Clinical Trials Glossary

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Clinical Trials Glossary

Postby patoco » Fri Jun 22, 2007 2:45 am

Clinical Trials Glossary

Pat O'Connor

Lymphedema People

http://www.lymphedemapeople.com

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ADVERSE EVENT (AE): An AE is any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during the study, having been absent at baseline, or if present at baseline, appears to worsen.

ADVERSE REACTION: (Adverse Event.) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time (See Side Effects).

ADVOCACY AND SUPPORT GROUPS: Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.

ANNUAL REVIEWS: Continuing review of the clinical trial conducted annually by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial.

APPROVAL (in relation to IRB/IEC): The affirmative decision of the IRB that the clinical trial has been reviewed (i.e. protocol, informed consent(s), conflict of interests, etc.) 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.

APPROVED DRUGS: In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (See Food and Drug Administration).

ARM: Any of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more (See Randomized Trial).

BASELINE: 1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.

BIAS: When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization (See Blind and Randomization).

BLIND: A randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. (See Single Blind Study and Double Blind Study).

CASE REPORT FORM (CRF): A printed, optical, or electronic (known as an eCRF) document designed to record all of the protocol-required information to be captured as part of the study.

CLINICAL: Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.

CLINICAL ENDPOINT: See Endpoint.

CLINICAL INVESTIGATOR: A medical researcher in charge of carrying out a clinical trial's protocol.

CLINICAL COORDINATING CENTER (CCC): A group organized to coordinate the clinical aspects of a multi-center trial. Most often, the CCC is headed by the Clinical Principal Investigator and is responsible for protocol development, clinical sites, and oversight of clinical study operations and facilities.

CLINICAL RESEARCH COORDINATOR (CRC): Person who handles the administrative and day-to-day responsibilities of a clinical trial, acts as liaison for the clinical site, and reviews all data and records before a monitor's visit. On small studies, this may be the study investigator. In a multi-site study, the coordinator at the CCC oversees the clinical research coordinators at the clinical sites and is called the Project Coordinator.

CLINICAL TRIAL: A clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (See Phase I, II, III, and IV Trials). The NIH defines a clinical trial/study as a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). 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. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered to be a clinical trial if the test will be used for medical decision making for the subject or the test itself imposes more than minimal risk for subjects.

COHORT: In epidemiology, a group of individuals with some characteristics in common.

COMMUNITY-BASED CLINICAL TRIAL (CBCT): A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.

COMPASSIONATE USE: A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.

COMPLEMENTARY AND ALTERNATIVE THERAPY: Broad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc. Internet Address: http://www.nccam.nih.gov.

CONFIDENTIALITY REGARDING TRIAL PARTICIPANTS: Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.

CONTRAINDICATION: A specific circumstance when the use of certain treatments could be harmful.

CONTROL: A control is the nature of the intervention control.

CONTROL GROUP: The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo (See Placebo and Standard Treatment).

CONTROLLED TRIALS: Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo.

DATA COORDINATING CENTER (DCC)/ Data Management Center (DMC): A group that is organized to handle data management in a multi-center trial. Activities of a DMC generally include creating a Data Management Plan (DMP), case report forms (CRF), data quality control, data collection data from clinical sites, editing data, preparing administrative and management reports and either performing data analysis of sending the study data to the Statistical Analysis Center (SAC).

DATA MANAGEMENT PLAN (DMP): A plan that documents the flow of participants and study forms through the study and the flow of data from the clinical sites to the DMC; defines the data handling and quality control procedures including error identification and resolution; identifies reports that describe study progress and status; and describes steps to derive an analytic data set from edited or "clean" records. Software and hardware systems along with quality control and validation of these systems are included along with documentation and quality control of analytic programs and tables.

DATA SAFETY AND MONITORING BOARD (DSMB): An independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.

DIAGNOSTIC TRIALS: Refers to trials that are are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied.

DOSE-RANGING STUDY: A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.

DOUBLE-BLIND STUDY: A clinical trial design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo (or another therapy). Double-blind trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study. See Blinded Study, Single-Blind Study, and Placebo.

DOUBLE-MASKED STUDY: See Double-Blind Study.

DRUG DEVICE PLAN: A plan that documents every aspect of study treatment involvement including procedures for verification that shipments are received, proper storage at site, dispensing instructions, return or destruction of intervention, and all necessary documentation. This also applies to any investigational device used in the study and would be referred to as the Device Plan.

