WCG IRB adheres to the highest standards of regulatory compliance.
We also use proven processes and techniques – applied in new and innovative ways – to address the inherent operational requirements of clinical trials. This includes being the first central IRB to receive AAHRPP accreditation, and also hold ISO 9001:2015 certification.
These achievements illustrate WCG IRB’s dedication to excellence and operational design, which enable us to deliver exceptional quality reviews and industry-leading turnaround times.
Our organization is routinely inspected by the Food and Drug Administration (FDA) – and found to be in good standing and compliant with federal regulations. This underscores WCG IRB’s commitment to championing scientifically and ethically sound research, safeguarding clinical trial participants, and demonstrating continuous improvement.
Use of Electronic Signatures
WCG IRB’s electronically signed regulatory documents are generated in compliance with 21 CFR Part 11 regulations covering electronic records and electronic signatures.
Electronic signatures are available for use in the signature module of the WCG IRB electronic workflow system. Security rights to access this module are given only to those with signature authority, as listed on the board membership rosters. All signers must attest to an understanding that electronic signatures are the legal equivalent of handwritten signatures prior to attaining signature security rights. A signer must enter a unique user name and password to access the electronic workflow system. The signer must re-enter his or her own unique password to access the signature module and affix the electronic signature. An electronic signature can only be applied by the user named in the signature. Proxy signatures—i.e., Dr. X signing for Dr. Y—are clearly indicated on the signed document. Sharing of passwords is prohibited.
Changes to records in the system, including all document signings, are recorded in a secure, electronically generated audit trail.
In 2003, our flagship IRB was the first central IRB to receive accreditation by the Association for the Accreditation of Human Research Protection Programs (AAHRPP®), an organization that endeavors to improve safeguards for clinical research participants. As per AAHRPP requirements, WCG IRB undergoes the organization’s rigorous reaccreditation process every five years. Most recently, we were awarded reaccreditation status by AAHRPP in September 2019.
WCG IRB Quality Policy
WCG IRB is an independent institutional review board providing ethical review for research studies involving human participants. WCG IRB recognizes the need to deliver the highest quality performance possible, throughout the organization, by complying with all applicable client, regulatory, and operational requirements. Our commitment to quality is based on effective and consistent operational systems, which are continually monitored. It is WCG IRB’s policy to meet these goals through continual process improvement.