Clinical research coordinator - AbsoluteAstronomy.com

The Clinical Research Coordinator (CRC) is responsible for conducting clinical trials using good clinical practice

Good clinical practice

Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...

http://www.fda.gov/oc/gcp/ (GCP) under the auspices of the Principal Investigator

Principal investigator

A principal investigator is the lead scientist or engineer for a particular well-defined science project, such as a laboratory study or clinical trial....

(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
Declaration of Helsinki
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association . It is widely regarded as the cornerstone document of human research ethics...

, rigorously, as defined by the International Conference on Harmonization Guidelines http://www.ich.org (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.
All clinical trials have current Institutional Review Board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

approval.
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.
Informed consent
Informed consent
Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...

is given freely by every participant.
All study documentation is recorded, handled and stored to allow accurate reporting, interpretation and verification.
Confidentiality of subjects is respected and protected.
Investigational products maintain Good Manufacturing Practice
Good Manufacturing Practice
"Good manufacturing practice" or "GMP" are practices and the systems required to be adapted in pharmaceutical manufacturing, quality control, quality system covering the manufacture and testing of pharmaceuticals or drugs including active pharmaceutical ingredients, diagnostics, foods,...

in storage, manufacturing and handling.
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

Institutional review board

An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...

submission, writing the informed consent

Informed consent

Informed consent is a phrase often used in law to indicate that the consent a person gives meets certain minimum standards. As a literal matter, in the absence of fraud, it is redundant. An informed consent can be said to have been given based upon a clear appreciation and understanding of the...

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

Adverse event

An adverse event is any adverse change in health or side effect that occurs in a person who participates in a clinical trial while the patient is receiving the treatment or within a previously specified period of time after the treatment has been completed.AEs in patients participating in...

reporting, preparing the case report form

Case Report Form

A Case Report Form is a paper or electronic questionnaire specifically used in clinical trial research. The Case Report Form is the tool used by the sponsor of the clinical trial to collect data from each participating site...

(CRF), submitting CRFs and other data to the Sponsor as necessary and study close-out.

Institutional Review Board submissions

All research involving human subjects must be approved by an Institutional Review Board

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

The IRB must approve the informed consent prior to study initiation and often the CRC is liaison between the IRB and the sponsor. The sponsor will have set requirements of the informed consent as does the IRB. Each local IRB is responsible for the review and approval of the informed consent, but the CRC is responsible for the communication between the IRB and the sponsor. §46.116 of the Code of Federal Regulations http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.116 outlines the elements of informed consent as:

Basic elements of informed consent

A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
A description of any reasonably foreseeable risks or discomforts to the subject;
A description of any benefits to the subject or to others which may reasonably be expected from the research;
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements of informed consent.

When appropriate, one or more of the following elements of information shall also be provided to each subject:

A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
Any additional costs to the subject that may result from participation in the research;
The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and
The approximate number of subjects involved in the study.

Contracting with pharmaceutical companies

The site conducting the clinical trial

Clinical trial

Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...

will negotiate the clinical trial agreement (CTA) to conform to its policies and procedures. The resolution of many contractual issues requires coordination between the sponsor, the PI and the site, which is usually responsibility of the CRC. The involvement of each party is essential to a successful CTA with mutually acceptable terms. The CTA should include terms for indemnification, confidentiality, publication, intellectual property, insurance, data safety and monitoring boards, subject injury, governing law and termination clauses.

Cost analysis and budget negotiations

To develop a cost analysis, the CRC will review the protocol schema and determine which procedures are standard of care versus research. The research charges will be included in the budget along with personnel effort, site initiation costs, IRB fees throughout the life of the clinical trial, pharmacy costs, travel costs for the PI and CRC to attend Investigator meetings, equipment, dedicated fax and computer lines, supplies, screen failures, subject stipends, subject travel costs, and any other items that are defined as a direct cost to the clinical trial. In addition, if the clinical trial is conducted at an Academic Medical Center (AMC) there will be an indirect cost rate that will be applied to the direct costs of the study. The indirect rate is approximately 30% for pharmaceutical trials and can be upwards of 50% for federal trials, depending on the AMC’s federally negotiated indirect costs rate http://www.ed.gov/about/offices/list/ocfo/intro.html.

Subject recruitment

Prior to agreeing to conduct the clinical trial, the CRC (and the PI) will determine if they have the appropriate patient population. The CRC is responsible for subject recruitment once the trial begins or establishing the research team that will recruit subjects. It is important that viable subject recruitment occurs beforehand as the clinical trial agreement will stipulate the number of subjects the site is required to recruit.

Patient care

The CRC will coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the protocol. The CRC will interact with the PI to assure patient receives appropriate medical evaluation and care when needed and will alert the PI of any serious adverse events that may occur throughout the course of the study.

Adverse events

Main Article: Adverse event

Adverse event

An adverse event is described as “any adverse change in health or "side-effect" that occurs in a person who participates in a clinical trial while the patient is receiving the treatment (study medication, application of the study device, etc.) or within a pre-specified period of time after their treatment has been completed.” The CRC must report all adverse events to the sponsor and all serious adverse events to the IRB and sponsor.

Preparing and submitting case report forms

Main Article: Case report form

Case Report Form

The purpose of the case report form (CRF) is to collect relevant data in accordance with the protocol and in compliance with regulatory requirements. The CRC will collect the data on the CRF and submit to the sponsor either electronically or paper format.

Study close

In accordance with the local IRB, the CRC will complete IRB study close documentation and make any appropriate notifications to the study subjects, research team, and pharmacies. The CRC will work with the sponsor’s clinical monitor in completing outstanding monitoring findings and queries. In addition, the CRC is responsible form complying with the record retention policies of the Food and Drug Administration

Food and Drug Administration

The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...

(FDA), the ICH, and the clinical trial agreement.

Clinical research coordinator certification

There are two organizations that provide certification for the CRCs: Association of Clinical Research Professionals http://www.acrpnet.org/certification (ACRP) and the Society of Clinical Research Associates http://www.socra.org (SoCRA). ACRP offers the only accredited* CRC designation in the field, the Certified Clinical Research Coordinator (CCRC®) and SoCRA offers the designation of Certified Clinical Research Professional. SoCRA established the Certification Program for Clinical Research Professionals in order to “create an internationally accepted standard of knowledge, education, and experience by which clinical research professionals will be recognized by the medical research community.”

ACRP's CRC and CRA Certification Programs are accredited by the National Commission for Certifying Agencies (NCCA), the accrediting body of the Institute for Credentialing Excellence. For more information on accreditation, visit www.credentialingexcellence.org/ncca.

External links

Good Clinical Practice in FDA Regulated Clinical Trials
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
Code of Federal Regulation §46.116 General Requirements for Informed Consent
Association of Clinical Research Professionals
Society of Clinical Research Associates
Clinical Research Resources (Organizations, Services, Training)
United States Department of Health and Human Services, Office for Human Subjects Protections (OHRP)
OHRP Institutional Review Board Guidebook
Indirect Cost Overview

The source of this article is wikipedia, the free encyclopedia. The text of this article is licensed under the GFDL.

Institutional Review Board submissions

Informed consent

Basic elements of informed consent

Additional elements of informed consent.

Contracting with pharmaceutical companies

Cost analysis and budget negotiations

Subject recruitment

Patient care

Adverse events

Preparing and submitting case report forms

Study close

Clinical research coordinator certification

See also

External links