Clinical trials of investigational medicinal products (CTIMPs) may be inspected by the Medicines and Healthcare Products Regulatory Agency (MHRA) in order to check that trials are being conducted in compliance with the UK Clinical Trial Regulations and GCP.
Please refer to GCP SOPs for investigator responsibilities concerning the conduct of HEY-sponsored CTIMPs. The forms and instructions below are important to ensure compliance with the UK Clinical Trial Regulations and GCP.
Set Up a Trial Master File
Use the Trial Master File List of Contents and ensure all documents on this list are present in the file. These comprise the essential study documents. Set up a TMF in a large lever arch file with 15 dividers.
- Study Personnel Contact sheet — contains details of everyone involved with the study including administrative staff.
- Study Tracking Log — required to record key study information such as versions of study documents, approval dates, amendments and study milestones. This log is requested by the MHRA during inspections.
- Visit Record form — to record R&D Department monitoring visits.
- Use the File Note Template to explain any documents that are not applicable or any missing documents, etc. (always state reason).
- Protocol Deviations Form — to record any unplanned deviations from the study or protocol.
- Study Patient List — this lists all the patients in the study, their contact details, casenote number, study number and when they were involved with the study.
- Study Medication Compliance form — it is important to record when and how much study medication is dispensed and returned by the patient and therefore what the patient compliance is.
- Summary of Product Characteristics (SPC) File Note — directs investigators to use the up-to-date SPC for study medications on the electronic Medicines Compendium.
- Record of Samples Stored — samples may include; blood, urine, tissue biopsies etc.
- All study personnel require training in the study protocol and procedures before being involved with the study. Training is documented on the Study Training Record.
- All study personnel need to complete the Study Delegation and Signature Log.
- Investigator and Sponsor Formal Agreement which investigators sign to confirm that they understand their responsibilities regarding the conduct of the clinical trial.
- Development Safety Update Report — needs to be sent to the MHRA, REC and R&D each year from when the MHRA CTA was issued for the duration of the study. Use the DSUR Template and Guide for Completing the DSUR.
- Indemnity Arrangements File Note — specifies indemnity arrangements for research in the NHS.
- Adverse Event Report form — keep this form with your patient data forms (CRFs) as a reminder to record all AEs at each study patient visit. This form also defines if the AE is serious. It is important to record all adverse events (AEs).
- Serious Adverse Event Initial and Follow-up Report forms — for recording and reporting Serious Adverse Events, Serious Adverse Reactions and Suspected Unexpected Serious Adverse Reactions. Initial serious event reports should be sent to R&D within 24hrs of first learning of the event.
- GCP SOPs File Note — directs investigators to use the up-to-date version of R&D’s Standard Operating Procedures for the conduct of HEY-sponsored CTIMPs.
- UK Clinical Trial Regulations File Note — a summary of the standards to which clinical trials with investigational medicinal products must adhere to in order to protect the safety of clinical trial participants and produce the highest quality clinical trial data.
- CRF Template — used for collecting patient’s study visit data. The template will need to be modified for each study to reflect the protocol.
- Data Management File Note — for specifying the data management process at the beginning of the study.
- Archiving File Note — details archiving arrangements. To be completed by the monitor at the end of the study.
Please refer to GCP SOPs for Pharmacy responsibilities concerning HEY-sponsored CTIMPs.
Set-up a Pharmacy Study File using:
- Pharmacy List of Contents
- Study Personnel Contact Sheet — same contact sheet as prepared for the TMF.
- Visit Record — to record R&D Department monitoring visits.
- Study Medication Accountability Forms for recording amount of study medication dispensed and returned along with dispense and return dates, batch numbers and expiry dates.
- File Note Template for explanations concerning documents that are not applicable, missing or located elsewhere or to explain deviations from the study or protocol.
The above documents have been created by the R&D QA team at Hull and East Yorkshire Hospitals NHS Trust. If you have any queries or feedback please contact either firstname.lastname@example.org or email@example.com. We would be grateful for acknowledgement if you have found these documents useful.