Data Management

Data Management Glossary from Cornell University

Primer on Data Management from DataONE

Guidelines for Effective Data Management Plans from ICPSR

Data Management course for Scientists from the ESIP Federation, with NOAA and the Data Conservancy

Adverse Event (AE)

"Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product." - FDA definition

Incidental Findings

"Incidental findings are discoveries of individual-level findings that are unrelated to the goals of the study.... While most incidental findings will be discovered during clinical research, be medical in nature and have potential effect on the subject’s health, such as those just mentioned, incidental findings can occur in social behavioral and other fields of research as well, and can have implications that are not directly related to medical care." - US Dept of Health & Human Services

Independent Data Monitoring Committee (IDMC) (Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee)

"An independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial." - FDA definition

Informed Consent

"A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed,
and dated informed consent form." - FDA definition

Serious Adverse Event (SAE) or Serious Adverse Drug Reaction (Serious ADR) 

Any untoward medical occurrence that at any dose:

• Results in death,
• Is life-threatening,
• Requires inpatient hospitalization or prolongation of existing hospitalization,
• Results in persistent or significant disability/incapacity, or
• Is a congenital anomaly/birth defect.

- FDA definition

Vulnerable Subjects

"Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent." - FDA definition