Definitions

Data Labels

  • Directly Identifiable:  Data/samples are considered to be directly identifiable if they are labeled with unique identifiers that allow the identity of the subject to be ascertained or readily ascertained by the investigator or associated with the information
  • Indirectly Identifiable:  Data/samples that have a link (code or key) to identifiable information about the person
  • Non-identifiable: Data/samples are considered to be non-identifiable when the data/samples cannot be linked to a specific individual either because the link (code or key) was never created or the link was destroyed

Deviations

  • Deviation: Any change/alteration to the CRC IRB-approved protocol without prospective IRB approval.
  • Major Deviation: Any change/alteration that has or has the potential to: 1) adversely affect the rights, welfare or safety of the subjects, 2) adversely affect the integrity of the research data, or 3) affect the subject’s willingness to participate.
  • Minor Deviation: Any change/alteration that has NOT or does NOT have the potential to: 1) adversely affect the rights, welfare or safety of the subjects, 2) adversely affect the integrity of the research data, or 3) affect the subject’s willingness to participate.
  • Exception: A one time, intentional change/alteration to the IRB-approved protocol that is approved by the IRB prior to implementation.

Noncompliance

  • Noncompliance: Failure to comply with the regulations, institutional policies, laws, or the requirements or determinations of the IRB.
  • Minor Noncompliance: Any noncompliance that is NOT persistent and does NOT: 1) adversely affect the rights and welfare of the subjects, 2) increase risks to subjects or others or alter the risk/benefit ratio, 3) compromise the integrity or validity, or 4) result from the willful, knowing, or intentional misconduct on the part of the investigator or research staff.
  • Serious Noncompliance: Any noncompliance that: 1) adversely affect the rights and welfare of the subjects, 2) increases risks to subjects or others or alter the risk/benefit ration, 3) compromises the integrity or validity, or 4) results from the willful, knowing, or intention misconduct on the part of the investigator or research staff.
  • Continuing Noncompliance: Any noncompliance that occurs in a persistent or repeated manner.
  • Suspension: IRB-approved research or some the activities in the research are temporarily stopped in order to protect human subjects pending completion of an investigation. Once the investigation is complete, a determination is made as to: 1) lift the suspension and allow protocol activities to resume or 2) terminate the study or some activities of the protocol.
  • Termination: IRB-approved research is permanently stopped. No further work may be done on this research.

Problems & Events

  • Unanticipated Problem Involving Risks to Subjects or Others: Any incident, experience or outcome that is: 1) unexpected (in terms of nature, severity, or frequency) given the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and the informed consent document, and the characteristics of the subject population being studied, 2) related or possibly* related to participation in the research, AND 3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized. *Possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research
  • Adverse Event: Any untoward or unfavorable physical or psychological occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
  • Serious Adverse Event: Any adverse event that: 1) results in death, 2) is life-threatening (places the subject at immediate risk of death from the event as it occurred), 3) results in inpatient hospitalization or prolongation of existing hospitalization, 4) results in a persistent or significant disability/incapacity, 5) results in a congenital anomaly/birth defect, or 6) based upon appropriate medical judgment may jeopardize the subject’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
  • Unexpected Adverse Event: Any adverse event occurring in one or more subjects participating in a research protocol, the nature, severity or frequency of which is not consistent with either: 1) the known or foreseeable risk of adverse events associate with the procedures involved in the research that are described in (a) the protocol-related documents, such as the IRB-approved protocol, any applicable investigator brochure, and the current IRB-approved informed consent document, and (b) other relevant sources of information, such as product labeling and package inserts or 2) the expected natural progression of any underling disease, disorder, or condition of the subject(s) experiencing the adverse event and the subject’s predisposing risk factor profile for the adverse event.
  • Unexpected 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 identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of the subjects.

Investigational Products

  • Investigational new drug: “…a new drug, antibiotic 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.” (21 CFR 312.3)
  • Investigational drug: “…a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.” (ICH GCP E6, section 1.33)
  • Biological product: “…any virus, therapeutic serum, toxin, antitoxin, or analogous product applicable to the prevention, treatment or cure of diseases or injuries …” (21 CFR 600.3)
  • Device: “…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.” (Food, Drug and Cosmetic Act, Chapter 2, Section 201(h))