Informed Consent form in Clinical Trial
Journal Title: International Journal of Drug Regulatory Affairs - Year 2019, Vol 7, Issue 1
Abstract
Informed consent form is a vital requirement for research study on the human participant. It is the consent which is given by the subject before participate in clinical trial. Informed consent mainly came in existence after the Nuremberg trail and the other guideline line like Helsinki Declaration and Belmont Report also play an important role in there evaluation. Informed consent form mainly contents the complete information about the clinical trial, protocol, duration, potential risk and benefit of the trial. Informed consent is revised from time to time, as the new information is available. In some case waiver of consent done by proper review by Institutional Ethic Committees (IEC).
Authors and Affiliations
Sunny Panwar, Hemant Pal, Amrish Chandra
Keywords
Related Articles
- EP ID EP495804
- DOI 10.22270/ijdra.v7i1.307
- Views 90
- Downloads 0
ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY: A REVOLUTIONIZED LC TECHNIQUE
High Performance Liquid Chromatography (HPLC) is a major technique for qualitative and quantitative drug analysis. More than 90% of drugs prescribed in official pharmacopoeias are being analyzed HPLC. HPLC analyzes the d...
STEVIA AN UNTOUCHED NATURE’S GIFT CAN BE A BOON TO DIABETIC
Plants and fungi are a vital part of healthcare. Over 80% of the global population rely on traditional medicine, much of which is based on plant remedies. Traditional Chinese medicine alone uses over 5,000 plant species....
Regulatory requirements for Dossier submission in African Countries (Kenya, Uganda, and Tanzania) - A Review
Africa is world’s second fastest growing pharmaceutical market. The CGAR of African Pharmaceutical market is 10.6%. African people suffer from numerous diseases. The local pharmaceutical market is weak and insufficient t...
A COMPREHENSION STUDY ON REGULATION OF HERBAL DRUGS IN USA, EUROPEAN UNION AND INDIA
The present study reviews the regulations of herbal drugs in the EU, US and India and throws light upon issues related to their clinical trials. Herbal drugs have been used for a long time in different systems of health...
Requirements for introducing Medical devices in India and US market - A comparative study of regulations
Medical devices are widely used in the healthcare sector and are manufactured by the pharmaceutical industry. The Government of India has periodically come out with certain guidelines, to be followed by the companies tha...