Protocol Development

To support the development and implementation of clinical trials at YCC, tools and expertise are provided to investigators. Templates are provided for clinical protocols and consent forms, to assist clinical investigators in the development, editing and formatting of clinical protocols, coordinates the budgets, contracts, IND (if applicable) and protocol approvals, and maintains an on-line web based protocol and consent retrieval system for YCC.

The YCC IIT Advisory Committee is charged with the reviewing all cancer and cancer-related, investigator-initiated, clinical trials proposed at Yale. The IIT Advisory Committee has a two-phased review. The initial review is at the concept level. This review should be done as soon as an Investigator begins considering an IIT. The second review is after the protocol is developed. The IIT Advisory Committee’s review encompasses the project’s scientific impact, proposed design, participant enrollment and impact on local patient needs, as well as considerations for engagement of external funders and collaborators, financial factors, and regulatory implications.

The IIT Advisory Committee functions to assign Investigators resources to support development of IIT protocols, and corresponding protocol documents, as well as to connect investigators to staff who will assist in the regulatory, administrative, and operational steps towards trial initiation. For additional information please visit YCC IIT Advisory Committee