The industry contracting group manages the negotiation, execution and account setup for clinical trials, including industry-sponsored or investigator-initiated protocols as well as trials initiated by non-industry entities (e.g., universities).
BU researchers should contact the industry contracting group at industry@bu.edu as early in the process as possible; preferably as soon as an industry study has been identified or as soon as a sponsor or contract research organization has approached a BU researcher for potential participation as a clinical trial site.
A typical industry clinical trial agreement request should proceed according to the following pathway:
Preliminary step, CDA negotiation
- Documentation Submission to Industry Engagement by Principal Investigator (PI)
- DA Request Form
- Draft Sponsor CDA
- Contract Negotiation by ICA
- Acknowledgment of document receipt
- Review, Redline & Negotiate CTA with sponsor
Documentation Submission to Industry Engagement by Principal Investigator (PI)
Contract Negotiation by Industry Engagement
- Acknowledgement of document receipt
- Review, Redline & Negotiate CTA with sponsor
- Informed Consent Forms Subject Injury Language
Parallel Actions by PI
- Budget negotiation:
- BMC – pricing and Medicare Coverage Analysis (MCA), required for studies using hospital resources
- Sponsor – PI is responsible for negotiating budgets with the sponsor
- IRB Submission
