Care New England Research

Clinical Trials/Industry Sponsored Research

Clinical trials and industry-sponsored projects have their own unique needs. Below you’ll find information specific to the work you do.

Sanction Screening

The purpose of the CNE Sanction & Exclusion Screening for Excluded Individuals and Entities Policy (Policy Number CNE-CC-001) “is to ensure compliance with State statutes and the federal Social Security Act, 42 U.S.C. §1128 which require healthcare providers to perform sanction screenings prior to the hire of employees and independent contractors or the engagement of individuals or entities supplying goods or services.

Sanction screening must be done on all research vendors, collaborators (not employed at CNE), consultants, contractors, CROs, sponsors, or institutions prior to engaging in contract discussion.

Research participants are considered patients for the purposes of sanction screening and do NOT need to be screened.

More information can be found here.

Budget and Protocol Review/Negotiation

Budget Review

In most cases, the sponsor will provide a draft budget that includes all reimbursable procedures, services, and personnel along with the proposed reimbursement. Each line item within the proposed budget needs to be carefully reviewed to determine if it is feasible from an operations perspective and also to assess our organization’s actual cost as compared to what the sponsor proposed.

It is also critical to ensure that reimbursement for PI and research personnel effort is reflective of the actual cost and that consideration is given to fees assessed by other service areas (eg IRB, Pharmacy, Lab, etc). Examples of costs incurred by our organization that a sponsor may not include in their original budget proposal include:

Start-up fees
Document retention and archiving
Study team reimbursement for amendments and annual IRB renewal
Reimbursement for screen failures

Budget Negotiation

Preliminary budget negotiation between the PI and the technical contact for the sponsor is encouraged. However, PIs should reach out to SPRA for established rates for fringe and facilities and administrative costs.

The Principal Investigator should not attempt to negotiate rates for facilities and administrative costs (or fringe benefits) that are different from the federally-approved rates for CNE and Affiliates, nor should it be implied that a reduction in the approved rates would be acceptable to CNE. Contact OSPRAward@carene.org if the sponsor indicates they do not wish to pay fully approved rates.

SPRA/Legal Contract Review and Execution

Coming Soon

Clinicaltrials.gov

**Although most industry-sponsored clinical trials are registered by the study sponsor, it is the responsibility of the CNE site principal investigator to ensure trials conducted at CNE sites are registered with accurate information at clinicaltrials.gov. The CNE Site PI should request the NCT number from the industry sponsor for their records and for inclusion on study-related Medicare claims as required by CMS regulations. Visit clinicaltrials.gov

Holdback

Industry sponsor contracts typically include a holdback clause that allows them to hold a certain percentage of payment until the completion of milestones or queries. When assessing the holdback rate, it is important to consider trial specifics, such as length of follow-up. As a general rule, PIs are encouraged to negotiate a holdback of less than 10%.

Manual invoicing

PIs are responsible for preparing invoices for items and services that not automatically invoiced as part of the terms and conditions of the contract.

Biospecimens

There are specific rules and regulations related to working with biospecimens. More information can be found here.

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