DRUG-DRUG INTERACTION: A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

DSMB: See Data Safety and Monitoring Board.

EFFICACY: (Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it (See Food and Drug Administration (FDA), Phase II and III Trials).

ELIGIBILITY CRITERIA: Summary criteria for participant selection; includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria)

EMPIRICAL: Based on experimental data, not on a theory.

ENDPOINT: Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.

ENROLLMENT LOG MASTER PARTICIPANT LOG: an essential document that records the chronological enrollment of participants by personal identification number (PIN) as they are enrolled into a clinical study. The Enrollment Log contains the study participant name or initials, study PIN #, informed consent date, and number and dates of visits participated in by the study participant. This should be kept in a secured location with procedures in place regarding who has access to remove and under what conditions. With today's computer systems, this log may be an extension of an automated screening log or may be generated by the computer.

EPIDEMIOLOGY: The branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.

ESSENTIAL STUDY DOCUMENTS: Documents that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. These documents include those referred in ICH GCP 8.0 Essential Documents for the Conduct of a Clinical Trial. See also Study Files/Master Binder. Exclusion Criteria - A list of criteria, any one of which excludes a potential participant from enrolling in a study.

ETHICS COMMITTEE: The job of an ethics committee is to make sure that research carried out in the NHS respects the dignity, rights, safety and well-being of the people who take part in medical research. A trial that takes place within the NHS cannot go ahead if an ethics committee has not approved it, and the protocol for a trial cannot be changed without the approval of the ethics committee. Ethics committee members include researchers and health care professionals as well as members of the public.

EXCLUSION/INCLUSION CRITERIA: Exclusion criteria determine who won’t be able to join a trial – for example, many trials exclude women who are pregnant, or who may become pregnant. This avoids any possible danger to a baby. Trials will also exclude people who are already taking a drug that may interact with the treatment being studied.

EXPANDED ACCESS: Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.

EXPERIMENTAL DRUG: A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (See Off-Label Use).

FEDERAL WIDE ASSURANCE: Institutions conducting clinical studies research (not otherwise exempt) supported by any agency of the U.S. Department of Health and Human Services (HHS), then the institution must have an OHRP-approved assurance of compliance with the HHS regulations (45 CFR 46.103) for the protection of human subjects.

FDA: See Food and Drug Administration.

FINANCIAL DISCLOSURE/CONFLICT OF INTEREST DOCUMENTATION: Certification that no financial arrangements with an investigator have been made where study outcome could affect compensation; that the investigator has no proprietary interest in the intervention; that the investigator does not have a significant equity interest in the sponsor of the covered study; and that the investigator has not received significant payments of other sorts; and/or disclosure of specified financial arrangements and any steps taken to minimize the potential for bias.

FOOD AND DRUG ADMINISTRATION (FDA): The U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. Internet address: http://www.fda.gov/.

GOOD CLINICAL PRACTICES: 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.
(http://www.fda.gov/oc/gcp/regulations.html)

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY (HIPPA): Legislation adopted by Congress which took effect in 2003 that strictly dictates the parameters that identifiable private health information (PHI) can be shared outside of the research environment. (http://www.hhs.gov/ocr/hipaa/)

HYPOTHESIS: A supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.

INCLUSION/EXCLUSION CRITERIA: The medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.

IND: See Investigational New Drug.

INFORMED CONSENT: The process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.

INFORMED CONSENT DOCUMENT: A document that describes the rights of the study participants, and includes 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. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

INSTITUTIONAL REVIEW BOARD (IRB): 1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants. 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, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial participant. Investigational Device Exemption (IDE) - An IDE is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational device to humans. Such authorization must be secured prior to interstate shipment and administration of any new device that is not the subject of an approved Pre-Market Approval Application (PMA) (21 CFR 812).

INTENT TO TREAT: Analysis of clinical trial results that includes all data from participants in the groups to which they were randomized ( See Randomization) even if they never received the treatment.

INTERVENTION NAME: The generic name of the precise intervention being studied.

INTERVENTIONS: Primary interventions being studied: types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.

INVESTIGATIONAL NEW DRUG: A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
IRB: See Institutional Review Board.

INVESTIGATIONAL NEW DRUG APPLICATION (IND): An IND is a request for authorization from the Food and Drug Administration (FDA) to administer an investigational drug or biological product to humans. Such authorization must be secured prior to interstate shipment and administration of any new drug or biological product that is not the subject of an approved New Drug Application or Biologics/Product License Application (21 CFR 312).

