If a Participant Service/ Item/ Procedure is utilizing BMC space:
1. Enter the study into VelosCT:
1.1. Enter information into the "Summary" tab and towards the bottom enter as many information as possible under the 'More Study Details' section
1.2.Initiate the study entry in VelosCT,
upload the following documents under the "Documents" tab:
Main Documents:
Must have CTA template (draft), Study Budget (draft) or
Funding Sheet and Full Study Protocol in order for CTO to initiate the review
process. ICF needs to be provided before the first round of external
negotiations begins.
Supplementary Documents: (can be provided as needed)
a. IPS Budget (if any); b. FDA IND Letter of Approval or FDA IDE
Letter of Approval (if available); c. Investigator brochure (as applicable).
1.3. After the upload of documents is complete, submit the
Study Initiation eForm under the “Forms” Tab. Once this is done, an email
notification will be received in the CTO Inbox and CTO will begin working on your clinical trial coverage analysis, budget, and contract
negotiation.
A draft coverage analysis will be completed in 12-15
business days if applicable. CTO will seek your and your study coordinator or
designee’s input during this work, and will require your approval on the
final version.
2. CTO to provide next step for ancillary services.
*Training material and videos available online at https://www.bmc.org/research-operations/clinical-trial-office
