¶ … 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...
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
The following information and items must be collected prior to the CRA's departure from the site:
1. An executed contract authorizing the CRA to perform oversight services for the pharmaceutical firm; and,
2. Copies of the items listed above.
A list of supplies for the visit (what you will bring with you to the site)
The following supplies will be taken to the site for the initial visit:
1. Handheld tape recorder for field notes;
2. A copy of the firm's organizational chart; and,
3. Legal pads and pens.
References
Hurst, C. & Dennis, B. (2013, Fall). Developing a clinical research associate training program at Dillard University: The impact of collaboration. ABNF Journal, 24(4), 104-107.
Jackson, L. A. (2007, June). A prescription for success: Finding career opportunities in the pharmaceutical industry. Black Enterprise, 36(11), 210-212.
