Copy of FDA Investigational Device Exemption letter from sponsor if study involves an investigational device
Copy of the Clinical Trial Agreement and budget if it is a sponsored study
BSLMC Administrative Review Process
New protocol available for review in iRIS with Melissa Cates added as Administrative Assistant (instructions below).
BSLMC Dept. of Research sends an email to PI and Contact listed in iRIS submission to initiate review process. The Administrative Review Application (2 page) is attached in email.
PI emails or faxes Administrative Review Application back to BSLMC Dept. of Research.
BSLMC Dept. of Research scans the Protocol Summary, Informed Consent and Administrative Review Application and emails the document to the Administrative Review Committee, (Nursing Administration, Pharmacy, Radiology, Pathology, Legal, IRB Chair, Director of Clinical Research.) The protocol is also sent to the appropriate Service Chief.
Research Operations Specialist routes the protocol to all other applicable departments, Managers of all areas that will be affected by the protocol, Medical Records, Patient Financial Services, Patient Access Services.
The budget and/or contract is reviewed to ensure billing compliance of any tests and services paid for by the research grant or industry sponsor.
All necessary research accounts are set up, approval of Medicare coverage is obtained for Investigation Devices Exception protocols.
Once approval of the IRB Chair, Service Chief and all departments is received an approval letter is sent from the BSLMC Director of Clinical Research to the PI and contact person via email.
For studies that will be using Research Contract Accounts or Research Plans, a meeting will be scheduled with the Dept. of Research to review the billing process.
ST. LUKE'S MEDICAL CENTER | 6720 Bertner | Houston, TX | 77030 USA | Telephone: 832-355-1000