Category: R

Recruitment

Active efforts by investigators to identify subjects who may be suitable for enrollment into a clinical trial. Subjects are selected on the basis of the

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Real World Studies

Real-world studies seek to provide a line of complementary evidence to that provided by randomized controlled trials (RCTs). While RCTs provide evidence of efficacy, real-world

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Randomized Allocation

A type of allocation strategy in which participants are assigned to the arms of a clinical trial by chance. Source: Clinicaltrials.gov

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Randomization

The process of assigning trial subjects to investigational treatment or control groups (may use a comparator) using an element of chance to determine the assignments

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Rolling Submission

[FDA] In a rolling submission (also known as rolling review), a drug company can submit completed sections of its Biologic License Application (BLA) or New

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Related Sequence

Sequences may be related to one another within one regulatory activity. The related sequence number should always be stated. In case of activities with only

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Regulatory Intelligence

Act of gathering and analyzing regulatory information and monitoring current regulatory climate and using this data to generate creative and innovative regulatory strategies designed to

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Regulatory Affairs

The department or function that is responsible for ensuring compliance with government regulations and interacts with the regulatory agencies. Each drug sponsor has a regulatory

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Regulatory Activity

A public authority or government agency responsible for exercising autonomous authority over some area of human activity in a regulatory or supervisory capacity. An independent

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Reference Listed Drug

[FDA] The listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application. Source: 21

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Rapporteur

[EMA] One of the two members of a committee or working party who leads the evaluation of an application. Source: EMA Glossary

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