S

In Pharmacovigilance, all the data on adverse events and other occurrences related or suspected to be related to investigational products. In eClinical, it is mostly data collected from subjects during clinical trials; this data helps to evaluate product safety and efficacy.

A software product that enables deploying a security gateway so that to enforce the security measures such as message authentication and integrity.

A review of data collected via CRFs, especially those related to adverse events and serious adverse events data records. The safety review is intended to identify any risks related to subject safety. This review can be done by physicians, pharmacovigilance teams, or other dedicated personnel as per study protocol.

A set of global randomization numbers within each period of the multiperiod study used to prevent unexpected unblinding.

In IWRS, the scrambled randomization feature is only available for multiperiod studies to mix up the subject randomization numbers in each cohort so that by viewing the randomization number itself user cannot tell to which arm the randomization number belongs.

A visit of a potential trial participant during which they meet the study team and discuss their options, questions, and concerns; as well as complete screening and baseline examinations or sign consent forms.

A unique identifier assigned to potential participants during the screening process, which occurs before they are enrolled in the clinical trial.

See also: subject ID.

In eTMF, a level of the file directory predefined by the Drug Information Association Reference Model (DIA RM). Sections are grouped within zones and help divide the documents of the zone into more specific categories. Each section defines a group of documents that share a similar purpose or function within the clinical trial.

A network protocol that provides file access, file transfer, and file management over any reliable data stream.

A laboratory test that provides approximate measurements of a substance, often yielding results in categories (for instance, normal and abnormal) or numerical ranges that are not highly precise. The example of semiquantitative tests can be urine protein tests, bilirubin levels, and so on.

An unanticipated event in a healthcare setting that results in death or serious physical or psychological injury to a patient, not related to the natural course of the patient's illness.

An adverse event that results in death, is life-threatening, requires subject hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.

In eClinical, an action of transporting items (drugs) between depots and sites. Also, an instance that represents a bundle of items being shipped together as one batch with the same shipment number (identifier) and status.

See also: return shipment and supply shipment.

An action or effect of a drug or treatment other than the intended effect. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems.

A case report form that is completed and submitted once. This can be a "Date of visit" form, that consists of simple questions for date, time, and other details of the subject's visit to the site.

See also: log form and grid form

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

A process of ensuring data accuracy and integrity within a clinical trial. SDR refers to a broad assessment and review of the source data beyond a simple verification process. It involves a comprehensive review of the collected subject data to evaluate its quality, consistency, and compliance with the study protocol, standard operating procedure, and regulatory requirements. During SDR, the clinical research associate (CRA) or data manager (DM) examines the data for completeness, accuracy, and compliance with the established criteria. They analyze trends, perform data reconciliations, and identify any potential anomalies or issues that may require further investigation or data clarification.

A process of ensuring data accuracy and integrity within a clinical trial. SDV involves the review and comparison of data recorded in the source documents against the data captured on the case report forms (CRFs). During SDV, a trained monitor or clinical research associate (CRA) compares the source data to the CRFs to identify any discrepancies or errors. They may review laboratory results, medical history, adverse event records, and other relevant information. Discrepancies found during SDV are usually documented and resolved through data clarification or query processes with the site personnel responsible for data collection.

An original record or certified copy of a record that provides evidence of the existence, activities, or results of a clinical trial or study.

Any person, company, institution, group, or organization that is a client of EDETEK and a user of the eClinical system.

In the eClinical system, the Sponsor role is assigned to the user who oversees or pays for a clinical trial and collects and analyzes the data. Before the study goes live, the Sponsor users work closely with the data managers, configuring CRFs and other aspects to make sure everything meets their requirements before giving the green light for the study to go live. In the course of a trial, the Sponsor users make requests for amendments in the system according to a new protocol version, changes in business requirements, or other needs.

Group of individuals involved in making the study conduct possible. This includes various roles such as principal investigators, study coordinators, data managers, clinical research associates, and others who contribute to the planning, execution, and management of the study.

A procedure specific to your operation that describes the activities necessary to complete tasks following industry regulations, provincial laws, or even individual standards for running the business.

A biostatistical tool used to manage and generate tables, listings, and graphs for clinical study reports and other purposes.

In IWRS, a variable that is used to divide a group of subjects into subgroups according to certain factors (demographic, clinical, and others).

In PV, an option to add a query question to ICSR and select a specific form, record, and data element that requires clarification. This way, when the EDC user addresses the query from PV and provides updated data, it can be populated directly to the ICSR.

See also: unstructured comment

A standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).

An eClinical application that provides functionality to design and configure a study (clinical trial), namely to configure CRFs, set subject phases, visits, and others.

The application supports the design of the CDSIC ODM-compliant electronic CRFs to support EDC and eDiary data collection and management.

Get to know all the possibilities of the app with the comprehensive SD User Guide.

A participant who is enrolled in a clinical trial and assigned to the site.

A unique identifier that is used to track and refer to the enrolled participants throughout the clinical trial.

See also: screening ID.

A specific phase that a subject has to complete in the course of a clinical trial to move further to the next phase. For instance, Screening, Enrolled, Randomized, and others.

In eClinical, subject phases are designed individually for each study via the SD application, although they are referenced in others, like IWRS or EDC.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

A crucial document that provides detailed information about a medicinal product, including its composition, therapeutic indications, dosing, contraindications, precautions, and the known safety profile. The SmPC is primarily intended for healthcare professionals and is prepared and approved by MAH or a pharmaceutical company and is a legal requirement for all authorized medicinal products in many countries. It serves as the basis for prescribing, dispensing, and administering medication to patients and is an essential reference for healthcare professionals in clinical practice.

In eClinical, a set of required parameters (for example, item units, minimum and maximum stock values) that is set to automate the process of drug supply to sites to always maintain a sufficient amount of medications for all subjects registered at this site.

In IWRS, the supply plan can be created and managed under the TREATMENT DESIGN tab > Supply Plan subtab.

In eClinical, a process of the item (drug) supply from depot to site or between sites. Even though the sites can return drugs to the depot, this process cannot be treated as a supply relationship.

In IWRS, a process of item (drug) delivery that is requested (manually or automatically according to a supply plan) by an applicant (site) from the supplier (depot or site).

A MedDRA term that groups HLGTs by aetiology (for example, Infections and infestations), manifestation site (for example, Gastrointestinal disorders), or purpose (for example, Surgical and medical procedures). Also, there is a SOC to contain issues about products and one to contain social circumstances.