Terms & Terminology in clinical research

Terms and Terminologyin Clinical research : 

Terms and Terminologyin Clinical research Amol Khedkar B.Pharm M.Tech(Biotech) Email: amolkhedkar@gmail.com +91-9763921244

Drug : 

Drug AThe substance used for diagnosis, treatment and prophylaxis of a disease AThe substance intended to be used to modify physiological systems or pathological states for the benefit of the recipient

Pharmacology : 

Pharmacology Pharmacology is defined as the science of drugs ,it consist of detailed study of drugs. Particularly their actions on living animals, organs or tissues. The actions may be beneficial or harmful.

Pharmacognosy : 

Pharmacognosy Pharmacognosy, the science of identification of drugs.It is the study of the sources of drugs derived from plants and animals and study of the physical and chemical properties of such substances.

Pharmacy : 

Pharmacy Pharmacy, the science of identification, selection, preservation, standardization, compounding and dispensing of medicinal substances.

Pharmacokinetics : 

Pharmacokinetics It is the study of ADME i.e. absorption, distribution, metabolism, Excretion of Drug. What body does to drug

Pharmacodynamics : 

Pharmacodynamics Pharmacodynamics, the quantitative study of the biological and therapeutic effects of drugs (what the drug does to the body). Such studies elucidate the mechanism of action of a drug

Therapeutics : 

Therapeutics Therapeutics which means to care for , to tend to or to nurse, and is a branch of medicine concerned with the cure of disease or relief of symptoms; it includes drug treatment

Chemotherapy : 

Chemotherapy Chemotherapy is the treatment of a disease or an ailment caused by pathogens like microbes, parasites etc by drugs. Its most general sense, refers to treatment of disease by chemicals that kill cells, specifically those of micro-organisms or cancer. In popular usage, it will usually refer to antineoplastic drugs used to treat cancer or the combination of these drugs into a standardized treatment regimen.

Toxicology : 

Toxicology Toxicology, the science of poisons which includes detection and measurement of poisons as well as treatment of poisoning. Poisons are substances that cause harmful, dangerous or fatal symptoms in animals and human beings; many drugs in larger doses act as poisons.

Pharmacoeconomics : 

Pharmacoeconomics Pharmacoeconomics, the analysis of the cost of drug therapy to the health care system and the society. It examines the link between the cost and the benefit (cost-benefit-analysis) of the individual health care measures

Pharmacoepidemiology : 

Pharmacoepidemiology Pharmacoepidemiology, the study of the use and effects of drugs in large numbers of people. It helps to gain further insight into the efficiency and safety of new drugs after they are released for community use. Such studies are essentially observational and case-control studies.

Pharmacogenetics : 

Pharmacogenetics Pharmcogenetics, the study of inherited (genetically mediated) differences (variation) in drug metabolism and response in humans.

Pharmacogenomics : 

Pharmacogenomics PPharmacogenomics, the science that examines the inherited variations in genes that dictate the drug response of humans, microbes (antimicrobials) and tumors (anticancer drugs), and explores the ways these variation can be used to predict whether a patient will have a good response to a drug, a bad response, or no response. This can help in the development of more target-specific and safer drugs.

Clinical Pharmacy : 

Clinical Pharmacy Clinical Pharmacy, involves cooperation of the pharmacist with the physicians in educating the patient about compliance and counselling him on how to take the medications, and monitoring the errors in taking the drugs.

Clinical Pharmacology : 

Clinical Pharmacology Clinical Pharmacology deals with the pharmacological effects of drugs in man.And provides information about the usefulness,potency and toxicity of new drugs in human being which is of great importance for the effective and safe use of drugs in man.

Pharmacopoeia : 

Pharmacopoeia Pharmacopoeia is an official code containing a selected list of the established drugs and medicinal preparations with descriptions of their physical properties and tests for their identity, purity and potency. Pharmacopoeia defines the standards which these preparations must meet and may mention their average doses for an adult. Examples are the Indian Pharmacopoeia (IP), the British Pharmacopoeia (BP), the United States Pharmacopoeia (USP) and the European Pharmacopoeia.

