Contracts and Budgets Terms
This is the set of limits we work within while negotiating budgets before requiring additional escalations.
What are the budget parameters?
This is a stand-alone agreement which is used when a site declines execution of a Master Clinical Trial Agreement, and is specific to a particular study and Principal Investigator.
What is the Clinical Trial Agreement (CTA)?
This checklist is sent to the CLM in conjunction with the US budget development providing info such as SF rates, site invoiced costs, central vendors, and number of sites on the trial.
What is the Budget Initiation Checklist?
This group prepares the initial study budgets for the US, along with the rest of the world to use for our trials.
Who is Global Contracting and Budgeting (Donna's Group)?
This manager grew up in the same home town as Martha Stewart and enjoys starting their day hiking with their 2 dogs Oliver and Norman.
Who is Jason Franschman?
This is the percentage added to budget items to cover a site's ongoing business expenses not directly attributed to clinical trials.
What is Overhead?
This agreement protects the DISCLOSURE of CONFIDENTIAL information.
What is the Confidential Disclosure Agreement (CDA)?
This TEAM (of peers) is your first resource for questions regarding internal processes and any other daily how-to's and what's next questions
What is The Site Services Team and Managers?
This is our Bayer Legal representative who establishes all budget parameters for new studies as well as reviews any and all contract and budgeting legal issues.
Who is Gary Coe?
Having visited 40 US states, this manager survived being caught in a rip tide for over three hours while visiting Hawaii.
Who is Zari Anthony?
This section of the protocol will have the majority (but not necessarily all) of the info used in developing the study budgets... procedures, visit info, etc.
What is the Schedule of Activities (SOA)/ Visit Schedule?
This agreement is valid for five years (Term), from the date of the last signature on the Agreement and is the governing document for ALL studies the site participates in during the Term.
What is the Master Clinical Trial Agreement (MCTA)?
This TEAM works directly with the Study Manager to develop the initial Global Study Budgets.
Who is the Global Budgets Team?
Say a site requests a fee not listed on our original budget and has provided back-up documentation, this study team role is your first level of escalation.
Who is the CLM?
This manager is the youngest of 8, has had 2 pet tarantulas... yet has fear of birds.
Who is Gennie Blank?
This database houses Clinical Contract Group documents (contracts, budgets, amendments, exhibits, etc.) and facilitates the internal exchange between the Site Services and Bayer U.S. Legal.
What is the eRoom?
This Agreement is used for a study associated with a Contract Research Organization (CRO) and is a Study-Specific Agreement. It must be accompanied with the “Non-Master Study-Specific Exhibit Template” which is customized and pertains to a particular study and Principal Investigator (PI).
What is the CRO Clinical Trial Agreement?
This TOOL is set at FMV high +35% and is your set of limits you can negotiate up to before requiring additional approvals.
What is our Negotiation Parameters?
This person reviews and approves our US Core FMV Budgets in a meeting with (formerly) the CCS and CLM approving overall study budget for all US sites.
Who is Amy Scheiss?
This manager enjoys playing online computer games in their (little) free time, and recently discovered their fear of heights while hiking on vacation.
Who is Lars Buggert?
We currently have 8 POD Institutions, in which we have dedicated study team personnel assigned for each site. Name 3..
Who is:
USOR, Johns Hopkins, Colombia, Sarah Cannon, MD Anderson, Dana Farber, Memorial Sloan Kettering, and START (South Texas Accelerated Research Therapeutics)?
This agreement is for use with any VA (Veterans Affairs) sites, and is provided by the VA at the beginning of negotiations.
What is the Cooperative Research & Development Agreement (CRADA)?
This TOOL is not only used (by the Global Budget Team) to initially develop our budgets, but it also receives the final FE budget info to incorporate rates into future budget builds.
What is Grants Manager/ MediData/ Edge Site Grants (ESG)?
Only this person can approve budgets over $5M, as long as Jorge Barreras has already approved.
Who is Ganesh Kamath?
While in the Army for Basic Training (in Fort Jackson, SC), this manager was sent home after blowing out a knee.. where they 'celebrated' their 21st birthday at scenic Fort Dix, NJ.
Who is Renee Creo?