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Q of the week

Q: What is a prospective, randomized, double-blind, controlled clinical trial?

 

Get the Answer: 

GoNitro (nitroglycerin)

It’s a nitrate vasodilator indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

Welcome to GCP HelpDesk Website 

In this website you will find Good Clinical Practice (GCP) related information for the Clinical Research Industry professionals on request. The GCP HelpDesk is designed to provide information for clinical research professionals with questions regarding handling, conducting and managing clinical research as per GCP, FDA and other Regulations.  This HelpDesk is aimed to provide transparency from resources and expertise in the field of Clinical Research with the recent developments and changes in the guidelines for clinical research professionals. The GCP HelpDesk is a searchable website that will match the question with solution by industry experts and other dedicated sites to a specific area. Both simple and complicated questions are welcomed by the GCP HelpDesk   and we will provide you the answer, if not hope to point you to the one who can. The GCP HelpDesk service is completely free and you can search for required information or by sending an email to GCP Help Desk by including your full name, email address, valid phone number, and a brief description of the problem. We will get back to you through email.

Feedback
Due to the nature of the clinical research industry and we understand that there is always scope to learn more and improve and we request you to provide your feedback on the design, suggested features or problems and errors you might discover to our team at Feedback  page and we appreciate your suggestion and comments.
 

Clinical Research Today

FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe ...

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The role of single-arm trials in the authorisation of new cancer medicines

The European Medicines Agency (EMA) and the European Society for Medical Oncology (ESMO) are co-organising a READ MORE

E-cigarettes: regulations for consumer products

mhra

The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers (Article 20). MHRA is responsible for implementing the majority of provisions under Article 20 and ...

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FDA approves vaccine to prevent cholera for travelers

fda

The U.S. Food and Drug Administration approved Vaxchora, a vaccine for the prevention of cholera caused by serogroup O1 in adults 18 through 64 years of age traveling to cholera-affected areas. Vaxchora is the only FDA-approved vaccine ...

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FDA targets unlawful internet sales of illegal prescription medicines during International Operation Pangea IX

fda

The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, announced that it took action this week against 4,402 websites ...

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E-cigarettes: regulations for consumer products

MHRA

The Tobacco Products Directive 2014/14/EU (TPD) introduces new rules for nicotine-containing e-cigarettes and refill containers ...

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Statement from FDA Commissioner Robert Califf, M.D. on the release of the final individual patient expanded access form

fda

The U.S. Food and Drug Administration finalized its efforts to streamline the process used by physicians to request expanded access, often called “compassionate use,” ...

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Yellow fever – Democratic Republic of the Congo

WHO

The National IHR Focal Point of the Democratic Republic of Congo (DRC) notified WHO of cases of yellow fever (YF) ...

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Two new combination therapies against chronic hepatitis C

The European Medicines Agency (EMA) has recommended the granting of marketing authorisations in ...

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FDA approves new diagnostic imaging agent to detect recurrent prostate cancer

fda

The U.S. Food and Drug Administration approved Axumin, a radioactive diagnostic agent for injection. Axumin is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based ...

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FDA approves new, targeted treatment for bladder cancer

fda

The U.S. Food and Drug Administration approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) ...

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Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.

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