Facilitate Contract Preparation

Key Reminders for Industry-sponsored Trials

• It is very important to initiate the budget and contract process in tandem with submitting for scientific and IRB approval. A study cannot commence until all institutional approvals (including a final CTA and budget) are in place.
• Please remember that when amending your study through the IRB, the contract/budget may also need amending. For studies which are live in OnCore, a SIFTER amendment should be submitted to request such changes.

Investigator-Initiated Studies

Typically, investigator-initiated studies may only involve CHOP faculty or other collaborating institutions that require subcontracts with these institutions. Pre-Award Research Administration facilitates this process through eSPA and assists the research community with applying for, negotiating, and managing externally sponsored research funding (government or foundation grants, contracts, etc.). They also serve as a primary interface with federal and not-for-profit sponsors and with peer institutions that collaborate with CHOP researchers.

• Work with your Research Business Administrator (RBA) and/or your division's Administrative Director to ensure sufficient funds are available to cover the cost of your trial and an appropriate agreement is in place. This should include appropriate amounts of effort for PI and Staff time.
• If you are preparing for a grant submission and the study has billable patient care services (including CHPS services), please ensure that a Pricing Request is submitted to CTFM via eSIFTER in eIRB to accurately capture the cost of the patient care services. Pricing Requests will be prepared by CTFM within OnCore.

Sponsored Projects Officers (SPO) assist with the submission of proposals and other non-financial grant-related activities. The Grants and Contracts Specialists issue outgoing subawards and research consulting agreements, as well as negotiate incoming subawards. The Pre-Award office is responsible for government, foundation, and other non-industry sponsors.

Please see Pre-Award Research Administration for more information and how to find your Sponsored Projects Officers or Grant and Contracts Specialists.

Key Reminders for Investigator-initiated Studies

• It is very important to initiate the budget and contract process in tandem with submitting for scientific and IRB approval. A study cannot commence until all institutional approvals (including a final CTA and budget) are in place.
• Contracts for investigator-initiated studies that are funded, directly or indirectly, by a for-profit industry sponsor are negotiated by CRCA.
• CRCA is not responsible for:
  • Retrospective data studies without prospective elements/subject contact.
  • Non-industry funded clinical trial agreements.
• The IRB webpage contains helpful information on study protocol creation, including protocol templates. For more information, please see Compile IRB submission, below.
• IRB fees are not typically charged for investigator-initiated studies.
• Please remember that when amending your study through the IRB that the contract/budget may also need amending.
• A clinicaltrials.gov record must be created by the Sponsor of any applicable clinical trial (ACT), as defined in 21 CFR 50.3, or for any NIH-funded clinical trial. Journal publication requirements may mandate registration of other research projects. The Office of Research Compliance (ORC) serves as the institutional Protocol Registration and Results System administrator for Clinicaltrials.gov. Determine whether your study requires registration or results reporting on clinicaltrials.gov. For further information please email ORC@chop.edu