Requirements and Resources
- Guidance document and risk assessment questions
- Co-Enrollment Prevention SOP Template
- Template Letter to the IRB
- Related frequently asked questions (FAQs)
Co-enrollment Prevention (CEP) SOP Development
Co-enrollment Prevention (CEP) SOPs – timeline
As of October 1, 2021, any current active or in development sites will have 3 months to develop their CEP SOP/process and obtain approval from the IRB/EC or institutional body following the implementation of the requirement.
As of January 1, 2022, any new sites being developed will need to put the SOP in place as part of the OCSO Site Activation requirements.
Communication with Community/Participants
Introduce the concept of co-enrollment prevention checks to study participants while the SOP is being developed, before you implement the new process. Assure participants of the site’s commitment to protecting their safety and wellbeing and educate them on how the new process will strengthen that commitment.
Consult the local CAB for recommendations on how best to communicate any new processes before implementation and seek their assistance in communication efforts.