Clinical trial records seem, to an outsider, like one of the least controversial parts of trial governance. They are the paperwork — signed consent forms, IMP accountability logs, dispensing records, temperature charts. They are also the first thing an inspector asks for and the part of a trial that causes the most anxiety at inspection time.

On 14 April 2026 the Medicines and Healthcare products Regulatory Agency published updated guidance on archiving and retention of clinical trial records. The guidance covers ownership, retention periods, data integrity and transitional provisions for trials that started under the pre-amendment regime. It is written for sponsors and investigator sites generally, but the provisions most directly affecting hospital pharmacy services are worth pulling out.

What the guidance covers

At high level, the guidance addresses:

• Ownership of essential documents. Which documents belong to the sponsor, which to the investigator site, and who retains them after the trial ends.
• Retention periods. How long specific categories of record must be kept, including adjustments for paediatric and long-term follow-up trials.
• Data integrity expectations. The MHRA's ALCOA+ principles (attributable, legible, contemporaneous, original, accurate — plus complete, consistent, enduring, available) as applied to trial records including electronic systems.
• Transitional provisions. How records from trials that began under the 2004 regime but continue under the amended regulations should be managed.

The guidance is expected to trigger a review — not usually an overhaul — of trust and sponsor SOPs over the coming months.

The pharmacy-specific records

Investigational pharmacy services hold several categories of record that fall within the scope of the guidance:

• IMP accountability logs. Per-patient dispensing, return and destruction records for trial medicines.
• Temperature monitoring records. Fridge and freezer logs covering the period IMP stock was held on site.
• Pharmacy trial file. Site master file copy of protocol, SmPC, investigator brochure, pharmacy SOPs, training records and delegation logs.
• Dispensing records. Both electronic (PAS / trial-specific EDC) and paper records of dispensing events.
• Unblinding logs. Where applicable, records of emergency unblinding.
• Destruction certificates. For IMP that was destroyed on site rather than returned to the sponsor.

Each of these has retention obligations. The guidance reaffirms that retention periods are measured from defined end-points — for most trials, the end of the trial or the last data-lock, whichever is longer — and that local archiving SOPs must specify the trigger date clearly.

Retention periods worth knowing

The headline retention periods relevant to pharmacy are:

• 25 years for essential trial documents in most modern commercial trials, in line with ICH GCP.
• Longer than 25 years for paediatric trials or trials with long-term safety follow-up, where the guidance recognises that retention may need to extend to the point where the youngest participant reaches adulthood plus a defined period.
• 5 years minimum for some non-commercial trials under the previous UK regime — the guidance clarifies transitional treatment of these.
• Local trust policies may require longer retention than the statutory minimum; the longer period applies.

Pharmacy teams running investigator-initiated trials are particularly likely to encounter variable retention periods depending on the protocol. The safest default is the longer of sponsor-agreed retention and the MHRA-specified minimum.

Data integrity in mixed-format archives

Most UK trust pharmacies now run hybrid archives — some records in trust electronic systems, some in paper files, some in trial-specific electronic data capture systems. The MHRA guidance reaffirms that ALCOA+ applies regardless of format. Three practical implications:

Readability over 25 years. A record kept only in a system that will not exist in its current form in 25 years is a compliance risk. Archives need a format-migration plan — typically print-to-PDF at trial closeout, with the PDF retained alongside the native record.

Accessibility. Records that are retained but cannot be retrieved at inspection count as "not retained" for practical purposes. Pharmacy SOPs should specify retrieval time expectations.

Change control. Any amendment to an archived record must itself be recorded, signed, dated and retained. The MHRA's language on this is unchanged but is emphasised in the new guidance.

Transitional provisions

A significant part of the April 2026 guidance covers the transitional period. Trials that started under the 2004-regime-as-originally-drafted and continue under the amended regulations sit at a particular risk. The guidance's approach is pragmatic: the retention period that was in force at the time of the event is the binding one, unless the amended regulations specify a longer period, in which case the longer period applies.

Pharmacy archive teams should, as part of their SOP review, audit trials whose start date falls in the transition window (broadly 2023–2025) and confirm that their retention triggers match the guidance. The usual cause of slippage is a local SOP still pointing to the original regulation's wording.

What trust pharmacy services should do

Three practical actions:

1. Map the current archive. List trials, their sponsors, their retention end-points and the location of the records. A simple spreadsheet is enough.
2. Compare the retention rules. For each trial, check the retention period against the new guidance's language. Flag mismatches.
3. Review the archive SOP. Update wording, retention triggers and destruction authorisation to reflect the guidance. Re-train the pharmacy archive team.

This is not a six-month project. For most sites it is a quarter's work to do thoroughly.

Where community pharmacy fits

Community pharmacy holds almost none of these records directly. The retention obligations rest with the sponsor and the investigator site, which in UK terms is usually a hospital trust. Community pharmacy's interface is indirect: a community pharmacist dispensing a non-trial medicine to a trial participant should know that the trial-specific records are held elsewhere and that the community pharmacy record is simply part of the patient's normal chronic-care file.

Where a community pharmacist is contacted by a trial sponsor for records relating to a patient — which does happen, typically for medication reconciliation — the normal NHS record-keeping rules apply.

Why this matters for the sector

UK trust pharmacy services have been investing steadily in trial infrastructure over the past decade. Most tertiary centres now run a professional investigational pharmacy team with dedicated archive, cold-chain and QA functions. The April 2026 guidance is part of the maturation of that environment. It clarifies rather than disrupts, but it still requires attention: an SOP review missed in 2026 becomes an inspection finding in 2028.

PharmSee's workforce dashboard at /salary and live job feed at /app/jobs show steady hiring across NHS trust pharmacy roles, including those with research and investigational remits. The growth of these roles is one of the quieter but more consequential trends in UK pharmacy employment.

Caveats

This piece summarises the MHRA guidance as published on 14 April 2026. It is not a substitute for reading the full guidance, the amended UK clinical trial regulations, or ICH GCP. Retention-period decisions for specific trials should be made by the trial sponsor's archivist or the trust R&D team in discussion with the pharmacy service, not on the basis of this overview alone.

Sources

• MHRA, Archiving and retention of clinical trial records, 14 April 2026.
• MHRA, Declaration of Helsinki and Clinical Trial Regulations alignment, 14 April 2026.
• The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended.
• ICH, Guideline for Good Clinical Practice E6(R2).