Adverse Drug Reaction : 

Adverse Drug Reaction In the pre-approval clinical experience with a new medicinal product or its new usages,particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e. there relationship cannot be ruled out. Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function

Adverse Event (AE) : 

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 adverse event (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

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

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

Unexpected Adverse Drug Reaction : 

Unexpected Adverse Drug Reaction An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product)

Clinical Trial/Study : 

Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

Applicable Regulatory Authority : 

Applicable Regulatory Authority Any laws and regulations addressing the conduct of clinical trials of investigational products

Approval(in relation to IRB) : 

Approval(in relation to IRB) The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, Good Clinical Practice (GCP), and the applicable regulatory requirements.

Audit : 

Audit A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Audit Certificate : 

Audit Certificate A declaration of confirmation by the auditor that an audit has taken place Audit Report A written evaluation by the sponsor's auditor of the results of the audit

Audit Trail : 

Audit Trail Documentation that allows reconstruction of the course of events Blinding/ Masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and doubleblinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

Case Report form(CRF) : 

Case Report form(CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject

Clinical Trial/ Study Report : 

Clinical Trial/ Study Report Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s),and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.

Comparator(Product) : 

Comparator(Product) An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial. Compliance (in relation to trial) Adherence to all the trial related requirement, GCP and the applicable regulatory requirements.

Confidentiality : 

Confidentiality Prevention of disclosure, to other than authorized individuals, of a sponsor's proprietary information or of a subject's identity.

Contract : 

Contract A written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.

Coordinating Committee : 

Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial. Coordinating Investigator An investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicentre trial.

Contract Research Organization : 

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 trial-related duties and functions.

Direct Access : 

Direct Access Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.

Documentation : 

Documentation All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Essential Document : 

Essential Document Documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced Good Clinical Practice (GCP) A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.

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

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.

Impartial Witness : 

Impartial Witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject’s legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.

Independent Ethics Committee(IEC) : 

Independent Ethics Committee(IEC) An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Informed Consent : 

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.

Inspection : 

Inspection The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organizations (CROs) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).

Institution (medical) : 

Institution (medical) Any public or private entity or agency or medical or dental facility where clinical trials are conducted Institutional Review Board(IRB) An independent body constituted of medical, scientific, and non-scientific members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Interim Clinical Trial/Study Report : 

Interim Clinical Trial/Study Report A report of intermediate results and their evaluation based on analysis performed during the course of a trial Investigational Product 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.

Investigator : 

Investigator A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator. Investigator Brochure A compilation of the clinical and non-clinical data on the investigational product(s) which is relevant to the study of the investigational product(s) in human subjects

Legally Acceptable Representative : 

Legally Acceptable Representative An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial. Monitoring The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).

Monitoring Report : 

Monitoring Report A written report from the monitor to the sponsor after each site visit and/or other trial-related Multicentre Trial A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.

Nonclinical Study : 

Nonclinical Study Biomedical studies not performed on human subjects Opinion (in relation to IEC) The judgment and /or the advice provided by an IEC

Protocol : 

Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments.

Protocol Amendment : 

Protocol Amendment A written description of a change(s) to or formal clarification of a protocol. Quality Assurance(QA) All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).

Quality Control(QC) : 

Quality Control(QC) The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.

Randomization : 

Randomization The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. Regulatory Authority Bodies having the power to regulate. In the ICH GCP guideline the expression Regulatory Authorities includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.

Source Data : 

Source Data All information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).

Source Documents : 

Source Documents Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories and at medico-technical departments involved in the clinical trial).

Sponsor : 

Sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial. Standard Operating Procedure (SOPs) Detailed written instructions to achieve uniformity of the performance of a specific function

Sub investigator : 

Sub investigator Any individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).

Subject/Trial Subject : 

Subject/Trial Subject An individual who participates in a clinical trial, either as a recipient of the investigational product or as a control. Subject Identification Code A unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial related data.

Trial site : 

Trial site The location(s) where trial-related activities are actually conducted. Well being(of the trial subject) The physical and mental integrity of the subjects participating in a clinical trial.

Vulnerable Subjects : 

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.