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.
| Trial Master File Management Policy | SOP: The purpose of this Policy is: • To provide guidance for setting up and maintaining a Trial Master File (TMF) in compliance with the principles of GCP, EU Clinical Trials Regulation (536/2014) the UK Medicines for Human Use (Clinical Trials) Regulations 2004 and subsequent amendments, and other relevant local regulations. • To define the roles involved in setting up and maintaining a TMF and their respective responsibilities. • To provide guidance on the content and format of the TMF. | |
| Tasks for Trial Manager | Document - list: Tasks for a trial manageer | |
| Site evaluation and activation SOP | SOP: The purpose of this Standard Operating Procedure (SOP) is:
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| Informed consent SOP | SOP: This SOP, and associated tools and templates, has been created by the MRC Clinical Trials Unit at UCL and partners for particular trials and studies and for roles and processes specific to this Unit. It may be useful for those in different countries and could be used as a template or example to adapt for other contexts. Country specific regulations, and the needs, resources, expertise and local knowledge in the setting will be important to take into account. | |
| Risk assessment SOP/risk assessment form | SOP: Risk assessment SOP | |
| An introduction to the principles of monitoring | Recorded presentation: A course produced by UKCRC CTU Network. | |
| Safety reporting SOP/safety management plan | SOP: This Standard Operating Procedure (SOP) describes the steps in the process for recording, managing and reporting Serious Adverse Events for Clinical Trials of Investigational Medicinal Products (CTIMPs), where MRC CTU at UCL are responsible for any aspect of safety management. For non-CTIMPs, the SOP will serve as guidance on elements which need to be considered, however, they may not all apply. | |
| Protocol Deviations and Violations SOP/examples of protocol deviations | SOP: The purpose of the Standard Operating Procedure (SOP) is to define and detail the processes for any change, divergence, or departure from study design or procedures as described in the approved study protocol. | |
| Serious Breach, Research Fraud or Financial Irregularity SOP | SOP: This SOP, and associated template, has been created by the MRC Clinical Trials Unit at UCL and partners for particular trials and studies and for roles and processes specific to this Unit. It may be useful for those in different countries and could be used as a template or example to adapt for other contexts. Country specific regulations, and the needs, resources, expertise and local knowledge in the setting will be important to take into account. Some areas of the SOP only apply to the UK and/or EU. |
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| ‘How to be a good trial manager’ | Webinar: How to be a good trial manager |
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