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Assignment no. 4 Clinical Trials

The document discusses key aspects of clinical trials, including the Belmont Report's ethical principles, WHO's Good Clinical Practice (GCP) guidelines, and differences between randomized and double-blind trials. It also outlines the four categories of ICH, the purpose of the Clinical Trials Registry-India (CTRI), components of a trial protocol, informed consent processes, the role of central laboratories, and the importance of pharmacovigilance in ensuring participant safety. Additionally, it lists ongoing clinical trials in India.

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5 views

Assignment no. 4 Clinical Trials

The document discusses key aspects of clinical trials, including the Belmont Report's ethical principles, WHO's Good Clinical Practice (GCP) guidelines, and differences between randomized and double-blind trials. It also outlines the four categories of ICH, the purpose of the Clinical Trials Registry-India (CTRI), components of a trial protocol, informed consent processes, the role of central laboratories, and the importance of pharmacovigilance in ensuring participant safety. Additionally, it lists ongoing clinical trials in India.

Uploaded by

abhaydeulkar11
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd
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Assignment no.

4- Clinical trials
1. Briefly explain Belmont report.
The Belmont Report outlines ethical principles and guidelines for
research involving human subjects, focusing on:
-Respect for Persons: Informed consent and respect for autonomy.
-Beneficence: Minimizing harm and maximizing benefits.
-Justice: Fair distribution of research benefits and burdens.
These principles guide researchers to ensure ethical conduct in studies
involving human participants.

2. Enlist WHO principles of GCP


-Ethical conduct
-Informed consent
-Scientific Validity
-Confidentiality
-Quality assurance

3. Write any differentiating points in Randomized trials and


double- blind trial.

Randomised trials Double- blind trial

Participants are randomly Both participants and researchers


assigned to different groups (e.g., do not know which group
treatment vs. control) to reduce participants are in, preventing
bias. bias from both sides.
Focuses on how participants are Focuses on masking who receives
allocated. the treatment.

4. What are the 4 categories of ICH?


Four categories of ICH are:
-Quality : Standards for drug quality, including stability and
manufacturing
-Safety : Guidelines on non-clinical safety testing.
-Efficacy : Clinical trial design, conduct, and reporting.
-Multidisciplinary (M): Cross-cutting topics like electronic standards.

5. What is The Clinical Trials Registry- India (CTRI)? What are its
uses? Note down any 2 ongoing clinical trials in India.
-The Clinical Trials Registry-India (CTRI):
Is a national database where all clinical trials conducted in India must
be registered before starting. It promotes transparency, accountability,
and ensures that trials are conducted ethically.

-Uses:
Provides public access to information on clinical trials.
Helps in preventing duplication of research and ensures trial results

-Ongoing Clinical trials in India:


Digoxin in patients with rheumatic heart disease: A randomized
placebo-controlled trial at the All India Institute of Medical Sciences in
New Delhi, and other locations
Sun Pharma-Moebius Medical’s anti-osteoarthritis injection showed
sustained pain relief in clinical trials.

6. List down different components of protocol.


-Objective
-background and rationale
-subject selective criteria
-treatment plan
-study procedure
-response evaluation criteria
-statistical section

7. Is inclusion and exclusion criteria required to begin with


clinical trial.
Yes, inclusion and exclusion criteria are required.

8. What is informed consent? How it is obtained in case of minor


or disabled subjects?
A process where a patient agrees to treatment or participation after
understanding risks and benefits.

For minors or disabled:


-Consent is obtained from a parent or legal guardian
-childs assents (agreement)
-a legally authorized representative
9. What is Central Laboratory?
A Central Laboratory is a lab that provides standardized testing
services for clinical trials, ensuring consistent and reliable results
across multiple study sites. It handles sample analysis, data
management, and reporting for the trial.

10. How is pharmacovigilance involved in clinical trials?


Pharmacovigilance in clinical trials involves:
monitoring and assessing the safety of investigational drugs by
collecting data analyzing, and reporting adverse events to ensure
participant safety and comply with regulatory requirements.

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