Research Monitoring & Oversight: Links and Resources

           Association of Clinical Research Professionals (ACRP)
The Association of Clinical Research Professionals provides leadership for the clinical research profession by promoting and advancing the highest ethical standards and practices.  The site offers information on ACRP membership and publications, education, research news updates and events.

           Food and Drug Administration (FDA)
FDA regulations can be found on this site as well as additional information for investigators involved in FDA studies or those just wanting to learn more about the FDA’s mission to promote and protect the public by helping safe and effective products reach the market.  This site offers research news, updates, hot topics, FDA activities, and valuable information for health professionals, patients, consumers, and industry.

           International Conference of Harmonization: Good Clinical Practice ( ICH GCP)
Good clinical practice is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve human subjects.  Compliance with this standard provides public assurance that the rights, safety, and well-being of subjects are protected.  This guidance should be followed when conducting a clinical trial.

           Office of Human Research Protections- U.S. Department of Health and Human Services (OHRP)
The Office of Human Research Protections is invaluable to Investigators and study staff who are eager to conduct research in accordance with the highest ethical standards.  The site provides assurance, IRB, informed consent and study conduct guidance for human subjects’ protection.  News updates, compliance information and recent OHRP activity is also available.

           Wake Forest University Health Sciences Institutional Review Board (IRB)
The IRB must approve all human-subject research conducted by a Wake Forest University Health Sciences- affiliated investigator.  This site provides all the necessary staff contacts, WFUHS IRB policies and procedures, submission requirements, and forms for the WFUHS investigators.

           Regulatory Affairs Professionals Society (RAPS)
The Regulatory Affairs Professionals Society (RAPS) represents the healthcare Regulatory Affairs (RA) profession.  The site provides information services for researchers interested in developing and introducing safe and effective health products, medical devices, pharmaceuticals, and biologics.  News, career and educational opportunities, professional certification, products, and services information can also be accessed here.

           Society of Clinical Research Associates (SOCRA)
The Society of Clinical Research Associates, Inc., is a non-profit, professional organization.  This site provides information services for the training, continuing education and development of clinical research professionals.