During a study or clinical trial
There are many aspects to consider during the running of a clinical trial or research study. The requirements are dependent on the risk and legal requirements associated with the project. The Newcastle upon Tyne Hospitals NHS Foundation Trust take a proportionate approach relevant to a study or trial to ensure deliverability, quality and successful recruitment.
ICH GCP is enshrined in The Medicines for Human Use (Clinical Trials) Regulations 2004 and it is expected that all clinical trials abide by the quality standards as set out in ICH GCP.
For clinical trials
Management of a clinical trial (drug, device, advanced therapy or complex intervention) is normally delegated to a clinical trials unit. The Trust, as a Sponsor, can aid you in deciding the most appropriate CTU for your work and in collaboration; decide on a pragmatic approach for the trial.
The Medical Research Council (MRC), Medicines and Healthcare products Regulatory Agency (MHRA) and Department of Health (DH) have released a joint position on risk adapted approaches.
The Trust endorse the approach, however; Chief Investigators are expected to work with Sponsor and their CTU in making decisions before the trial begins on what elements of proportionality can be used, depending on the risk classification.
Some trial management considerations for trials are:
- Recruitment strategy
- Required Committees (Data Monitoring, Trial Steering, Joint committee)
- Level of monitoring (on-site, for cause, central)
- Vendor assessments
The Trust (and delegated CTU) will complete a risk assessment at the start of a trial in collaboration with the Chief Investigator. As risks can change over the life cycle of a study (due to population, clinical advances for example) it is important that the risk assessment is revisited on a regular basis. As a Sponsor the Trust expect that risk assessment and mitigation form a continuous element to trial progress and, where applicable, design and procedures are adapted accordingly.
Where the risk of a study is low or medium (for example: questionnaires) study management and progress is to follow the UK Policy Framework for Health and Social Care Research.
The Trust again adapts a proportionate approach to ICH GCP and study progress requirements which can be discussed with your R&D representative during set-up.
Confirmation of Capacity Study Progress
If your study has been submitted to R&D for Sponsorship review please contact Nuth.firstname.lastname@example.org for an update on the progress of this review. Please be aware that we aim to review study sponsorships within 10 days. Please make sure you have submitted all the correct documents in order for the review to be completed in a timely manner.
Any studies submitted to R&D for Confirmation of Capacity and Capability Review will be assessed for validity within 2 working days. Once you have email confirmation that your study is being passed to an R&D Officer, an update on the study progress will be conveyed within 5 working days.
Should any issues arise during the Capacity and Capability review an Officer will liaise with the team or the sponsor. For this purpose, could you please make sure a sponsor contact is provided on the Host Capability Form submitted at review.
Once the review is complete and financial sign off has been given an R&D officer will then proceed to contact sponsor to organise the contract signatures. We aim to have a contract fully executed within 1 week but this is sponsor dependent.
Please email the designated R&D Officer directly for a study update at any point in the review process.