Following an inspection by the Medicines and Healthcare products Regulatory Agency (MHRA) in August 2011, it was identified that the Standard Operating Procedures (SOPs) employed by the R&D Department for the governance of research across the Gloucestershire Consortium were no longer fit for purpose.
It was proposed that a more comprehensive system of SOPs was required to ensure that robust systems were in place to manage both the set-up and approval of research projects as well as their post approval management and monitoring. This was particularly important if the Consortium Trusts wished to continue sponsoring Clinical Trials of Investigational Medicinal Products (CTIMPs).
Since the Inspection Report, a series of draft SOPs have been produced and this page summarised the main purpose of each SOP, as well as highlighting where further SOPs will be required.
All SOPs are currently in a draft form, pending agreement through the Consortium. Because of this, some of the SOPs have gaps, where references to other number SOPs are yet to be finalised. It is, however, hoped that the main body of the SOPs are clear and otherwise accurate in relation to the procedures and processes they describe.
Information about the Standard Operating Procedures
1. R&DSOP01 – Research Documentation and File Management for Research
Relatively self-explanatory, this SOP outlines the procedure for maintenance of the correct and appropriate documentation in a manner suitble for managing the conduct of the trial and enabling evalation by audit and inspection as essential for GCP compliance.
All staff working on a trial should be familiar with the lay out and requirements of the file that is relevant to their role and therefore anyone involved in research should be aware of this SOP.
This SOP must be referred to as soon as a trial is being considered for adding to the Trust trial portfolio. This will ensure that the necessary procedures to secure the quality of every aspect of the trial shall be complied with.
2. R&DSOP02 – Training
All research hosted and sponsored by the Trust must be conducted to the highest quality and standards possible. To do this all staff must be trained in all aspects of research relavant to commensurate with their role and level of involvement within a trial.
The Medicines for Human Use (Clinical Trials) Regulations 2004 states that no person shall conduct a clinical trial unless done so under the expectations of good clinical practice. Therefore all staff will receive GCP training alongside their Trust and specific professional training to maintain their professional registration.
Any member of staff, honorary member of staff or external researcher undert a Letter of Access should refer to this SOP to ensure they are yp to date with appropriate training and education requirements for undertaking research.
This SOP should be referred to in the trial set-up phase and should be regularly referred to during the course of any trial delivery to ensure all stadd are aware of all training required and that it is provided and documented.
3. R&DSOP03 - Informed Consent in Research
This SOP described the ongoing process for receiving informed consent from a trial participant. It outlines the informed consent procedures for adult participants and informed consent procedures for more vulnerable participants (Minors and Incapacitated Adults).
This SOP applies to all investigators and research team members involved in CTIMP and non-CTIMP studies. The sponsor will make the decsion which staff groups are permitted to receive informed consent / assent and this information will be detailed in the Research Ethics Committee (REC) application. Locally the decision will be made at set up who will be delegated the responsibility and this will be detailed in the submission paoperwork sent to the Trust for R&D Approval.
This SOP is applicable for all clinical trials sponsored, co-sponsored and hosted by the Trust. It should be read alongside any trial specific requirements as detailed in the trial protocol. It should be referred to during the trial feasibility, set up and throughout the recruitment and follow up phase of the trial.
4. R&DSOP04 – End of Trial Procedures
The purpose of this SOP is to set out the matters to be considered upon the complation of a trial and the steps to be taken, including the notification of relevant bodies.
In this SOP the phrase 'Close Down' will be used throughout and is synonymous with 'Close Out' and 'Completion'. Typically 'Close Out' referes to the offical visit of the sponsor or delegated representative to a participating site to review documentation before formally closing the trial at that site.
This SOP will be used at the end of the trial as defined in the trial protocol (the end of the recruitment period does not automatically signifies the end of the trial). It will be used for all the following types of research:
- a CTIMP or a non-CTIMP that is sponsored or co-sponsored by the Trust
- a CTIMP or a non-CTIMP hosted by the Trust taking into consideration an SOP for this purpose provided by the trial sponsor
5. R&DSOP05 – Trial Archiving
The purpose of this SOP is to describe the procedure for archiving trial documentation for all trials undertaken within the Trust.
Retention of trial documentation is a legal requirement for clincal trials of Investigational Medicinal Products, and it is GCP to treat non-interventional studies and clinical trials of medical devices similarly.
The procedure for archiving may vary epending on the sponsoring organisation. However, the Trust has a responsibility to ensure that appropriate arrangements are in place for archiving research documentation in accordance with applicable legislation and guidelines.
This SOP is for allr esearch staff working within the Trust. The responsibility of the archiving process applies to Chief Investigators of trials sponsored by the Trust and Principal Investigators of trials hosted by the Trust and sponsored by an external organisation.
R&DSOP Pharmacovigilance 01 - Safety Reporting
Clincial trials of Investigational Medicinal Products (CTIMPs) are legally reglated by the Medicines for Human Use Act 2004 and regulations made by statutory instruments under that Act. This legal framework imposes a number of reporting requirement in addition to those relating to specific adverse events.
These reports must be made to the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Research Ethics Committee that gave the favourable ethical opinion for the study (REC).
We would appreciate any comments you may have on these to enable a period of “consultation in use” where they can be refined and finalised to ensure they are fit for purpose.
Any further suggestions of SOPs that are required would also be welcomed.