1) Give an example of successful stakeholder engagement in protocol and/or IC development. What changes were made as a result of the input gathered?
Answer: Our CAB never suggested on protocol. They just asked some information and made understanding. However researcher gathered their questions and edited some on protocol. Most of them concerned on ICF and media. They commented and suggested about language we used and illustrated. Researcher agreed with them and tried to adjust as their recommend. The issue that researcher cannot change are target population in the study. One thing we cannot edit is target population. They often suggested to do not mention” low risk population or high risk population” and “volunteer who positive or negative”. They said that it should be discriminate for the one who cannot enroll in the study.
2) If a protocol gets sent to your trial site in final form, how would you address the GPP recommendation for stakeholder involvement in protocol development?
Answer: Even though the protocol was finalized, our investigator provides protocol to CAB for review. All of our sponsors concern about community engagement so we can make amendment on protocol after CAB reviewed and asked for some information. All of sponsor can accept the amendment. However CAB never suggested about risk from invasive procedure or intervention. I hope they can do in the future.
