Glossary N through R
NDA – New Drug Application.
Needleless Systems – Devices that do not use needles for administration of medication or fluids or collection of blood or body fluids after initial access is established.
New Drug Application (NDA) – Application requesting FDA approval to market a new drug for human use.
Notification – Notification is the act of giving notice or information to the regulatory authority, but where review of documents or issue of an opinion/approval by the authority is not required for trial commencement (an acknowledgment of receipt may be provided).
Obligations – Responsibilities for aspects of the control, management, and conduct of a clinical trial.
Occupational Exposure – Reasonably anticipated skin, eye, mucous membrane, or parenteral contact with blood or other potentially infectious materials that may result from the performance of an employee’s duties.
Omitted Data – Data that has an impact on the study outcome and is not reported to the CRF. An example of omitted data includes the failure to correctly report exclusion criteria.
Pain Relief Scale – A categorical scale (none, a little, some, a lot, complete) for indicating the level of pain relief being experienced by a patient.
Pain Scale – A categorical scale (none, mild, moderate, severe) for indicating the level of pain being experienced by a patient.
Perceptible Pain Relief – The time point at which the patient feels that they first perceive pain relief post dose.
Potential Investigator – Individual who is being considered to conduct a clinical trial.
Potentially Infectious Material – Blood or body fluid that may potentially contain a bloodborne pathogen, such as blood or semen, vaginal secretions, cerebrospinal fluid, synovial fluid, pleural fluid, peritoneal fluid, amniotic fluid, or pericardial fluid. Saliva or any body fluid or tissue where it is difficult or impossible to determine contamination must also be considered infectious.
Procedural Documents – Standard Operating Procedures.
Program – Any activity associated with a Protocol, consisting of advertising media and/or support materials directed to potential research subjects, CCS sites, or consumers.
Program Files – Consist of documents pertaining to the conduct of a CCS program, including, but not limited to final IRB/IEC approved Protocol/advertisements, final approved screening questionnaires, internal/ external communication and CCS training/QA documentation, and are stored in the CCS file room and serve as an archive for all program-specific information.
Program Manager – Individual who directs a drug development program that may includemany separate projects.
Project – The evaluation of a company or other entity for potential merger, acquisition, strategic joint venture, or other similar form of collaboration.
Project Manager – Individual functionally responsible for the coordination and management of activities associated with all or part of a project.
Project-Specific Documents – Extensive working instructions or comprehensive procedures applicable to certain projects, tasks, or locations
Project Team – Assigned representatives from each functional group involved in performing the project workscope (e.g., Biostatistics, Data Management, Clinical, PVG, Regulatory, and Medical Writing).
Proprietary – Information or product that is owned by an individual or company that may be protected under a copyright or patent. Such information is considered to be a trade secret and is not to be disseminated without the written consent of the individual or company.
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 guidelines, the term Protocol refers to Protocol and Protocol amendments.
Protocol Amendment – Change to a clinical Protocol that affects the safety of subjects, the scope of the investigation, or the scientific quality of the study. Requires IRB/IEC approval, and notification and/or approval of regulatory agencies prior to implementation.
Protocol Author – Individual responsible for coordinating development of a clinical Protocol.
Protocol Number – Unique identifying code for a clinical Protocol.
Protocol Violation – Failure to comply with the Protocol that results in a significant added risk to the subject; failure by the subject or investigator to adhere to significant (inclusion/exclusion/primary endpoint criteria defined by the clinical team) Protocol requirements yet the subject is enrolled and/or continuing in the study without prior client company approval; and noncompliance to GCP (FDA regulations and/or ICH GCP guidelines).
Quality Assurance – 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 applicable regulatory requirements.
Quality Control – The operational techniques and activities undertaken to verify that the requirements for quality of the trial-related activities have been fulfilled.
Query- Request for the clarification of an item contained in a CRF (e.g., clarification of inaccuracy, discrepancy, or item requiring resolution).
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. (ICH)
Randomization Code – A schedule identifying the treatment each subject will receive during each study period while participating in a clinical trial.
Randomization Team – Individuals involved in the generation, receipt, storage, or distribution of randomization information. It must include at least one degreed statistician and at least one quality reviewer. Each team member must have a designated and comparably qualified backup. Randomization team members must not serve as project team members on any project where they also function as randomization team members.
Regulatory Agency Report – Notification of facts to a regulatory agency, which may be made periodically (e.g., annual updates) or as required (e.g., serious adverse event reporting).
Regulatory Authority – National body (e.g., Food and Drug Administration [FDA]; Medicines Control Agency [MCA]; Bundesinstitut für Arzneimittel und Medizinprodukte [BfArM]; Health Protection Branch [HPB], etc.) controlling the use and approval of medicinal products and devices.
Rescue Medication – The pain relief medication provided to the patient at their request if the patient does not achieve adequate pain relief from the study medication.
Research Agreement – Shall mean any agreement entered into between CRO/SMO or the client company and the investigator regarding a particular study. The Research Agreement shall set forth all obligations and services to be performed by the investigator in compensation therefore.
RPA – Radiation Protection Advisor.
RPS – Radiation Protection Supervisor.