STUDY DOCUMENTATION REQUIRED WITH APPLICATION SUBMISSION Attached N/A Protocol Attached N/A Informed Consent (draft or approved), if applicable Schedule of Events for all procedures. Must indicate which procedures take place at BSLMC and include CPT codes for outpatient procedures and ICD-10 for inpatient Attached N/A procedures. Must indicate which procedures are paid by research and which are standard of care, and be signed by principal investigator. Attached N/A CITI training certificates for all non-BCM/BSLMC listed personnel ADDITIONAL DOCUMENTS Attached Copy of IRB approval letter. Not required at time of administrative application submission but must be submitted before administrative approval is issued. Pending Attached Drug studies must attach the investigator’s brochure, if available. N/A Attached Imaging protocol and/or pharmacy dispensing protocol (if applicable) N/A Attached Request for Clinical Research Center Support N/A Attached Supplement for Studies Managed by Catholic Health Initiatives Institute for Research and Innovation (CIRI) N/A Attached List of CHI study sites, not including BSLMC N/A DEPARTMENTS/AREAS & REGULATORY COMMITTEES Check all that will be utilized for this study. Note: each utilized area must administratively approve before BSLMC administrative approval can be given. Include a brief (1-3 sentences) description of activities that will be conducted, anticipated number of patients to be seen in the area and how area staff will be impacted. For clinical areas, indicate if research visits will be part of the normal clinical workflow. Special Regulatory Committees - Lasers: Describe work to be performed
STUDY DOCUMENTATION REQUIRED WITH APPLICATION SUBMISSION Attached N/A Protocol Attached N/A Informed Consent (draft or approved), if applicable Attached N/A Schedule of Events for all procedures. Must indicate which procedures take place at BSLMC and include CPT codes for outpatient procedures and ICD-10 for inpatient procedures. Must indicate which procedures are paid by research and which are standard of care, and be signed by principal investigator. Attached N/A CITI training certificates for all non-BCM/BSLMC listed personnel ADDITIONAL DOCUMENTS Attached Pending Copy of IRB approval letter. Not required at time of administrative application submission but must be submitted before administrative approval is issued. Attached N/A Drug studies must attach the investigator’s brochure, if available. Attached N/A Imaging protocol and/or pharmacy dispensing protocol (if applicable) Attached N/A Request for Clinical Research Center Support Attached N/A Supplement for Studies Managed by Catholic Health Initiatives Institute for Research and Innovation (CIRI) Attached N/A List of CHI study sites, not including BSLMC DEPARTMENTS/AREAS & REGULATORY COMMITTEES Check all that will be utilized for this study. Note: each utilized area must administratively approve before BSLMC administrative approval can be given. Include a brief (1-3 sentences) description of activities that will be conducted, anticipated number of patients to be seen in the area and how area staff will be impacted. For clinical areas, indicate if research visits will be part of the normal clinical workflow. Special Regulatory Committees - Lasers: Describe work to be performed