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The contract can be signed once the study has received contingent approval from the Institutional Review Board (IRB). This guideline also includes expedited studies.
An investigator can accrue subjects to a clinical trial only after the protocol has received final IRB approval. A clinical trial cannot receive final IRB approval until the contract is fully-executed. (Subject accrual is also contingent upon the policies of the sponsor.)
No, OCTR must negotiate all CDA’s for UConn Health and its faculty. However, the principal investigator must review the CDA. Generally, the principal investigator will also be required to sign.
No, a designated signatory for UConn Health also signs the agreement.
Industry (e.g., pharmaceutical and/or biotech companies and universities) may sponsor or support clinical trials. Cancer cooperative group clinical trials are federally-funded groups that sponsor multi-site clinical trials. Cooperative groups may also be supported by industry/biotech companies.
Federal agencies, foundations, the PI’s institution or department also support investigator-initiated studies.
OCTR negotiates all industry-sponsored and industry-supported clinical trial agreements, including but not limited to industry -sponsored clinical trial agreements, “university to university agreements,” co-operative group contracts, sub-contracts, amendments, investigator agreements, material transfer agreements, letters of indemnification, and agreements for foundation supported clinical trials.
OCTR does not negotiate federally-funded investigator-initiated clinical trials or clinical trials/clinical research in which the Prime Award is in response to a public solicitation (e.g. Request for Information (RFI), Request for Application (RFA), Funding Opportunity Announcement (FOA).
In this instance, the proposals will be negotiated by the staff in Sponsored Programs Services (SPS) .
It is a study that is authored by the principal investigator that purports a clinical trial that was authored by a researcher at the UConn Health or at another academic institution. Generally, these studies are financially supported by industry/biotech companies, foundations, federal agencies, or an academic institution.
If the clinical trial includes John Dempsey Hospital (JDH), University Medical Group (UMG) or Dental charges a Budget Workbook must be done before the protocol is submitted to the IRB. It can be in the midst of budget negotiations at the time of submission. Therefore, a contract for a clinical trial which included such charges cannot be signed without a Budget Workbook being done. If there are no JDH, UMG or Dental charges, a Budget Workbook is not necessary and a memo from OCTR stating such is adequate.
The original is given an InfoEd number stored in the OCTR.
Copies of the contract are retained for the amount of time that is specified in the clinical trial agreement, usually between five (5) and ten (10) years.
If the contract contains “subject injury language” the IRB must review The fully executed contract to compare the subject injury language in the consent and contract before granting final approval.