Clinical Trial Regulatory Compliance
Jump to navigation
Jump to search
A Clinical Trial Regulatory Compliance is a Regulatory Compliance that adheres to all the clinical trial-related requirements, good clinical practice requirements, and the applicable regulatory requirements.
- AKA: Clinical Trial Compliance.
- Example(s):
- a policy or regulation recommended by the World Health Organization,
- a policy or regulation approved by the Food and Drug Administration,
- a policy or regulation recommended, or enforced by the Centers for Disease Control and Prevention (CDC),
- …
- Counter-Example(s):
- See: Clinical Trial Regulatory System, Health Policy, World Health Assembly (WHA), International Health Regulation (IHR), Decentralized Clinical Trial.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-12-4.
- Compliance
- Adherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements. (ICH E6)
- Compliance
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Regulatory_compliance Retrieved:2021-12-4.
- In general, compliance means conforming to a rule, such as a specification, policy, standard or law. Regulatory compliance describes the goal that organizations aspire to achieve in their efforts to ensure that they are aware of and take steps to comply with relevant laws, policies, and regulations.[1] Due to the increasing number of regulations and need for operational transparency, organizations are increasingly adopting the use of consolidated and harmonized sets of compliance controls. This approach is used to ensure that all necessary governance requirements can be met without the unnecessary duplication of effort and activity from resources. Regulations and accrediting organizations vary among fields, with examples such as PCI-DSS and GLBA in the financial industry, FISMA for U.S. federal agencies, HACCP for the food and beverage industry, and the Joint Commission and HIPAA in healthcare. In some cases other compliance frameworks (such as COBIT) or even standards (NIST) inform on how to comply with regulations. Some organizations keep compliance data—all data belonging or pertaining to the enterprise or included in the law, which can be used for the purpose of implementing or validating compliance—in a separate store for meeting reporting requirements. Compliance software is increasingly being implemented to help companies manage their compliance data more efficiently. This store may include calculations, data transfers, and audit trails.[2] [3]
- ↑ Compliance, Technology, and Modern Finance, 11 Journal of Corporate, Financial & Commercial Law 159 (2016)
- ↑ Norris-Montanari, J. (27 February 2017). "Compliance – Where does it fit in a data strategy?". SAS Blogs. SAS Institute, Inc. Retrieved 31 July 2018.
- ↑ Monica, A.D.; Shilt, C.; Rimmerman, R.; et al. (2015). "Chapter 4: Monitoring software updates". Microsoft System Center Software Update Management Field Experience. Microsoft Press. pp. 57–82. ISBN 9780735695894.