A day in the life of a CRA

Clinical Research Associates work with medical research clinical trials, both for the parmacuetical industry and for hospitals who want to develop and try out new methods.

Clinical Research Associates work with medical research clinical trials, both for the pharmaceutical industry and for hospitals who want to develop and try out new methods.

A life in the day of CRA (Clinical Research Associate)

Professionall assistance to investigator

Clinical Research Organisation (CRO)

Clinical Research Associate (CRA)

Clinical Research oordnator(CRC)

Good clinical Practice (GCP)
Founded on the ethical principles described in the Helsinkideklaration.

In stark contrast to what happended during the infamous Tuskegee Syphilis experiment in USA between 1932 og 1972.

The Tuskegee Syphilis experiment

The United States government did something that was wrong—deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens. . . . clearly racist. —President Clinton's apology for the Tuskegee Syphilis Experiment to the eight remaining survivors, May 16, 1997.

For forty years between 1932 and 1972, the U.S. Public Health Service (PHS) conducted an experiment on 399 black men in the late stages of syphilis. These men, for the most part illiterate sharecroppers from one of the poorest counties in Alabama, were never told what disease they were suffering from or of its seriousness. Informed that they were being treated for “bad blood,”1 their doctors had no intention of curing them of syphilis at all.

The data for the experiment was to be collected from autopsies of the men, and they were thus deliberately left to degenerate under the ravages of tertiary syphilis—which can include tumors, heart disease, paralysis, blindness, insanity, and death.

n “As I see it,” one of the doctors involved explained, “we have no further interest in these patients until they die.” read more on www.

Background

Increasing international co-operation within the realm of medical research demands increased understanding and qualifications for the health worker regarding qualification, harmonization, quality assurance and teamwork.

The national and international development in research and formal regulations and jurisdiction directs focus on the necessity of qualified personnel

Jurisdiction

New administrative rules and guidelines for GCP during clinical trials were issued as part of EU’s directive from 1.may 2004.

International trials that are carried out in the EU have to comply with GCP and all health workers that work with clinical drug trials must be able to document knowledge of GCP.

Training of project workers include the following themes:

Responsibility and competence

GCP

Project evaluation and man agement

Budget management

Quality assurance of source data versus Clinical Report Forms (CRF)

Quality assurance of Standard Operating Procedures (SOP’s)

Working daily duties consists of:

Checking that planning, implementing and completing of the tasks that are defined in the protocol are executed in accordance with GCP and that research book-keeping and accounting are done of participants, methods and medications in the different phases of the trial.

Vision

Professional assistance to the Investigator defined as:

Effective and well educated staff assures good clinical research practice and ethics and play an important role in the integration of national and international research programmes

Be a part of staking out a research trail- a clear path- that other researchers may walk to investigate the repetitiveness of results

To create a secure environment for transparency when results are to be revealed.