Julie James, Aldona Kirkham Anne Moore UHL Clinical Trial Monitors and Trainers Sept 2017

Site File Management

Objectives To gain insight/knowledge of the documentation required for conducting a research study To understand the relevance of these documents to the researcher/team To understand your responsibilities with regards to the management of essential documents

What is an Investigator Site File/ Trial Master File? It is a collection of documentation that allows the conduct of the trial, the integrity of the trial data and the compliance of the trial with GCP and all applicable regulatory requirements to be evaluated It is also essential to allow the trial to be effectively managed and allow the appropriate individuals access to the necessary trial documentation

What is an Investigator Site File/ Trial Master File? The documentation within the site file should be sufficient to adequately reconstruct the trial activities undertaken, along with key decisions made concerning the trial thus ensuring that a clear audit trail is maintained. Consideration should be given to the site file being a stand-alone set of documentation that does not require additional explanation from the Sponsor or the Site Staff.

Who is responsible- Single Site Study ? Chief Investigator Sponsor Principal Investigator

Investigator Site File(ISF) Who is responsible? Investigator Site File(ISF) The Principal Investigator is responsible for creating and maintaining the investigator site file. This may be delegated to a member of the research team and must be reflected on the delegation of authority log.

Who is responsible? Multi Centre Study Chief Investigator Sponsor Principal Investigator

Who is responsible? Multi Centre Studies - Trial Master File(TMF) The Chief Investigator is responsible for the maintenance of the Trial Master file. This file will contain information with regards to the conduct of the study/trial at the Chief Investigator site plus information to evidence trial compliance at all collaborating centres

Trial Master File What additional Information would be found in the TMF with regards to collaborating centres?

Investigator Site File The format of the study investigator site file structure is not set in stone, you can customise your file to the study but it must contain all essential documents relevant to that study. Your Sponsor will provide guidance documents to ensure you are compliant with this. Further information can be found on the NIHR website.

Essential Documents Essential documents are those documents which individually and collectively permit evaluation of the conduct of a study and the quality of the data produced. These documents serve to demonstrate the compliance of the Investigator and the Sponsor with the standards of Good Clinical Practice and with all applicable regulatory requirements.

Site File Creation and Maintenance When should a site file be created?

How should the file be labelled and identified?

Who should have access to the site file?

Should all documents be stored in one file?

Study Scenario The SURPRISE study , is a single centre study exploring concepts of health and exercise. The study is financed via a Grant. 50 subjects will be recruited in total. The subjects will be in the study a total of one year. All subjects will undertake screening consisting of a full body scan, questionnaires and blood samples. They will then be randomised to receive either a face to face exercise programme or on online programme. Some of the bloods will be sent to the local hospital for analysis and some will be sent to an external hospital for analysis.

You have 15 minutes to complete Group Work Utilise the blank indexes that you have been given and in teams or pairs consider what documents you would expect to find under each heading at the commencement of the study You have 15 minutes to complete

Where should the site file be stored?

How often should the site file be reviewed/updated?

You have 10 minutes to complete Group Work Utilising the index you created, consider what you would review and what would possibly need updating during the progress of the study. You have 10 minutes to complete

Points to consider when undertaking a regular site file review

Points to consider when undertaking a regular site file review .

Points to consider when undertaking a regular site file review

Points to consider when undertaking a regular site file review

End of Study Once the study has completed and the end of study declaration has been submitted – what actions should be taken to ensure the study is ready for archiving?

How long should the site file be archived for?

Where will the site file be archived?

Summary Should be created prior to commencement of the study and maintained throughout the lifecycle of the study Stored in a secure lockable area & limit access to research team only Should be a stand alone set of documents that provide evidence of compliance with the Sponsor, GCP and regulatory requirements. Must be archived in accordance with the relevant sponsor SOPs

Useful links Health Research Authority - http://www.hra.nhs.uk/ UHL R&I website - http://www.leicestersresearch.nhs.uk/ National Institute for Health Research - http://www.nihr.ac.uk/ NHS Research & Development Forum - www.rdforum.nhs.uk INVOLVE - Supporting public involvement in NHS, public health and social care research - http://www.invo.org.uk UKCRC Regulatory & Governance Advice Service - http://www.ukcrc.org University of Leicester – https://le.ac.uk/ ICH GCP - http://www.ich.org/ichnews/newsroom/read/article/ich-q3cr6- guideline-reaches-step-4-of-the-ich-process-copy-1.html

Any Questions?

Contacts Julie James Clinical Trials Monitor & Trainer julie.james@uhl-tr.nhs.uk Aldona Kirkham Clinical Trials Monitor & Trainer aldona.h.kirkham@uhl-tr.nhs.uk Anne Moore Clinical Trials Monitor & Trainer anne.m.moore@uhl-tr.nhs.uk R&I Office Leicester General Hospital Telephone 0116 258 4686

Thank You Certificates of attendance will be forwarded to delegates The complete slide presentation will be forwarded to delegates