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Q of the week

Q:Does sponsor require to maintain MSDS (Material Safety Data Sheet) for placebo used in clinical trial?

 

 

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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 proposes ban on electrical stimulation devices intended to treat self-injurious or aggressive behavior

FDA

The U.S. Food and Drug Administration announced a proposal to ban electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public ...

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FDA launches first ad campaign focused on dangers of smokeless tobacco among rural teens

USFDA

The U.S. Food and Drug Administration announced it is expanding its award-winning “The Real Cost” campaign to educate rural, white male teenagers about the negative health consequences associated with smokeless ...

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Promoting high-quality clinical research to develop more and better medicines for children

The European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) will hold its 8th annual ...

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FDA takes steps to withdraw approval of the swine drug carbadox due to safety concerns

fda

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) took the first step toward rescinding its approval of the use of carbadox ...

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FDA approves first leadless pacemaker to treat heart rhythm disorders

fda

The U.S. Food and Drug Administration approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. ...

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FDA proposes limit for inorganic arsenic in infant rice cereal

USFDA

The U.S. Food and Drug Administration is taking steps to reduce inorganic arsenic in infant rice cereal, a leading source of arsenic exposure in infants. Relative to body weight, rice intake ...

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FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow

The U.S. Food and Drug Administration approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung abnormalities after they receive a ...

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FDA approves new psoriasis drug Taltz

The U.S. Food and Drug Administration approved Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis. 
Psoriasis is ...

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MHRA contributing to the global fight against Zika

The Medicines and Healthcare products Regulatory Agency (MHRA), as a member of the International Coalition of Medicines Regulatory Authorities (ICMRA), has pledged its support ...

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FDA approves Cinqair to treat severe asthma

The U.S. Food and Drug Administration approved Cinqair (reslizumab) for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older. Cinqair ...

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FDA proposes ban on most powdered medical gloves

The U.S. Food and Drug Administration announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial ...

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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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