INVESTIGATOR MEETING/SITE INITIATION VISIT: A meeting or visit held prior to participant enrollment at a site(s). The purpose is to acquaint all site personnel with the relevant aspects of the study prior to any participant enrollment and involves the review/discussion of the following: protocol, case report form completion, missed visits, IRB/IEC reporting requirements, adverse event reporting, etc.

MANUAL OF PROCEDURES (MOP): The MOP is developed to facilitate consistency in protocol implementation and data collection across study participants and clinical sites. Further, the MOP provides reassurance to all participants that scientific integrity and study participant safety are closely monitored and increases the likelihood that the results of the study will be scientifically credible. The MOP is analogous to a toolkit in that it contains information needed for the conduct and operations of a clinical trial and can be used as a training document.

MASKED: The knowledge of intervention assignment. See Blind

MASKING/BINDING: A procedure in which one or more parties in the 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).

MASTER STUDY FILES: File or binder that contains copies of the documents that are generally known as essential documents or regulatory documents. In a multi-site trial, the Master Study Files will include copies of essential documents from each of the study sites and is typically maintained by the CCC. Please see Study Files/Regulatory Binder.

MEDICAL SAFETY MONITOR (MSM): Appointed by the Principal Investigator (PI) to oversee a clinical research project if there is more than minimal risk to the study participants. The NINDS requires that each DSMB-monitored trial have an assigned MSM, independent of the study investigators with no apparent conflict of interest, who is responsible for review of individual serious adverse events (SAEs) as they occur, and regular reporting of SAEs to the DSMB and others, as appropriate. Some SMC's may also identify a MSM to review SAEs. The NINDS Program Director must approve of the MSM and specific monitoring procedures she/he will follow. The Medical Safety Monitor will prepare regular reports concerning SAEs (not segregated by treatment group) (not segregated by treatment group) for submission to the PI, the DSMB and, as appropriate, the FDA.

META-ANALYSIS: Small beneficial effects of treatments, rather than miracle cures, are often the best that can be hoped of new medical treatments. These small improvements can be very important. But many trials do not manage to recruit sufficient numbers of participants to detect these small improvements, so researchers cannot give an accurate answer about how safe or effective a new treatment is. In this case, researchers can bring together the results of a number of similar trials to give a more accurate answer about the value of a particular treatment. This method of combining results of more than one trial is called a meta-analysis.

MONITORING REPORTS: A document that records the monitoring site visits conducted during the study and includes the name and signature of the person conducting the site visit, date(s) and purpose of the visit.

MONITORING PLAN: A monitoring plan then describes the type of monitoring that will take place (e.g. sample or all participants within a site; key data or all data), the schedule of when these activities are to take place, how they are reported, and a timeframe to resolve any issues found.

NATURAL HISTORY STUDY: Study of the natural development of something (such as an organism or a disease) over a period of time.

NEW DRUG APPLICATION (NDA): An application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA (21 CFR 314). (http://www.fda.gov/cder/regulatory/appl ... troduction)

OFF-LABEL USE: A drug prescribed for conditions other than those approved by the FDA.

OPEN-LABEL TRIAL: A clinical trial in which doctors and participants know which drug or vaccine is being administered.

ORGANIZATIONAL PLAN: The plan that describes the purpose and roles of each study staff member in each of the participating study organizations.

ORPHAN DRUGS: An FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for these diseases or conditions. Orphan drug status, however, gives a manufacturer specific financial incentives to develop and provide such medications.

PEER REVIEW: Review of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.

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

PHASE I TRIALS: Initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.

PHASE II TRIALS: Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.

PHASE III TRIALS: Expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.

PHASE IV TRIALS: Post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.

PLACEBO: A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. (See Placebo Controlled Study).

PLACEBO CONTROLLED STUDY: A method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested 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.

PLACEBO EFFECT: A physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.

PRECLINICAL: Refers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out.

PRE-SCREENING AND SCREENING PROCESS: Potential study participants' medical history and background are reviewed to determine if eligible for study enrollment. Processes must be in place for that document how individuals are identified and contacted, questions to be asked at pre-screening and screening, how are responses recorded, and how are people tracked for further follow-up.

PREVENTION TRIALS: Refers to trials to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.

PROCESS SITE VISIT (PSV): The purpose of the visit is to review the general processes and operations of a clinical trial and obtain an overview of the study status.

