What does CARE stand for?
The Center for Advanced Research Excellence, LLC.
What is CARE?
CARE is a strategic initiative to develop the clinical research portfolio for Tenet in the Florida Region (“Region”). CARE is a limited liability corporation established to provide leadership, oversight and management of clinical research activities.
What are CARE’s goals and objectives?
CARE has been tasked with the centralization of clinical research activities. CARE’s goal is to centralize the management of clinical research activities. CARE’s objective is to develop efficient and effective clinical research processes and to establish strategic partnerships and advance clinical research initiatives in the Region.
What services does CARE provide?
CARE provides central clinical trial management which includes: contract negotiation, data collection, clinical research coordinator support, financial cost analysis, regulatory expertise and IRB study processing, protocol development and study start-up support services (“Services”).
Who does CARE provide services to?
CARE can provide services to anyone wanting to perform clinical research at a Tenet facility or at a clinical practice operated by Tenet. Any investigator not employed by Tenet has the option to contract with CARE for Services. Clinical research studies that involve a Tenet-employed physician as the Principal Investigator that are opened or conducted at any hospital or practice owned by Tenet require submission and processing through CARE.
Can a physician who is not employed by Tenet use CARE services?
Yes. A physician who is not employed by Tenet may utilize CARE Services. However, a physician who is not employed by Tenet is not required to utilize CARE services.
Is a physician who is not employed by Tenet required to use CARE Services for conducting a clinical trial at a hospital owned by Tenet?
What should I do if I have a new clinical research study and request CARE Services?
Contact the Director of Clinical Research for the Region, Dr. Liset Taybo at firstname.lastname@example.org
If I am utilizing CARE Services, who do I contact for assistance with coverage analysis, hospital cost analysis and/or time analysis required for the study?
Contact the CARE Clinical Financial Analyst, Yvonne Mejias at email@example.com
When did this new centrally managed clinical research submission process become available?
March 1st, 2014.
When did hospitals owned by Tenet contract with CARE for Services?
On February 14th, 2014, a Master Hospital Research Agreement between Tenet Healthcare, Florida Region Hospitals and CARE was signed and executed by Marsha Powers, Regional CEO on behalf of the Tenet Healthcare, Florida Region.
What is the expected turnaround time when CARE provides oversight from the initial study contact to study initiation?
The turnaround time is contingent upon the timeliness of responses to requests for information and the availability of all required study documentation.
Does the study require review by the Hospital FRC?
Yes. If a study is taking place at a hospital owned by Tenet, it requires review and approval by the hospital FRC. The study must also be reviewed and approved by CARE’s FRC. CARE’s FRC approval would not be required in the event a study is conducted at a Tenet hospital for a non-Tenet physician.
Who can sign the confidentiality disclosure agreement with the Sponsor?
When CARE is providing oversight of a study, the Confidentiality Disclosure Agreements are to be signed by the Director of Clinical Research, Dr. Liset Taybo who is the signatory official for CARE. In the event the hospital is conducting the study for a non-Tenet physician that does not involve CARE, the CDA is signed by the CEO of the hospital. The individual investigator may additionally sign the CDA in acknowledgement.
Do hospitals owned by Tenet have access to eCATS packages for studies submitted by CARE?
Yes, the hospital will be provided access to any eCATS package which involves a Tenet owned hospital. CARE staff will add the hospital involved to the specific eCATS package granting access to the package for facility review at the hospital required levels.
Does the hospital submit the required CMS (Novitas) study package for review and authorization?
The hospital will submit the Medicare Contractor Pre-approval Package specific to the hospital for Medicare Part A. CARE will be responsible for submitting CARE’s Medicare Preapproval for Medicare Part B. As each party is ultimately responsible to ensure accurate and appropriate billing of study-related interventions, the Medicare submissions are done by the party responsible for the billing claims to CMS.
Where can I access the new CARE FRC policies, procedures and forms?
For electronic copies, contact the CARE FRC Program Coordinator, Lilian Liens at firstname.lastname@example.org
When will the CARE IRB be available for use?
The CARE IRB is expected to begin conducting reviews August 1st, 2014.
Who can use the CARE IRB for oversight?
Any investigator performing or conducting research at a hospital or practice owned by Tenet.
Is use of CARE IRB mandatory for all investigators?
No. CARE IRB oversight will be mandatory when the study involves an investigator employed by Tenet and the hospital does not have its own internal IRB. However, use of CARE IRB oversight by a physician who is not employed by Tenet is not mandatory. A physician who is not employed by Tenet is free to use any IRB he/she desires so long as the facility owned by Tenet has a contract in place with the external IRB.