Tessa St. Rose is a Clinical

FDA clinical trial coordinators

is responsible for conducting clinical trials using good clinical practice (GCP) under the auspices of the Principal Investigator (PI). Good Clinical Practices Principles have been defined by Madelene Ottosen, RN, MSN, of The University of Texas Health Science Center at Houston as:
  • All trials are conducted ethically, as defined by the Declaration of Helsinki, rigorously, as defined by the International Conference on Harmonization Guidelines (ICH).
  • Benefits outweigh risks for each patient.
  • Rights, safety and well-being of patients prevail over science.
  • All available non-clinical and clinical information on any investigational agent can support the trial as designed.
  • All trials are scientifically sound and clearly described.
  • Medical decisions and care are the responsibility of qualified health care professionals, specifically physicians and, if applicable, dentists.
  • Everyone involved in the clinical trial is qualified by training, education and experience.
  • All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
  • Confidentiality of subjects is respected and protected.
  • Systems to ensure quality are implemented in all aspects of the trial.

Although the PI is responsible for the conduct of the trial, “it has been said that the CRC is the heart and soul of the research study and that, ultimately, it is the CRC who carries forward the research goals, thereby playing a significant role in the success of the research study. Most importantly, CRCs are often involved in essential duties that have been traditionally performed by the PI, such as conducting the informed consent process and ensuring compliance with the protocol”. The CRC’s primary responsibility, as with all clinical research professionals, is the protection of human subjects, but the CRC has many other responsibilities. Although not inclusive, some of the CRC responsibilities include preparing the Institutional Review Board submission, writing the informed consent document, working with the institutional official in contract negotiations, developing a detailed cost analysis, negotiating the budget with the Sponsor (i.e. pharmaceutical company or granting agency), subject recruitment, patient care, adverse event reporting, preparing the case report form (CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.

Institutional Review Board submissions[edit]

All research involving human subjects must be approved by an Institutional Review Board. Each IRB has requirements for protocol submissions which usually require the preparation of an IRB application and informed consent document. A study cannot begin unless IRB approval is obtained.

Informed consent[edit]

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Does the European clinical trials directive really improve clinical trial approval time?

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