SC Liver Research Consortium FAQ's


	FREQUENTLY ASKED QUESTIONS Click on question to display answer How do you consistently beat study milestones? SC Liver Research Consortium holds master contracts with 71 consortium sites, allowing Sponsors to easily negotiate a single contract and single budget with SCLRC. This greatly expedites the contract and budget negotiating process across the consortium sites, thereby speeding up the study start-up process and getting sites initiated for study enrollment as quickly as possible. We can offer you one or all of our sites (you decide) for your enrollment. How do you streamline the whole process? We keep site dossiers for all 71 sites with regulatory documents for each Principal Investigator. CROs or Sponsors can get exactly what they need from one place, by using SCLRC as the single point of contact. Having regulatory documents before the investigator meeting takes place, in addition to having all sites under master agreement, has proven invaluable to our associates. If I enter into an agreement with SCLRC, am I committed to only using SCLRC sites for my trial? No. You can use all our sites, some of our sites, or just a few. For example, if you had a partially-enrolled trial with sites dropping out unexpectedly, you could make up the difference in anticipated study enrollment by getting SCLRC involved. Or, if you are behind on your enrollment goals, and need to enroll quickly, you can select all of our sites in order to reach study milestones. Do you have a master agreement template? Yes. Once we begin a dialogue with a Sponsor, with CDAs in place, we forward you a template of our master agreement. Our master agreements, with regard to contract language (data ownership, confidentiality, publication, etc.), are basically the same from site to site; standard academic/medical center language. As long as the Sponsor does not request drastic changes, the contracting process is very efficient. How does the contracting process work? SCLRC negotiates a single contract with the Sponsor. We then assist the Sponsor with selecting the sites that will best meet their study needs. With a contract in place, our Contracts Officer contacts the individual sites with Riders (protocol, budget and investigator disclosure specific to that clinical protocol). Master agreements are already in place with our sites, so contract negotiations can begin right away using this method. This has made it possible for Sponsors to regain ground on a study that is falling behind or leap ahead with a new study. Do your sites have a different contract with SCLRC compared to the Sponsor's contract with SCLRC? Some site's master agreements have minor differences. The differences in contracts usually occur in the areas of publishing and indemnification. Some sites want specific indemnification with the Sponsor. We are flexible about customizing the protocol riders as long as the Sponsor keeps in mind that our ability to promise and deliver results with speed depends upon the protocol rider not requiring too many changes. What is your relationship with CROs? One of the reasons we work so well with CROs is that we do not compete with them. Since sponsors usually contact us in the early stages, we are sometimes asked to suggest or select a CRO. Once a CRO is in place, we meet in person or via teleconference and clarify the responsibilities for each party. How do you determine the patient population availability? We query our investigators and patient databases to provide Sponsors with an accurate representation of what the SCLRC sites have to offer. How soon can you generate a proposal? SCLRC can generate a study proposal as soon as a CDA is in place, a final draft of the protocol is available, and a study timeline and number of sites or total patients is established. SCLRC can typically draft a proposal within 1-2 weeks. If another company came to you with a similar drug or competing study, would you decline? If a new study proposal would compete with enrollment of an ongoing SCLRC study, we would turn the new proposal down. It reflects very poorly on an investigator if they have two studies competing for the same patient population. We frequently turn down similar studies. We are sensitive to this issue, as well as the issue of confidentiality. How do you handle non-performing sites? Sites in the consortium are carefully selected based on their reputation for successfully conducting research. We keep track of performance metrics for each consortium site, and also perform routine site visits. This lends to first-hand knowledge of each site's research capabilities. Besides budget and contract help, what else can you provide? Highly motivated Principal Investigators Project Management (site payments, IRB submission assistance, problem resolution) Hold IND (original submission packet, report SAE's and write the annual report) CRO Collaboration Up-to date regulatory documents Design and/or review protocols Organize Advisory Board and/or Investigator Meetings Continuing Medical Education – Annual Hepatitis B&C Infectious Disease Training Program and End Stage Liver Disease Program offered in multiple cities nationwide