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Question:According to Indian GCP, how long does all the study related documents need to maintain by Sponsor after completion of the clinical trial?

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Telephone Report
Notification via telephone to the FDA of unexpected fatal or life threatening advent associated with a clinical study.
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.

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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 first generic esomeprazole

The U.S. Food and Drug Administration approved the first generic version of Nexium (esomeprazole magnesium delayed-release capsules) to treat gastroesophageal reflux disease (GERD) in adults and children ages 1 and older. Esomeprazole is a proton pump inhibitor that reduces the amount ...

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UK-Regulator asks those with diabetes to check insulin pumps

MHRAMedicines and Healthcare products Regulatory Agency (MHRA) is asking people with a particular insulin pump to check the clock resets to the correct time and date when they change the battery or when the power is interrupted.

A fault with ...

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Diclofenac tablets now only available as a prescription medicine in UK

MHRAPeople will no longer be able to purchase diclofenac tablets, used to treat pain and inflammation, from pharmacies without a prescription from their doctor due to the small risk of heart problems the Medicines and Healthcare products Regulatory Agency (MHRA) announced ...

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Federal judge approves consent decree with California dietary supplement maker

A California dietary supplement manufacturer was ordered by a federal court to stop selling its products until the company comes into compliance with the U.S. Food and Drug Administration’s dietary supplement manufacturing regulations and other requirements listed in the consent decree. 

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FDA approves first-of-kind device to treat obesity

January 14, 2015, the U.S. Food and Drug Administration approved the Maestro Rechargeable System for certain obese adults, the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness.  

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FDA approves anti-clotting drug Savaysa

The U.S. Food and Drug Administration approved the anti-clotting drug Savaysa (edoxaban tablets) to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem.

Atrial fibrillation is ...

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FDA grants first CLIA waiver for nucleic acid-based flu diagnostic test

The U.S. Food and Drug Administration granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for ...

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Regulator helps to create new cancer medicine facility

A brand new facility that ensures the continued supply of a critical cancer medicine forms the basis of the first case study released from the Innovation Office today at the Medicines and Healthcare products Regulatory Agency (MHRA).

This new technology features a ...

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FDA approves weight-management drug Saxenda

The U.S. Food and Drug Administration approved Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity.

The drug is approved for use in adults with a body mass ...

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FDA approves Xtoro to treat swimmer’s ear

The U.S. Food and Drug Administration approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear.

Acute otitis externa is an infection in the outer ear and ear canal, usually caused by bacteria ...

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CFDA issues the Third Supplements to Chinese Pharmacopeia (2010 edition)

China Food and Drug Administration (CFDA) recently issued an announcement on the implementation of the Third Supplements to Chinese Pharmacopeia (2010 edition). The Third Supplements to Chinese Pharmacopeia (2010 edition) will go into force as of February 1, 2015. The Third ...

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Opinion Poll

How does GCP require the informed consent of a trail subject to be obtained?
 
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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