Anti IL5 and Churg Strauss Syndrome: a double blind, placebo controlled trial

Project: Research project

Project Details

Description

SCOPE of WORK

The scope of work for each local site principal investigator (PI) has two major parts. The first part (called core responsibilities) lists duties that are independent of the number of patients enrolled. Core responsibilities are listed below and represent a 2.5-5% effort commitment by each site program leader (and/or associated physicians). The second part (called patient related responsibilities) involves duties directly related to the actual number of patients enrolled and per patient reimbursement is based on time spent. All responsibilities are for the duration of the grant (4 years).
For Drs. Bochner at Northwestern University, he will not be recruiting patients from his practice. Instead, during years 1 and 2 he will be developing a novel ELISA to measure levels of soluble Siglec-8 in serum samples collected at other clinical sites. Although he has previously published on a surface plasmon resonance-based assay to measure this, Dr. Bochner needs to improve the sensitivity of the assay by converting it to a true ELISA. This will require the generation of a new pair of capture and detection anti-Siglec-8 antibodies and validation of the assay in the early years of this grant.

Northwestern PI core responsibilities include:
1. Ensuring that all associates, colleagues, and employees assisting in the conduct of the trial are informed about their obligations
2. Maintaining the necessary infrastructure and trained personnel to properly conduct the study
3. Administrative work related to general study concerns and adherence to associated deadlines
4. Participation in regular teleconferences and meetings
5. Frequently communicating and actively participating with staff at the institution, administrative core at National Jewish Medical Center in Denver and the Data Coordinating Center to discuss the status of the grant and to complete any outstanding items
6. Reviewing and providing feedback in a timely manner for all grant-related documents
7. Agreeing to abide by the data sharing plan as outlined in the grant application
8. Conducting research in an ethical and honest manner
9. Participating in mechanistic studies (Bochner lab)

PI patient related responsibilities include the following tasks:
Not relevant to Dr. Bochner as there will not be any patients recruited at Northwestern University.

Clinical Research Coordinator (CRC) and their roles
Not relevant to Dr. Bochner as there will not be such a person located at Northwestern University.
StatusFinished
Effective start/end date8/15/137/31/16

Funding

  • National Jewish Health (6182014/5U01AI097073-03)
  • National Institute of Allergy and Infectious Diseases (6182014/5U01AI097073-03)

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