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Terms & Titles to Know

AE A negative experience encountered by an individual during the course of a clinical trial, that is associated with the drug. An AE can include previously undetected symptoms, or the exacerbation of a pre-existing condition. When an AE has been determined to be related to the investigational product, it is considered an Adverse Drug Reaction.
Blinding The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
CDA (Confidentiality Disclosure Agreement) Agreement between institution/investigator and sponsor that all information regarding clinical trial will be kept confidential. Sponsor must have signed CDA before releasing a protocol to the investigator. Also known as a secrecy agreement
CRF (Case Report Form) A record of pertinent information collected on each subject during a clinical trial, as outlined in the study protocol.
CRO (Contract Research Organization) A person or an organization (commercial, academic or other) contracted by the sponsor to perform one or more of a sponsor's study-related duties and functions.
CTA (Clinical Trial Agreement) Agreement between the institution and the sponsor detailing the expectation regarding funding, intellectual property, etc. Must be negotiated before patients may be enrolled in the clinical trial. Also know as a contract.
DCF (Data Clarification Form) Request from Sponsor or CRO to clarify a discrepancy in the CRFs submitted. Also known as a query.
FDA Form 1572 A list of commitments and requirements by the FDA for each investigator performing drug/biologics studies. Also referred to as a statement of the investigator. Must be signed and dated by the principal investigator before each new clinical trial. Must be updated with any changes in site location, laboratory facilities, or investigators throughout the trial. Updated 1572s must be signed by the principal investigator and submitted the CRO.
ICF (Informed Consent Form) The voluntary verification of a patient's willingness to participate in a clinical trial, along with the documentation thereof. This verification is requested only after complete, objective information has been given about the trial, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternative therapies available, and of the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki.
Investigator's Brochure Relevant clinical and non-clinical data compiled on the investigational drug, biologic or device being studied.
IRB An independent group of professionals designated to review and approve the clinical protocol, informed consent forms, study advertisements, and patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB's responsibility to ensure that the study adheres to the FDA's regulations.
Monitor Person employed by the sponsor or CRO who reviews study records to determine that a study is being conducted in accordance with the protocol. A monitor's duties may include, but are not limited to, helping to plan and initiate a study, and assessing the conduct of studies. Monitors work with the clinical research coordinator to check all data and documentation from the study. See also CRA.
Phase I Study The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II Study After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.
Phase III Study The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
Phase IV Study After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
Placebo An inactive substance designed to resemble the drug being tested. It is used as a control to rule out any psychological effects testing may present. Most well-designed studies include a control group which is unwittingly taking a placebo.
Principal Investigator A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.
Protocol A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before investigational drugs may be administered to humans.
Protocol Amendment Changes or clarifications made in writing to the original protocol.
SAE (Serious Adverse Event) Any adverse event (AE) that is fatal, life-threatening, permanently disabling, or which results in hospitalization, initial or prolonged.
SAM (Sponsored Awards Management) The University of South Carolina office that negotiates and regulates funding and grant monies generated by clinical research studies.
Source Documents All information contained in original records and certified copies of results, observations or other facets required for the reconstruction and evaluation of the study that is contained in source documents. Location where information is first recorded including original documents, data and records.
Sponsor Individual, company, institution or organization taking responsibility for initiation, management and financing of study.
Study Coordinator Site administer for the clinical study. Duties are delegated by the investigator. Also called research, study or healthcare coordinator, and data manager, research nurse or protocol nurse.
Sub Investigator Helps design and conduct investigation at a study site.
USCeRA (The University of South Carolina Electronic Research Administration) The internet based system that allows for a proposal to be submitted electronically to the SAM office.