This reading list draws together resources that we think will be helpful if you are working on setting up a trial. It is not an exhaustive list but rather a recommended package of resources. The list includes slides, a recorded webinar, a video, example documents, and Standard Operating Procedure documentation with example templates. 

 

 

Introduction to clinical trials from concept to management Lecture slides: An introduction to clinical trials from concept to management by Lizzie George, Statistician at MRC Clinical Trials Unit.

Team Science – the importance of the team in clinical trials Lecture slides: An introduction to Team Science and the importance of the team in clinical trials by Anna Griffiths, Clinical Project Manager at MRC Clinical Trials Unit at UCL, UK.

How to be a good Principal Investigator Recorded webinar: A webinar on how to be a good Principal Investigator by Dr Duncan Gilbert, Consultant Clinical Oncologist and Senior Lecturer in Cancer and Clinical Trials at MRC Clinical Trials Unit at UCL, UK. 

Tasks for Trial Manager Document - list: A list of tasks for a Trial Manager.  

Clinical Input in MRC CTU at UCL Trials SOP Document + tools/templates:  The purpose of this Standard Operating Procedure (SOP) is: To define the aspects of clinical trials conducted by MRC CTU at UCL where clinical expertise is required; To define the training requirements for clinicians involved in CTU trials; To describe how and where clinical input into trials should be documented.

Example of costing template Document: This is an example of a costing template used by trials at MRC CTU. It may be useful as an example for centres and organisations who are new to clinical trials. 

Trial Oversight Committees Lecture slides: An introduction to Trial Oversight Committees by Matthew Sydes at MRC Clinical Trials Unit. 

What is Patient and Public Involvement? Video: This film explores how patients and the public can work together with doctors and researchers on clinical research. There are many different ways this is done. In this short film, three of our patient representatives talk about their experience of being involved in clinical trials. 

Site Training SOP Document + tools/templates: The purpose of this Standard Operating Procedure (SOP) is: To define the roles and responsibilities involved in the site training process; To outline the procedures for study specific training of investigator(s)/site staff in order to ensure that: Investigator(s) are qualified by training to conduct the study; Investigator(s) have the required information to assume responsibility for the enrolment of eligible patients and for the conduct of the study in accordance with the protocol and applicable regulations. This includes training the site staff on their responsibilities and updating training requirements as deemed appropriate; Adequate information/training is provided to the investigator(s) and site staff. To ensure training needs at sites are identified and fulfilled; To ensure training has been documented by both Sponsor and Site. 

Statistical Principles SOP Document + tools/templates: The purpose of this Standard Operating Procedure (SOP) is: To outline statistical principles and considerations in the design, conduct, analysis, and reporting of intervention studies (trials). Some but not all points are also relevant to observational studies; To define the role and responsibilities of the Trial Statistician and interactions with other members of the trial team. Access to statistical expertise is essential throughout the design, conduct, and analysis of the trial.  

 

 

 

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