R
Glossary
- randomization
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A process during which subjects receive their random numbers and are assigned to different arms based on the randomization scheme.
- randomization method
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A method used to assign participants to different treatment groups. In the eClinical system, you can select between the following randomization methods:
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Block: this randomization method involves dividing participants into blocks or groups, with each block containing a predetermined number of participants. The treatment allocation is randomized within each block.
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Block Stratified: this randomization method is similar to block randomization but incorporates an additional factor called stratification. Stratification involves dividing participants into subgroups based on certain factors such as age, gender, disease severity, or other relevant characteristics. In IWRS, for this method, you also need to select the stratification strategy.
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Complete: this randomization method is the simplest and most basic and involves a random allocation of participants to treatment groups without any specific blocking or stratification. Each participant has an equal chance of being assigned to any treatment group.
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- randomization scheme
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A scheme (plan) according to which subjects enrolled in a study are randomized and receive their treatment.
- recipient
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In IWRS, a person that is assigned to receive and handle the site or depot correspondence, for instance, shipment requests, consignment confirmation letters, and others.
- reconciliation
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A process of confirmation that the items (drugs) intended for destruction are indeed eligible to be destroyed and in the established quantity.
For instance, after the subject treatment ended, they returned a vial of unused tablets which the site now has to dispose of. The clinical research coordinator (CRC) counts that there are 15 tablets left and marks those in the IWRS system as ready for destruction. Then, the clinical research associate (CRA) comes to the site to validate the calculations done by CRC on the leftover drug and verify that the amount of items to be destroyed is correct. This process of validation is called reconciliation.
- replacement subject
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A new subject that qualifies all the criteria to be enrolled and randomized into the same arm as the subject discontinued from the study who needs to be replaced to keep the arm balance intact.
- retired LLT
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A Lowest Level Term (LLT) that is retired from the latest version of the MedDRA dictionary and no longer used for medical coding.
- return shipment
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In IWRS, a process of item (drug) return from a site to the acceptance depot. Only the depots set in the IWRS system as the return can receive the return shipments.
- route
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In medical coding according to WHODrug, a method by which a drug is administered to a patient. It describes how the drug enters the body, which can impact its efficacy and safety. Common routes include oral (by mouth), intravenous (injection into a vein), intramuscular (injection into a muscle), subcutaneous (injection under the skin), and topical (applied to the skin). Each route has specific coding to ensure consistent data collection and reporting.
- R script
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A script written in the R programming language, designed to perform various data analysis or statistical tasks, for instance, the generation of custom on-demand reports.