The Research Glossary

Statement of the Investigator form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial. The investigator verifies that he or she has the experience and background needed to conduct the trial and that it will be done in a way that is ethical and scientifically sound.

The portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA).

Electronic Records and Electronic Signatures-Provides guidance for companies using paperless record-keeping systems and ensures the use of electronic record-keeping systems are documented securely, authenticity, and are adequately maintained.

regulations pertaining to INDs

Protection of Human Subjects. Compliance with these parts is intended to protect the rights and safety of subjects involved in investigations filed with the Food and Drug Administration.

Financial Disclosure by Clinical Investigators.This section and conforming regulations require an applicant whose submission relies in part on clinical data to disclose certain financial arrangements between sponsor(s) of the covered studies and the clinical investigators and certain interests of the clinical investigators in the product under study or in the sponsor of the covered studies.

Institutional Review Boards. Ensures initial and continuing review of research. Regulates reportings, changes, approvals, and eliminates apparent immediate hazards to the human subjects. .

regulations pertaining to devices.

A value that is outside of the normal range value, both low or high.

Error free data, any changes or amendments should be accompanied by documentation to support the changes.

A list or disclosure of any known/potential costs that could accrue beyond the trial procedures

An unintended reaction to a drug taken at a normal dose.

any untoward medical occurrence in a study subject administered a pharmaceutical product; it does not necessarily have a causal relationship with the treatment.

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a notice or announcement in a public medium promoting clinical trial.

Principles by which Good Documentation of data: Attributable, Legible, Contemporaneous, Original, Accurate, and Complete

Other available treatments or no treatment at all.

A professional group that publishes research to advance public health and advocates for the interests of registered physician-members

Used to express willingness to participate in research by persons who are by definition too young to give informed consent but are old enough to understand the proposed research in general, its expected risks and possible benefits, and the activities expected of them as subjects.

credentialing organization recognizing professionals involved in all aspects of clinical studies/trials who have demonstrated the knowledge, skills, and abilities to perform ethical and responsible clinical research by passing proctored exams.

This means that the evidence or data collected is attributable to the person collecting it. This ensures accountability. This contains a record of who performed an action and when.

The initial time point in a clinical trial that provides a basis for assessing changes in subsequent assessments or observations. At this reference point, measurable values such as physical exam, laboratory tests, and outcome assessments are recorded.

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The potential positive outcomes that should be disclosed to the participants.

A point of view or preference which prevents impartial judgment in the way in which a measurement, assessment, procedure, or analysis is carried out or reported.

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A sample of material, such as urine, blood, tissue, that may be used for a laboratory test or stored in a biorepository to be used for research.

The financial plan for clinical trials, including cost and expenses.

a record of the information collected from a subject during a trial. The information that is collected is based on what the protocol specifies.

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is a division of the U.S. Food and Drug Administration (FDA) that monitors drugs.

A credential award for those who has met eligibility requirements, demonstrated proficiency of specific knowledge and job‐related skills, and passed the standardized certification exam.

An abnormal value with a result where a course of treatment has had genuine and quantifiable effects

Clinical trials are a kind of clinical research designed to evaluate and test new interventions such as a device or medications. Clinical trials are often conducted in four phases. The trials at each phase have a different purpose and help scientists answer different questions.

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typically work for CROs. They are responsible for monitoring the study at study sites. They visit sites and look at the data collected and make sure the site is following the protocol. They work closely with the clinical research coordinators at the study sites.

An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.

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NIH defines a clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Clinical trials are used to determine whether new biomedical or behavioral interventions are safe, efficacious, and effective. Behavioral clinical trials involving an intervention to modify behavior (diet, physical activity, cognitive therapy, etc.) fit this definition of a clinical trial.

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CTA serve as a legally binding contract between a sponsor and site. It outlines each party's responsibilities and obligations for the clinical trial.

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A software system used to manage clinical trials in clinical research. This CTMS will serve as a single, centralized, web-based enterprise resource to support clinical research studies conducted

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This is a visit in which the sponsor of the research study ensure that all of the necessary aspects of the study closure have been completed

The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.

an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance or consent

Any form of reimbursement or monies for time/ or travel. This can be in many forms, checks, on a loaded payment card, gift card, or transportation card. Other compensations may include hotel, travel, and food.

