilities of both the sponsor and the investigator.

Subject means a person who participates in an investigation, either as a recipient of the investigational new drug or as a control.  A subject may be a healthy human or a patient with a disease.

Significant Risk Devices is a device that presents a potential for serious risk to the health, safety, or welfare of a subject.  Significant risk devices my include implants, devices that support or sustain human life, and devices that are substantially important in diagnosing, curing, mitigation or treating disease or in preventing impairment to human health.  Examples include sutures, cardiac pacemakers, hydrocephalus shunts, and orthopedic implants. 

Unexpected Adverse Drug experience are any adverse drug experience the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current IND application and that has not been previously observed.  The FDA has set forth Med Watch forms for reporting serious or unexpected adverse drug experiences.  Serious or unexpected adverse drug experiences are to be reported to the FDA no later than 15 calendar days after knowledge of the adverse event.