A Cra S Initial Site Visit to a Pharmaceutical Firm

¶ … Clinical Research Associate (CRA) Visit to a Major Pharmaceutical Firm

An agenda for the visit that you will send to the site prior to the visit

The agenda set forth in Table 1 below will be sent to the pharmaceutical firm preparatory to the site visit:

Agenda for CRA Site Visit

Activities

9:00-9:30 A.M.

Introductions and orientation

9:30-10:15 A.M.

Preliminary presentation to selected division chiefs and researchers concerning the CRA's role and responsibilities

10:15-10:30 A.M.

Break

10:30-12:00 A.M.

Meetings with researchers and clinicians in their divisions concerning purpose of clinical trials, relevant protocols and controlling legislation

a.m. -- 1:00 P.M.

Lunch

p.m. -- 2:00 P.M.

Review of research to date and findings

p.m. -- 3:00 P.M.

Meeting with pharmaceutical firm's staff attorneys concerning U.S. Food and Drug Administration requirements for clinical trials (Jackson, 2007)

3:00 p.m. -- 4:00 P.M.

Concluding presentation concerning the findings that emerged from the site visit

4:00 p.m. -- 4:30 P.M.

Questions and answers

The desired outcome of the visit (what you must know as a result of the visit)

The initial site visit should provide the CRA with the background information needed to formulate appropriate areas for oversight and identify the principals who are involved in the research.

A list of items that must be housed at the site (what you will need at the site during your visit)

The following items should be available to the CRA during the initial visit:

1. Copies of all proposals and finalized studies for ongoing and planned clinical trials;

2. Findings from ongoing clinical trials; and,

3. A roster of the lead researchers and responsible executives (Hurst & Dennis, 2013).

A list of what you must collect from the site before you leave