M

A batch of items (drugs) produced together at one time. This information is not used for logistics purposes or system processes of IWRS but exists in the system for the traceability of manufactured drugs.

A feature that enables you to build the source-target relations between data entities (fields, arms, strata, and so on) so that ultimately, to present the data of the source area in the required structure or format of the target area.

In PV, an entity that holds the marketing authorization or license for a pharmaceutical product. This authorization allows the MAH to market and sell the medicinal product in a specific region or country. The MAH is typically a pharmaceutical company or any legal entity responsible for the product's authorization. In the eClinical system, MAH can be treated as another name for a sponsor.

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

A certified professional coder in the healthcare industry who is responsible for reviewing the patient's post-visit medical records and translating them into globally acceptable medical codes according to MedDRA, WHODrug, and other dictionaries.

A process of converting healthcare diagnoses, procedures, medical services, and equipment into universal alphanumeric codes. This is done to standardize the representation of healthcare data for various purposes, including billing, insurance claims, and medical record-keeping. The dictionaries used for medical coding in eClinical are WHODrug and MedDRA.

An internationally used set of terms relating to medical conditions, medicines, and medical devices created to assist regulators with sharing information.

The FDA's Safety Information and Adverse Event Reporting Program that interacts with the FDA Adverse Event Reporting System (FAERS or AERS). MedWatch is used for reporting an adverse event or sentinel event.

Significant events or phases within the lifecycle of a clinical trial are called milestones. Milestones are configured, documented, and tracked according to the study plan and protocol, representing key stages of the clinical trial process, such as study initiation, site training, patient enrollment completion, and many others. They are critical for planning, monitoring, and managing the trial progress effectively.

A person who is the main line of communication between the sponsor and the investigator. The monitor provides assistance to investigators, ensuring that the trial is conducted and documented properly. In the clinical trial industry, often referred to as a clinical research monitor or clinical research associate (CRA).

An activity in which a monitor, usually a clinical research associate (CRA), visits sites to review and verify study-related activities, including data collection, patient safety, and adherence to the study protocol. The monitor also verifies that the study complies with relevant regulatory requirements and GCP guidelines.

A monitor template is created for recording the details of a monitoring visit, such as information about the subject's enrollment and retention, source data verification, protocol deviations discovered at the site, and so on. Since the monitoring visit data may vary, to accurately and efficiently capture and record the information, you can create the following types of forms in a monitor template: simple, log, and grid.

The simple and log forms are straightforward and incorporate questions and answers for the reviewer to provide details of their monitoring visit. Grid forms are two-dimensional forms comprising rows and columns that can be used to answer multiple questions for different fields of the same question.