1.1 Adverse Drug Reactions (ADRs) In clinical experience prior to the authorisation of a new medicinal product or its new uses, in particular because the therapeutic dose(s) may not be established, all undesirable and unintended adverse reactions to a medicinal product associated with any dose, regardless of the dose, shall be considered as adverse reactions of the medicinal product. The term “drug reactions” means that a causal link between a drug and an adverse event is at least a reasonable possibility, i.e. this link cannot be excluded. For marketed medicinal products: reaction to a medicinal product that is harmful, unintentional and occurs at doses normally used in humans for the prophylaxis, diagnosis or treatment of disease or to impair physiological function (see ICH Guidelines on Clinical Safety Data Management: definitions and standards for accelerated notification). 1.54 Sponsoring Investigator A person who, alone or with others, undertakes and conducts a clinical trial and under whose direct direction the investigational medicinal product is administered, dispensed or used by a subject. The term does not include anyone other than an individual (e.g., it does not include a corporation or organization). The duties of a sponsoring investigator include both those of a sponsor and those of an investigator. Describes the obligations and obligations that investigators assume when conducting industry-sponsored clinical trials in accordance with ICH E6 and Investigational New Drug (IND) requirements, including FDA Form 1572 requirements. Discusses the investigator`s responsibilities, including conducting the study, reporting requirements, required study files, and communicating with the IRB, federal agencies and the sponsor. EU Clinical Trials Regulation (EU/536/2014): clinical trial fulfilling one of the following conditions: (a) the assignment of the subject to a specific therapeutic strategy is decided in advance and is not part of normal clinical practice of the Member State concerned; (b) the decision to prescribe investigational medicinal products shall be taken at the same time as the decision to enrol the subject in the clinical study; or (c) diagnostic or monitoring procedures are applied to subjects in addition to normal clinical practice.
(referred to in Article 2(2) of Regulation (EU) No 536/2014) 1.14. Comparator (product) An investigational or marketed product (i.e. an active control) or placebo used as a reference in a clinical trial. 1.36 Investigator`s brochure Compilation of clinical and non-clinical data on the investigational medicinal product(s) relevant to the human study of the investigational medicinal product(s) (see 7th Investigator`s brochure). Discusses topics of importance to researchers who are also study sponsors (research sponsors) and conducts investigator-initiated studies. Covers how to determine whether an Investigational New Drug (IND) application is required, the role of the sponsoring investigator, documentation required for INDs, and reports to be submitted to the FDA for active INDs. Also includes information on the additional responsibilities that sponsoring researchers take on in their dual roles. The following links provide DMID staff and clinical investigators with information on IDID procedures for handling and administering investigational drugs in DMID-funded clinical trials. The DMID Office of Regulatory Affairs (ORA) should be contacted for specific questions. Describes the responsibilities of investigators when using investigational drugs in accordance with GCP standards. This includes requirements for the shipment and storage of investigational drugs and the recording of the receipt, use and final disposal of investigational drugs. Also examines what investigational drugs are and the management requirements for their use by study participants.
Describes the role of industry sponsors in conducting clinical trials as part of an investigational new drug (IND) application in accordance with FDA regulations. Provides an overview of definitions, procedures and schedules related to the development of a new drug. Also includes electronic records and signatures in accordance with 21 CFR Part 11 and the requirements ClinicalTrials.gov in accordance with 42 CFR Part 11. An investigational drug is a preventive (vaccine), therapeutic (drug or biologic), instrument, diagnostic or palliative drug used in a clinical trial. An investigational drug may be an unlicensed product or a licensed product if it is used or assembled (formulated or packaged) differently from the approved form, if it is used for an unapproved indication, or if it is used to obtain additional information about an approved use. 1.60 Unexpected adverse reaction An adverse reaction that is not consistent in nature or severity with the applicable product information (e.g., brochure or package insert or summary of characteristics of an unauthorized investigational medicinal product (see ICH Clinical Safety Data Management Guideline: Definitions and Standards for Expedited Reporting). 1.12. Clinical trial/study Any human study intended to detect or verify the clinical, pharmacological and/or pharmacodynamic effects of one or more investigational medicinal products and/or to detect adverse reactions of one or more investigational medicinal products and/or to investigate the absorption, distribution, metabolism and excretion of an investigational medicinal product in order to establish its safety and/or efficacy.