Startup timeline

Site Start-up Timeline Expectations

Site Selection

1 RCC sends site selection survey.

Deadline: 3 weeks

2 NCC sends commitment letter if site selected to participate.

Email will include trial synopsis, trial budget and timeline for CTA and regulatory packet.

Clinical Trial Agreement

1 NCC Contracting sends CTA.

Email will include CIRB approval letter and notice for single IRB. CTA includes the payment schedule and statement of work.

Deadline: 6-8 weeks

2 If CTA not completed within twelve weeks, or otherwise communicated timeline, the trial PI may decide to drop site.

Regulatory Packet

1 NCC Regulatory or NCC PM sends regulatory packet.

Email will include ICD template, local context or investigator form and FDA forms, if applicable.

Deadline: 6-8 weeks

2 If regulatory packet not completed within twelve weeks, or otherwise communicated timeline, the trial PI may decide to drop site.