You probably heard news or stories such as Misconduct Delayed Drug Approval or Duke Settles Negligence Suit.
The Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and well-being of trial subjects are protected, consistent with the principles that have their origin in the Declaration of Helsinki.
The first is to ensure the protection of the patient. The subject’s consent should have been obtained before any study procedure were performed. Each subject is monitor to ensure accuracy and completeness of the data generated. If an SAE occurred, the monitor will confirm that the SAE has been reported promptly and completely.
The objective of the ICH GCP Guideline is to provide a unified standard practice for the United States, Japan and the European Union (EU) to facilitate the mutual acceptance of clinical data by the regulatory authorities in these jurisdictions.
So what are the essential documents during the conduct of a clinical trial?
1- Investigator Brochure documents relevant and current scientific information around the investigation product (IP) has been provided to the investigator.
2- Signed Protocol (including Amendments) and Case Report Forms (CRF) document investigator and sponsor agreements.
3- Informed Consent Form documents the information given to trial subjects.
4- Financial Aspects of the trial documents the financial agreement between the investigator/institution and the sponsor / research for the trial.
5- Signed agreement between involved parties. For example, sponsor and CRO.
6- Institutional Review Board (IRB) / Ethics committee (IEC) documents the trial has been subject to IRB/IEC review and given approval opinion. For example this includes but not limited to protocol and any amendments, CRF (if applicable), informed consent form, subject compensation.
7- Regulatory authority(ies) approval/notification of protocol documents approval/notification by the regulatory authority compliance with the applicable regulatory requirements(s).
8- Curriculum Vitae and/or other relevant document evidencing qualifications of investigator and sub-investigator as document eligibility to conduct trial and/or provide medical supervision of subjects.
9- Normal value(s)/range(s) for medical / laboratory technical procedures documents normal values of the tests.
10- Sample of label(s) attached to investigational product containers document compliance with applicable labeling regulations and appropriateness of instructions to the subjects.
11- Decoding procedures for blinded trials documents how, in case of an emergency, identify of blinded investigational product without breaking the blind for remaining subject’s treatment.
12- Master randomization list documents method for randomization of trial population.
13- Pre-trial monitoring report documents the site is suitable for the trial.
Note: Any or all documents listed in this guidelines may be subject to, and should be available for audit by the sponsor’s auditor and inspection by the regulatory authority(ies). Any revision to any of the above documents should be added to the files during the trial as evidence.
After completion of a trial, some other documents such as completed subject identification code list, audit certificate, clinical study report and final trial close-out monitoring report shall be available to document completion of the trial.
Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. Basic Ethical principles refers to those general judgements that serve as a basic justification for the many particular ethical evaluation of human actions. Respect for persons where persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well being.
Do not harm – hippocratic maxim
Who ought to receive the benefits of research and bear its burdens?
An injustice occurs when some benefit to which a person is entitled to or when ought to be treated equally. This principle applies to the rights, safety and well-being of the trial subjects with most considerations and should prevail over interests of science and society.
Conducting clinical trials, in accordance with this principles of good clinical practice (GCP), makes it possible to test the effectiveness and safety of medicines, hence, it is important the understand the principles established in the guidelines.
http://www.ich.org/home.html and http://www.the-scientist.com/
Anayansi is an EDC Developer Consultant and clinical programmer for the Pharmaceutical and Biotech industry with more than 13 years of experience.
Available for short-term contracts or ad-hoc requests. See my specialties section (Oracle, SQL Server, EDC Inform, EDC Rave, OpenClinica, SAS and other CDM tools)
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