Vendor Questions.docx

Questions

1. Can you confirm the # of FTEs needed and/or do we need to have people “on demand” ?

On demand.

2. Can you provide more definition around the quality section 3.3: GCP Program Quality Support (PQS) to the VA Cooperative Studies Program Hourly; no travel required ?

Only a designated Lead Monitor would performs these sub tasks. This work does not require travel and can be performed at home.

3. Can the VA answer what the anticipated number of clinical site visits will be?

Currently there are 8 active studies and 138 active sites. This is a dynamic and rapidly changing environment and is subject to constant change.

3.3.2 Creation of GCP tools to be used by the sites?

The Monitor who is a “Lead” for the study would be required to develop tools for both sites and monitors. Development of study specific reports templates, summary and tools to be used and submitted by the Monitor during a visit.

3.3.3 - Design data from casebooks for organizing patient files at investigative sites? Can the VA confirm if this is more or less organizing the “protocol specific” data within the patient file (and compare to that of the EDC/trial specific data capture tool) or does the VA intend to have such contractor design CRF’s/EDC tool being used on the study?

Creation of Study Specific tools to be used by the site (participant binders, regulatory trackers and logs and Essential binder documents and filing system.