Are there blank spaces in the data collection points? Even if there is an N/A you must write “N/A” in order to satisfy this element of ALCOA-C!

Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study_assignment. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study_assignment.

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Ensurance of the participants' private information being in compliance with HIPAA and all privacy laws.

A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research.

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Potential issues that could result from a subject withdrawing prior to completion date.

Site information, including address, email address and phone numbers for study staff. Contacts may also include IRB and Sponsor information.

Is the documentation happening in real time vs. retroactively documenting an occurrence.

this is when the IRB re-reviews the study to determine if it is appropriate for the study to continue, as is or with modifications.

This is the Clinical Trial Agreement (CTA) of Clinical Research Agreement (CRA). This is an agreement with a for-profit company providing funding or a drug/device for a Clinical Trial. This can be a Sponsor-initiated or Investigator-Initial-Clinical Trial

The group of individuals in a clinical trial assigned to a comparison intervention.

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The regimen is being compared to a control; the control being a placebo (medically ineffectual treatment) or a standard treatment.

A clinical trial in which at least one group of participants is given a test intervention, while at least one other group concurrently receives a control intervention.

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A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).

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A CAPA Plan is a series of actions taken to resolve a compliance issue, and most importantly, to prevent further recurrence. A CAPA plan will focus on the immediate noncompliance and the broader scope of the problem.

The communication between site and sponsor, CRO, or any other important person(s).

a company that provides clinical trial management services for the pharmaceutical, biotech, and medical device industries.

A curriculum vitae is a document that showcases a persons’ academic and professional accomplishments. It is used to apply for positions within areas where a person's specific knowledge or expertise is required.

A software system to manage relationships with customers

a committe of experts reviewing clinical trial data on an ongoing basis to ensure the safety of study subjects and validity and integrity of the data.

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Plan included with the grant application for clinical trials which establishes the overall framework for data and safety monitoring, how adverse events will be reported to the IRB and the NIH and, when appropriate, how the NIH Guidelines and FDA regulations for INDs and IDEs will be satisfied.

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This is the process of locking a clinical trial database. This action is taken to prevent any further changes to the database. The database is locked after review, query resolution and determination that it is ready for analysis.

The processes of handling the data collected during a clinical trial from development of the study forms/CRFs through the database locking process and transmission to statistician for final analysis.

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A plan that documents the processes for handling the flow of data from collection through analysis. Software and hardware systems along with quality control and validation of these systems, as relevant are described.

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Trials executed through telemedicine and mobile/local healthcare providers, using processes and technologies that differ from the traditional clinical trial model

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studies executed virtually through telemedicine with our without a “site”, using processes and technologies differing from the traditional clinical trial model.

is a set of ethical principles regarding human experimentation developed originally in 1964 for the medical community by the World Medical Association (WMA). It is widely regarded as the cornerstone document on human research ethics

a list of who is authorized to do certain tasks on a trial.

refers to the practice of looking for better ways to identify a particular disorder or condition.

A trial design in which neither the investigator or the subject knows which treatment the subject is receiving.

Indication that the clinical trial intervention produces a desired therapeutic effect on the disease or condition under investigation.

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A test used to check a heart’s rhythm and electrical activity

an electronic record of the information collected from a subject during a trial. The information that is collected is based on what the protocol specifies.

A digital version of a COA (Clinical Outcome Assessment), which measures and records how a patient is feeling or functioning

is a web-based software application used to collect, clean, transfer, and process data in clinical trials.

is an electronic version of a patients medical history, that is maintained by the provider over time, including demographics, progress notes, problems, medications, ect.

an alternative to the conventional paper consent form, this must be desinged compliant with 21 CFR Part 11.

An electronic investigator site file (eISF) is a technology solution designed to organize, collect, store, track, and archive required and essential study documents for an individual site involved in a particular research study

Electronic patient-reported outcomes (ePRO) are patient-provided information about symptoms, side effects, drug timing and other questions recorded on an electronic device during a clinical trial

An electronic version of regulatory at the CRO and Sponsor level. Tells the story of how the trial ran across all sites told by the official documents maintained.

