This reading list draws together resources that we think will be helpful if you are working as an on-site clinician 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 | |
| Clinical input in MRC CTU at UCL Trials SOP | SOP: Clinical input in MRC CTU at UCL Trials | |
| 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.. | |
| PIS template | Template from SOP This document is associated with the Informed Consent SOP. | |
| Safety reporting | SOP: Safety Reporting SOP and Safety Management Plan (from Safety Reporting SOP) | |
| 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. | |
| What is patient and public involvement? | Video: What is patient and public engagement? |
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