Jessica I appreciate your input that stakeholder engagement is not limited to time but an ongoing, “live” process. Now the final protocol is with you it has gone through you regulatory process and ready for recruitment. The challenge this poses is that the mother brings this participant to study ques for the process. The mother then goes to another health care provider for her medical attention.
Now because the protocol only provided a budget for treatment of participants for study related harms/injuries and minor ailments, upon consultation can stakeholders require that mothers too should be treated and ask the sponsor to review the budget? How can this be enforced to comply with GPP?
