Clinical Trials
Clinical Trials Office
The Clinical Trials Office provides the Children's research enterprise with comprehensive contract and budgeting services for industry sponsored and investigator-initiated clinical trials, from the initial negotiation phase through contract execution.
Getting Started:
The CTO process begins with any of the following supportive documents, or by contacting the CTO directly. Please submit the documents via email to allison.hannibal@childrens.harvard.edu.
- Protocol
- Informed Consent Form
- Proposed Contract from Industry Sponsor
- Proposed Budget from Industry Sponsor
If you have any questions, please contact us at 617-919-3231.
Process:
CTO Process Diagram
The CTO is responsible for:
- Contracts:
Negotiation and management of industry sponsored research agreements including, Material Transfer Agreements (MTA), Clinical Confidential Disclosure Agreements (CDAs), Clinical Research Collaboration Agreements, and Clinical Trial Agreements (CTAs). Click here to learn more about the importance of CDAs and MTAs.
- Budgets:
Development and negotiation of industry sponsored research study budgets for all clinical research study subject care, intervention or observation.
- Study Tracking Sheets:
Developing study tracking sheets (“STS”) for all studies involving study subject care, intervention or observation using CHB services. Study tracking sheets serve as the documentation for applying each patient’s research service rendered to the appropriate fund.