Clinical site
Encyclopedia
A clinical site is a medical facility staffed with a clinical investigator
(MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to. The foundations for these regulations are defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and regulatory authorities, which set the guidelines for good clinical practice
(GCP) at clinical sites.
Per ICH
GCP
4.1.1 the investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical trial
, should meet all the qualifications specified by the applicable regulatory requirement
(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the institutional review board
/independent ethics committee (IRB/IEC), and/or the regulatory authority(ies).
Per ICH GCP 4.1.2 the investigator should be thoroughly familiar with the appropriate use of the investigational product
(s), as described in the clinical protocol, in the current Investigator's Brochure
, in the product information and in other information sources provided by the sponsor.
Per ICH GCP 4.1.3 the investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. Per ICH GCP 4.1.4 the investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). Per ICH GCP 4.1.5 the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
* Japan Ministry of Health
Clinical investigator
A clinical investigator involved in a clinical trial is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the...
(MD) and qualified for performing clinical research. To be qualified as a clinical site, strict regulations are to be adhered to. The foundations for these regulations are defined by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and regulatory authorities, which set the guidelines for good clinical practice
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
(GCP) at clinical sites.
Per ICH
Ich
Ich may refer to:* Ich , an album by German rapper Sido.* Ichthyophthirius multifiliis, often shortened to ich, a disease of freshwater fish.** Cryptocaryon or marine ich, a similar disease of marine fish....
GCP
Good clinical practice
Good Clinical Practice is an international quality standard that is provided by International Conference on Harmonisation , an international body that defines standards, which governments can transpose into regulations for clinical trials involving human subjects.Good Clinical Practice guidelines...
4.1.1 the investigator(s) should be qualified by education, training, and experience to assume responsibility for the proper conduct of the clinical trial
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
, should meet all the qualifications specified by the applicable regulatory requirement
Regulatory requirement
Regulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the Food and Drug Administration to establish these...
(s), and should provide evidence of such qualifications through up-to-date curriculum vitae and/or other relevant documentation requested by the sponsor, the institutional review board
Institutional review board
An institutional review board , also known as an independent ethics committee or ethical review board , is a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the...
/independent ethics committee (IRB/IEC), and/or the regulatory authority(ies).
Per ICH GCP 4.1.2 the investigator should be thoroughly familiar with the appropriate use of the investigational product
Investigational product
An investigational product is a pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for an unapproved...
(s), as described in the clinical protocol, in the current Investigator's Brochure
Investigator's brochure
In drug development, the Investigator's Brochure is a comprehensive document summarizing the body of information about an investigational product obtained during a drug trial. The IB is a document of critical importance throughout the drug development process and is updated with new information...
, in the product information and in other information sources provided by the sponsor.
Per ICH GCP 4.1.3 the investigator should be aware of, and should comply with, GCP and the applicable regulatory requirements. Per ICH GCP 4.1.4 the investigator/institution should permit monitoring and auditing by the sponsor, and inspection by the appropriate regulatory authority(ies). Per ICH GCP 4.1.5 the investigator should maintain a list of appropriately qualified persons to whom the investigator has delegated significant trial-related duties.
See also
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
- Clinical trialClinical trialClinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- Data Monitoring CommitteesData Monitoring CommitteesA Data Monitoring Committee — sometimes called a Data and Safety Monitoring Board — is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing.- Need for a DMC :...
- Food and Drug AdministrationFood and Drug AdministrationThe Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
(FDA) - European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
(EMEA)
* Japan Ministry of Health
- European Forum for Good Clinical PracticeEuropean Forum for Good Clinical PracticeThe European Forum for Good Clinical Practices is a European think tank which works on the ethical, regulatory, and scientific framework of clinical research in Europe...
(EFGCP)
External links
- Clinical Site Resources (Clinical Trials Networks, Best Practices: NIH Roadmap)
- Site Operations (NIH)
- Spaulding Clinical