eRegulatory Software and the UK eISF: What a Site Is Actually Buying
eRegulatory software and an eISF describe the same file under two names. The American term carries FDA expectations, and the UK file is read against ICH E6(R3) and regulation 31A. This comparison records what seven named platforms state about themselves, checked on 7 November 2026.
Trial Documentation Software for UK Clinical Trials Units (CTUs)
The best software for UK clinical trials units (CTUs) to manage trial documentation holds three record sets on one structure: the sponsor trial master file, oversight of each participating site’s file, and the unit’s own procedures and training records. This comparison records what ten named platforms state about themselves.
Best eTMF Software for UK Trials: A 2026 Comparison
The best eTMF software for clinical research is the system that proves four things a UK buyer can check: retention for at least 25 years, direct access for an MHRA inspector, a stated hosting location, and a named CDISC TMF Reference Model version. This comparison records what nine vendors state themselves.
How AI Finds Documentation Gaps in an Investigator Site File
A check compares the records a trial should hold against the records actually filed, reads each document to confirm what it is, and compares dates across related records for contradictions. This guide covers the expected set, classification, four site file contradictions, flag scoring and routing, and what a flag proves.
What Belongs in a Pharmacy Site File?
A pharmacy site file holds every record that proves how a trial pharmacy managed IMP for one study. This guide covers the essential records ICH E6(R3) places in it, a twelve-section numbered folder structure, who maintains and signs each section, and which records sit outside the study file.
How Long Must eSource Records Be Kept, and How Do You Archive Them?
eSource records must be kept for at least 25 years after the trial ends, and archived so the entry, its metadata and its audit trail still open. This guide covers the UK retention clocks, the archive and backup distinction, readable-format archiving and vendor exit terms.
How to Move a Site from Paper Source to eSource Mid-Study
A site moves from paper source to eSource mid-study by agreeing the change with the sponsor, fixing a single cut-over date, and re-signing the source declaration on that date. This guide covers who approves the change, the six documents that change on the date, what happens to the paper already collected, and why dual running is the risk that matters.
How to Build a Source Data Plan Before the Site Initiation Visit
A source data plan settles, for every data point the protocol collects, what the original record is, who may create it and how the value reaches the sponsor. This guide covers the six decisions the plan settles, how the site and sponsor agree them, the four documents it produces and a build sequence measured in weeks.
Certified Copies: When Can a Scanned Record Replace the Original Source?
A scanned record can replace the original source when the copy has been verified to hold the same information as the original. This guide covers the ICH and MHRA definitions, the two verification routes, who certifies at the site, which records a scan cannot replace, and when an original may be destroyed.
What Is a Source Data Location Log and Who Signs It Off?
A source data location log is the site’s written record of where the original of every data point is held, signed and dated by the principal investigator. This guide covers what belongs in the log, how specific each entry must be, who signs it off, where it is filed and how versions are controlled.
