analyze the differences between GCP-related laws, regulations, guidance, and SOP
ID: 121753 • Letter: A
Question
analyze the differences between GCP-related laws, regulations, guidance, and SOPs. Explain how they reflect the influence of the ICH "Guideline for Good Clinical Practice E6(R1)."
Evaluation Criteria Include:
Provide a clear and focused explanation of your response to the issues raised here
Provide an understandable and realistic rationale for your view of the impact of the laws and regulations
Is information from the textbooks and other sources integrated into your analysis appropriately? You must provide complete citations for all sources.
Is the paper professionally presented? It is important to present your information as clearly and succinctly as possible. (Do not sacrifice thoroughness for mere brevity.) Please proofread carefully for grammar and spelling errors.
Support your assumptions by citing in APA format any reputable source material used
Explanation / Answer
Good clinical practice(GCP) is a global standard pertaining to ethics and scientific quality for trials which involve human subjects (Devine, Dagher, Weiss, & Santana, 2008). The purpose of GCP is to make sure the accuracy, authenticity, and reproducibility of the data generated by a clinical trial in order to take scientific knowledge forward ("NCBI", 2008). GCP ensures that clinical research taking into account human subjects is aligned with appropriate laws, regulations and ethical principles which act as an assurance regarding the rights, confidentiality, and well-being of subjects along with the credibility of the clinical trial data and the outcome. United States, European Union, and Japan together developed these over the past 25 years through the International Conference on Harmonization (ICH), which has a role in developing and harmonizing technical requirements for drug development (Devine, Dagher, Weiss, & Santana, 2008).
The process of ICH is flexible which gives rise to the differences between GCP related laws, regulations, guidelines, and SOPs as according to the requirements new working groups are formed, and with the establishment of new working groups older documents are updated. E.g.- completion of guidance on the assessment of drugs that have the potential to lengthen the QT interval by an expert working group (Devine, Dagher, Weiss, & Santana, 2008). The objectives of the ICH guideline for GCP comprise achieving greater agreement in interpreting and applying technical guidelines and requirements for product registration; minimizing unnecessary delay in global development and availability of new medicines and maintaining safeguards to protect public health (Daniel, 2011). The GCP guidelines revolve around Glossary of Terms; the Principles of ICH GCP ; Institutional Review Board (IRB), or Independent Ethics Committee (IEC) ; investigator; sponsor; clinical trial protocol and protocol amendments ;the investigator’s brochure and essential documents for the conduct of a clinical trial.
There can be variation in the GCP related guidance and SOPs as an outcome of a clinical trial is associated with umpteen factors which include climatic factors, food habits, occupation, genetics, and other environmental factors. In a paper by Vind-Kezunovic and Serup(2016), it was opined that "application of topical products by individuals is inherently variable and accurate dosing can be difficult to control. Variation of the dose used under optimal conditions in drug trials is unknown".The trial was part of a double-blind, randomized, placebo-controlled good clinical practice (GCP) study designed to investigate the local tolerability and safety on healthy skin of captopril 1% ointment versus a placebo ointment. It was observed that there was a major variation of test ointment application studied under GCP conditions with adherent participants which must be considered in clinical trials.
The differences in GCP related laws that can arise is due to the fact that each country is having its own set of laws besides GCP and this leads to minor variations which are important as well like privacy laws which are country specific (Chin & Lee, 2008). These can lead to a very serious situation and can affect the conduct of clinical trials in a significant manner. It is a matter of fact that though most of the countries have adopted the output of ICH, there exist variations in GCP from one country to another.
References
1. Chin, R., & Lee, B, Y.(2008). Principles and practice of clinical trial medicine. London: Academic press
2. Daniel, R. (2011). The Essentials of The Essentials of Good Clinical Practice (GCP). Volcano corporation. Retrieved from http://www.ucdmc.ucdavis.edu/clinicaltrials/Training/documents/CTSC_clinical_training_GCP_Redline_2011.pdf
3. Devine, S., Dagher, R, N., Weiss, K, D., & Santana, V, M. (2008). Good Clinical Practice and the Conduct of Clinical Studies in Pediatric Oncology. Pediatr Clin North Am, 55(1), 187.
4. NCBI. (2008). Good Clinical Practice Research Guidelines Reviewed, Emphasis Given to Responsibilities of Investigators: Second Article in a Series. J Oncol Pract, 4(5), 233–235.
5. Vind-Kezunovic, D., & Serup, J, V. (2016). Variation of topical application to skin under good clinical practice (GCP): A "best performance" scenario. J Dermatolog Treat.,27(5), 422-4.
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