The Society of Clinical Research Associates, (SoCRA) defines a Clinical Research Associate (CRA) as someone who "functions as an administrator, coordinator, consultant, educator, or researcher" in clinical trial management. SoCRA offers certification and continuing education programs for members and non-members.
The Association for Clinical Research Professionals (ACRP) delineates two separate definitions, clinical research coordinator and clinic research associate. A clinical research associate here is defined as "a monitor, an auditor, or a project director", and is employed" by the sponsor, or by a contract research organization (CRO)". A CRA in this case operates independently from the study site. ACRP also offers certification and continuing education programs for its members and non-members.
The Drug Information Association (DIA) is an organization in which health professionals exchange and share information on the discovery, development, evaluation, and utilization of health care medicines and technologies. The DIA provides opportunities for continuing education to professionals.
The CRA Registry is an organization with whom auditors, monitors, data reviewers and study coordinators can register their resumes for potential employers such as CROs, Pharmaceutical sponsors, and Medical Device companies.
Clinical trial management (research studies) is a stringently regulated process in which human subjects (volunteers) participate in research study.
- CenterWatch More than 5,200 clinical trials are listed here, actively recruiting human subjects. Search by therapeutic area and geographic region.
There are several organizations that monitor the participation and the safety of human subjects in drug studies, as well as regulate the conduct of research studies, worldwide. The International Conference on Harmonisation is one organization in which regulatory authorities from Europe, Japan and the United States join with experts from the pharmaceutical industry to discuss scientific and technical aspects of product registration. In the United States, The Food and Drug Administration (FDA) regulates the drug research and development process. Institutional Review Boards (IRBs) are regional, state, or local agencies that ensure the safety of human subjects.
An investigational new drug (IND) , a new health product, or a new treatment for an existing product must undergo strict studies and tests before it is made available to the public.
During these studies, human subjects are monitored by specific procedures that are outlined in the study's protocol (design). Data is collected and analyzed, based upon the protocol. Safety (how safe a study drug or a mechanical device is for human subjects) and efficacy (how well the drug or the device is in the treatment) are monitored closely.
There are typically four phases during a drug's development, during which safety and efficacy is constantly monitored. The following are simplified definitions:
- Phase I --- a study drug is given to healthy human subjects; GOAL: to see if the drug is safe
- Phase II --- a study drug is given to human subjects with the specific disease; GOAL: to see if the study drug is safe and if the study drug is effective against the specific disease
- Phase III--- two drugs (a study drug and a similar drug) are compared by giving the study drug to one group of human subjects with the specific disease and an already established effective drug to another group of human subjects with the specific disease; GOAL: to see if the study drug is as effective or more effective than the established drug
- Phase IV --- the study drug is made available to the public
Some of the responsibilities of a CRA include:
- initiation of clinical trials (identifying qualified investigators, qualifying trial sites, submitting appropriate documents to regulatory bodies, coordinating trial with sponsors, etc..)
- monitoring of clinical trials (reviewing inclusion / exclusion criteria for human subjects, qualifying study entry for human subjects, conducting site initiation / interim / and close-out visits, etc..)
- data validation transcribed by site to case report forms (verifying accuracy, matching source documents to case report forms, etc. )
- monitoring site quality (coordinating procedures and processes of a protocol in a timely, efficient manner).
- preparation and submission of monitoring trip reports, as well as expense reports and site reports, etc.)
- development and maintenance of site relationship during the conduct of the clinical trial
Some of the responsibilities of a PM include:
- administration of clinical trials (assisting investigators / sites in regulatory document submission, etc.)
- preparation and facilitation of clinical trial trainings (investigator start-up meetings, teleconferences, etc.)
- monitoring site quality (coordinating procedures and processes of a protocol in a timely, efficient manner).
- monitoring of safety and efficacy data (preparing appropriate reports for regulatory and site submission, etc.)
- coaching and training of new employees
- conducting in-services to sites and employees
- initiation and preparation of letter of confidentiality and letter of agreement to / from investigator
