ACCORD webinars

The trial end date should be defined in the protocol. Typically, this is the LPLV and not the funding end date. The end of trial definition is used by the regulators to determine the regulatory window for publishing final results.

Clinical trial results should be proactively shared with participants in a clear, accessible format, ideally tailored to their preferences. Commonly used methods to share results include; end of study information or newsletter, verbal information provided at study visits, study websites, study social media accounts. The summary must be written in plain English and participants should be given the option to receive results, choosing how they’d like to receive them. 

The summary of results is not a peer-reviewed journal article. Journal publication is encouraged but separate, and often takes longer due to peer review and editorial processes. The summary of results must be published in the registry where the trial is registered, e.g. ISRCTN.

No, delaying clinical trial result reporting to accommodate journal preferences is generally not acceptable and violates ethical and regulatory obligations.

Clinical trial Sponsors and Investigators are ethically and legally obliged to report results within specific timeframes, regardless of journal publication concerns. Some journals may have policies against publishing results that are already publicly available. However, most reputable journals now accept prior posting of results in trial registries or institutional repositories as long as it’s not a full manuscript. The International Committee of Medical Journal Editors (ICMJE) supports public posting of trial results and does not consider registry results as prior publication.

Calendar days.

Not necessarily, it would need to comply with one of the conditions, most likely A (already used in clinical practice in the same way - not a given if the populations are different) or B (used at the same or higher dose in another approved trial).

The MHRA guidance requires System Organ Class (SOC) and Preferred Term (PT) codes for the SUSAR (Suspected Unexpected Serious Adverse Reaction) reporting and for all the SAEs (Serious Adverse Event) mentioned in the DSUR (Development Safety Update Report).This is already what we are doing. 

So far there is no mention of the code that should be used for AEs (Adverse Event) so we will ask trial teams to use at least the SOC codes, until the MHRA guidance is updated with more clarification on that point.

Ensuring clinical trial data remains readable for 25 years requires robust archiving strategies and clearly assigned long-term custodianship. Predicting tech availability decades ahead is tricky, and staff turnover is inevitable. But regulatory bodies like the MHRA mandate long-term data retention, so systems must be built to withstand time. The Sponsor is legally responsible for ensuring data is archived and accessible. Long-term data preservation strategies will be included in the study risk assessment and may include validating archiving platforms and performing periodic format migration for example reviewing the data to ensure it is readable or migrated to new formats as technology evolves.

For hosted trials, archiving arrangements should be discussed with the Sponsor at the start of the trial (e.g. at Site Initiation Visit (SIV)) so there are no surprises at the end of the trial in terms of cost, where electronic data is to be stored and if this complies with local policies.

Yes, archiving costs should be included in grant applications. If the funder does not wish to pay these costs, this needs to be discussed with the Sponsor at the sponsorship review and approval stage.

Yes, similar changes are expected for non-CTIMPs, aiming to align processes more closely with CTIMPs under the new UK clinical trial regulations.

While the 2025 amendments to the UK Medicines for Human Use (Clinical Trials) Regulations primarily target CTIMPs (Clinical Trials of Investigational Medicinal Products), the Health Research Authority (HRA) has confirmed that some changes will also affect non-CTIMP studies. These changes are designed to improve consistency, transparency, and efficiency across all types of clinical research.

We are aiming to issue participant facing documents (protocol, consent forms etc) in January 2026.

No immediate protocol changes are required for studies approved before the new regulations. A Modification of an Important Detail (MOID) must be submitted within six months to update terminology. If a substantial modification occurs within that period, updated terminology must be included at that time. This requirement is applicable to CTIMPs or combined device-CTIMPs only. 

Classification rules are detailed in MHRA Guidance. Previous ACCORD webinar also cover this. Study teams may contact ACCORD directly for clarification via our usual channels. 

Core principles remain unchanged: data must be complete, accurate, consistent, attributable, and secure. E6(R3) emphasises risk‑based, proportionate validation. ACCORD has released an updated computer system validation and data integrity policy outlining Sponsor expectations and this is available on our website.  

Primary packaging labelling is generally required when IMPs are QP‑released. Commercial off‑the‑shelf IMPs in standard packaging will not routinely require primary packaging labels. This approach will be documented in risk assessments. 

Archived data must remain complete, accessible, readable, and secure for the full retention period (25 years for CTIMPs). ACCORD encourages validated long‑term platforms (e.g., Data Vault). Obsolete media (CDs, USBs) should be avoided; migration plans must be documented. 

E6(R3) introduces a detailed data governance section. Requires risk‑based quality control across all data handling stages. Includes expectations for metadata review, audit trail interpretability, and system validation. Personnel identifiable data handling principles remain unchanged. 

New feasibility work should use the updated template. If drafting has begun on an old version, switching is recommended unless it would cause significant delay. 

ACCORD allows a 12‑month grace period to complete updated GCP training. Teams must still familiarise themselves with updated processes immediately. 

Legal changes apply to CTIMPs, but HRA has aligned terminology and processes across study types. Non‑CTIMPs should follow updated modification terminology, transparency expectations, and GCP principles.