Clinical Trial Applicable Regulatory Requirement
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A Clinical Trial Applicable Regulatory Requirement is a law or regulation that addresses the conduct of a clinical trial.
- AKA: Clinical Trial Applicable Regulation.
- Example(s):
- any law and regulation pertaining to the conduct of a clinical trial required by an Institutional Review Board (IRB), Clinical Trial Regulatory System, or local authorities.
- Clinical Trials Regulation (EU) No 536/2014,
- …
- Counter-Example(s):
- See: Applicable Clinical Trial, Clinical Trial Application, Clinical Trial Information System, Clinical Trial Management System, ICH E6 Good Clinical Practice (GCP) Guideline.
References
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-14.
- QUOTE: Applicable regulatory requirement
- Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where trial is conducted. (ICH E6)
- QUOTE: Applicable regulatory requirement
2021b
- (NIH, 2021) ⇒ https://clinregs.niaid.nih.gov/country/canada#quality,_data_&_records_management Last content review/update: August 06, 2021.
- QUOTE: As stated in the CanadaFDR and the CA-ICH-GCPs, the sponsor is responsible for implementing and maintaining quality assurance (QA) and quality control (QC) systems with written standard operating procedures (SOPs) to ensure that trials are conducted and data generated, recorded, and reported in compliance with the protocol, the CA-ICH-GCPs, and the applicable regulatory requirements.
2021c
- (EMA, 2021) ⇒ https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trials-regulation Retrieved: 2021-11-19.
- QUOTE: The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trials Regulation (Regulation (EU) No 536/2014) comes into application on 31 January 2022. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database for clinical trials foreseen by the Regulation. The European Medicines Agency (EMA) sets up and maintains CTIS, in collaboration with the Member States and the European Commission.
2018
- (FDA, 2018) ⇒ FDA (2018). "E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1) Guidance for Industry".
- QUOTE: 1.4 Applicable Regulatory Requirement(s)
- Any law(s) and regulation(s) addressing the conduct of clinical trials of investigational products.
- QUOTE: 1.4 Applicable Regulatory Requirement(s)
2002
- (WHO, 2002) ⇒ World Health Organization (2002).["Handbook For Good Clinical Research Practice (GCP) Guidance for Implementation".
- QUOTE: Research should be conducted according to the approved protocol and applicable regulatory requirements. Study records documenting each trial-related activity provide critical verification that the study has been carried out in compliance with the protocol.