List of criteria guiding enrollment of participants into a study_assignment. The criteria describe both inclusionary and exclusionary factors, (e.g. inclusion criterion - participants must be between 55 and 85 years old; exclusion criterion

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The process of registering or entering a patient into a clinical trial. Once a patient has been enrolled, the participant would then follow the clinical trial protocol

an electronic version of the story of how a trial ran, told by the official documents maintained. Referred to as a “reg binder” or “ISF” at the site level.

When correcting data, it should meet the ALCOAC GDP with one line crossing out the error, then initial, date, and short explanation of the correction.

A type of eligibility criteria. These are reasons that a person is not allowed to participate in a clinical study

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This is also known as the “Inspectional Observations”. This is a list of conditions or practices that indicate the potential violation of the FDA’s requirements. The observations on the FDA Form 483 are listed in descending order of importance. This is not an all inclusive list but more of a snapshot of possible issues noted at the site. This form is a public document that is available only by request.

Is the process of evaluating the particular site for the possibility of conducting the clinical trial or study. This process is to ensure that the site is able to to conduct the trial, within the budget and the timeline as well as maintain the integrity of the data and participant safety

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When a clinical investigator or staff member has disclosable financial interests and arrangements, the disclosure statement submitted to FDA is required to include a description of any steps taken to minimize the potential for bias resulting from any of the disclosed financial interests and arrangements.

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

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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 participants are protected.

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The guideline that outlines requirements for designing, conducting, recording and reporting trials that involve the participation of human subjects

The term that describes the standard by which documents are created and maintained.

is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

A government agency that provide health services to Americans.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that required the creation of national standards to protect sensitive patient health information from being disclosed without the patient's consent or knowledge.

The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as protected health information (PHI).

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A patient or healthy individual who is or becomes a participant in research, either as a recipient of the intervention or as a control.

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Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) Identifiable private information

A type of eligibility criteria. These are the reasons that a person is allowed to participate in a clinical study

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The protocol will specify the inclusion/exclusion criteria for enrollment into a clinical trial. This is colloquially referred to as I/E ("I" "E") in the field. The inclusion criteria must be present and the exclusion criteria absent for a subject to be eligible for the trial.

An informed consent document is typically used to provide subjects with the information they need to make a decision to volunteer for a research study. Federal regulations (45 CFR 46.116 ) provide the framework for the type of information that must be included as part of the consent process.

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An informed consent form is a document used in clinical research that outlines important information about the study to potential participants. It is a legal document that provides prospective participants with an explanation of the purpose, procedures, and risks associated with the research study, as well as the potential benefits and alternatives. The informed consent form also explains the participant's rights and obligations during the study, including their ability to withdraw at any time without penalty. The form is usually written in lay language and must be signed by the participant or their legally authorized representative before they can participate in the study. The informed consent process is an essential part of ethical research, ensuring that participants fully understand the risks and benefits of the study before they decide to participate. It is also a legal requirement in most countries and is necessary to protect both the participants and the researchers.

A document that describes the rights of a study participant and provides details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document.

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In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects. Sometimes called an Independent Ethics Committee(IEC)

An independent body constituted of medical, scientific, and nonscientific members whose responsibility it 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 trials, protocols and amendments, and of the methods and material to be used to obtaining and documenting informed consent of the trial participant.

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Helps clinical trial sponsors and sites manage the patient and drug supply logistics throughout a clinical trial.

are the technologies that research sites use to enroll patients into clinical trials, randomize patients, and manage study drug supplies. Othernames: Interactive Web Response System (IWRS)/Interactive Voice Response System (IVRS)

This visit is conducted by the CRA to review source documents and study related materials to ensure protocol and regulatory compliance. This visit is completed during the conduct of the study

supports aviation with global standards for airline safety, security, efficiency and sustainability.

an organization that brings together the regulatory authorities and pharmaceutical industry to discuss scientific and technical aspects of drug registration.

