Appendix B sets out what a clinical trial protocol and its amendments should generally contain: general information (title, identifiers, sponsor and investigator details), background (product, nonclinical and clinical findings, risks and benefits, population, references), objectives and purpose, design (primary and secondary endpoints, design type including adaptive, platform or decentralised designs with a schematic, randomisation and blinding against bias, product, dosage, form, packaging and labelling, preparation and administration, schedule of events, durations, stopping, discontinuation and dose adjustment rules, product accountability, code maintenance and code breaking), selection of participants (inclusion and exclusion criteria, pre-screening and screening), discontinuation of intervention and withdrawal, treatments and permitted or prohibited medications and compliance monitoring, efficacy and safety assessment (parameters, methods, timing, adverse event recording and reporting), statistical considerations, and the further sections on direct access to source records, quality control and assurance, ethics, data handling and record keeping, finance and insurance and publication policy, as applicable.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.