This reading list draws together resources that we think will be helpful if you are working as an on-site clinical nurse on a trial. It is not an exhaustive list but rather a recommended package of resources.
| Operational overview – SOPS and trial toolkits | Slides: Operational overview – SOPs and trial toolkits | |
| Informed consent SOP | SOP with templates: 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.. | |
| Informed consent form template | Template from SOP: This document is associated with the Informed Consent SOP. | |
| PIS template | Template from SOP: This document is associated with the Informed Consent SOP. |
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| CRF and worksheet development and maintenance SOP | SOP: The purpose of this SOP is to outline procedures, roles and responsibilities for developing and maintaining Case Report Forms (CRFs) to facilitate optimal data collection and quality which meets the requirements of the study protocol. | |
| CRF Completion Guidelines Template | Guideliness template: 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. | |
| Protocol deviations and violations SOP | 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. | |
| Guidance notes on completion of SAE form | Guidance: This document is associated with the Safety Report 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. |
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| What is patient and public involvement? | Video: What is patient and public engagement? |
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