Game,

In my experience requesting IRB approval is the final administrative and/or planning activity undertaken to conduct a clinical trial. Although not an exhaustive list, prior to recruitment of the first subject into the study, Cardiogenics may/will have:

1. identified, organized and established their research team (IMO a CRO has been hired)
2. identified collaborators and clinical sites (Wayne State hospitals)
3. collected and reviewed data on the pool of patients from which recruitment will occur
4. defined in writing the recruitment strategy(ies) to be followed
5. crafted the study protocol, clinical investigators brochure and Manual of Operating Procedures (reviewed by Wayne Sate IRB)
6. established a data and safety monitoring plan (reviewed by Wayne State IRB)
7. crafted tools for data collection and data management (reviewed by Wayne State IRB)
8. assembled materiel required to conduct the trial, i.e. POC analyzers and troponin 1 cartridges (reviewed by Wayne State IRB)

Communications issued by Cardiogenics lead me to believe the company has submitted an application to the FDA for an Investigational Device Exemption (IDE) and that both POC analyzers and troponin 1 cartridges have been manufactured. With IRB approval, the Prinicipal Investigator under contract, hospital personnel participating in the study trained or being trained on how to conduct the trial in their facility; patient recruitment should begin shortly.

Ante