A procedure or treatment such as a drug, nutritional supplement, gene transfer, vaccine, behavior or device modification that is performed for clinical research purposes.

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a request from a study sponsor to obtain FDA approval to administer investigational drug to humans.

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The IP may be a drug, biologic, medical device, or combination product that has not received a marketing approval.

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(sometimes called Clinical Investigator or more often Principal Investigator (PI)) is an individual responsible for the preparation, conduct, and administration of a clinical trial.

This is a meeting where everyone involved with the new clinical trial to meet and become familiar with the study, including learning about the roles of the study

The Investigator’s Brochure is a comprehensive compilation of clinical and nonclinical data on the investigational product (drug, supplement, device or other product) maintained by a drug developer or investigator that contains the body of information about the investigational product obtained before and during a drug trial.

This is the process in accordance with FDA regulations, to which the IRB must review and approve all research involving humans prior to any research activities may begin. The IRB has the authority to approve, require modification in or disapprove the research.

Documentation after it has happened and notating it as “late entry”.

Is the documentation able to be read easily and clearly.

The long form embodies all the elements of informed consent as required under 21 CFR 50.25. When the long form is used, a copy must be provided to the person signing the form, that is, the subject or the subject's legally authorized representative.

A set of procedures describing study conduct. A MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites.

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A procedure in which the investigator administering the assessments and intervention as well as the participants in a clinical trial are kept unaware of the treatment assignment(s). Single blinding usually refers to the study participant(s) being unaware, and double blinding usually refers to the study participant(s) and any of the following being unaware of the treatment assignment(s): investigator(s), monitor, and data analyst(s).

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The primary Federal agency for conducting and supporting medical research.

A unique identification code given to each clinical study record registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier

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An application submitted by the manufacturer of a drug to the FDA, after the clinical trial has been completed, for a license to market the drug for a specified indication.

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Also know as a confidently agreement. This is a contract that establishes a confidential relationship. The party or parties signing the agreement agree that sensitive information they may obtain will not be made available to any others.

A abnormal value that does not have a genuine effect.

The total amount of subjects the sponsor wants to enroll into participation in the study.

A ten point code that describes the basic principles of ethical behavior in the conduct of human experimentation.

The safety and data monitoring body for observational studies with large or vulnerable populations or risks associated with tests or standard of care.

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A federal government agency within the Department of Health and Human Services (DHHS) charged with the protection of human subjects participating in government funded research. It issues assurances and oversees compliance of regulatory guidelines by research institutions.

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Provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services.

A study in which the subjects and the investigator are aware of the drug and/or dose that is being administered.

A clinical trial in which investigators and participants know which intervention is being administered.

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Is the documentation the first pen to paper? Fun fact- if you take your measurements down on a napkin- that napkin is now SOURCE! Original records should be preserved, meaning the material used should be durable, in the case of duplicates, the creator of the original records should confirm the authenticity of the copies.

Refers to a medicine that can be bought without a prescription.

Subject, Sponsor, and/or Site has the right to terminate their participation at any point during the trial.

not inclusive ● Study Title- This is meant to explain the key features of the study purpose, design, population , procedures, timeline, and participant safety. ● Study Name ● Title Page ● Summary ● Flow Chart/Study Schema/Schedule of Events ● Baseline -An initial measurement that is taken at an early time point and used for comparison over time to look for changes. ● Introduction ● Study Objectives ● Study Design ○ Is it controlled? If so, what is the control? ○ Is it randomized? ○ Is it blinded? ● Randomization procedures ● Blinding ● Unblinding (breaking the blind) procedures ● IP ○ Name ○ Storage ○ Dosage ○ Formulation ○ Route of administration ○ Regimen ● Subject Selection ● I/E ● Enrollment Procedures ● Pre-Screening ● Screening ● Concomitant Medications (“Conmeds”) ○ Prescription ○ OTC ○ Herbal Supplements ○ Vitamins ● Exclusionary Medications ● AEs ● SAEs ● Data Recording ● Data Quality Assurance ● Data Analysis/Statistics

A type of observational study that collects information about patients' medical conditions and/or treatments to better understand how a condition or treatment affects patients in the real world

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The process (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.

