Things that are required to include in CRO oversight activities are given as follows:
1. CRO oversight plan:
Sponsor organizations should ensure to have an oversight for the payments they are paying to CRO for their study trials because at the end of the studies, sponsor organizations are accountable in front of FDA for the conduct of clinical study.
2. Kick-off meeting:
Sponsor companies should have an initial kick-off meeting as oversight activity when they are fully outsourcing their trials. These meetings should include the discussions as follows:
· Key milestones and deliverables.
· Looking at the priority documents, protocols, systems and the processes going to be used in the trials.
· As Sponsor Company, they should have proper understanding of the SOPs of the CRO companies for their studies.
· Talking about the roles and responsibilities from both sponsor and CRO side throughout the conduct of the study.
· Discussion for the communication plans.
· Discuss the scope of the CRO work.
3. Create risk management plan:
Sponsor companies should create their own risk management plan by listing out the risks by having that information from the CRO. This will help them to know and understand all the processes and issue that can arise during studies and how they can overcome those barriers.
4. Standing meeting:
Sponsor organizations should have standing meetings after paying CRO for conducting the study, in order to have continuous monitoring. This standing meeting should include aligning action item log, the decisions being made and the risks involved in study. The lasts minutes of the standing meeting can be utilized to make the meeting minutes for all the performance and decisions been made.
This standing meeting saves a lot of time that goes waste in correcting and reviewing the meeting minutes.
5. Lesson learned meeting:
Having a lesson learned meeting as an oversight activity at the end of the study is very important that helps to review the processes and progress of the study in a work relationship between CRO and sponsors. This involves the reviewing of metrics and KPIs and it is helpful in order to make further improvements in future.
These are the oversight activities that companies should be perform in order to make their study successful and it also helps in building a healthy CRO-Sponsor relationship.