This post brings clarity to the concept of research-related procedures in regards to the scientific protocol document, eProtocol application, and consents. Research-related procedures should be handled in a consistent manner, regardless of whether or not it is a radiation procedure or a non-radiation procedure. The key understanding of research-related procedures is very basic, ie, any procedure that a study participant would not normally undergo if not participating in a research study. This means that a procedure that could normally be conducted would be handled as normal or regular medical care in eProtocol and the consent, and that a procedure that would not normally be conducted, or is conducted at excess frequency, will be handled as research-related procedures (RRP). RRP required adequate disclosure in the eProtocol application and consent document, including a complete and accurate discussion of the risks of the research-related procedures.
When CCTO-Regulatory is requested to assist with an eProtocol application, modification, or consent, we may ask the Protocol Director / Principal Investigator to confirm or identify which procedures are research-related.
Please also note that these definitions do not use nor include the term “Standard of Care / SOC.” SOC refers to a procedure that is conducted according to the standards of Stanford Medicine, and neither includes nor excludes that a research subject would normally undergo the procedure. It is common for research studies to include research-related procedures that are to be conducted according to the standards of Stanford Medicine (ie, SOC), but the procedures either would not be conducted except for the study, or will be conducted at excess frequency. The fact that these procedures are conducted according to “SOC” does make them regular care, ie, not research procedures. All procedures that are not part of regular care, or more frequent than standard care, are research-related procedures. The determination of whether a procedure would normally be conducted, or is conducted at normal frequency, is the doctor’s medical decision, per ICH E6(R1-2) GCP. Depending on the study, the doctor may make this decision independently, or may concur with the proposal of others, such as an industry sponsor or the Ankura coverage determination.
For questions, please contact CCTO-Regulatory@Stanford.edu.