NHS R + D Consortium

Timelines

From EU Directives 2001/20 and 2005/28 [Download PDF]

Indemnity/ insurance

Arrangements for Trust-sponsored clinical research trials [Download PDF]

Trust’s R&D Department provides:

Reminder Labels for writing up study visits in patients medical records Stop-Alert Stickers, Notification Sheets and the Trust’s Alert Notification Policy (to explain how to use the stickers and sheets). Write on the notification sheet that the patient is involved with a clinical trial. Give title of study and contact name, address and tel no. Also add, ‘Do Not Destroy These Medical Records Unless Authorised by Contact Name’. An ICH GCP booklet Section 4 p16-27 concerns investigator responsibilities.

GCP Forms for Trust Sponsored non-Commercial Investigational Medicinal Product Clinical Trials

Standard Operating Procedures: Please refer to
For responsibilities of investigators / research staff concerning compliance within GCP, monitoring of research studies and reporting of serious and non-serious adverse events. Also refer to SOPs for definitions of acronyms.
Under the European Clinical Trials Directive, you will require a CTA (Clinical Trials Authorisation) to run a trial if you are using a medicine as the intervention or control. The MHRA will charge a fee for the issue of a CTA. Please visit their website [new page] for details.

The forms and instructions below are important to ensure compliance with GCP and hence, that a clinical study is being conducted according to the legal requirements stipulated in the EU Directives 2001/20/EC and 2005/28/EC. [Summary of instructions for the use of GCP forms]

Note: Don't forget to add your study details at the top of each form before printing them out.

Set-up a Trial Master File (large lever arch folder with 14 dividers) that contains all original signed documents.

List of Contents – ensure all documents on this list are present in the file. Use the File Note Template to explain, e.g. any documents that are not appropriate, or for any missing documents etc (always state reason).
Visit Record form to record R&D Department monitoring visits
Study Personnel Contact sheet – contains details of everyone involved with the study including administrative staff.
All study personnel to complete the Task Delegation and Signature form.
Patient Screening and Recruitment Record - if you are keeping your patient records on the computer, you may find it easier to combine this form with the Patient ID Code List form
Record of Samples Taken - samples may include; blood, urine, tissue biopsies etc.
Adverse Event Report form - keep this form with your patient data forms as a reminder to record all AEs at each study patient visit. This form also defines if the AE is serious.
SAE/SUSAR Initial and Follow-up Report Forms – for recording Serious Adverse events / Suspected Unexpected Serious Adverse Reactions.
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.
End of trial declaration form
Investigator and sponsor formal agreement which you sign to confirm that you understand your responsibilities regarding the conduct of your clinical trial according to GCP.
Archiving file note template - for archiving details of trial files and data at the end of the study.
Annual safety report - which needs to be sent to the MHRA, REC and Trust each year from when the CTA was issued for the duration of the study.

Pharmacy Staff

Please refer to GCP SOP01 – Monitoring and GCP SOP 03 - Amendments & archiving for responsibilities concerning GCP compliance and monitoring of clinical trials.

Set-up a Pharmacy Study File using the List of Contents:

Study personnel Contact Sheet
Visit Record
Study Medication Accountability Forms for recording amount of study medication dispensed and returned along with dispense and return dates.
File Note Template for explanations concerning documents and procedures that are not applicable, or documents that are missing.