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Researchers test an experimental drug or treatment in a small group of people for the first time. The researchers evaluate the treatment’s safety, determine a safe dosage range, and identify side effects.

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The experimental drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

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The experimental study drug or treatment is given to large groups of people. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

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Post-marketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use.

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A placebo is an inactive treatment. In fact, a placebo may be in a pill or tablet form, or it may be an injection or a medical device. Whatever the form, placebos often look like the real medical treatment that is being studied except they do not contain the active medication.

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A method of investigation in which an inactive substance/treatment (the placebo) is given to one group of participants, while the test article is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.

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The aim of a preclinical study is to collect data in support of the safety of the new treatment. Preclinical studies are required before clinical trials in humans can be started.

Activities before obtaining informed consent to determine initial eligibility for and interest in a study. Pre-screening may be performed over the telephone, in-person or on-line and may not include any research procedures

A visit to ensure pre-qualification of a site and eliminate sites that do not possess adequate qualities to conduct the trial.

This is to ensure pre qualification of the site and eliminates sites that do not meet the qualifications to conduct the clinical trial or study. This visit must take place to determine if additional resources should be used in order to perform a Site initiation Visit

Looks for better ways to prevent disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

The person in charge and responsible for a clinical trial.

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A pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.

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A person's health information including but not limited to demographics, medical history, test/lab results, insurance information, ect.

Directions for how to run a particular trial.

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A written description of a change(s) to or formal clarification of a protocol.

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Failure to conduct a study as described in the protocol. The failure may be accidental or due to negligence and in either case, the protocol deviation should be documented. This also includes failure to comply with federal laws and regulations, the institution's commitments and policies, and standards of professional conduct and practice. Examples of noncompliance include:

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Internal document created as part of the ongoing quality control process summarizing compliance with the protocol and listing protocol deviations and/or violations.

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The reasoning behind a trial being conducted- what is the end goal? What is the desired outcome?

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 GCP and the applicable regulatory requirements.

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The internal operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of trial related activities have been fulfilled (e.g., data and form checks, monitoring by study staff, routine reports, correction actions, etc.).

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explores ways to improve comfort and the quality of life for individuals with a chronic illness.

The process of assigning clinical trial participants to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.

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The patient population is randomly allocated to treatment groups. This helps reduce bias by ensuring there isn’t a pattern in assigning treatment to the subjects.

The act of trying to find the right patients for a clinical trial.

The targeted number of patients to screen or enroll in a clinical trial.

Advertisements and other items used to help find participants in the study.

The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal.

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The story of how a trial ran is told by the essential documents maintained. Referred to as “reg binder” or “ISF” at the site level.

A systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

the process of keeping patients/subjects in the study or engaged to participate in the study.

The strategy and tactics designed to keep patients enrolled in clinical trials, and from discontinuing participation and “dropping out.”

the targeted number of patients to keep in the tria after enrollment. Should be as close to 100% as possible.

The site’s plan to keep patients in the study long-term.

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The potential negative outcomes that need to be disclosed to the participants.

an adaptive approach that directs monitoring focus and activities to the evolving areas of greatest need which have the most potential to impact patient safety and data quality.

A plan that outlines the oversight of a clinical trial.

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An independent individual, often a clinician who is appointed by the NIA and performs data and safety monitoring activities in low-risk, single site clinical studies. The SO advises the NIA regarding participant safety, scientific integrity, and ethical conduct of a study_assignment. The SO is advisory to the Institute Director.

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the process by which activities are evaluated to determine whether they are eligible for enrollment in a clinical trial.

An essential document that records all individuals who entered the screening process. The screening log demonstrates the investigator’s attempt to enroll a representative sample of participants.

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A process designed to determine individual’s eligibility for participation in a clinical research study_assignment.

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aims to find the best ways to detect certain disorders or health conditions

This is any untoward medical occurrence at any dose that results in death, is life-threatening, requires hospitalization (or prolongation of hospitalization), results in persistent or significant disability, or is a birth defect.

