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 (CRO) 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 ICA by Principal Investigator (PIPrincipal Investigator
View Boston University's policy on...)
DA Request Form
Draft Sponsor CDA
Contract Negotiation by ICA
Acknowledgment of document receipt
Review, Redline & Negotiate CTA with sponsor
Documentation Submission to ICA by Principal Investigator (PI)
Copy of Assurances (IRB, IACUCInstitutional Animal Care and Use Committee
IACUC oversee..., etc.); if pending review, please provide proposal number and submission date