How Should a Site Manage IMP Returns, Reconciliation and Destruction?
A site manages IMP returns, reconciliation and destruction as one continuous record rather than three separate tasks. Every unit that comes back is logged against the participant who received it, counted into a running balance, and held in quarantine until the sponsor authorises its disposal in writing.
Receipt and Quarantine: Why Every Delivery Is Locked Until Someone Releases It
Every IMP delivery is locked in quarantine until a named member of pharmacy staff completes the receipt check and records a release decision. This guide covers the receipt sequence, the check against the packing list, the batch and expiry capture, the transit temperature record and the grounds for rejection.
How to Get a Trial Pharmacy to Green Light Before the Site Initiation Visit
A trial pharmacy reaches green light by finishing the local set-up work behind a first dispense. This guide covers the four permissions behind green light, the pre-SIV checklist, who signs the readiness sign-off, the six conditions for a first dispense, and what a protocol amendment changes.
Veeva SiteVault eSource Alternatives for NHS and Academic Sites
Veeva SiteVault eSource alternatives for NHS and academic sites fall into four groups: a site eSource platform the site licenses, a sponsor-issued system, the hospital EPR used as source, and the site’s own forms. This guide covers what Veeva publishes about SiteVault eSource and which routes are open today.
eSource Software for UK Research Sites: What to Compare Before You Buy
eSource software for a UK research site is compared on six things: validation evidence, the depth of the audit trail, how access control maps to delegation, the route data takes to the sponsor’s system, the position on the hospital EPR, and the exit terms. This guide sets out the question to ask under each heading.
Tracing One Visit from Source Entry to Query Resolution
One visit traces from source entry to query resolution through five stages, and each stage writes its own entry into the audit trail. This worked example follows one hypothetical UK site visit through booking, capture, investigator endorsement, a monitor query and filing.
How Does a Visit Schedule Become an eSource Form?
A visit schedule becomes an eSource form when every row of the protocol’s schedule of events is built as a field on a validated electronic form. This guide covers the six build decisions, where the visit window lives, out-of-window visits, unscheduled visits and what an amendment changes.
EHR-to-EDC Integration vs Site eSource: Which Suits an NHS Trust?
EHR-to-EDC integration suits an NHS trust that needs the same structured fields across many studies and has digital capacity to maintain an interface. This guide compares the two routes on data coverage, the trust approval chain, what the EPR supplier controls and where the cost falls.
UK Model Agreements for Clinical Trials: mCTA and mNCA
A UK model clinical trial agreement is a standard-form contract published nationally so the terms are settled before a study reaches a site. This guide covers the mCTA and mNCA, the full template suite, who signs, the appendices and schedules, unmodified use in each nation, and what April 2026 changed.
Which Studies Are Excluded From UK Trial Set-Up KPIs?
The UK clinical research delivery KPIs exclude studies on four grounds: study type, completion of the measured step, the state of the recorded dates, and portfolio membership. This guide covers what each of the seven indicators leaves out, which time the clocks remove, and which research never enters the measurement at all.
