Standard Operating Procedures (SOPs) should be developed for all aspects of study conduct and management in order to ensure that studies are conducted and data generated, recorded and reported in compliance with the protocol, the principles of GCP and applicable regulatory requirements. SOPs should be a set of clear and concise written instructions, designed to ensure that performance of an activity is standardardised, regardless of who is carrying it out
Template SOPs associated with an Investigational Medicinal Product (IMP), and include the receiving of, and disposal of an IMP, and temperature recording.
Monitoring involves overseeing the progress of the study in order to confirm that:
• the rights and well-being of participants are protected. • the data are accurate, complete and verifiable from source documents, where the source document is not the CRF itself. • the study is conducted in compliance with the current approved protocol, SOPs, the principles of GCP and regulatory requirements. The extent and nature of monitoring should be proportionate to the risks to participants, the organisation and/or data quality and results, as determined in the risk assessment carried out at the planning stage.
Through this facility research sites can register and let would-be collaborators and sponsors know about them, their previous experience and what type of research they would like to take part in. In turn, research groups wishing to find other sites to collaborate with can post their research plans and explain what they are looking for in terms of disease prevalence perhaps, or was facilities a research site has.
These free, certificated and recognised courses are provided to give a general introduction to many of the key steps involved in setting up a study they include short topics such as Good Clinical Practice, Good Laboratory Practice and longer modular courses and cover many of the required steps such as setting the question, data management and community engagement.
The Process Map is a cross-cutting tool that guides the process of setting up a study and provides links to explanations about each component step and any tools, templates and training that exist on each step.
