P

Also known as Prescribing Information (PI) or Summary of Product Characteristics (SmPC), a document approved by regulatory authorities and provided by pharmaceutical companies for healthcare professionals. This document accompanies the marketed medicinal product and contains important safety and prescribing information.

A batch of items collected into one package for shipment or other logistic purposes. Using packaging lots with their unique lot numbers gives depots and sites the ability to differentiate between different batches of drugs to track, for instance, release and expiration dates or other useful information.

A data management, healthcare, software, or another organization that cooperates with the sponsor to provide data or services for a study.

See also: institution

In IWRS, a period is a study phase in which the subjects are grouped and randomized. The Period functionality in the application is the main unit of the configuration of the subject randomization process.

The period configuration is a complex process of defining the screening conditions (factors) and cohorts of subjects that are further assigned to different arms according to the randomization scheme.

In IWRS, the value is used to divide subjects into different periods or cohorts in a clinical trial.

There are two types of period factors in IWRS:

A method of randomization that involves the preparation of a randomization list before initiating the randomization process for the study. Randomization of subjects is first performed into blocks according to preset stratification factors and then into arms according to specific ratios.

See also: dynamic randomization

The regulatory authority responsible for the evaluation and approval of pharmaceuticals, medical devices, and regenerative medicine products in Japan. The PMDA is an independent administrative agency under the Ministry of Health, Labour and Welfare (MHLW) of Japan. It plays a critical role in ensuring the safety, efficacy, and quality of healthcare products available in the Japanese market.

An eClinical application that provides instruments for the collection of AE data from clinical trials, post-marketing, and literature. It carries out centralized management and scientific data evaluation through analysis, reporting, signal detection, and other methods, building a comprehensive pharmacovigilance informatization management and data integration system. The module is fully integrated with the EDC system and third-party systems through Safety Gateway. Also, the module supports a global regulatory submission of ICSR through E2B R3 electronic transmission.

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

A substance or treatment designed to resemble the investigational product but has no therapeutic effect. It is used as a control to help researchers determine whether the actual drug or treatment is truly effective.

An instance created in eTMF in place of a source file that has not yet been uploaded to the system (for example, has not yet been collected or completed).

Placeholders are a helpful tool in the process of filling out the Trial Master File (TMF). With the placeholders, you preserve the eTMF integrity until the source files become available.

A MedDRA distinct descriptor (single medical concept) for a symptom, sign, disease diagnosis, therapeutic indication, investigation, surgical or medical procedure, and medical social or family history characteristic. Each PT has at least one Lowest Level Term (LLT) (itself) and synonyms and lexical variants (for example, abbreviations, different word order, or else). Each LLT is linked to only one PT.

A person responsible for overseeing and conducting the research study at a specific investigational site or multiple sites, depending on the study's design. The role of a PI is multifaceted and involves various responsibilities, such as study oversight, protocol adherence, participant recruitment and informed consent implementation, regulatory compliance, and so on.

In the eClinical system, the Principal Investigator (PI) role that is assigned to a person who oversees the data entering and signs off subjects—gives authorized confirmation that all the entered data is valid and follows the industry standards. The responsibilities of PI can vary depending on study requirements.

In the pharmaceutical industry, a medicinal product or drug that is being monitored for its safety and efficacy. A product can be a prescription drug, biologic, vaccine, herbal medicine, or any other health-related product that is used to diagnose, treat, prevent, or alleviate medical conditions in humans.

A document that contains comprehensive and up-to-date safety information about a medicinal product. It is also commonly known as the Summary of Product Characteristics (SmPC) or Prescribing Information in different regions or countries. The PDS/SmPC provides essential details about the product's composition, indications, contraindications, dosage and administration, clinical pharmacology, pharmacokinetics, interactions, adverse reactions, warnings, precautions, and other important safety information.

A group of products that share the same key ingredient and data sheets but can have different concentrations of the active ingredient.

An investigational product that is used in a study. In eClinical, it can be viewed as an equivalent to a drug name to distinguish items at all stages of their lifecycle—manufacturing, shipment, dispensation to subjects, or else.

Another name for the product unit in the IWRS system is item unit.

In a clinical trial, a document that describes the objectives, design, methodology, statistical considerations, and aspects related to the organization of a study.

A divergence from the IRB or sponsor-approved study design or procedures defined in the protocol, consent document, or study materials. The deviation can occur due to multiple reasons, such as a subject missing their visit, enrolling a participant who did not meet all the inclusion criteria, failing to perform a required lab test, and so on.

A key parameter in dynamic randomization algorithms that influences the likelihood of a participant being assigned to a particular treatment arm compared to the other arms.