We create a tool called “CO SOP list” at CO which can be used for study teams to start with to generate their study specific SOP list. However, we’re also struggling on a few points below:
a. Do company level general SOPs applying for all employees should be listed? E.g. Quality policy, quality manual?
b. We might be able to ensure for all SOPs owned by CO/Medical/PV/Drug Supply (which are crucial to clinical study operations) to be covered and up-to-date, but not able to cover SOPs that applying for/coming from all cross-functions, e.g., should their applicable SOPs be included as well?
c. We’re sure that if there’re outsourced services but adopting our internal process, then relevant SOPs should be listed as for contractors’ training requirements, but how about fully in-house studies? Is it necessary cuz all the members will receive the standard SOP trainings?