PROGRESS ASSESSMENT VISIT (PAV): The purpose of the visit is to assure that the safety and rights of clinical participants are upheld. Activities may include reviewing essential documents, ensuring protocol compliance, verifying that the study is properly conducted, assuring that adverse events are identified, and verifying data quality.

PROTOCOL: A study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment (See Inclusion/Exclusion Criteria).

PROTOCOL ADMENDMENTS: A written description of a change(s) to or formal clarification of a protocol. These should be version controlled with dates and stored with the protocol.

PROTOCOLS DEVIATION REPORT: Internal documents created for the ongoing quality control with respect to protocol compliance and determination of protocol deviations and/or violations.

Protocol Deviations: Failure to conduct all aspects of the 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:
§ Failure to obtain/maintain approval for research,
§ failure to obtain informed consent when required,
§ failure to file adverse event reports,
§ performance of an unapproved study procedure,
§ performance of research at an unapproved site,
§ failure to file protocol modifications and failure to adhere to an approved protocol.

QUALITY ASSURANCE (QA): The externally 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 requirement(s), i.e. site or center audits, external monitoring, etc..

QUALITY CONTROL (QC): 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, i.e. data and form checks, monitoring by study staff, routine reports, and correction procedures.

QUALITY OF LIFE TRIALS (or Supportive Care trials): Refers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness.

RANDOMIZATION: A method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant (See Arm).

RANDOMNIZATION CODE: The codes that decipher the randomization assignment numbers. The randomization codes and corresponding randomization assignments are kept under "lock and key" by the study statistician or designated staff member to protect the study blind. It is a good idea to generate more randomization assignment numbers than will be needed. The format for assigning treatment groups through randomization should prevent the investigators from accurately guessing to which treatment group a patient will be assigned.

RANDOMIZATION PLAN: The statistician or data management group details the procedures that sites must follow to randomize a patient and ensures that randomization is applied consecutively. Randomization and blinding/unblinding procedures should be determined prior to the enrollment of the first subject.

RANDOMIZED TRIAL: A study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized. (See Arm and Placebo).

RECRUITMENT PLAN: The plan that outlines how individuals will be recruited for the study and how the study will reach the recruitment goal. Recruitment plans should ideally describe each site's catchment area, potent sources of participants, and methods to reach referring physicians and patients.

RETENTION PLAN: The plan that details the methods in which the study will use in order to maintain study participation in the clinical trial, i.e. follow-up phone calls, send reminder letters, etc.

RISK-BENEFIT RATIO: The risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated.

SAFETY MONITORING BODY (SMB): For trials that require independent oversight, a SMB can be appointed or recruited depending on study size and associated risk.

A study SMB is one of the following entities:

§ Data Safety Monitoring Board (DSMB) - An independent data monitoring committee that is established by the NINDS to assess, at regularly scheduled intervals, the progress of a clinical study including enrollment, safety data, data quality and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial.

§ Study Monitoring Committee (SMC) - appointed by the principal investigator in consultation with NINDS, the SMC may appropriately monitor single site studies or studies in which risk is minimal. Usually the SMC will be composed of one or more scientists (generally physicians and a statistician) who are not involved in the study. The NINDS may appoint its own representative. The NINDS Program Director must approve the SMC membership and the specific monitoring procedures. In general, an SMC will operate in a manner similar to a DSMB Safety Monitoring Plan - The NIH and NINDS require that grants and protocols include a section describing the proposed plan for ongoing safety monitoring. This section will detail who is to be responsible for study monitoring (i.e., a DSMB, a SMC, an MSM, or the study investigator), what data will be monitored (i.e., performance and safety data only vs. efficacy data as well), and the frequency. the Safety Monitoring Plan will also describe whether there will be an interim analysis and its timing (e.g., "the interim analysis will occur when half the participants have completed the 6 month follow-up visit"). The plan will specify "stopping guidelines", as relevant and other criteria for the SMB to follow in the review of the interim data. A preliminary monitoring plan must be submitted as part of the Research Plan portion of the grant application. The plan will be examined as part of the peer review process, and comments and concerns will be included in an administrative note in the Summary Statement. NINDS staff will ensure that all concerns are resolved before the grant award is made.