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An IRB approved short form may be used in appropriate situations where the elements of the consent form are presented to the subject or subject’s legal authorized representative. It is a written summary of the information to be presented orally which is signed by the subject or subject’s LAR.

A study that is set up so that participants do not know which study treatment they are getting.

This is a visit conducted to evaluate the sites and it’s investigators, resources and the sites capabilities to conduct study terms. Infrastructure, adequacy and availability of the site facilities

The site initiation visit is a required visit to prepare and set up a research site to conduct a study and must occur prior to patient recruitment.

This is a critical visit that’s completed by the Sponsor prior to the start of the study. During this visit the Sponsor ensures that the investigators team has all of the necessary resources and is ready to conduct the human subjects research conducted under the Investigational New Drug (IND) or Investigational Device Exemption Application (IDE). The SIV ensures that the Investigator and team is aware of the responsibilities with the Study Protocol and are familiar with the study documentation, investigational product management and administrative procedures.

This is a meeting with a sponsor representative in order to ensure that the institution is fully capable and equipped to run the clinical study or trial. This visit may also be referred to as the Site Selection Visit (SSV) or Pre Study Qualification Visit (PSQV)

Record of the monitor (CRA) visiting the site. They are required to sign in and sign out.

an organization established to support global clinical research communities

credentialing organization recognizing professionals involved in all aspects of clinical studies/trials who have demonstrated the knowledge, skills, and abilities to perform ethical and responsible clinical research by passing proctored exams.

Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, participant diaries, recorded data from automated instruments, x-rays, etc.) that are used in a clinical trial.

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documents in which data collected for a clinical trial is first recorded. The data is usually later entered in an electronic data capturing system (EDC).

This is the process by which the data within the CRF or other data that has been collected is compared against the original source of information

The company, institution or organization that takes on legal responsibility for the initiation, management and/or financing of the research.

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Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals.

Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

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Established safety criteria that would either pause or halt a study due to reasons including but not limited to futility or risk(s) to the participants.

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Separation of a study cohort into subgroups or strata according to specific characteristics such as age, gender, etc., so that factors which might affect the outcome of the study, can be taken into account.

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This is also known as the Feasibility Award, when a site is chosen by the sponsor to conduct a trial based on their feasibility.

in a clinical trial, the participants make up the study population.

A delegated member of the research tream that helps back up the PI and preform study related procedures.

Any unfavourable occurrence in a trial participant that is judged to have a major impact on their health and was not anticipated and could potentially be due to the intervention under investigation.

The Belmont Report summarizes ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice.

Regulatory at the CRO and Sponsor level. Tells the story of how the trial ran across all sites told by the official documents maintained.

a list of who is trained to do what on a trial.

looks for better ways to treat disorders from developing or returning. Different kinds of prevention research may study medicines, vitamins, vaccines, minerals, or lifestyle changes.

The trial master file (TMF) is the collection of essential documents which allows the conduct of a clinical trial to be reconstructed and evaluated

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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 a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application) or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

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Unanticipated problems involving risks to subjects or others, which meet all of the following criteria:

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Any problem or event that in the opinion of the local investigator meets all three of these criteria: Serious, Unanticipated (Not already described as a potential risk in the approved materials), and Related.

A procedure in which one or more parties to the trial are made aware of the treatment assignment(s).

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A response to the Tuskegee Syphilis Study. Signed into law in 1974 and created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Identifies the basic principles of research conduct and oversees human experimentation in medicine

Third party companies to help with services and ancillary procedures of the clinical trial. Some examples may be payment services, central readers for procedures or imaging, and/or recruitment companies.

Ensuring patients agree completely unforced or uncoerced to be a subject in the study trial. Giving the patient alternatives, risk/benefits, and ample time to consent.

Includes children, pregnant women, prisoners, handicapped persons, the mentally disabled, people with acute or chronic severe mental illness, economically disadvantaged, and educationally disadvantaged. When some or all of the subjects are likely to be vulnerable to coercion or undue influence additional safeguards should be included in the study to protect the rights and welfare of these subjects.