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Q of the week

Q: What is a case-control study in medical research?

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Interim analysis

Any analysis intended to compare treatment arms with respect to efficacy or safety at any time prior to the formal completion of a trial. (ICH E9)

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

EMA concludes defective device in ROCKET study does not impact Xarelto’s safety

The European Medicines Agency (EMA) has concluded that a defect with the international normalised ratio (INR) ...

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First specific replacement therapy to treat rare bleeding disorder

The European Medicines Agency (EMA) has recommended granting a READ MORE

FDA approves first drug to show survival benefit in liposarcoma

The U.S. Food and Drug Administration approved Halaven (eribulin mesylate), a type of chemotherapy, for the treatment of liposarcoma (a specific type of soft tissue sarcoma) that cannot be removed by surgery ...

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FDA resolves criminal and civil actions against cheese manufacturer

Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) by introducing adulterated food into interstate commerce.

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FDA approves Integra Omnigraft Dermal Regeneration Matrix to treat diabetic foot ulcers

The U.S. Food and Drug Administration approved a new indication for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. The matrix device, which is made of silicone, cow collagen, and shark cartilage, is placed over the ulcer and provides ...

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Dangerous diet pills not the answer to New Year’s resolutions

The Medicines and Healthcare products Regulatory Agency (MHRA) are warning people to be aware of the dangers of buying diet pills online.

The Medicines and Healthcare products Regulatory Agency (MHRA) are warning ...

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FDA approves Zurampic to treat high blood uric acid levels associated with gout

The U.S. Food and Drug Administration approved Zurampic (lesinurad) to treat high levels of uric acid in the blood (hyperuricemia) associated with gout, when used in combination with a xanthine oxidase inhibitor (XOI), a type of drug approved to reduce the production of ...

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FDA approves new orphan drug to treat pulmonary arterial hypertension

The U.S. Food and Drug Administration approved Uptravi (selexipag) tablets to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive, and debilitating rare lung disease that can lead to death or the need for transplantation.

“Uptravi offers an additional treatment option for ...

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FDA approves wearable defibrillator for children at risk for sudden cardiac arrest

The U.S. Food and Drug Administration approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an READ MORE

FDA takes action against Vermont dairy farm for illegally administering drugs to cattle

The U.S. Department of Justice entered a consent decree of permanent injunction in the District of Vermont against the Correia Family Limited Partnership, doing business as Wynsum Holsteins, a dairy farm located in West Addison, Vermont, and its partners, Anthony Correia, Barbara ...

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FDA clears military traumatic wound dressing for use in the civilian population

The U.S. Food and Drug Administration cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in ...

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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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