SAFETY MONITORING PLAN: A plan that outlines the independent oversight and communication structure of a Safety Monitoring Body (SMB) or Medical Safety Monitor (MSM), procedures for documenting and reporting of adverse events, serious adverse events and unexpected adverse events, procedures for ensuring human subject protection, and criterion for pausing or stopping the study due to safety concerns.

SCREENING LOG: An essential document that records all individuals who entered pre- screening or screening and details the reasons why an individual was not enrolled or the enrollment date. The screening log demonstrates the lack of bias in the selection of participants and the investigator's attempt to enroll a representative sample of participants.

SCREENING TRIALS: Refers to trials which test the best way to detect certain diseases or health conditions.

SERIOUS ADVERSE EVENT (SAE): Any untoward medical occurrence that:

§ 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.

SIDE EFFECTS: Any undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects (See Adverse Reaction).

SINGLE-BLIND STUDY: A study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study. (See Blind and Double-Blind Study).

SINGLE-MASKED STUDY: See Single-Blind Study.

SITE MONITORING REPORT: A written report from the monitor to the investigator after each site visit and/or other trial-related communication according to the study's SOPs. The report outlines the overall status of the clinical site, study-related issues and suggestions for resolutions of issues.

SITE SIGNATURE LOG/DELEGATION OF AUTHORITY: Documents the delegation of authority by the principal investigator through signatures and initials of persons authorized to execute specific study functions, i.e. informed consent process, physical exams, CRF completion, etc.

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

STANDARD OPERATING PROCEDURES (SOPS): Detailed written instructions to achieve uniformity of the performance of a specific function across studies and patients at an individual site.

STANDARD TREATMENT: A treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition.

STANDARDS OF CARE: Treatment regimen or medical management based on state of the art participant care.

STATISTICAL ANALYSIS CENTER (SAC): A group organized to handle the statistical reporting and analysis of a multi-center trial. Activities include development of the Statistical Analysis Plan, presentation of data in listings and tables for the SMB, and statistical analysis of the data.

STATISTICAL ANALYSIS PLAN: A plan developed by the study statistician that describes the study from an analytical standpoint, study endpoints, primary and secondary analysis including definitions of data to be used in these analyses, and proposed stopping rules.

STATISTICAL SIGNIFICANCE: The probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.

STOPPING RULES: Established safety criterion that would either pause or halt the study because of futility or risk(s) to the participants in or to be enrolled in the study.

STUDY COMMUNICATIONS PLAN: A plan that summarize and describes the communication flow between study centers, investigators, committees, etc. It also describes the handling of inquiries and emergency situations.

STUDY ENDPOINT: A primary or secondary outcome used to judge the effectiveness of a treatment.

STUDY FILES/STUDY BINDER: General study records commonly known as essential study documents. They are usually kept in a Master Study Binder (or Regulatory Binder). Also known as Master Study Files, Administrative Binder, Investigator Binder, and Investigator Study File.

STUDY TYPE: The primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing.

TOXICITY: An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.

TRAINING PLAN: A plan that details what training and certifications are required of study staff in order to participate in the clinical trial and plans for continuous training as necessary in the event of modifications to the study, i.e. good clinical practice, HIPAA, human subject protection, protocol specific training, data collection, etc.

TREATMENT ACCOUNTABILITY: A record that documents the study intervention (i.e. drug, device, etc.) receipt, dispensing, and returns. Accountability logs generally document the quantity and date intervention received from CCC or other source. Individual patient accountability logs document the participant identification number, quantity dispensed, lot or device number, amount of intervention remaining, quantity and date of intervention destruction/return, etc.

TREATMENT IND: IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the U.S. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trial.

TREATMENT TRIALS: Refers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

UNEXPECTED ADVERSE EVENT: Any adverse event that has not been previously observed or such experience that is not anticipated and not indicated in either the protocol or Investigator's Brochure.

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

Original Post October 23, 2006 - 369 views

Glossary Sources:

AIDSinfo.glossary of HIV/AIDS-related terms
CenterWatch, Inc. Patient Resources: Glossary.
ECRI (formerly the Emergency Care Research Institute).
Eli Lilly and Company. Lilly Clinical Trials Glossary.
MediStudy.com Inc. ClinicalTrials: A-Z Glossary.
National Cancer Institute. Cancer.gov Dictionary.
http://www.ninds.nih.gov/funding/resear ... ossary.htm
patoco
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Re: Clinical Trials Glossary

Postby patoco » Thu Oct 08, 2009 10:46 am

Reviewed October 8, 2009
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