September 22, 2022
Navigating the regulations and requirements related to clinical data and research data can be confusing. Registries (i.e. databases, repositories) can be valuable tools for understanding both clinical and research data. Unlike a clinical registry, research registries or repositories involving data and/or specimens require IRB oversight.
July 19, 2022
Most research teams are aware of the requirements to list clinical trials and upload results to clinicaltrials.gov, but did you know you are also required to post the consent form? The 2018 Requirements state that a consent form must be posted to a designated federal website after the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject.
March 8, 2022
The requirement to obtain legally effective informed consent from participants in clinical research is one of the central protections provided under the regulations. When it has been determined that a prospective participant does not have the capacity to provide legally effective informed consent, informed consent must be obtained from a legally authorized representative (LAR). Do you know how to determine who would be considered an acceptable LAR?
January 24, 2022
Lack of study team member qualifications and training documentation are the most common findings discovered in SOM clinical studies that are audited/reviewed by UNC’s Clinical Trials Quality Assurance (CTQA) program. In fact, incomplete and/or inaccurate qualifications and documentation of training were identified in 80% of the reviews conducted over the past 5 years. Take a moment to consider how you can ensure you are prepared and meeting the requirements.
July 8, 2021
As clinical research professionals, we focus on maintaining privacy, confidentiality, and data security for our participants. To ensure appropriate handling of Protected Health Information (PHI) and HIPAA compliance when sharing PHI with external parties, be sure to assess whether a business associate agreement (BAA) is required!
May 5, 2021
The 21st Century Cures Act enables patients to easily and quickly access their own health records. At UNC, notes and results will be shared once finalized in Epic, but NOT research notes. Make sure you’re in the know!
May 3, 2021
The requirements for obtaining and documenting informed consent for research studies are defined by the FDA, DHHS, ICH GCP, and local IRBs. The requirements vary depending on the exact study characteristics. Knowing what applies and how to operationalize the required procedures for various studies can seem overwhelming, but there are some general best practices to keep in mind!
October 21, 2020
Research studies that are considered FDA-regulated are required to comply with specific FDA rules and regulations. It is imperative that the PI and study team understand what applies and how to maintain compliance. Is your research FDA-regulated?
August 25, 2020
Many research participants are also patients undergoing clinical care. Many study investigators are also clinicians providing clinical care. When is it important to clearly delineate between clinical research and clinical care? Always!
July 18, 2020
With increased needs for technology solutions and electronic tools for conducting clinical research, it is important to recognize who has responsibility for determining if those tools are appropriate for clinical research use. Hint, it’s not the IRB.