What Is a Clinical Trial Pharmacy and How Does It Differ from Routine Dispensing?
A clinical trial pharmacy receives, stores, dispenses and accounts for IMP on the investigator’s behalf, and traces every unit well past supply. This guide covers what the service does, how it differs from routine dispensing, and the in-house, outsourced and homecare models that run it.
Who Is Accountable for IMP at a Trial Site?
The investigator or institution is accountable for IMP at a trial site. This guide takes the roles one by one, from trials pharmacist, technician, ATO, prescriber and research nurse to monitor, QA, sponsor and inspector, and shows which hold accountability, which record and which only read.
From Depot to Patient: The Twelve Steps a Trial Medicine Takes
A trial medicine takes twelve steps from the sponsor’s depot to the patient and on to final disposition, and each step leaves its own record. This guide walks the IMP chain of custody step by step, names the record each handover leaves, and shows the four places those records end up.
What Is an Investigational Medicinal Product?
An investigational medicinal product is a medicine or placebo that a clinical trial tests or uses as a reference. This guide covers the UK definition in regulation 2, the difference between an IMP, a NIMP and an auxiliary medicinal product, when a licensed drug becomes an IMP, and what a kit is and who numbers it.
Who Uses eSource in a Clinical Trial? From Research Nurse to Sponsor
eSource in a clinical trial is used by seven roles, from the research nurse who records the observation to the sponsor who receives the reported data. This guide covers what each role does with the record, which four of them may change data, which three only read it, and the ICH E6(R3) clauses behind each duty.
eSource vs EDC: Where Source Data Ends and the CRF Begins
eSource and EDC differ by which record holds the original. eSource is the site’s first electronic capture of an observation, and EDC is the sponsor’s route for receiving reported data. This guide covers where source data ends and the CRF begins, when the CRF itself is the source, what a transcription step adds, and which party controls each record.
Types of eSource: Direct Data Capture, EHR, EHR-to-EDC and ePRO
The four types of eSource in clinical trials are direct data capture, the EHR used as source, EHR-to-EDC transfer and ePRO. This guide covers what each type captures, who enters the data, how the value reaches the CRF, and what FDA, EMA and ICH E6(R3) guidance says about each one.
What Counts as Source Data in a Clinical Trial?
Source data in a clinical trial is all the information held in original records, and in certified copies of those records, that is needed to reconstruct and evaluate the trial. This guide covers the ICH definition, the difference between source data and a source document, the test that separates an original from a copy, and which record holds the source for each data type.
eSource in Clinical Trials: A Complete Guide for UK Research Sites
eSource in clinical trials is trial data recorded electronically at the point of first capture, so the entry itself is the original source record. This guide covers the four types of eSource, who uses it, the record lifecycle, what UK law and ICH E6(R3) require, benefits and limits, and what to check before buying.
Clinical Trial Site Selection: Best Practices for UK Studies
Best practice in clinical trial site selection is to choose each site against evidence it has already produced, rather than the estimate on its feasibility form. This guide covers what the April 2026 UK rules put on the decision, the nine criteria that predict delivery, how to test a site’s real access to its population, and the measures that show whether the choice was right.
